Healthcare

The Hygienically Clean Healthcare Standard defines the criteria for producing and certifying hygienically clean reusable textiles for healthcare facilities. It monitors the entire textile processing cycle, from handling and transporting soiled healthcare textiles to in-plant processing and delivery back to the customer.

This Standard ensures that best management practices (BMPs) are documented and implemented, and that the facility complies with all federal, state, and local regulatory requirements. It mandates adherence to specific requirements and guidelines related to the handling and processing of textiles in 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

Eligibility

Before applying for the program, please review the complete Hygienically Clean Healthcare Standard. This will clarify which textiles require testing. To be eligible for Hygienically Clean Healthcare certification, you must successfully complete two consecutive rounds of microbiological testing that demonstrate your processes produce Hygienically Clean Healthcare linens and garments with negligible levels of harmful bacteria.

Microbiological Sample Testing Process

All testing is conducted by a Hygienically Clean-approved laboratory accredited by a recognized accreditation body under the ILAC MRA (Mutual Recognition Arrangement) or by federal or state agencies for microbiological testing. Acceptable third-party accreditation bodies include the International Accreditation Service (IAS), the American Association of Laboratory Accreditation (A2LA), and the ANSI-ASQ National Accreditation Board, operating as ACLASS. Laboratories recognized by federal or state agencies, such as the EPA, FDA, Department of Agriculture, CDC, CPSC, and OSHA, are also approved. All samples must be submitted using the appropriate 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

Quality Assurance Manual

Your facility is required to maintain a Quality Assurance (QA) Manual to ensure that best management practices (BMPs) are documented and implemented, as specified in the Quality Assurance Program of the Standard. This Standard serves as a guide for 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

To obtain Hygienically Clean certification, your facility must successfully pass an independent, third-party audit that verifies your commitment to compliance and the implementation of best management practices (BMPs) as outlined in the Hygienically Clean Standard. The audit primarily focuses on evaluating your Standard Operating Procedures (SOPs) and demonstrating the BMPs described in your QA Manual that minimize risk. Additionally, audits assess practices related to the handling and processing of textile products used in healthcare settings to ensure adherence to Centers for Disease Control and Prevention (CDC) guidelines.

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 granted for a three-year period once your facility successfully completes the onsite audit and the final round of microbiological sample testing.

To maintain certification, quarterly testing is required, along with the payment of an annual certification fee. You will be provided with a testing schedule.