The 2011 HLAC Standardsand

Laundry Issues in Health Care

Lynne Sehulster, PhD, M(ASCP)

Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

June 6, 2011

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.

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

Introduction to the Centers for Disease Control and

Prevention (CDC)

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

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

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

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

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

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

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

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

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

The Healthcare Laundry Accreditation Council (HLAC)

2011 HLAC Standard

The HLAC Standard for 2011 

 

The Healthcare Laundry Accreditation Council

Accreditation Standards for Processing Reusable Textiles

for Use in Healthcare Facilities

2011 Edition

 

Published June 2011

by

 

The Healthcare Laundry Accreditation Council

P.O. Box 1805, Frankfort, IL 60423

Office: 1-815-464-1404 • Toll-free: 1-855-277-HLAC (4522)

www.hlacnet.org

 

© 2011. 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

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

IntroductionStates 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

Preamble: This portion of the 2011 Standard is more comprehensive and informative compared to the Introduction and Background in the 2006 Standard:

Content Improvements

FormatEach 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

VerbsGreater clarification – scorable statements are clearly identified, and “must” statements are presented in bold-face type

CitationsScorable 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!

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.

Expansion Example

• 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.

• 2011 Standard:3. Contingency Planning

3.1. Contingency Planning

3.1.1. 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.

3.1.2. The contingency plan shall include the following components:

3.1.2.1. Plant and transportation contingency protocol,

3.1.2.2. Call chain,

3.1.2.3. A list of backup laundry facilities, and

3.1.2.4. A backup source of textiles, if needed.

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

Part I. Basic Elements1. 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 simplifiedPhysical 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 managementPiped Air, Water, Wastewater, and Chemicals Management Comply with local regulations, DHS CSAT: hazardous chemicals

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

Part I. Basic Elements5. 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

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

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

Part II. The Textile Processing Cycle

3. Washing and Extraction Equipment Washing Extraction

4. Drying (not new, but given its own subpart) Equipment Drying

5. FinishingIroning EquipmentFolding and StackingPackaging (moved into this subpart)

Reprocessing Requirements

Part II. The Textile Processing Cycle

6. 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

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

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 TextilesGeneral RationaleFoldingSurgical Textile Pack AssemblyWrapping and PackagingLabeling/Identification of Packs

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)

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

HLAC Standard 2011: Appendices

Will “Hygienically Clean” Remain the Standard for Healthcare Textile

Reprocessing?

Mucormycosis Outbreak

andHospital Textiles

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%)

Additional Results• Patient specimens:

– 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

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

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”

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

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?

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

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

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

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. 2010 Decennial Infection Prevention and Epidemiology Conference, poster #160

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

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

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”