S02 F3-3 HLAC Accreditation Standards 09.21.2023 523A5-10-316 Laundry Building 45.pdf

Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities

HLAC

Accreditation

Standards

HLAC Accreditation Standards

Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities 2023 Edition, Implementation Date: January 1, 2023

THE HEALTHCARE LAUNDRY ACCREDITATION COUNCIL

22640 Hazel Lane | Rapid City, SD 57430

Toll-free: 855-277-HLAC (4522) Phone: 815-436-1404 www.hlacnet.org

© Copyright 2023. All Rights Reserved. Healthcare Laundry Accreditation Council.

TAbLE OF CONTENTS

Part I. Basic Elements Part I - 1. Textile Control Procedures

1.1. Textile Specifications

1.2. Textile Maintenance

1.3. Provider Inventory Management

Part I - 2. Laundry Facilities

2.1. Physical Design, Ventilation, Fixtures, and Signage 12

2.2. Physical Plant and Equipment Maintenance . . . 13

2.3. Management of Hazardous Materials

Part I - 3. Contingency Planning

3.1 Contingency Planning

3.2 Plant Contingency Protocol

3.3. Contingency Call Chain

3.4. Backup Facility Contracts

Part I - 4. Laundry Equipment

4.1. Documentation

4.2. Water quality

4.3. Equipment Operation

4.4. Preventive Maintenance

4.5. Equipment Calibrations

4.6. Recordkeeping for New, Existing, and/or Used

Equipment

Part I - 5. Laundry Personnel

5.1. Personnel Qualifications

5.2. Personnel General Responsibilities

5.3. Health and Hygiene

5.4. Personal Protective Equipment (PPE) and Attire . 19

5.5. Occupational Safety and Health Elements

5.6. Training and Educational Programs

Part I - 6. Laundry Customers

6.1. Contact

6.2. Visitation

6.3. Customer Complaints

Part I - 7. Quality Assessment

7.1. Textile products used in healthcare facilities shall be

of a quality to ensure patient and healthcare personnel comfort and textile durability

7.2. Quality Control

7.3. Quality Assurance

7.4. Process Monitoring

Part II. The Textile Processing Cycle Part II - 1. Handling, Collection and Transportation of Soiled Healthcare Textiles

1.1. Standard/Universal Precautions

1.2. Handling and Collection

1.3. Transportation

1.4. Carts Used for Soiled Textiles

Part II - 2. Sorting

2.1. Soiled Sorting Area

2.2. Standard/Universal Precautions

2.3. Sorting Soiled Textiles

2.4. Foreign Object Policies

Part II - 3. Washing and Extraction

3.1. Washing

3.2. Extraction

Part II - 4. Drying

4.1. Equipment

4.2. Drying

Part II - 5. Finishing

5.1. Ironing Equipment

5.2. Folding and Stacking

5.3. Packaging

5.4. Reprocessing Requirements

Part II - 6. Storage

6.1. Rationale

6.2. Storage Areas

2023 HLAC ACCREDITATION STANDARDS

CONTENTS

TAbLE OF CONTENTS

6.3. Storage Options

6.4. Reprocessing Requirements

Part II - 7. Delivery of Cleaned Healthcare Textiles

7.1. Clean healthcare textiles must be transported, delivered to the customer’s storage area, and stored by methods designed to minimize microbial contamination from surface contact or airborne deposition

7.2. Delivery methods:

7.3. Cart Function and Cleanliness

7.4. Vehicle Considerations

Part III. Surgical Pack Assembly Room Standards Part III - 1. Physical Facilities of Surgical Pack Assembly Area/Room

1.1. Floors, Walls, Ceilings and Vents

1.2 Separation of Work Areas

1.3. Ventilation Requirements for Proper Air Flow and

Climate Control

1.4. Lighting

1.5. Storage Area for Clean Textile Packs

Part III - 2. Surgical Pack Assembly Room Entry and Admission

2.1. Policies:

2.2. Hand Hygiene Practices

Part III - 3. Surgical Textile Assembly Process

3.1. Carts Used to Move Clean Surgical Textiles to the

Surgical Pack Assembly Room

3.2. Inspection of Clean Surgical Textiles Prior to Pack

Assembly

3.3. Maintenance of Surgical Textiles

Part III - 4. Preparation and Wrapping of Surgical Textiles

4.1. Preparation

4.2. Folding

4.3. Surgical Textile Pack Assembly

4.4. Wrapping and Packaging

4.5. Labeling and Identification of Packs

Part III - 5. Storage and Transportation of Surgical Textile Packs

5.1. Storage of Surgical Textile Packs

5.2. Transportation of Surgical Textile Packs

Part III - 6. Surgical Textile Pack Assembly Room Personnel

6.1. Qualifications

6.2. Training and Competency

6.3. Health and Personal Hygiene

6.4. Attire and Personal Protective Equipment (PPE) . 45

Part IV. Certified Hygienic Testing Part IV - 1. Overview

Part IV - 2. Testing Specifications

2.1 Guidelines

2.2 Testing Overview

2.3 What to Test For

2.4 Sampling for Microbiological Testing

2.5 Sample Shipment Protocol

Part IV - 3. HLAC Certification

3.1 Initial Certification

3.2 Recertification

3.3 Audit Process

Part IV - 4. HLAC Recommended Laboratories

Part IV - 5: Recommended Ongoing Quality Improvements

Part IV - 6. References

Part IV - 7. Quick Reference

7.1 Table 2. Quick Certification Guide

7.2 Documents Checklist

Part V. Best Practices & Regulatory Requirements - Coming Soon!

Appendices Appendix A: Glossary and Terminology Appendix B: Abbreviations Appendix C: Standards Verification Methods Appendix D: Training Requirements Summary Appendix E: Design Ventilation Parameters for Healthcare Laundry Areas Appendix F: References

PREAMbLE

2023 HLAC ACCREDITATION STANDARDS

PREAMbLE

1. Introduction The Healthcare Laundry Accreditation Council (HLAC) is the leading authority on laundry standards for the preparation of hygienically clean, reusable healthcare textiles. The HLAC Accreditation Standards incorporates federal regulations and evidence-based guidelines as well as best industry practice and are established as the minimum acceptable practice in this endeavor.

With this 2023 revision, the HLAC Accreditation Standards continue to heighten awareness of patient safety, infection prevention and control and quality improvement in the healthcare textile industry.

Major changes to the 2023 standards include:

• Highlights the standards that direct impact hygienically clean linen. Standards that do not directly affect this end outcome have been downgraded to shall or should statements or eliminated.

• NEW Addition of new standards to ensure regulatory compliance. New standards will be indicated with a “new” icon next to the item.

• Eliminating subjectivity.

• Reducing duplication.

• Emphasis on validating the effectiveness of a laundry’s performance through process monitoring.

• HLAC will no longer enforce standards that are covered by other governing agencies (such as the National Fire Protection Association) unless they affect hygienically clean linen.

• Should/may statements have been removed from the body of the standards and placed in a separate section to provide additional recommendations on best practices for facilities.

• Updated terminology, citations, appendices, and references.

• New appendices include:

– Methods to verify compliance with the standards.

– Summary of training requirements.

2. Interpretive Guidance

2.1.1 A “must” statement is one for which compliance is required. The directive of the statement is supported by any or all of the following resources:

a. Federal mandates, regulations (e.g., OSHA, U.S. Food and Drug Administration [FDA], U.S.

Environmental Protection Agency [EPA]) that are law;

b. State and/or local government regulations;

c. Evidence‐based, peer‐reviewed best practices/recommendations for infection prevention and laundry procedures that directly impact the provision of hygienically clean textiles from federal agencies (e.g., Centers for Disease Control and Prevention [CDC]) and professional entities (e.g., Association for the Advancement of Medical Instrumentation [AAMI], Association of periOperative Registered Nurses [AORN], Association for Professionals in Infection Control and Epidemiology [APIC], Facilities Guidelines Institute [FGI]. Guidance documents published by these agencies and entities are typically adopted by reference by authorities having jurisdiction (AHJ) and are often cited as “gold standard” in a court of law;

and

d. Healthcare Laundry Accreditation Council (HLAC) decisions specific for the laundry industry processing healthcare textiles for patients and personnel in healthcare facilities.

The “must” statements will be bold‐face text in the Standards and compliance will be scored by the inspectors. The expectation is that all “must” Standards are met (i.e., 100% compliance).

2.1.2 A “shall” statement represents a best practice based on infection prevention and laundry industry consensus and compliance is strongly recommended. Such statements are intended to assist the healthcare laundry industry as it transitions to a higher standard of practice.

“Shall” statements are scored by the inspectors, but will not be presented as bold‐face text. The expectation is that at a minimum 90% of these “shall” Standards are met. “Shall” Standards may, at some point in future editions, be elevated to “must” statements as industry and regulatory events warrant.

2.1.3 The combination of the “must” and “shall” statements in addition to the HLAC inspection will determine if the provider is awarded accreditation. Laundries found to be out of compliance and needing to make simple repairs or remediation are given the opportunity to correct these within a predetermined time frame and/or submit to repeat inspection.

2.1.4 “Should” and “may” statements represent suggested courses of action for which a strong industry consensus may not be available, or are part of emerging practices and/or technology, or are required for regulatory compliance.

“Should” and “may” statements are recommended for implementation, but are not scored. These statements have been removed from Parts I-III of these standards and added to a new section in Part IV titled “Best Practices”. These standards may, at some point in future editions, be elevated to “shall” or “must” statements as industry and regulatory events and/or as quality published evidence warrants.

3. Safety and Regulatory Compliance These standards do not address all of the safety or health issues associated with commercial or industrial laundry operations. It is the responsibility of the laundry facility to document and demonstrate compliance with all local, state, and federal regulations and operating permits.

It is expected that this documentation will include:

3.1 A list of all major laundry processing equipment.

3.2 Confirmation that equipment conforms to the manufacturer’s recommendations and complies with applicable local, state, and federal codes/regulations.

3.3 A written routine and preventative maintenance schedule for each piece of equipment as described by the manufacturer’s Instructions for Use (IFU) or appropriate regulatory requirement.

3.4 Documentation of conformation with local electrical and fire codes.

3.5 Documentation that the gas and steam supply conforms to the equipment manufacturer’s recommendations and any state regulations.

3.6 Evidence of compliance with local regulations or the Authority having Jurisdiction as they pertain to air, water, and chemicals management, if applicable.

3.7 Evidence of waste water and/or air quality permit compliance, if applicable.

3.8 Compliance with hazardous chemical (e.g., hydrogen peroxide) regulations (i.e., Department of Homeland Security Chemical Security Assessment Tool [CSAT], local hazardous materials license or permit) must be documented and available for review, if applicable.

3.9 A written Regulated Medical Waste management agreement/plan, which is communicated with the customer, detailing the delegation of procedures to follow when biohazardous medical waste is found among soiled healthcare textiles.

3.10 For customers in the United States, documentation of compliance with the following OSHA requirements including:

• 29 CFR 1910.1030 - Bloodborne pathogens

• 29 CFR 1910.1030 App A - Hepatitis B Vaccine Declination (Mandatory)

• 29 CFR 1910.1200 - Hazard Communication

• 29 CFR 1910.1200 App E - Guidelines for Employer Compliance (Advisory)

4. Clarification of Universal vs. Standard Precautions Universal precautions refers to a standard set of guidelines to prevent the transmission of bloodborne pathogens (BBP) from exposure to blood and other potentially infectious materials (OPIM).

OPIM is defined by the Occupational Safety and Health Administration (OSHA) as:

• The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

Personnel may be exposed to BBP via contaminated laundry which may be soiled with blood or other potentially infectious materials or may contain sharps.

In 1996, the CDC created a new category referred to as Standard Precautions. The term Universal Precautions is no longer used by the Infection Prevention and Control community.

Standard Precautions are the minimum infection prevention practices that apply in all settings where health care is delivered, including healthcare laundry facilities. These practices are designed to both protect personnel and prevent the transmission of infections among patients. Standard Precautions include:

• Hand hygiene.

• Use of personal protective equipment (e.g., gloves, masks, eyewear).

• Respiratory hygiene / cough etiquette.

• Sharps safety (engineering and work practice controls).

• Safe injection practices.

• Sterile instruments and devices.

• Clean and disinfected environmental surfaces.

OSHA standards for bloodborne pathogens (BBP, 29 CFR 1910.1030) and personal protective equipment (PPE, 29 CFR 1910 Subpart I) require employers to protect workers from occupational exposure to infectious agents through the use of universal precautions. Adhering to standard precautions in healthcare settings is recommended by the CDC and protects workers from a wider range of infectious disease hazards than the BBP standard.

While the terms are not interchangeable, they are safety concepts that overlap. This document will refer to both of these standards as Universal/Standard Precautions.

5. Important Information About the Use of These Standards The standards are intended to be used to obtain or maintain accreditation in the HLACA Accreditation Program. The standards represent the collective best judgment of HLAC leaders. Use of the standards is not a guarantee of health or safety of any individual. Many factors impact outcomes in individual circumstances.

Part I 1.Textile Control Procedures

2. Laundry Facilities

3. Contingency Planning

4. Laundry Equipment

5. Laundry Personnel

6. Laundry Customers

7. Quality Assessment bASIC ELEMENTS

PART I. bASIC ELEMENTS

PART I. bASIC ELEMENTS

Part I - 1. Textile Control Procedures

1.1. Textile Specifications

1.1.1. The provider shall have written textile specifications that meet customer needs and ensure consistent performance.

1.1.1.2. These specifications shall be reviewed, at a minimum, annually by the service provider and the customer.

1.1.2. Provider/customer contracts shall include the extent of service for the contract period, signature of both entities, and the date signed.

1.2. Textile Maintenance

1.2.1. The provider shall have a documented grading system, outlining the grading standards for the healthcare textiles being processed.

1.2.1.1. The grading documentation shall be accessible where personnel may refer to it.

1.2.2. These standards shall outline which defects may be repaired, which defects require replacement, and the point at which previously repaired textiles should be discarded.

1.2.3. If a provider has a textile repair program, the provider shall ensure that all personnel having responsibility for making repair and replacement decisions understand and comply with the grading standards.

1.3. Provider Inventory Management

1.3.1. The provider and customer shall jointly determine the par level for the facility, whereupon the provider shall use an inventory management system that ensures an adequate supply of clean textiles to meet the customer’s needs.

1.3.2. Methods to ensure that an adequate supply of textiles is available to the provider and customer shall include documentation of historical fill rates for rental operations and/or documentation of clean pounds shipped as a percentage of soil pounds received for customer‐owned goods (COG) operations.

1.3.3. The provider and customer shall document in writing the provision of inventory for situations where increased need (e.g., surge capacity in response to a disaster) is anticipated and what adjustments are acceptable.

Part I - 2. Laundry Facilities

2.1. Physical Design, Ventilation, Fixtures, and Signage

2.1.1. Based on the workflow pattern principle where processing of soiled textiles flows to clean textiles, the laundry facility’s physical layout and maintenance procedures must ensure efficiency, minimize environmental contamination, and protect the material and hygienic integrity of the processed textiles. (CDC HICPAC GL EIC 2019; ANSI/AAMI ST65:2018 Std.3.2.3.1; FGI 2014: 2.1-5.2 Linen Services)

2.1.2. Soiled Textiles Area

2.1.2.1. The essential laundry facility design must have a functional separation of areas that receive, store, or process soiled textiles from areas that process, handle, or store clean textiles by one the following methods:

2.1.2.1.1. Physical barrier (e.g., walls or structural partitioning with a means of entry to and from the soiled textiles area), which includes negative air pressure in the soiled textiles area with venting directly to the outside (positive air flow from the clean textiles area through the soiled textiles area); or

2.1.2.1.2. Functional barrier by negative air pressure in the soiled textiles area and positive air flow from the clean textiles area through the soiled textiles area with venting directly to the outside. (CDC HICPAC GL EIC, 2019; ANSI/AAMI ST65:2018; Std.3.2.3.1, 3.3.4; ANSI/AAMI ST79:2017; Std. 3.2.2; FGI GL 2014: Table 7.1, ANSI/ASHRAE/ASHE Std. 170‐2021 Table 7)

Note: Laundry facilities failing to meet this standard will be automatically re-inspected for compliance.

2.1.2.1.2.1. Air pressure differentials in these areas must be monitored and documented daily

2.1.2.2. The physical environment and layout of the soiled sorting area shall be designed to permit orderly soiled textile sorting and other manipulations and processes.

2.1.2.3. Warning signs about the presence of contaminated textiles and the need to follow Standard/Universal Precautions must be posted in work areas where potentially contaminated textiles are stored or sorted prior to processing.

2.1.2.4. PPE shall be strategically located and available in work areas where potentially contaminated textiles are stored or sorted. (OSHA 29 CFR 1910.1030)

2.1.2.5. Handwashing facilities must be located in all areas where soiled or contaminated textiles are handled in the laundry. (OSHA 29 CFR 1910.1030; CDC HICPAC GL Hand Hygiene 2002; CDC HICPAC GL EIC, 2019; ANSI/AAMI ST65:2018; Std. 3.3.7; ANSI/AAMI ST79:2017; Std. 3.2; FGI GL 2014:

2.1‐5.2 Linen Services; AHE Practice GL 3rd ed. Section. 2)

2.1.2.6. Emergency eyewash equipment shall be available with unobstructed access in all areas where soiled textiles are processed. (ANSI/AAMI ST65:2018; Std. 3.3.8; ANSI/AAMI ST79:2017; Std. 3.3.7;

OSHA 29 CFR 1910.1030)

2.1.3. Clean Textile Staging and Storage Areas

2.1.3.1. In the provider’s facility, the textile staging and storage areas for cleaned, processed textiles must be in compliance with the following specifications: free of vermin; devoid of lint;

without obvious moisture contamination. (ANSI/AAMI ST65:2018; Std. 9.6.1; ANSI/AAMI ST79:2017;

Std. 11.1)

NEW

2.1.3.2.Ventilation of the storage area

2.1.3.2.1. Storage area must be free of dust and lint

2.1.3.2.2. Storage area must be under positive air pressure relative to adjacent spaces, thereby preventing intrusion of contamination from soiled textile areas. (FGI GL 2014: Table 7.1)

2.1.3.3 Policies and protocols must reflect a facility‐specific strategy for ensuring the hygienically clean quality of the stored, processed textiles.

2.1.3.4. The facility shall establish a schedule of visual inspection of the stored textiles and recording the observations.

2.1.3.5. Specifications for Clean Textiles Storage Shelves

2.1.3.5.1. Shelves must be placed approximately 2 inches from the wall to safeguard package integrity. (ANSI/AAMI ST65:2018; Std. 9.6.1;ANSI/AAMI ST79:2017; Std. 11.1)

2.1.3.5.2. The bottom shelf must be of solid nonporous construction, free from visible soil and dirt, and at a minimum of 8 inches from the floor for accessible cleaning to prevent contamination. (ANSI/AAMI ST65:2018; Std. 9.6.1;ANSI/AAMI ST79:2017; Std. 11.1)

2.1.3.5.3. The top of any item on the top shelf must be a minimum of 18 inches below the ceiling to prevent impairment of ventilation, sprinklers, and lighting. (ANSI/AAMI ST65:2018;

Std. 9.6.1;ANSI/AAMI ST79:2017; Std. 11.1)

2.1.3.5.4. Any porous material (e.g., cardboard, paper, etc.) must not be used as a shelf liner in the clean textiles storage area and to store clean textiles.

2.1.4. Other Fixtures and Signage

2.1.4.1. Hand hygiene resources (i.e., handwashing facilities or antiseptic hand cleaner and cleaner dispensers) must be available in or around all work areas and in personnel support areas. (OSHA 29 CFR 1910.1030; CDC HICPAC GL Hand Hygiene 2002; CDC HICPAC GL EIC, 2019; ANSI/AAMI ST65:2018; Std. 3.3.7; ANSI/AAMI ST79:2017 Std. 3.3.5.7; FGI GL 2014: 2.1‐5.2 Linen Services; AHE Practice GL 3rd ed. Section. 2)

2.1.4.2. Emergency eyewash and shower equipment shall be available with unobstructed access for immediate emergency use in all areas where chemicals are used and/or stored. (ANSI/AAMI ST65:2018;

Std. 3.3.8; ANSI/AAMI ST79:2017; Std. 3.3.7; OSHA 29 CFR 1910.151 (c))

2.1.4.3. Safety features (e.g., emergency lighting, signage, fire alarms, door accessibility and egress, safety perimeter for robotics, equipment guards, etc.) must be evident and operational to safeguard personnel and persons. (OSHA 29 CFR 1910.1030; OSHA Instruction PUB. 8‐1.3 Guidelines for Robotics Safety)

2.2. Physical Plant and Equipment Maintenance

2.2.1. Maintenance of equipment and spaces in a laundry facility processing healthcare textiles shall follow documented provider’s policies and procedures.

2.2.2. Cleaning, Decontamination, and Disinfection

2.2.2.1. The physical environment (e.g., floors, walls, ceilings, vents, working surfaces, and installed equipment) must receive scheduled cleaning appropriate for the surface, the frequency dependent upon the level of contamination, and the operation performed in the area according to facility policy. (ANSI/AAMI ST65:2018; Std. 3.3.3; AHE Practice GL 3rd ed. Section. 2)

2.2.2.1.1. The cleaning schedule must be maintained on a current basis and available for inspection.

2.2.2.2. Environmental surfaces (e.g., walls, ceilings, vents, and equipment) must be subjected to periodic and as needed blow down processes from ceiling downward to minimize the buildup of dust and lint.

2.2.2.2.1. Blow down, vacuuming, or other suitable cleaning practice must be performed when no other processing of textiles is occurring in that area and must not be performed in pack rooms. (ANSI/AAMI ST65:2018; Std. 3.3.3)

2.2.2.3. Clean textile working surfaces (e.g., counters, benches, tables, etc.) must be kept clean of visible soil, dust, and lint. (OSHA: 29.CFR 1910.1030; CDC HICPAC GL EIC, 2019)

2.2.2.4. Working surfaces that become contaminated with blood or other potentially infectious material (OPIM) must be decontaminated, cleaned, and disinfected with hospital grade disinfectants labeled tuberculocidal or disinfectants with specific label claims for human immunodeficiency virus [HIV] or hepatitis B virus [HBV]). (OSHA: 29 CFR 1910.1030; CDC HICPAC GL EIC, 2019; AHE Practice GL 3rd ed. Section 7.1)

2.2.2.5. Process monitoring shall be used to verify cleaning effectiveness of surfaces including carts.

(Guh A, Carling P for the Environmental Evaluation Workgroup. Options for evaluating environmental cleaning. December 2010; ANSI/AAMI ST65:2018; Std. 6.4 ANSI/AAMI ST79:2017; Std. 13; AHE Practice GL 3rd ed. Section 17)

2.2.2.6. Work practices when using conventional washer extractors

2.2.2.6.1. Cleaning and disinfection of surfaces

2.2.2.6.1.1. Surfaces (i.e., surfaces exterior to conventional washer extractors) that are used to both unload and load conventional washer extractors must be non‐porous and easily cleaned.

2.2.2.6.1.2. Routine cleaning and disinfection of surfaces, using a cleaning/disinfection strategy appropriate for the type of contamination when loading and unloading conventional washer extractors after each load, must be consistent with the principles of functional separation.(OSHA: 29 CFR 1910.1030; CDC HICPAC GL EIC 2019: ANSI/AAMI ST79:2017 Std. 6.2, 7)

2.2.2.6.2. Work flow and functional separation

2.2.2.6.2.1. Functional and physical separation of soiled and clean textiles must be followed when conventional washer extractor equipment is used.

2.2.2.6.2.2. For conventional washer extractor equipment that utilizes sling delivery systems for loading soiled textiles, clean textiles must not be stored under the soiled slings unless there is a mechanism present to protect the clean textiles.

2.2.2.6.2.3. Personnel handwashing practices and personal

protective equipment (PPE) usage while using conventional washer extractor equipment must be in accordance with Part I, Subpart 5, Sections 5.3.3 Hand Hygiene and 5.4, PPE and Attire. (CDC HICPAC GL Hand Hygiene 2002; ANSI/AAMI ST65:2018; Std. 4.4; ANSI/AAMI ST79:2017; Std.4.4, 4.5.1, 4.5.2; OSHA 29 CFR 1910.1030)

2.2.3. Pest Control Program

2.2.3.1. The provider must have documentation of a current integrated pest management (IPM) program consistent with healthcare‐recommended practices and with evidence of scheduled treatments. (CDC HICPAC GL EIC, 2019; EPA Integrated Pest Management in Buildings. 2011; AHE Recommended Practice Series: Integrated Pest Management 2nd ed, 2019.)

NEW

REFER TO

Part I - 5.3.3 Hand Hygiene

Part I - 5.4 PPE and Attire

2.3. Management of Hazardous Materials

2.3.1. The provider must have knowledge of issues and regulations concerning the management and disposal of hazardous substances/wastes to facilitate any provider-customer negotiations on this topic.

2.3.2 If the customer fails to adhere to proper hazardous substances/waste management practices, the provider shall reject any laundry items contaminated with these substances/wastes and return these to the customer.

2.3.3. Hazardous substance‐related wastes must be handled separately from other customer trash/ solid wastes and disposed of per facility policy developed in accordance with applicable local regulations or the AHJ for hazardous waste. (OSHA: 29 CFR 1910.1200; Integrated Pest Management in Buildings.)

2.3.4. The provider ‐ customer Policy and Procedures shall include some indication that the issue of management of pharmaceutical contaminated textiles has been addressed (pharmaceutical definitions provided by the local regulations or the AHJ).

Part I - 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, (ideally HLAC accredited), and

3.1.2.4. A backup source of textiles, if needed.

3.2 Plant Contingency Protocol

3.2.1. The provider shall provide a mechanism to inform a step‐by‐step procedure in the event of an emergency and shall be available to supervisors, each of whom may be responsible for execution of the protocol.

3.2.2. Personnel shall be familiar with the major elements of the plant contingency protocol in advance of emergencies.

3.3. Contingency Call Chain

3.3.1. The call chain shall be written, complete, current, and available to all supervisory personnel, so that timely and accurate contact can be made in case of an emergency.

3.3.2. The call chain shall be maintained by a designated person, who is responsible for updating it at least annually or when personnel changes occur, and distributing the list to personnel.

3.4. Backup Facility Contracts

3.4.1. The provider shall have written contracts in place with one or more alternate laundry providers (ideally HLAC-accredited) that can cover their volume, detailing when and how these providers will process textiles in an emergency.

3.4.1.1. These contracts shall be updated signed, and dated every three years at a minimum.

3.4.2. The provider shall have adequate transportation capabilities with contingency planning.

3.4.3. The provider shall have written contracts in place with one or more alternate textile suppliers, detailing the services and delivery times provided (does not apply to COG).

Part I - 4. Laundry Equipment

4.1. Documentation

4.1.1. Equipment safety documentation shall consist of safety instructions, describing the potential hazards associated with the equipment use; appropriate safeguards; and complies with ANSI Z8.1-2016 regarding safe operation and maintenance of equipment. (ANSI/AAMI ST65:2018; Std. 10.2.2)

4.2. Water quality

4.2.1. The operator shall confirm that incoming water used in the laundry process meets an acceptable range for hardness, alkalinity, pH, iron and other heavy metals so that wash operations of the laundry can achieve the result of hygienically clean and appropriate chemistry balance for patient use (ANSI/AAMI ST65:2018 Std.

10.3.2.2)

4.2.2. The provider should consider softening their water when the hardness is 2 grains/gallon (34.2 parts per million [ppm]) or higher. (ANSI/AAMI ST65:2018; Std. 10.4.3.3)

4.3. Equipment Operation

4.3.1. The scale for weighing load size shall be inspected and calibrated by an outside auditor on a scheduled basis, but at a minimum annually; and the results made available to the customer upon request. (ANSI/AAMI ST65:2018; Std. 6.2.2; 6.4.2)

4.3.2. The chemical delivery system must be calibrated according to the standards of the supplier at least monthly. (ANSI/AAMI ST65:2018; Std. 6.4.2)

4.3.3. The design and size of water heater equipment must be appropriate for the provider’s needs at peak operating times and to maintain the specified heated water temperature per desired cycle.

(ANSI/AAMI ST65:2018; Std. 10.4.3.4)

4.4. Preventive Maintenance

4.4.1. Equipment must be inspected, cleaned, and receive scheduled preventive maintenance according to the manufacturer’s instructions or according to facility policy and procedures, if instructions are not available. (ANSI/AAMI ST65:2018; Std. 10.5.1‐2)

4.4.2. Preventive maintenance shall include replacement of worn expendable parts, lubrication, and calibrations. (ANSI/AAMI ST65:2018; Std. 10.5.2‐3)

4.4.3. Equipment preventive maintenance must be documented and kept on file. (ANSI/AAMI ST65:2018;

Std. 10.5.5)

4.5. Equipment Calibrations

4.5.1. Equipment shall be calibrated periodically as specified in the manufacturer’s instruction manual or as determined by facility policy and procedures, if a manufacturer’s schedule is not available. (ANSI/AAMI ST65:2018; Std. 10.5.4)

4.5.2. Calibration shall be performed by personnel trained and/or certified in calibration specified by the manufacturer. (ANSI/AAMI ST65:2018; Std. 10.5.4)

4.6. Recordkeeping for New, Existing, and/or Used Equipment

4.6.1. A maintenance record shall be kept on file for each piece of equipment. (ANSI/AAMI ST65:2018; Std.

10.5.5)

4.6.2. The following information shall be recorded:

• Service details (e.g., date for request and completion, reason for service, repair);

• Equipment details (e.g., type, model, serial number, and location of the equipment);

• Parts and repair details (e.g., parts, repair descriptions);

• Personnel involved (e.g., provider authorization, service technician name).

Part I - 5. Laundry Personnel

5.1. Personnel Qualifications

5.1.1. All personnel shall be qualified for their positions through education, training, or level of prior experience, and these qualifications shall be documented in employee files. (ANSI/AAMI ST65:2018; Std. 4.1;

ANSI/AAMI ST79: 2017 Std. 4.2, 4.3)

5.1.2. New personnel shall work under the close supervision of qualified personnel until they have demonstrated competency in the given task or procedure. (ANSI/AAMI ST65:2018; Std. 4.1; ANSI/AAMI ST79:2017 Std. 4.2.1)

5.2. Personnel General Responsibilities

5.2.1. Supervisors/managers/personnel shall: (ANSI/AAMI ST65:2018; Std. 4.2.1; ANSI/AAMI ST79:2017 Std.

4.2.1)

5.2.1.1. Safely and correctly operate assigned equipment;

5.2.1.2. Safely and correctly perform assigned processing activities;

5.2.1.3. Correctly interpret and safely implement the Exposure Control Plan;

5.2.1.4. Recognize and understand potential hazards from equipment defects and improper performance of the job; and

5.2.1.5. Understand the risk of injury that defective or improperly operating equipment may inflict. (ANSI/ AAMI ST65:2018; Std. 4.2; ANSI/AAMI ST79:2017 Std. 4.2)

5.3. Health and Hygiene

5.3.1. The provider must have policies and procedures to prevent healthcare textiles from being handled by or exposure to personnel with potential health issues (i.e., illness, open wounds or sores, and skin injuries.) (CDC HICPAC GL IC HCW, 1998; ANSI/AAMI ST65:2018; Std. 4.4; ANSI/AAMI ST79:2017 Std. 4.4)

5.3.2 Personnel must adhere to good work practices to minimize or eliminate exposures to blood, OPIM, chemical, and mechanical hazards. This includes, but is not limited to:

5.3.2.1. Use of personal protective equipment (PPE) when handling contaminated and soiled textiles; (CDC HICPAC GL EIC, 2019; OSHA: 29 CFR 1910.1030)

5.3.2.2. Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses must be prohibited in work areas where there is a reasonable likelihood of occupational exposure to bloodborne pathogens (BBP). (OSHA: 29 CFR 1910.1030)

5.3.3. Hand washing and hand hygiene indications:

5.3.3.1. Personnel must wash their hands after restroom use, before eating, and when hands become inadvertently contaminated with blood, OPIM, or other body substances. (CDC HICPAC GL Hand Hygiene 2002; ANSI/AAMI ST65:2018; Std. 4.4.; ANSI/AAMI ST79:2017 Std. 4.4; OSHA: 29 CFR 1910.1030)

5.3.3.2. Personnel must practice hand hygiene (handwashing or using alcohol‐based hand sanitizers) before donning gloves and after removal of gloves. (CDC HICPAC GL Hand Hygiene 2002)

5.3.3.3. Personnel responsible for packing, wrapping, storing, or transporting clean textiles must maintain proper hand hygiene at all times. (ANSI/AAMI ST65:2018; Std. 4.4)

5.4. Personal Protective Equipment (PPE) and Attire

5.4.1. Personal protective equipment:

5.4.1.1. The provider must supply the PPE to personnel in the workplace. (OSHA: 29 CFR 1910.1030)

5.4.1.2. Reusable PPE (e.g., aprons or overalls) penetrated by blood or OPIM must be removed immediately or as soon as feasible and be laundered by the provider. (OSHA: 29 CFR 1910.1030)

5.4.1.3. PPE must be changed if moving from an area where soiled operations were performed into an area where clean operations are performed. (ANSI/AAMI ST79:2017 Std. 4.5.2)

5.4.1.4. All PPE must be removed and placed in an appropriate receptacle prior to leaving the work area. (OSHA: 29 CFR 1910.1030; ANSI/AAMI ST79:2017 Std. 4.5.1)

5.4.2. Personnel attire and adornments:

5.4.2.1. All personnel must wear clean garments without visible soil or dirt in accordance with the provider’s policies and procedures. (ANSI/AAMI ST65:2018;Std. 4.5; ANSI/AAMI ST79:2017 Std. 4.5)

5.4.2.2. Hair and beard covers must be worn in areas where clean textiles are processed. Beard covers do NOT need to be worn if facial hair is less than 0.5 inches long. If religious head coverings such as hijabs, veils, turbans or bonnets are worn, they should be clean, unadorned, constructed of tightly woven and low-linting material, and should fit securely, with loose ends tucked in the scrub top.

Coverings such as kippahs and yarmulkes that cover only a portion of the hair and scalp may be worn under another head covering. (ANSI/AAMI ST65:2018; Std. 4.5; ANSI/AAMI ST79:2017 Std. 4.5; AORN 2019)

5.4.2.3. Artificial nails should not be worn in the laundry while processing clean textiles. Artificial nails are defined as any substance or device applied or added to the natural nails to augment or enhance the nail, including bonding, extensions, tips, wraps, gel and acrylic overlays, and tapes. (ANSI/AAMI ST65:2018;

Std. 4.5; ANSI/AAMI ST79:2017 Std. 4.5; CDC HICPAC GL Hand Hygiene 2002; AORN 2020)

5.4.2.4. Personnel who handle clean healthcare textiles must change work garments whenever their garment becomes soiled or contaminated. (ANSI/AAMI ST65:2018; Std. 4.5.1; ANSI/AAMI ST79:2017 Std. 4.5.1)

5.5. Occupational Safety and Health Elements

5.5.1 The provider shall have a documented biohazard communication system, identifying soiled healthcare textiles using color‐coding and/or labeling and adhere to Standard/Universal Precautions. (OSHA 29 CFR 1910.1030)

5.5.1.1. This documentation shall be accessible where personnel may refer to it.

5.5.2. The provider must implement an occupational safety and health program based on the OSHA Bloodborne Pathogen Standard and Standard/Universal Precautions to prevent personnel exposure to or contact with blood or OPIM. (OSHA: 29 CFR 1910.1030)

5.5.3. Exposure Control Plan (ECP):

5.5.3.1. The provider must develop an Exposure Control Plan (ECP) that contains, but is not limited to the following: (OSHA: 29 CFR 1910.1030)

5.5.3.1.1. Schedule for compliance (i.e., when each part of the Plan is accomplished in the facility).

5.5.3.1.2. Procedure for evaluating the circumstances surrounding exposure incidents.

5.5.3.1.3. An Exposure Determination Plan (EDP), containing: (OSHA: 29 CFR 1910.1030)

5.5.3.1.3.1. A list of all job classifications in which all personnel in those job classifications have occupational exposure,

5.5.3.1.3.2. A list of job classifications in which some personnel have occupational exposure, and

5.5.3.1.3.3. A list of all tasks and procedures that are performed by personnel in a job classification where exposure may exist.

5.5.3.1.4. The Exposure Control Plan must be accessible to all personnel.

5.5.3.1.5. The Exposure Control Plan must be reviewed and updated at least annually.

5.5.4. Develop a hepatitis B vaccination program:(OSHA: 29 CFR 1910.1030)

5.5.4.1. Records must reflect the offering of hepatitis B vaccine by the provider and the acceptance OR documented refusal of the personnel.

5.5.4.2. Hepatitis B vaccine must be offered to personnel upon hire if they are candidates for vaccination

5.5.5. Develop a standing process for post exposure management for blood and/or OPIM.

5.5.5.1. Records must reflect a standing process for post‐exposure management for blood and/or

OPIM

5.5.6. Develop a hazardous materials (e.g., non‐biological, chemical, radiological, etc.) safety plan and policy:

5.5.6.1. Where laundry personnel may be exposed to textiles contaminated with potentially hazardous substances from the customer, a written hazardous substance safety plan must be developed. (OSHA: 29 CFR 1910.1200; The OSHA Technical Manual: Haz Drugs, Sec 6, Chap 2)

5.5.6.1.1. The hazardous substance safety plan must be readily available and accessible to all personnel (i.e., full‐time personnel, temporary personnel, contractors, and trainees).

5.5.6.1.2. The hazardous substance safety plan must be reviewed and updated as appropriate at least annually.

5.5.6.2. Where laundry personnel may be exposed to textiles contaminated with potentially hazardous substances from the customer, the provider must develop a policy for management of hazardous substance‐contaminated textiles that includes, but is not limited to:

5.5.6.2.1. Wash process;

5.5.6.2.2. PPE requirements for affected personnel;

5.5.6.2.3. Training records for these personnel; and

5.5.6.2.4. Written record of provider/customer discussion regarding proper containment for hazardous substance contaminated textiles.

5.5.7. All vehicle drivers shall meet all requirements of the federal and state Department of Transportation (DOT). (www.dot.gov)

5.5.7.1. The provider shall maintain documentation of this compliance and make it available for inspection.

5.6. Training and Educational Programs

5.6.1. General elements:

5.6.1.1. Personnel must receive standard safety training of laundry operations applicable to their respective position(s), including, but not limited to safe operations of equipment per manufacturer’s instructions and notification procedures when malfunctions occur.

5.6.1.2. Training options shall include, but are not limited to the following:

5.6.1.2.1. In‐plant (in‐service) training sessions facilitated by a person experienced in the topic;

5.6.1.2.2. Formal external training programs, including classes, workshops, and seminars.

5.6.1.3. Personnel shall receive the provider’s standard training for the correct handling of healthcare textiles. Topics shall include:

5.6.1.3.1. Specific types of fabrics being processed;

5.6.1.3.2. Appropriate surgical textiles pack processes according to each pack’s use requirements;

5.6.1.3.3. Proper use, placement, and heat‐sealing process for patching surgical textiles; (ANSI/AAMI ST65:2018; Std. 4.2.2., 4.3, 7.2.1)

5.6.1.3.4. A copy of the grading standards.

5.6.2. Bloodborne Pathogens Exposure Control Training:

5.6.2.1. Key topics for this training must include, but are not limited to:

5.6.2.1.1. Personal hygiene and proper handwashing and hand hygiene techniques; (CDC HICPAC GL Hand Hygiene 2002; CDC HICPAC GL IC HCW, 1998)

5.6.2.1.2. Use of PPE according to the facilities exposure control plan, including one or more of the following, but not limited to, gloves, gowns, aprons, safety goggles, and masks; [ANSI/ AAMI ST65:2018; Std 4.5.2; CDC HICPAC GL IC HCW, 1998; OSHA: 1910.1030)

5.6.2.1.3. How to correctly don and doff PPE

5.6.2.1.4. Engineering controls and work practices to minimize the risk of exposure to blood or

OPIM; (OSHA: 1910.1030)

5.6.2.1.5. Orientation on the provider’s Exposure Control Program;

5.6.2.1.6. Orientation to hazard communications, including labeling and color‐coding; and

(OSHA: 29 CFR 1910.1030)

5.6.2.1.7. Post‐exposure procedures, including immediate action, treatment, follow‐up, and record keeping. (OSHA: 29 CFR 1910.1030; CDC HICPAC GL IC HCW, 1998)

5.6.3. Hazardous Substance Contaminated Textiles training:

5.6.3.1. Key topics for this training must include, but are not limited to:

5.6.3.1.1. Exposure risk to textiles contaminated with hazardous substances or excreta from patients who have received hazardous substances (e.g., radioisotopes, chemotherapeutics, etc.)

in the past 48 hours; (CDC HICPAC GL IC HCW, 1998)

5.6.3.1.2. Communications among supervisors and personnel for hazardous substance management procedures;

https://www.transportation.gov/

5.6.3.1.3. Identification and segregation of soiled textiles from patients exposed to hazardous substance contaminated, reusable textiles in bags designated solely for the containment of reusable hazardous substance exposed textiles;

5.6.3.1.4. Use of PPE including one or more of the following, but not limited to, gloves, gowns, and eye protection, if splashing is possible; 5.6.3.1.5. Hand hygiene; and

5.6.3.1.6. Disposal of contaminated one time use PPE in thick, leak‐proof colored or labeled plastic bags for hazardous substances‐related wastes.

5.6.3.1.7. Proper handling of other reusable PPE. (OSHA: 29 CFR 1910.1200; The OSHA Technical Manual: Haz Drugs, Sec 6, Chap 2)

5.6.4. Department of Transportation (DOT) regulations (www.DOT.gov) training:

5.6.4.1. Key topics in this training shall include, but are not limited to:

5.6.4.1.1. Random drug testing;

5.6.4.1.2. Operator training;

5.6.4.1.3. Certified driver license requirements

5.6.4.1.4. Bloodborne pathogens exposure

5.6.5. Training Documentation

5.6.5.1. All training must be documented in writing and kept on file for 3 years from the date of training. [ANSI/AAMI ST65:2018; Std. 4.3; CDC HICPAC GL IC HCW, 1998; OSHA: 29 CFR 1910.1030)

5.6.5.2. The documentation must include, but is not limited to: (OSHA: 29 CFR 1910.1030)

5.6.5.2.1. Dates of training;

5.6.5.2.3. Topic;

5.6.5.2.4. Trainer’s name, title, signature, and qualifications;

5.6.5.2.5. Copies of printed training materials;

5.6.5.2.6. Validation that the training objectives and a minimum level of competency were achieved; and

5.6.5.2.7. Certificates or signature proof of personnel’s attendance.

5.6.5.3 The facility must demonstrate the presence of a validation process for all educational activities that includes tracking to ensure 100% completion of the training by all relevant staff.

Part I - 6. Laundry Customers

6.1. Contact

6.1.1. The provider shall maintain a written list of all customer contacts for access of information exchange and service.

6.1.2. The provider shall have a 24/7 customer service capability to receive customer messages (e.g., voicemail, email, etc.).

https://www.transportation.gov/

6.2. Visitation

6.2.1. The provider must make their plants available to customers and prospective customers for inspection.

6.2.2. The provider should annually visit the customer’s healthcare facility for the purpose of conducting a walk‐through of all areas where healthcare textiles are used, collected, transported or stored.

6.3. Customer Complaints

6.3.1. The provider must maintain records of any written communication regarding administrative or policy issues or problems with customers, including names of personnel involved and the resolution.

Part I - 7. Quality Assessment

7.1. Textile products used in healthcare facilities shall be of a quality to ensure patient and healthcare personnel comfort and textile durability.

7.2. Quality Control

7.2.1. Textile quality shall be defined and documented between the provider and the customer.

7.2.2. The provider processing COG textiles shall comply with pre‐established textile maintenance standards as specified by each customer.

7.2.3. Defined quality standards shall keep mending and patching to a minimum.

7.2.4. The entire processing cycle shall have documented quality control procedures to ensure the cleanliness and serviceability of the textiles to include:

7.2.4.1. Requirements to rewash, repair, or replace textiles as necessary to maintain quality standards.

7.2.4.2. Planned and posted traffic patterns where required (e.g., pony washers) to minimize the potential for contaminating clean textiles.

7.2.4.3. Limited traffic in all areas of the facility to authorized personnel as outlined in the provider’s policies and procedures. (ANSI/AAMI ST65:2018; 3.2.4; ANSI/AAMI ST79:2017; Std. 3.2.3)

7.3. Quality Assurance

7.3.1. The provider shall maintain records of any laundry processing and/or quality assurance problems experienced and mutually agreed upon solutions. A customer call log may be used for this purpose.

7.3.2. The provider and personnel shall periodically review the entire service program (i.e., safe and efficient work environment, competency of the workforce, and quality assurance of the textile process and product) and make adjustments as necessary and appropriate.

7.4. Process Monitoring

7.4.1. Providers shall engage in process monitoring to verify that ongoing operations are producing clean textiles that will meet customer expectations and needs.

7.4.2. Providers shall prepare detailed process monitoring checklists and use them to document key elements of laundry processing.

7.4.2.1. Process monitoring checklists shall include, but are not limited to, the following items:

7.4.2.1.1. Chemical supplies: Refer to HLAC Standard Part I Subpart 4 Section 4.3. Elements 4.3.3.

and 4.3.4.

7.4.2.1.1.1. The provider shall verify with the manufacturer and chemical supplier that laundry chemicals are appropriate for the equipment in accordance with the equipment manufacturer, textile classifications, and water temperatures being used.

7.4.2.1.2. Titration: (ANSI/AAMI ST65:2018; Std. 6.4.4)

7.4.2.1.2.1. Monthly titrations of the correct wash chemistry shall be performed according to the formula for each major classification of soil. (ANSI/AAMI ST65:2018; Std. 6.4.3.e)

7.4.2.1.3. Equipment:

7.4.2.1.3.1. All provider equipment that directly impacts hygienically clean linen (such as ironers, dryers, presses, washers, etc.) shall be included in the provider’s Preventive Maintenance (PM) Program and checked according to the manufacturer’s instructions.

7.4.2.1.3.2. Ironer temperatures shall be based on the equipment manufacturer’s manual and recommendations appropriate for the type of fabric being processed.

7.4.2.1.4. Finished products:

7.4.2.1.4.1. The quality of finished products shall be maintained as pre‐defined by the customer and shall be sufficient to meet the needs of the customer.

7.4.2.1.4.2. A variety of process monitors should be used to indicate how the provider process has performed including:

7.4.2.1.4.2.1. Rewash rates;

7.4.2.1.4.2.2. pH spot tests; and

7.4.2.1.4.2.3. Residual chlorine spot tests.

Part II

1. Handling, Collection and Transportation of Soiled Healthcare Textiles

2. Sorting

3. Washing and Extraction

4. Drying

5. Finishing

6. Storage

7. Delivery of Cleaned Healthcare Textiles

THE TEXTILE

PROCESSING CYCLE

PART II. THE TEXTILE PROCESSING CYCLE

PART II. THE TEXTILE

PROCESSING CYCLE

Part II - 1. Handling, Collection and Transportation of Soiled Healthcare Textiles

1.1. Standard/Universal Precautions

1.1.1. All soiled textiles must be assumed to be contaminated. (CDC HICPAC GL EIC 2019; OSHA: 29 CFR 1910.1030; AHE Practice GL 3rd ed. Section 4)

1.1.2. Standard/Universal Precautions must apply to all personnel who handle soiled textiles during moving, containing, loading, unloading, and sorting said textiles. (CDC HICPAC GL EIC 2019; OSHA: 29 CFR 1910.1030; AHE Practice GL 3rd ed. Section 4)

1.2. Handling and Collection

1.2.1. All healthcare textiles must be handled and collected in accordance with federal regulations or the Authority having Jurisdiction (AHJ), thereby minimizing potential exposure of laundry personnel to bloodborne pathogens…