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The 2011 HLAC Standards and Laundry Issues in Health Care

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1 The 2011 HLAC Standards and Laundry Issues in Health Care
Lynne Sehulster, PhD, M(ASCP) Division of Healthcare Quality Promotion Centers for Disease Control and Prevention June 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 improved General topics addressed Upcoming issues in healthcare laundry Implications of the 2009 Rhizopus outbreak Do 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, DC CDC is not a regulatory agency Public health epidemiology, public health applications, outbreak investigations, guidelines 6 public health program Offices Office of Infectious Diseases 8 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 infections Collaborate with Federal government partners FDA, EPA, CMS, USDA, AHQR Major 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 Control Collecting, Transporting, and Sorting Contaminated Textiles and Fabrics Parameters of the Laundry Process Special Laundry Situations Surgical Gowns, Drapes, and Disposable Fabrics Antimicrobial-Impregnated Articles and Consumer Items Bearing Antimicrobial Labeling Standard 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 followed Annual 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 clean Not quantified for microorganisms, but assume textiles are generally rendered free of vegetative pathogens Through a combination of soil removal, pathogen removal, pathogen inactivation, contaminated textiles are rendered hygienically clean Carries 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 use Transport to laundry Wash cycle: Flush, main wash, bleaching, rinsing, souring Dried and pressed Packaged, loaded into carts Delivery back to the hospital

11 Laundry Operations If using hot water washing, water temperature >71° C (>160° F) is needed Some healthcare facilities may not have access to water at this temperature Chlorine bleach (50 – 150 ppm) is effective laundry additive, especially in hot water One of the rinses includes a mild acid (sour) to neutralize residual alkalinity from the wash Helps to inactivate microorganisms Reduces 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 regulated Lower temperature wash cycles can be used with appropriate detergents and laundry additives New detergents and processes (e.g., oxidative products) need study

13 Laundry Transport / Storage
Separate clean textiles from contaminated textiles when transporting in a vehicle Physical barriers and/or space separation Clean, unwrapped textiles can be stored in a clean location for short periods of time Unwrapped textiles should be stored so to prevent inadvertent contamination by soil or body substances This is the part of the overall process that is most vulnerable to outside contamination

14 The Healthcare Laundry Accreditation Council (HLAC) 2011 HLAC Standard

15 The HLAC Standard for 2011 Supersedes the HLAC Standard of 2006
The Healthcare Laundry Accreditation Council Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities 2011 Edition Published June 2011 by P.O. Box 1805, Frankfort, IL 60423 Office: • Toll-free: HLAC (4522) © All Rights Reserved. Healthcare Laundry Accreditation Council Supersedes the HLAC Standard of 2006 More detailed, less ambiguity Comprehensive in scope Thoroughly referenced Its message: Patient-focused infection prevention Advances the industry

16 HLAC Accreditation HLAC Standard developed from both laundry operations and infection prevention expertise Inspection process assesses compliance with the Standard Accreditation is voluntary Renewal every 3 years is necessary to maintain accreditation Healthcare 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: Introduction States the purpose of the Standards: minimum acceptable healthcare laundry practices Important Terminology Defines Universal Precautions; identifies key participants – provider, customer, end user, inspector Interpretive Guidance Defines the scoring level associated with each statement’s verb – must, shall, should, may Disclaimer Focuses 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 Improvements Format Each Standard statement has a unique number and addresses a single point, not multiple items which previously created scoring problems Content Comprehensive 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 reprocessing Verbs Greater clarification – scorable statements are clearly identified, and “must” statements are presented in bold-face type Citations Scorable statements include citations to support the statement where available, including government regulations, professional association standards, and peer-reviewed literature evidence Message: 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 Planning 3.1. Contingency Planning Contingency 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, and A backup source of textiles, if needed. 2006 Standard: 3. Contingency Planning 3.1 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 separation Primarily accomplished via structural design and ventilation specifications Conceptually also can include work practices to keep clean textiles separate from soiled textiles Hygienically clean textiles Contact with clean surfaces at minimum Disinfected surfaces may be indicated

21 Part I. Basic Elements 1. Textile Control Procedures
Textile Specifications Textile Maintenance Provider Inventory Management 2. Laundry Facilities Physical 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 extractors Management 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 Elements 3. 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 Elements Laundry 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 Elements 6. 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 Extraction Drying (not new, but given its own subpart) Equipment Drying 5. 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 Requirements 7. 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 packs 1. 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 Packs 2. 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 Standards Appendix A: Glossary/Terminology Provides definitions for terms used in the Standard Appendix B: Abbreviations Spells out and defines the abbreviations Appendix C: Ventilation Parameters for Healthcare Laundry Areas Provides ventilation specifications in hospital laundry Appendix D: CFR Text for FDA Devices Provides the device storage and handling text from FDA in the Code of Federal Regulations Appendix E: References Bibliography of the references used in the Standard Appendix F: Acknowledgements Outside reviewers and experts providing comment during the revision process Appendix G: HLAC Board of Directors 2009, 2010, and 2011 HLAC Boards participated in the review and revision process

32 Will “Hygienically Clean” Remain the Standard for Healthcare Textile Reprocessing?

33 Mucormycosis Outbreak and Hospital Textiles

34 Mucormycetes Mucormycetes are ubiquitous molds
23 pathogenic species; Genus Rhizopus causes half of all infections Rhizopus oryzae most common; genetic variety observed within species Mucormycosis: Skin is common site of infection Invasive 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 oryzae Environmental cultures: Hospital A: 13/13 cultures (+) for Rhizopus oryzae Laundry facility: No Rhizopus oryzae R. oryzae from one patient and from clean linen/cart had the same genetic subtype


40 Conclusions Hospital linens were the most likely vehicle to have brought Rhizopus in contact with the patients Genetic subtyping of fungal isolates supported this epidemiologic hypothesis Contamination of clean linens with Rhizopus happened repeatedly, but might have been intermittent Hospital linens should be laundered, shipped, and stored in a manner that minimizes exposure to environmental contaminants

41 Things to Consider Some have called for purposeful sanitization of laundry because of the outbreak Laundering process was not implicated Some are advocating treating textiles to leave antimicrobial chemicals as residue Do 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, prions Sufficient number of pathogen: Infectious dose Mode of transmission: Contact, droplet, airborne Portal of entry: Broken skin, mucous membrane, respiratory tract, ingestion Susceptible host: Age, immunity, medical conditions Other possible links include reservoir, portal of exit 42

43 What is the Evidence to Justify Purposeful Sanitization?
Outbreaks of infection associated with clean healthcare textiles still a rare event Europeans have promoted laundry disinfection More active in laundry disinfection research Is laundry disinfection a cost-effective process?

44 Why is This Significant?
Hospital environmental and medical equipment surfaces rapidly become contaminated Recent studies demonstrate that: Hands and gloves of healthcare workers readily acquire pathogens after contact with contaminated surfaces Healthcare workers can transfer these pathogens to subsequently touched patients and inanimate surfaces Patients subsequently can become colonized/infected Hospital environmental and medical equipment surfaces rapidly become contaminated Recent studies demonstrate that: Hands and gloves of healthcare workers readily acquire pathogens after contact with contaminated surfaces Healthcare workers can transfer these pathogens to subsequently touched patients and inanimate surfaces Patients subsequently become colonized/infected These findings have led to an increased focus on the importance of hand hygiene, cleaning and disinfecting hospital surfaces and medical equipment 44

45 Basic Strategy Elements for Preventing and Eliminating Contamination of Environmental Surfaces
Prevent environmental surface contamination Handwashing / hand hygiene Use of barrier coverings on clinical touch surfaces Responsible use of gloves, personal protective equipment (PPE) Clean–to–dirty work flow whenever practical Avoid dirty-to-clean work flow as much as practical Remove environmental surface contamination Cleaning Inactivate environmental surface contamination Disinfection for inanimate surfaces Antisepsis for living tissue

46 HACCP for Laundry Hazard Analysis and Critical Control Point
Similar to the ICRA currently used in hospital infection prevention program Assess all aspects of the laundering process to identify opportunities for contamination to occur Owner/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 residents During a wash cycle, do not mingle used cleaning cloths in with clothing from healthy residents High numbers of spores may remain on the cloths if used with a non-sporicidal disinfectant Use of sporicidal disinfectant will reduce the viable spore number From: 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 safety Research new developments using validated methods to assess antimicrobial properties Make the case for change to your healthcare customers Publish in peer-reviewed journals Continue 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 Standard The members of the HLAC Standards Committee and the members of the HLAC Board of Directors for deliberation and debate Jonathan 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”

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