Healthcare Hygienically Clean Certification

The Hygienically Clean Healthcare Standard establishes the criteria for the production and certification of hygienically clean reusable textiles for use in Healthcare facilities and to monitor the complete textile processing cycle, from handling and transporting soiled healthcare textiles, to in-plant processing and delivery back to the customer.

The Standard ensures that ensure that BMPs are documented and followed, and the facility complies with all federal, state, and local regulatory requirements. The Standard requires adherence to the following requirements and guidelines relevant to the handling and processing of textiles Healthcare facilities:

• Centers for Disease Control and Prevention (CDC/HIPAC)
• The Joint Commission (TJC – formerly JCAHO)
• The Occupational Safety and Health Administration (OSHA)

The Standard must be used as a guide for you to create your Quality Assurance (QA) Manual for certification and to prepare your facility for the onsite audit.

Standards

Certification Transfer Policy

Inspection Protocol – Onsite | Inspection Protocol – Virtual | Submittal Policies

Eligibility

Upon applying for the program, you should read the entire Hygienically Clean Healthcare Standard. This will clarify the textiles that require testing. To become eligible for Hygienically Clean Healthcare certification, you must pass two consecutive sequences of microbiological testing of textiles indicating that your processes are producing Hygienically Clean Healthcare linens and garments and negligible presence of harmful bacteria.

Microbiological Sample Testing

All testing is done by a Hygienically Clean-approved laboratory accredited by an accreditation body recognized under the ILAC MRA (Mutual Recognition Arrangement) or recognized by federal or state agencies for microbiological testing. Examples of acceptable third-party accreditation bodies include the International Accreditation Service (IAS), American Association of Laboratory Accreditation (A2LA), and ANSI-ASQ National Accreditation Board doing business as ACLASS. Laboratories recognized by federal or state agencies such as EPA, FDA, Department of Agriculture, CDC, CPSC, and OSHA are also approved. All samples must be submitted on the correct Chain of Custody (COC) form provided by the approved laboratory.

Click here to get more information on submitting samples for testing for eligibility.

Use the links below to download forms as required for one of the approved labs:

USP 62 and RODAC Test COC Form

Chain of Custody Forms:

Quality Assurance Manual

Your facility must have a Quality Assurance (QA) Manual to ensure that BMPs are documented and followed as outlined in the Quality Assurance Program of the Standard. The Standard provides you with a guide to documenting the policies and procedures your facility follows to produce Hygienically Clean textiles. Your QA Manual must include the following policies and procedures:

Best Management Practices (BMPs)

• Plant Facilities
• Housekeeping
• Laundry Process
• Compliance with OSHA Regulations

Audit Process

Hygienically Clean certification requires your facility to pass an independent, third-party audit that confirms your dedication to compliance and processing using BMPs as outlined in the Hygienically Clean Standard. The focal point of the audit is the evaluation of your Standard Operating Procedures (SOPs) and demonstration of BMPs as described in your QA Manual that minimize risk. Audits also evaluate practices relevant to handling and processing textile products used in healthcare settings for adherence to Centers for Disease Control and Prevention (CDC) directives.

The audit confirms essential evidence that:

• Employees are properly trained and protected
• Managers understand legal requirements
• OSHA-compliant
• Facility operates effectively

The Audit process consists of two parts:

1. Initial review of your QA Manual conducted by the Auditor prior to your Audit.
2. Comprehensive audit of your facility focusing on the demonstration of your SOPs as outlined in the QA Manual and the Hygienically Clean standard.

Click here to learn more about the Audit Process

Certification is awarded on a three-year basis once your facility has passed your onsite audit and the final round of microbiological sample testing.

Maintaining certification requires testing on a quarterly basis and remittance of an annual certification fee.  A schedule for testing will be provided to you.

Hygienically Clean Healthcare Brochure for Customers and Prospects
Included in this brochure: the quantified proof of laundry performance that Hygienically Clean certifies as well as the government and professional standards the certification reflects

Hygienically Clean Healthcare Video for Customers and Prospects
Learn how the certification provides essential evidence that laundry employees are properly trained, requirements and voluntary standards are followed and the physical plant operates correctly

Laundry Tour Planner for Healthcare Professionals
This checklist and guide plots a sequence for a laundry tour highlighting control points in a workflow important to ensure cleanliness of healthcare textiles (HCTs)

Curbing the Infection Risk of Healthcare Garments
Download the whitepaper that recommends techniques for washing employee uniforms based on research on home laundering effectiveness

Epidemiologist’s Technical and Critical Review
Assessing certification methodology, impacts of adoption of Hygienically Clean standards on patients, care givers and broad public health

Six C’s Handling Clean Linen in a Healthcare Environment
Whitepaper

Six C’s Handling Soiled Linen in a Healthcare Environment
Learn about this training video for healthcare facility staff to ensure they comply with safety rules and use linen wisely.

Hygienically Clean Healthcare vs. HLAC
How the Hygienically Clean Healthcare certification adds product quality measures to robust process quality assessment

Quantifying Hygienically Clean Removes All Doubt
With patients’ health at stake and healthcare providers under financial and compliance pressures to cost-effectively deliver services, the time for quantifiable laundry certification has come. This whitepaper explains Hygienically Clean’s synergy with efforts to bring performance measurement into medicine

Member Toolkit
Downloadable assets that members can use to promote the industry, their market sector and company including videos, customizable promotional flyers and social media posts

Contact Samlane Ketevong, Senior Director of Certification and Accreditation at certification@trsa.org or (540) 632-1914 to discuss any questions about eligibility, testing, and the audit process.