Scope of Work for IIET 6.11.2025.docx

Scope of Work for Initial Efficacy Testing of Autoclaves

Objective: The purpose of this Scope of Work (SOW) is to define the requirements for a qualified vendor to perform Initial Efficacy Testing (IET) on each autoclave model used for the on-site treatment of infectious waste at Argonne National Laboratory. The objective of the IETs is to verify and document that each autoclave effectively renders infectious waste non-infectious, thereby ensuring its safe disposal. Additionally, the results of the IETs will be used to establish validated operating parameters for the ongoing treatment of infectious waste.

Scope: The selected vendor shall conduct Initial Efficacy Testing (IET) on up to eight autoclave models located at Argonne National Laboratory. An Argonne employee will operate the autoclaves for each test at the direction of the vendor. All testing activities must be performed in accordance with the applicable provisions of 35 Illinois Administrative Code (IAC) 1422.124, under Subtitle M. The eight autoclaves to be tested include:

1. Getinge Vacuum Steam Sterilizer, Model 533LS

2. Getinge Vacuum Steam Sterilizer, Model 533LS

3. Tuttnauer Model 3870M

4. Tuttnauer Model 3870EA

5. Primus Model PSS8-B-MESD

6. Tomy SX-7000

7. Tomy SS325

8. Hirayama HV-50 Upright Autoclave- 50 Liters Tasks:

1. Preparation and Planning:

· Review 35 IAC 1422.124 to gain a thorough understanding of the regulatory requirements and procedures for conducting Initial Efficacy Tests (IETs) on autoclaves used for on-site infectious waste treatment.

· Evaluate Argonne’s Initial Efficacy Test (IET) Report for Autoclaves Used for On-Site Infectious Waste Treatment (attachment). Based on your understanding of 35 IAC 1422.124, determine whether the report complies with IEPA regulatory requirements. If deficiencies are identified, revise the document accordingly to ensure compliance.

· If the IET plan deviates from the requirements of 35 IAC 1422.124, contact the Illinois Environmental Protection Agency to obtain formal approval for the deviations.

· Use the updated IET report to accurately record and document the Initial Efficacy Tests conducted at Argonne.

2. Equipment and Materials:

· Provide all necessary equipment and materials required to perform the Initial Efficacy Test (IET), including self-contained biological indicators (SCBIs) that contain Geobacillus stearothermophilus spores, as specified by regulatory standards.

· Collaborate with Argonne’s Biosafety Program Manager to determine and approve the specific brand of SCBI to be used during the IET procedures.

3. Conducting the IET:

· Conduct the Initial Efficacy Test (IET) for each autoclave model in accordance with the procedures specified in 35 IAC 1422.124 and document on Argonne’s IEPA compliant IET plan procedures.

4. Reporting:

· Complete a separate Argonne Initial Efficacy Test (IET) plan for each autoclave model tested. This document will serve as the official testing report.

· Provide recommendations for any required adjustments to autoclave cycle settings to ensure successful IET performance and the effective inactivation of infectious waste.

5. Deliverables:

· An updated Initial Efficacy Test (IET) Report for Autoclaves Used for On-Site Infectious Waste Treatment that complies with all applicable regulatory requirements, including 35 Illinois Administrative Code (IAC) 1422.124 under Subtitle M.

· For each model of autoclave , a completed Initial Efficacy Test (IET), fully documented using Argonne’s current (or revised, if applicable) IET reporting template, demonstrating successful validation of the autoclave’s ability to render infectious waste non-infectious.

Schedule: The vendor will coordinate with Argonne to establish a mutually agreeable schedule for conducting the IET. The testing should be completed within [insert time frame] from the start date.

Qualifications: The vendor must have experience in conducting efficacy testing for autoclaves and be familiar with the relevant regulatory standards. The vendor should also have access to the necessary equipment and materials for performing the IET.