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”