Standard: For Producing Hygienically Clean Reusable Textiles For Use in The Food and Beverage Industry (Apparel)
Standard: For Producing Hygienically Clean Reusable Textiles For Use in The Food and Beverage Industry (Apparel)
Standard: For Producing Hygienically Clean Reusable Textiles For Use in The Food and Beverage Industry (Apparel)
1.2. This standard describes procedures for quality assurance (QA); quality control inspections, sampling, and
testing; minimum performance specifications; certification; outsourcing of services; non-compliance
procedures; recordkeeping; and an appeal process to ensure the production of hygienically clean textiles.
1.3. This standard applies to reusable textiles used in food and beverage industry establishments.
1.4. Microbiological testing applies to hygienically clean textiles as they leave the laundry. Best practices
documentation applies to all aspects of laundry processing including transportation of the textiles to their
destination under the care and custody of the customer.
1.5. This standard does not address all safety or health issues associated with food and beverage commercial or
industrial laundry operations. It is the responsibility of the laundry facility to comply with all federal and
state regulations (incorporating CDC and applicable guidelines) and operating permits.
2. Background
2.1. Please see Appendix 2 for a history of laundry certification programs.
3. Terminology
3.1. Definitions
3.1.1. Hygienically Clean: Free of pathogens in sufficient numbers to cause human illness.1
This may be the most quoted definition for hygienically clean, yet no one has scientifically or
quantitatively defined what the term “sufficient numbers” means. For the purpose of this
certification program textiles are considered hygienically clean if they comply with the
Minimum Microbiological Performance Specifications in Section 8.2.
3.1.2. A “Must” statement is one for which compliance is required.
3.1.3. A “Shall” statement represents a best practice, is recommended for implementation, but is not
mandatory.
4. Procedures
4.1. Application – Application must be made for TRSA certification of hygienically clean reusable textiles on
forms supplied by TRSA.
4.2. Fees – Each application must be accompanied by an application fee as set forth in the TRSA Hygienically
Clean Fee Schedule.Your application fee will expire if your facility is not certified within 12 months.
1 Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST 65:2008, Processing of reusable surgical textiles for use in
health care facilities, 2008, Arlington,VA
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4.3. Processing - Upon receipt of the application and application fee, the paperwork will be processed to
completion under the guidelines for certification in Sections 5, 6, 7, and 8.
4.4. Testing – Testing may begin prior to the submission of the application. Initial test results must be submitted
60 days after the submission of your application. Secondary test results must be submitted no later than 45
days after the initial results are received.
4.5. Compilation of Quality Assurance Manual - The quality assurance (QA) manual must be compiled prior to
the initial inspection. An inspection must be scheduled within 60 days of the secondary sample submission
meeting the standard requirements.
4.6. Certificate of Compliance – For each application that certification is granted, a Certificate of Compliance
stating conformance to production of hygienically clean textiles will be issued. The facility will then be given
permission to use the TRSA logo indicating conformance to this standard.
4.7. Hygienically Clean E-Learning Course - Each certified plant must ensure there is at least one dedicated
Hygienically Clean expert. Each facility is required to identify an expert to complete the Hygienically Clean
E-Learning Course during the certification process. The E-Learning certificate will be verified as a part
of the inspection process. Plants that are currently certified without a Hygienically Clean Expert will be
required to complete the course as a part of the renewal process.
4.8. Right to Appeal – The client has the right to appeal any decision by TRSA in executing any provisions in
this standard. See Appendix 1 on Appeals.
The QA manual incorporates the following BMPs that are important to the production of hygienically
clean textiles. How the facility complies with each BMP must be documented and the documentation will
be a key focus when a TRSA inspector visits a laundry to conduct an inspection. Laundry BMPs subject to
mandatory federal regulations covered in Section 5.5 - Compliance with OSHA Regulations will not be
duplicated in this Best Management Practices section.
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
3
personal protective equipment is mandatory based on compliance with the OSHA
Bloodborne Pathogen standard.
5.1.3.2. Washing Procedures
• Wash Formulas
Each classification must have established standard wash formulas for the following
factors to optimize the cleaning and the productivity of the wash process:
• Cycle time: Pre-wash, wash, rinse, and final rinse times
• Water levels/usage: Total water usage and/or water levels;
• Temperature: Wash cycle, bleach cycle, and rinse cycle temperatures;
• Chemical usage: Chemical types and usage levels for each step in the wash
process.
• Wash Temperature
Hot-water washing – if hot water is used the water temperature shall be at a
temperature prescribed by the chemical manufacturer.
Low-temperature water washing – if low-temperature (<70oF) laundry cycles
are used, then chemicals suitable for low-temperature washing at proper use
concentrations, as prescribed by the chemical manufacturer, shall be used.
• Use of disinfectants (e.g. chlorine)
The circumstances, conditions, and procedures regarding when bleach or other
disinfectants are added shall be described in the QA manual.
• Final pH
Each classification shall be soured to a pH which is suitable for skin compatibility
and for proper finishing processes.
• Extraction
The provider shall extract and/or dry the clean textiles in a manner that preserves
the integrity of the textiles, minimizes microbiological growth after washing,
and prepares the textiles for efficient ironing or folding. Damp textiles shall not
be inappropriately stored (e.g., tightly packed and poorly ventilated) as this may
prevent drying and facilitate microbiological growth.
5.1.3.3. Drying Procedures
• The drying procedures shall be controlled and monitored for each textile
classification to ensure appropriate drying.
• Hot, dry loads shall be subjected to sufficient cool-down to enable personnel to
handle the textiles comfortably and to minimize wrinkling.
• Drying must be done in a manner which ensures textiles are dried to proper
moisture content without subsequent microbiological recontamination. Cleaned,
dried goods must be separated from all soiled goods.
5.1.3.4. Garment Inspection Procedures
• Garments are sorted and inspected prior to delivery.
• Garments needing replacement are removed and replaced. The replacements are
put through the HACCP/GFSI washprocess.
• Garments needing mending or repairs are identified, repaired, and re-inspected.
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
• Once the textiles complete and pass final inspection, they are processed and poly-
wrapped for redelivery, consistent with customer requirements. (Poly-wrap shall
be used on items for redelivery unless a written exception is received from the
customer.)
5.1.3.5. Transportation
The QA manual must describe in detail procedures for the following functions:
• The process for servicing food accounts must be designed and executed to
prevent cross-contamination
• Service reps must be trained on pick-up/delivery
• Items must be covered during transportation to prevent cross-contamination
• HACCP/GFSI Trained service reps arrive for scheduled pick-up/delivery.
• Items shall be transported in designated and covered containers.
• Service trucks shall be cleaned on a regular basis to minimize infection and
contamination
• Trucks shall be swept out daily and decontaminated at least twice a month.
• Reusable cart covers must be cleaned after every use.
• Proper PPE and gloves must be worn at all times when handling soiled linen.
• All linen retrieved from a customer location and delivered to the soiled processing
area must be cleaned prior to the delivery to the customer.
5.1.3.6. Delivery
The QA manual must describe in detail procedures for the following functions:
• The functional separation concept must continue during transportation of clean
textiles to and from the food and beverage industry customer.
• Containers and carts used to transport soiled linen must be properly cleaned
before they are used to transport clean linen.
• The term “properly cleaned” means either steam-cleaned or cleaned with an
EPA-approved cleansing agent/disinfectant and water solution (accurately mixed
as directed by the manufacturer’s instructions).
• Hand sanitizer and gloves must be available for use in all delivery trucks.
Employees must be trained on proper hand hygiene, and proper hand hygiene
BMPs must be followed. Spill kits shall also be available for use when necessary.
• Laundries must package, transport, and store clean textiles and fabrics by
methods that ensure their cleanliness and protect them from dust and soil during
interfacility loading, transport, and unloading (CDC/HIPAC).
5.2. Facilities should use HACCP principles to:
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5.2.6. Establish procedures of validation and verification to confirm that the HACCP system is working
effectively
5.2.7. Establish documentation concerning all procedures and records appropriate to these principles and
their application
5.2.8. Establish records required to show ongoing conformance to CCP requirements, Also document
effective corrective action that may occur if there is a non-conformance.
5.3. Establishment of operational flow chart – The QA program/manual shall contain an operational flow chart
that outlines the laundry process and its Critical Control Points for producing Hygienically Clean linen.
(including, but not limited to the following)
5.3.1. Soil Pickup – Soiled Garments and textiles are kept sealed and away from clean garments to
prevent cross contamination
5.3.2. Soil Unloading – Garments and textiles are dropped off at a designated area
5.3.3. Soil Sorting – Food Soiled Garments are separated from industrial items and sorted by degree of
soil, color and fabric
5.3.4. Washing and Conditioning – Garments are washed using manufacturers’ care instructions, ensuring
proper temperatures and chemical injections as prescribed by the chemical manufacturer.
5.3.5. Finishing – Garments are properly dried and transported to the finishing area
5.3.6. Clean Sorting and Inspection – Garments are inspected. Items passing inspection are sorted and
prepared for delivery per customer requirements. Others are redistributed for replacement or repair
5.3.7. Final Inspection and Bagging – After final inspection, clean garments are covered to protect them
from cross contamination, consistent with customer requirements
5.3.8. Delivery Back to the Customer – Products are loaded on the truck and transported back to the
customer. Soiled Garments are kept separated and away from clean garments to prevent cross
contamination
5.4. Regular monitoring of the laundry process and critical control points are needed to ensure the production
of a high quality hygienically clean product. Monitoring must be continuous, and any necessary changes to
processes and procedures should be properly communicated, trained and documented.
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
6. Facility Inspections
6.1. General
Inspectors shall have access to certified facilities during normal business hours to conduct inspections for
the purpose of determining compliance with this standard. Inspections will be scheduled at a mutually
agreeable time between the TRSA inspector and the laundry facility. Expenses incurred by TRSA for on-
site inspections will be the responsibility of the facility seeking certification.
6.2.1. An initial on-site inspection will be conducted by a representative of TRSA to evaluate compliance
with the provisions of this standard.
6.2.2. Depot Inspections are required to be inspected along with the initial on-site inspections and
with all renewals. Depot inspections will be conducted by a representative of TRSA to evaluate
compliance with the provisions of this standard.
6.2.2.1. Depot requires a separate QA manual.
6.2.2.2. Facility inspected for general compliance to provisions of the standard.
6.2.2.3. See Appendix 3 for Inspection requirements
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6.3. Quality Control Inspections
6.3.1. After the initial on-site inspection, facilities shall be inspected on a three-year basis.
6.3.2. An additional supplemental inspection may be conducted within the three-year period.
6.3.2.1. Three failed consecutive tests generate a supplemental inspection.
6.3.2.2. Inspection requires review of the QA manual including recent lab reports.
6.3.2.3. Facility inspected for general compliance to provisions of the standard.
6.3.2.4. See Appendix 3 for Inspection requirements
6.4. On-site Confirmation of the Operational Flow Chart.
6.4.1. The TRSA inspector will verify that the facility has an operational flow chart on site and that the
management team has ensured that permanent operations are carried out according to operational
flow chart. The inspector will monitor operations to ensure the flow chart’s accuracy and follow
up with the management team regarding deviations or modifications. The confirmation of the flow
diagram should be performed by a person or persons with sufficient knowledge of the processing operation.
6.5. On-site ATP Testing of Hard Surfaces
6.5.1. The TRSA inspector will use the most commonly adopted method for real-time monitoring of
cleaning process performance to verify the regular cleaning of hard surfaces that come in contact
with the textiles. A real-time ATP surface hygiene test will be used to provide an objective
indication of cleanliness in seconds. RLU limits have been established for a Pass of less than or
equal to 50, caution range of 51-100, and an automatic failure of anything 101 or above.
7.1.1. In all cases items are to be shipped to the laboratory in separate air-tight plastic bags or plastic
wrapping that are labeled with the following information.
• Name of laundry
• Location of laundry (number and street, city, state, zip code)
• Name of contact person for this facility
• Contact phone number and e-mail
• Date of production
• Textile description
• Items should be mailed using an overnight or two day delivery service.
• Remember to include the chain of custody form in the box
7.2. Initial Qualification
7.2.1. For initial qualification of a facility the Contacts in the plant shall select 2 textiles for
microbiological testing (one terry item and one flat item). Samples must pass testing on three
consecutive rounds and the plant must pass inspection prior to qualification. Samples must be
shipped to a laboratory chosen by the facility that is on the TRSA-approved laboratory list.
Samples shall include, but are not limited to: Pool Towels, Bath Towels, Hand Towels, Bath Mats,
Washcloths, Pillow Cases, Sheets, Blankets, Comforters, Bed Skirts, Mattress protectors, Shower
Curtains, Mattress Pads, Aprons, Smocks, Floor Mops, Spa and Salon linens, Dining Room
tablecloths, napkins and functional table linens.
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
7.3.1. The probationary period ends when three consecutive months of microbiological testing meet the
minimum Microbiological Performance Specifications outlined in Section 8.2 and the plant has
passed inspection. Microbiological testing of textile items must be conducted in each of the first
three months. After the initial samples meet the microbiological criteria, (Section 7.2.1 above),
textile samples must be selected on a rotating basis such that in the first three months six different
textile items are tested. Plants will be allowed to resubmit/re-test one failed test result in
the probationary period. If a failed test result is received, the plant must immediately
resubmit the same item for testing to the same test lab. See 7.8.1
7.4. Quality Control Microbiological Testing
7.4.1. After successful completion of the precertification period, microbiological testing will be
conducted on a quarterly basis.
7.4.2. Four times yearly, two textile items must be submitted by plant personnel to an approved
laboratory for microbiological testing. Samples must be selected on a rotating basis, with a goal of
testing twenty eight (28) different textile items at least once in the first three-year period.
7.4.3. If any textile item fails quarterly microbiological testing, TRSA may require that product to be one
of the textiles tested quarterly until it is reasonably assured there are no compliance issues.
7.5. Triennial On-site Inspections
7.5.1. At least once every three years a TRSA representative will physically visit each laundry facility and
select two items for microbiological testing. The products selected will be those projected to have
the highest potential to fail to meet the minimum performance specifications in Section 8.2 based
on previous microbiological testing. The representative will ship the samples to a TRSA-approved
laboratory chosen by the client for microbiological testing.
7.6. Significant Process Change Testing
7.6.1. When a facility makes a significant change in the laundry process that may affect compliance
with this standard, e.g. major washing equipment or chemistry changes, a microbiological test on
the two most prominent Food Service textile items processed shall be conducted to confirm the
facility remains in compliance.
7.7. Optional Testing
7.7.1. A laundry may conduct additional microbiological testing at their discretion. Test results must be
immediately reported to TRSA after receipt.
7.8. Non-compliance Testing
7.8.1. Upon notification of a test failure, the facility must contact TRSA, immediately select a sample
of the textile item that failed for re-test, and ship it by next-day-air to the same laboratory that
conducted the non-complying test. Test results must be provided to TRSA as soon as the test results
are available.
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8.2. Minimum Microbiological Performance Specifications
Microbiological and Yeast/Mold testing must be performed using the following test methods: RODAC Plate
count quarterly and United States Pharmacopeia (USP) 62 semi-annually.
9. Certification
9.1. Facility Certification
Evaluation of the facility’s application, facility inspection, and test data will result in:
• TRSA certification of the laundry as complying with the requirements in this standard for producing
hygienically clean textiles, or
• Disapproval for lack of evidence justifying certification to the requirements of this standard
(See section 4.5 – Right to Appeal and Appendix 1 – Appeals, Complaints, and Resolution of Disputes.)
10. Outsourcing
10.1. If a facility is unable to fulfill its obligations or agreements for any reason and outsources work to another
laundry, extension of the TRSA Hygienically Clean certification to the outsourced textiles will be restricted
as follows.
10.1.1. If the outsource laundry is also certified by TRSA, the TRSA certification logo may be used to
indicate the textiles are certified as hygienically clean.
10.1.2. If the outsource laundry is not certified by TRSA, no documentation, e.g. invoices, bills-of-lading,
or any other form of correspondence associated with the laundry processed by the outsource
laundry, may carry the TRSA certification logo. If the customer expects TRSA Hygienically Clean
certified textiles through contracts or other agreements, the customer must be made aware the
textiles processed by the outsource laundry are not certified to the TRSA Hygienically Clean –
Food and Beverage Industry standard.
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
11.1.1. For each incidence of non-compliance, a Corrective Action Request (CAR) will be issued. The
facility has 30-days to respond to the CAR and bring the plant back into compliance. If corrective
action is taken within 30-days to bring the facility back into compliance the certification will
not lapse. Failure to completely address all CARs within 30-days will result in certification being
revoked, suspended, or modified depending on the severity of the non-compliance issue.
11.2. Reinstatement Following Revocation or Suspension of Certification
11.2.1. After a facility is brought back into compliance certification is reinstated and a new probationary
period started. Microbiological testing following the procedures in Section 7.4 must be conducted
until test results from three consecutive months are in compliance with Section 8.2.
12. Recordkeeping
All applications, inspection records, and test results must be maintained by the laundry for as long as a facility is
certified plus an additional three years. TRSA will also maintain copies of all applications, inspection records, and
test results for the same duration as the laundry.
13. References
Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST 65:2008, Processing of reusable surgical
textiles for use in health care facilities, 2008, Arlington,VA
Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST65:2000, Processing of Reusable
Surgical Textiles for Use in Health Care Facilities,
German Certification Association for Professional Textile Services, RAL-GZ 992/2 – Hospital Linen, Bönnigheim,
Germany
German Institute for Standardization, European Standard EN 14065: 2002, Laundry processed textiles –
Biocontamination control system, Berlin, Germany, November 2002
Healthcare Laundry Accreditation Council (HLAC), Healthcare Accreditation Standards for Processing Reusable Textiles
for Use in Healthcare Facilities 2011 Edition, Frankfort, IL, June 2011
Industrial Launderer, Preventing Bacteria from Spreading Through Uniforms, November 2006
Institute for Sustainability and Hygiene International, Certification Standards for Processing Reusable Linen, MacKenzie,
Brisbane, Queensland, Australia, April 2011
Standards Australia and Standards New Zealand, AS/NZS 4146:2000, Australian/New Zealand Standard – Laundry
practice, February 2000
Textile Rental Services Association of America, Guidelines for Healthcare Linen Service-1999, By Joint Committee on Healthcare
Laundry Guidelines, Alexandria,VA, 1999
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), Guidelines
for Environmental Infection Control in Health-Care Facilities, Recommendations of CDC and the Healthcare Infection
Control Practices Advisory Committee (HICPAC), Atlanta, GA, 2003
11
Appendix 1
Appeals, Complaints, and Resolution of Disputes
1.0 PURPOSE/SCOPE
The purpose of this procedure is to describe the process for identifying, recording, and resolving applicant or
certificant complaints, inspection and testing non-conformances, and appeals of certification decisions. This
procedure applies to all TRSA employees and inspectors engaged in certification, inspection and testing activities,
and to all applicants and certification holders, hereinafter referred to collectively as “Customers.”
2.0 RESPONSIBILITY
TRSA personnel are responsible for:
3.0 PROCEDURES
3.1 Administrative Review of Complaint or Appeal
When a complaint or appeal is received by TRSA, it will be documented on a TRSA Disposition Form.
The Manager of Certification Programs will examine all pertinent data and any decisions based upon the
data. The disposition form, results of the review and recommended actions will be put into a report by the
Manager of Certification Programs. If further action is deemed necessary, TRSA will retest or re-inspect
and reissue the appropriate report. If the new data impacts a certification decision, a new decision will be
documented and issued. Should this Administrative Review fail to resolve the complaint or appeal, the
matter will be referred to the Technical Review Board.
If a dispute arises between a Customer and TRSA that cannot be resolved by the initial Administrative
Review and recommended actions, the Customer may obtain a review of the complaint or appeal by
the Technical Review Board. The Customer may present to the Manager of Certification Programs of
TRSA a written statement of its position. The matter will then be referred to the Technical Review Board.
The Customer will be offered a full opportunity, in person and by counsel if desired, to be heard by and
to present any relevant additional evidence to the Technical Review Board. Unless otherwise agreed to
in writing by both parties, the Technical Review Board will make a final decision on the matter within
fourteen (14) days.
The Technical Review Board will consist of three members and two alternates. The members and the
alternates will be appointed by the TRSA Board of Directors from TRSA member companies. Any
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
Technical Review Board member or alternate who has a conflict of interest or is otherwise unable to
maintain impartiality will be ineligible to participate in the appeal. In such event, the Board of Directors
will appoint one of the alternates to serve on the Technical Review Board for that appeal. Decisions of the
Technical Review Board will be final.
4.0 RECORDS
The Manager, Certification Programs will maintain a log and records of all customer complaints and appeals and
the details and results of investigations and corrective actions. Records will be maintained for the duration of the
contract plus five years.
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Appendix 2
Laundry Certification Background
Historically certification of laundries processing reusable textiles for use in the healthcare industry have been based on the
laundry process with no requirement for microbiological testing of products. Certification standards in the United States2,3,
Australia and New Zealand4, and Europe5 all base certification on a laundry’s process with no mandatory microbiological
testing of textile products.
In the United States the status quo is no microbiological testing of reusable textiles. This may be the result of statements
made by the U.S. Centers for Disease Control (CDC) in their Guidelines for Environmental Infection Control in Health-
Care Facilities6. Three quotes from the CDC Guidelines shed light on the reasons the CDC does not recommend routine
microbiologic testing.
1. “Before 1970, U.S. hospitals conducted regularly scheduled culturing of the air and environmental surfaces (e.g.
floors, walls, and table tops). By 1970, CDC and the American Hospital Association (AHA) were advocating
the discontinuation of routine environmental culturing because rates of health-care-associated infection had
not been associated with levels of general microbiological contamination of air or environmental surfaces, and
because meaningful standards for permissible levels of microbiological contamination of environmental surfaces
or air did not exist.” (pg. 88)
2. “In the absence of microbiologic standards for laundered textiles, no rationale exists for routine
microbiologic sampling of cleaned health-care textiles and fabrics. (emphasis added)” (pg. 102)
3. “Although contaminated textiles and fabrics in health-care facilities can be a source of substantial numbers of
pathogenic microorganisms, reports of health-care-associated diseases linked to contaminated fabrics are so few
in number that the overall risk of disease transmission during the laundry process likely is negligible.” (pg. 98)
The take-away from this CDC document is routine microbiologic testing is not necessary.
While the CDC does not recommend routine microbiological testing of cleaned textiles and fabrics, testing for compliance
in a certification program is not routine testing; it is testing to validate compliance with a performance-based standard.
TRSA’s certification program is predicated on microbiological testing for several reasons. The trend, both domestically and
internationally, is moving toward microbiological testing of reusable textiles for use in healthcare facilities. Today, customers
are asking members of TRSA to conduct microbiological testing on their textiles. Internationally, the German Certification
Association for Professional Textile Services RAL – Hygiene Certificate Program includes mandatory microbiological
testing of textiles7. In Australia, the Institute for Sustainability and Hygiene International’s Certification Standards for
Processing Reusable Linen8 CSHLS program also requires mandatory microbiological testing.
TRSA does not believe lack of mandatory testing under federal or state regulations in the U.S. is a compelling reason not
to include mandatory microbiological testing in our certification program. Requiring independent, third-party testing
provides our customers with tangible evidence that the textiles they are using are hygienically clean, and verification that
2 The Healthcare Laundry Accreditation Council (HLAC), Healthcare Accreditation Standards for Processing Reusable Textiles for Use in Health-
care Facilities 2011 Edition, Frankfort, IL, June 2011
3 Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST65:2000, Processing of Reusable Surgical Textiles for Use in
Health Care Facilities,
4 Standards Australia and Standards New Zealand, AS/NZS 4146:2000, Australian/New Zealand Standard – Laundry practice, February 2000
5 German Institute for Standardization, European Standard EN 14065 : 2002, Laundry processed textiles – Biocontamination control system,
Berlin, Germany, November 2002
6 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), Guidelines for Environmental Infec-
tion Control in Health-Care Facilities, Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee
(HICPAC), Atlanta, GA, 2003
7 German Certification Association for Professional Textile Services, RAL-GZ 992/2 – Hospital Linen, Bönnigheim, Germany
8 Institute for Sustainability and Hygiene International, Certification Standards for Processing Reusable Linen, MacKenzie, Brisbane,
Queensland, Australia, April 2011
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STANDARD FOR PRODUCING HYGIENICALLY CLEAN REUSABLE TEXTILES FOR USE IN THE FOOD AND BEVERAGE INDUSTRY (APPAREL)
the commercial laundry process does what it is recognized by the CDC to do – result in production of hygienically clean
reusable textiles.
The frequency of microbiological testing selected for this certification program is not based on any federal or state
regulatory requirements because none exist. No testing regimen selected would have a statistical basis as there is no
database to draw from. This standard is the first of its kind in the U.S. requiring microbiological testing. As stated earlier,
the referenced domestic and international laundry standards1, 2, 3, 4 certify laundries based on the laundry process with
no mandatory microbiological testing. With the existing paradigm for laundry certification, any testing frequency is an
improvement over the status quo of no testing. For this certification program, testing will be conducted in each of the
first three months of certification, followed by semiannual testing if all testing in the first three months passes the criteria
established in Section 8.2.
Selection of the bacteria to target for certification testing was also a challenge for the same reasons stated in the previous
paragraph. Lack of federal and state guidelines and the CDC statement of fact that there are no microbiologic standards
for laundered textiles led to an Internet search for potential resources to identify which bacteria should be targeted. The
CDC publishes a list of the top ten pathogens that account for 84 percent of all Healthcare-associated Infections (HAIs).
In addition to bacteria to identify for testing, it was decided a test method must be identified so all testing laboratories
would use the exact same procedures to identify the bacteria present. And finally, a survey was conducted to determine
the bacteria being tested for when laundries are asked to conduct microbiological testing by customers. The two bacteria
that stood out were staphylococcus aureus and pseudomonas aeruginosa, both of which are on the CDC Top 10 list. Other
research indicated Escherichia coli (E-coli) was a very important bacteria to target.
Based on this internet research two test methods stood out. Test method United States Pharmacopeia (USP) 62 –
Microbiological Examination of Nonsterile Products:Tests for Specified Microorganisms targets all three of these bacteria that are on
the CDC Top 10 list as well as a fourth, candida albicans. This test method is considered by TRSA to be a microbiological
test for hygienically clean as defined in Section 3 of this standard and was selected for our certification program.
USP 61 - Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, is a quantitative enumeration of
mesophilic bacteria (a microorganism that grows best at 68° to 131°F (20° to 55°C)) and fungi that may grow under
aerobic conditions. The pass/fail criterion selected for the TRSA hygienically clean certification program is ≤ 20 cfu, the
lowest acceptance criterion for microbiological quality in USP 61.
RODAC-Replicate Organism Detection And Counting Microbiological test is modeled on European Standards.
Commercial laundries have been operating for over a century with virtually no link between reusable textiles and
pathogenic disease transmission to hotel patrons or workers. There are no federal or state regulations requiring a laundry
to be certified. There are no federal or state standards requiring microbiological testing of reusable textiles. TRSA feels this
standard, with mandatory microbiological testing, is “raising the bar” in certifying laundries for producing hygienically clean
reusable textiles.
15
Appendix 3
Depot Inspection and Supplemental Inspection Requirements
Standard HyC
5.1.2 Housekeeping X
5.1.3.4 Transportation X
5.1.3.5 Delivery X
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1800 Diagonal Road, Suite 200
Alexandria, VA 22314
877.770.9274 § www.hygienicallyclean.org