DRAFT PWS SPD Sterile Processing Service.docx

Department of Defense Defense Health Agency Performance Work Statement

General Leonard Wood Community Hospital (GLWCH) Interim Off-Site Sterile Processing Department Support Services

09 October 2026

PART 1

GENERAL INFORMATION

1.0. General Information: The government has an urgent requirement to locate interim off-site sterile processing services for General Leonard Wood Community Hospital located at 4234 Illinois Avenue, Fort Leonard Wood, Missouri 65473.

1.1. Description of Service: The contractor shall provide all personnel, equipment, supplies, turn-key transportation, tools, materials, supervision, and other items necessary to perform off-site instrument reprocessing and logistical support for General Leonard Wood Community Hospital (GLWCH). This includes the complete cycle of pickup of contaminated items, decontamination, inspection, assembly, sterilization (including both steam and low-temperature modalities), and delivery of clean/sterile surgical instruments and powered equipment. (Note: Processing flexible endoscopes is explicitly excluded from this contract).

1.1.1. Estimated Volume of 225 Standard Tray Units (or equivalent) per week.

1.1.2. Trays may be government owned, leased or on consignment.

1.1.3. Pickup and Drop Off Location:

1.2. Background: General Leonard Wood Community Hospital has as a requirement to establish a service contract with a certified sterile processing facility to support its operational readiness during Sterile Processing Department (SPD) Renovation. GLWCH may require overflow and supplemental sterile processing services to ensure surgical instruments are available for patient care when in-house capacity is exceeded or unavailable.

1.3. Period of Performance (PoP): The Period of Performance shall consist of a Base Year of six (6) months from the date of contract award, with the potential for two (2) six (6) month option periods, if exercised by the Government.

1.4. Objectives:

· To establish a reliable process for the sterilization and assembly of Government utilized surgical trays.

· To ensure all services are performed in accordance with applicable state, federal, and industry standards for sterile processing.

· To maintain a clear and auditable tracking system for all surgical trays from pick-up to delivery.

· To ensure the timely return of fully disinfected, sterilized, and assembled surgical trays to support GLWCH’s surgical schedule.

1.5. Scope: The contractor shall provide all necessary labor, equipment, materials and transportation to perform full disinfection, sterilization, and assembly of GLWCH surgical trays. Services include the establishment of GLWCH as a customer in the contractor's tracking system, transporting government owned contaminated trays/materials to and from GLWCH, performing full disinfection sterilization, ensuring quality control, and delivery within time frames noted in Part 4.1.6 of this PWS.

1.6. Federal Regulations: The contractor shall be duly licensed and certified to provide sterile processing services in the state of Missouri. The contractor shall comply with all applicable standards and legal requirements from accrediting bodies, including but not limited to The Joint Commission (TJC) and the Association for the Advancement of Medical Instrumentation (AAMI).

1.6.1. Applicable Regulations and Manuals: The contractor must ensure all facilities, processes, and transportation methods strictly adhere to the most current versions of the following standards:

ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

ANSI/AAMI ST108: Water for the processing of medical devices. Defense Health Agency (DHA): Applicable DHA guidelines regarding sterile processing and infection control.

OSHA and The Joint Commission (TJC): All relevant health, safety, and operational standards.

1.7. Geographical Location: The contractor’s sterilization and processing facility must be physically located within the state of Missouri.

1.8. Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor is responsible for ensuring all trays are returned fully disinfected, assembled, and sterilized.

1.8.1. Quality Assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the government to evaluate performance and to ensure the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.8.2. Defect Rate and Liability:

1.8.2.1. Defect Rate: The Contractor shall maintain a defect rate of 1% or less. Defects include retained bioburden, wet packs, missing items, damaged passive layers due to improper chemical use, or water mineral spotting.

1.8.2.2. Damage/Loss Liability: The Contractor is fully financially responsible for the repair or replacement of any items lost during transport/processing, or items suffering severe corrosion or fluid invasion (specifically regarding Stryker/Arthrex handpieces) resulting from contractor negligence or failure to follow Instructions for Use (IFUs).

1.8.3. Billing and Tray Equivalency Chart: Billing shall be calculated based on the following equivalency metrics establishing the baseline of "1 Unit":

1.9. Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. A full description of the COR's duties and limitations will be provided in the COR designation letter. The COR is not authorized to change any of the terms and conditions of the resulting contract.

Name of COR:

COR Email Address:

COR Telephone Number:

Name of Alternate COR:

Alt COR Email Address:

Alt COR Telephone Number:

1.10. Contractor Responsibilities:

1.10.1. Operational Security (OPSEC) Training: New Contractors shall complete Level I OPSEC training within 10 calendar days of their reporting for duty. Training is located at http://cdsetrain.dtic.mil/opsec/index.htm (IAW AR 530-1). For contracts that cross fiscal years, or for contracts with option years, all Contractor personnel shall complete annual OPSEC awareness training. Course certificates shall be provided to the COR within five calendar days of completion.

1.10.2. Anti-Terrorism (AT) Level I Training: All contractor employees, including sub-contractor employees, requiring access to army installations, facilities, and controlled access areas shall complete AT Level I Awareness training within 10 days after starting performance under this contract. The contractor shall submit certificates of completion for each affected contract employee and subcontractor employee, to the COR or to the KO within five calendar days after completion of training by all contractor/subcontractor personnel. AT level I awareness training is available at the following website: https://jko.jten.mil/courses/atl1/launch.html.

1.10.3. Access and General Protection/Security Policy and Procedures: All Contractor and sub-contractor personnel performing tasks on this PWS shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures which will be provided to the Contractor by a Government representative within five working days of award. Contractor shall provide all information required for background checks to meet installation access requirements as performed by the installation Provost Marshal Office, Director of Emergency Services or Security Office. Requesting Contractor shall submit request for installation pass to the COR. Contractor personnel shall comply with all personal identity verification requirements as directed by DoD, HQDA and/or local policy. Should the Force Protection Condition (FPCON) at any facility or installation change, the Government may require changes in Contractor security matters or processes.

1.10.4. iWatch Training: Within 10 calendar days of award and within 10 days of new Contractor employees commencing work on this award, all Contractor and sub-contractor employees shall review the FLW Directorate of Emergency Services (DES) web link for iWatch training located at http://www.wood.army.mil/LEC/iWatch/iWatch.htm. This locally developed training will inform employees of the types of behavior to watch for and how to report suspicious activity. Suspicious activity shall be reported to the COR.

1.10.5. Information Assurance (IA) Awareness Training: Not Required.

PART 2

DEFINITIONS AND ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

2.1.6. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.7. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.8. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.2. ACRONYMS:

ANSI American National Standards Institute OR Operating Room OSHA Occupational Safety and Health Agency

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.0. The Requiring Activity Authority has assessed the need for Government Furnished Property, Materials and services, and determined:

3.1. Services: The government will ensure materials are ready for pickup at the specified time and location, verify quantity and types of sets to be transported at time of pickup, and track and check delivered items in accordance with this PWS.

3.1.1. The government will provide a baseline inventory of specific items to be delivered at time of award.

3.2. Material: The government will provide standard compliant rigid containers, blue wrap, and peel packs to be utilized by the contractor during the assembly process unless otherwise stated prior to contractor pickup.

3.2.1. The government is transitioning from the rigid containers to Aesculap containers. The parts can be interchanged with other Aesculap containers but cannot be mixed/matched with other brands of rigid containers.

3.3. General Maintenance: The government remains responsible for standard repair and replacement of unserviceable instruments due to normal wear and tear.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.0. The Contractor shall supply the following:

4.1. Logistics and Transportation

4.1.1. Turn-Key Transport: The contractor shall perform 100% of the pickup and delivery of all items from designated facility loading dock on a regular schedule recurring between Monday-Friday from 8:00 am to 3:00 pm CST.

4.1.2. Point of Hand-Off and Labor: The designated hand-off point shall be the GLWCH loading dock. The contractor’s personnel (e.g., the driver) shall be solely responsible for the physical loading, securing, and unloading of all items onto and off of the transport vehicles. GLWCH staff will not perform vehicle loading operations.

4.1.2.1. The contractor will request Post Access from the GLWCH Contract Support Office at time of award for each designated driver.

4.1.3. Transport Carts: The contractor shall provide all enclosed, cleanable transport carts necessary to safely and securely move instruments between the GLWCH SPD, the loading dock, and the contractor’s facility in accordance with infection control standards.

4.1.3.1. Quality and Integrity of Trays: The contractor shall ensure that all returned trays are complete, with all instruments present, and that wrappers or containers are free of tears, holes, or moisture. The contractor staff shall notify the Technical Point of Contact (TPOC) and COR immediately of any compromised or incomplete trays.

4.1.4. Chain of Custody Manifest: At the time of pickup and delivery at the GLWCH loading dock, the contractor and a GLWCH representative must jointly verify and sign (or digitally scan/acknowledge) a manifest of all items. Assumption of liability transfers to the contractor the moment the manifest is signed at pickup, and transfers back to the government upon signed delivery and inspection at GLWCH.

4.1.5. Vehicle Compliance: Transport vehicles must meet all Department of Transportation (DOT) requirements for transporting infectious waste. Vehicles must have secure, environmentally controlled compartments that maintain and actively log temperature and humidity controls and ensure strict physical separation of clean/sterile and contaminated items.

4.1.6. Turnaround Time and Delivery Windows: The contractor shall provide a standard 24-hour turnaround time (e.g., items picked up at 2:00 pm on Monday must be delivered by 2:00 pm on Tuesday) for items picked up Monday through Thursday, and a maximum 72-hour turnaround for items picked up on Friday through Sunday. Pickups and deliveries shall occur exclusively within designated facility delivery windows (e.g., Monday through Friday, 8:00 am – 3:00 pm).

4.1.7. Contingency: The contractor must maintain an active disaster/severe weather plan to ensure continuity of services.

4.2. General Instrument Care and Reprocessing

4.2.1. Instrument Integrity & Passive Layers: The contractor must employ reprocessing methods that protect the passive layer (chromium and iron oxide layer) of all stainless steel instruments. The use of highly acidic or highly alkaline cleaners without proper neutralization, prolonged exposure to harsh disinfectants (including iodophors), or exposure to sodium chloride/chlorine solutions is strictly prohibited.

4.2.2. Water Quality & Stain Prevention: The contractor must utilize water purification systems and maintain water quality that strictly complies with ANSI/AAMI ST108 standards to prevent hard-water mineral deposits, spotting, and corrosion. The contractor must ensure steam and boiler water are monitored regularly to prevent spotting or rainbow-tinted staining resulting from steam impurities or excessive neutralizing amines.

4.2.3. Cooling Times: The contractor must allow all instrumentation to cool adequately inside the facility as recommended by AAMI ST79 standards before being handled, bagged, or placed into transport carts to prevent condensation and wet packs.

4.3. Specialty and Oral Surgery Instrumentation: The contractor must process all Oral and Maxillofacial Surgery (OMFS) and dental instrumentation.

4.3.1. Galvanic Corrosion Prevention: Because oral surgery instruments frequently utilize softer 400 series stainless steel or dissimilar metals (e.g., brass, aluminum, copper), the Contractor must segregate dissimilar metals during the wash cycle. If segregation is not feasible, neutral pH cleaners safe on soft metals must be utilized to prevent galvanic corrosion and replating.

4.4. Complex Powered Equipment and Wellness Center Items

4.4.1. Powered Handpieces (Stryker & Arthrex): The contractor must process Stryker power tools and Arthrex shaver handpieces with strict adherence to the manufacturer's IFUs. Under no circumstances shall powered handpieces be fully immersed in liquid or placed in an ultrasonic cleaner unless explicitly directed by the IFU. The contractor is responsible for utilizing the correct manufacturer-approved lubricants and performing basic operational testing/purging prior to sterilization.

4.4.2. Low-Temperature Items (Cameras & Light Cords): The contractor must have the capability to perform low-temperature sterilization for heat-sensitive items. The Contractor must strictly adhere to the manufacturer's IFU for all surgical cameras, rigid scopes, and fiber-optic light cords to prevent the degradation of lenses, fiber optics, and cable housings.

4.4.3. Armed Forces Wellness Center (AFWC) Masks: The contractor shall reprocess AFWC masks, verifying material compatibility to ensure the masks are not degraded by the sterilization method used (e.g., avoiding high-heat steam for incompatible plastics/silicones).

4.5. Tracking and Documentation

4.5.1. System Onboarding: Prior to full performance, the contractor shall conduct a site orientation with GLWCH SPD leadership and the COR and ensure the facility's inventory is fully established and mapped within the Contractor’s tracking system.

4.5.2. Tracking: The contractor must utilize an instrument tracking system capable of logging all trays and items, ensuring 100% accountability from pickup to delivery via established barcoding protocols.

4.5.2.1. The contractor shall supply a report that includes the number of units processed each month per pickup no later than the 10th day of each month following the completed month of service. This report shall be submitted to the COR and TPOC via email or at time of pickup or delivery nearest the 10th day of each month.

4.5.2.2. Deliverables: The contractor shall provide the following documents throughout the period of performance.

4.5.2.2.1. Daily Sterilization Load Record and Equipment Log: Proof of compliance for daily runs and equipment efficacy to be issued daily upon delivery of clean sets. This report must include load records showing Biological Indicators (BIs) and Chemical Indicators. It must also include Equipment Tests such as daily Bowie-Dick tests and weekly Vacuum Leak Tests in accordance with AAMI ST79 and sterilizer IFUs.

4.5.2.2.2. Daily Transportation Environmental Log: Data log printouts/reports showing temperature and humidity levels inside vehicles’ clean/sterile compartment during transit in compliance with ST79.

4.5.2.2.3. Monthly Quality Report: The contractor shall submit a monthly report showing a summary of internal defect tracking, equipment maintenance and turnaround time performance.

4.6. Wide Area Work Flow: The contractor shall submit invoices monthly through Wide Area Work Flow (WAWF) following the completion of each month of service. Not all months will include services or invoicing.

4.7. Root Cause Analysis (RCA): The contractor shall submit a formal report as needed detailing the cause of a critical defect such as a ruined hand piece or widespread spotting, and the corrective action taken.

PART 5

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. Failure to meet these standards will result in the corresponding financial deductions or liability being applied to the Contractor.

PART 6

DELIVERABLES SCHEDULE

This schedule outlines the specific deliverables required by the contract, along with their frequency, due dates, and the recipient.

DHA PWS, FEB 2024

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