PWS - Sterile Processing Services Version 2.pdf

Department of Defense Defense Health Agency

Performance Work Statement

Sterile Processing Services Medical Treatment Facility (MTF)

David Grant medical Center, Travis AFB

Solicitation Number:

Version: 2

Date: 16 Apr 2026

Table of Contents

SECTION NO. AND TITLE PAGE NO.

PART 1 – General Information 3

PART 2 – Definitions, Acronyms, and Applicable Publications/Instructions 8

PART 3 – Government Furnished Property 10

Appendix A 11

PART I

1.0 GENERAL INFORMATION

1.1 Requirement: This is a non-personal services contract to provide Sterile Processing Services

1.2 Description of services: The Contractor shall provide contingency sterile processing services for the Sterile Processing Department (SPD) at David Grant Medical Center (DGMC), Travis AFB, CA.

The Contractor shall provide all management, personnel, equipment, tools, materials, transportation, and supplies necessary to perform:

• Collection and transportation of contaminated instruments and trays from DGMC

• Cleaning, decontamination, disinfection, assembly, packaging, sterilization, and return delivery

• Quality control testing and documentation

• Equipment calibration and maintenance (contractor-owned equipment)

All services shall be performed in accordance with AAMI ST-79, AORN, CDC guidelines, and manufacturer IFUs.

The Contractor shall:

• Provide 24/7 technical support

• Provide expedited processing for urgent requirements

• Perform instrument return quality audits

• Ensure all devices comply with FDA 510(k) requirements

• Be responsible for any lost or damaged instruments.

1.3 Background: DGMC currently performs all sterile processing in-house for the operating room, 25 clinics, and a dental clinic. This contract provides contingency capability when DGMC SPD operations are unavailable or degraded. Services will be activated in the event of sterilization equipment failure, facility emergencies, or during scheduled maintenance/construction periods, such as the MILCON project which may impact the availability of the SPD trailer. Use of this service is expected to be on a recurring basis due to the limited throughput and reliability of the current SPD trailer. The Contractor shall provide off-site sterile processing capability including facility, staffing, equipment, and transportation.

1.4 Objectives: Provide a fully operational contingency SPD capability to ensure uninterrupted clinical operations. The Contractor shall process Government-owned reusable medical devices and instrument sets in compliance with all regulatory standards.

1.5 Scope of Work: The Contractor shall provide end-to-end sterile processing services including transportation, cleaning, assembly, sterilization, and delivery.

Environmental Control:

• Assembly: 60°F–73°F

• Storage: ≤75°F

• Humidity: 30–60%

• Air exchanges: minimum 4 per hour

Transportation of contaminated and sterilized items:

• Use closed, leak-proof, puncture-resistant containers

• Maintain vehicle temperature 65°F–72°F

• Document temperature before and after transport

• No patient-sensitive information or data (HIPAA/PHI) will be involved in transport.

Quality Control Requirements:

• Daily sterilization testing prior to first load

• Biological Indicator (BI) testing with every load

• Immediate notification of positive BI results or equipment failures to DGMC SPD leadership.

• Maintain records for 3 years

• Provide traceable documentation with each delivery, including a chain-of-custody log.

Sterilization Testing Requirements:

• Daily Bowie-Dick testing

• Weekly vacuum leak testing

• BI testing with each load

• Document sterilizer ID, load number, date, and contents

Instrument Processing Requirements: All processing shall follow manufacturer IFU.

Includes:

• Proper cleaning sequence

• Proper packaging methods

• Use of Class 5 chemical indicators

• Protection of delicate instruments

Eye Instrument Processing:

• Dedicated sink, ultrasonic, and washer required

• Fresh enzymatic solution per use

• Inspection under magnification

• Strict adherence to IFU to prevent TASS

Performance Standards:

• Standard turnaround: within 24-36 hours, depending on pickup time.

• Emergency turnaround: within 24 hours

• 100% compliance with AAMI, AORN, CDC

• All reports provided with each shipment

Estimated Workload

Sets/Instruments Daily/Weekly/Monthly quantities

Small sets 92/462/2000

Peel packs 80/385/1549

1.6 Period of Performance (POP): 1 June 2026 – 31 May 2027 to include 3 option years:

1 June 27 – 31 May 28 1 June 28 – 31 May 29 1 June 29 – 31 May 30

1.7 Administrative specifications

Place of performance: Contractor facility with pickup/delivery to David Grant Medical Center, Travis AFB, CA. The contractor's facility should ideally be located within a 2-3 hour travel radius of DGMC.

Recognized Federal holidays: Contractor is required to perform services on holidays.

Hours of operation: Pickup and delivery shall occur Monday–Friday, 0700–1500. Emergency support shall be available as required.

Emergency Services: On occasion, services may be required to support contingency plans outside the normal duty hours.

Base Access: The contractor and its personnel shall comply with all base access and security requirements for Travis AFB to gain access.

1.8 Quality

1.8.1 Quality Control (QC): The Contractor shall develop, implement, and maintain an effective Quality Control Plan (QCP) to ensure all services are performed in accordance with this PWS.

The QCP shall:

• Identify methods to prevent, detect, and correct deficiencies

• Ensure non-recurrence of defective services

• Include inspection procedures, documentation methods, and corrective actions

The QCP shall be:

• Submitted with the Contractor’s proposal (if required), or

• Submitted to the Contracting Officer (CO) and COR within 5 business days of contract award or when changes occur

Any changes to the QCP shall require CO approval prior to implementation.

1.8.2 Quality Assurance (QA): The Government will evaluate Contractor performance in accordance with the Quality Assurance Surveillance Plan (QASP).

The QASP will:

• Define surveillance methods and frequency

• Establish acceptable performance thresholds

• Identify remedies for non-compliance

1.8.3 Quality Assurance (QA) Performance Testing: The Contractor shall perform all required QA testing in accordance with AAMI ST-79, AORN, CDC guidelines, and manufacturer Instructions for Use (IFU).

Requirements:

• QA testing shall be conducted prior to initiating sterilization loads

• Biological Indicator (BI) results and sterilization parameters shall:

• Accompany each processed load, or be transmitted with delivery documentation

All records shall include:

• Date and time

• Load number

• Sterilizer ID

• Contents of load

The Contractor shall:

• Maintain QA records for a minimum of 3 years

• Provide written operating instructions for equipment maintenance (daily, weekly, monthly) upon request

1.8.4 Service and Testing Reporting: The Contractor shall provide legible and complete testing reports to DGMC SPD leadership (Element Leader or Section Chief).

Reports shall include:

• Date and time of testing

• Type of test performed

• Results

• Corrective actions taken (if applicable)

Reports shall be provided with each delivery or via an agreed-upon electronic method. Positive BI results or equipment failures must be reported IMMEDIATELY.

1.9 Services Summary:

1.9.1 Procedures: The Contractor shall follow standard commercial quality control practices to ensure services are performed in accordance with this PWS.

Procedures shall:

• Identify and prevent defective performance

• Ensure corrective action and non-recurrence of deficiencies

All deficiencies shall be addressed in accordance with FAR 52.212-4(a), Inspection/Acceptance.

Service Objective PWS Section Performance Threshold and Remedy Biological Indicators with every load IAW

IFU

1.8.3

Provide records showing negative (-) result.

If positive (+), what corrective actions were taken? Reprocess the load and provide printouts.

Print out for each sterilizer load

1.8.3 Printout provides time, temperature, and

pressure, IAW IFU for the sterilizer and instruments. If parameters not met, provide corrective actions taken, and reprocess the load.

Bowie-Dick testing 1.8.3 Run daily in an empty sterilizer before processing the first load. Report pass or fail IAW IFU. Report actions taken and test until achieving a passing result.

Daily testing of Ultrasonics

1.8.3 Perform cleaning verification tests to test

cavitation, and soil removal (internal and external). Provide results based on IFU for test used. Report actions taken and test until achieving a passing result.

Daily testing of washers before use and with every cycle

1.8.3 Test for soil removal with a presence or

absence of a marker on a coupon IAW IFU for the mechanical washer and test verification used. Provide results based on IFU for test used. Report actions taken and test until achieving a passing result.

Provide legible testing report to SPD

1.8.4. 100% of the time.

1.9.2 Key personnel (Contractor):

The Contractor shall designate a Contract Manager responsible for overall performance of this contract.

The Contractor shall:

• Provide the name of the Contract Manager and an alternate in writing to the CO

• Ensure the Contract Manager has full authority to act on all contract matters

Availability:

• Monday–Friday, 7:00 AM – 4:30 PM (excluding Federal holidays unless otherwise required)

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R- Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

AAMI Association for the Advancement of Medical Instrumentation AORN Association of perioperative Registered Nurses BI Biological Indicator CDC Centers for Disease Control and Prevention CO Contracting Officer(s) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction IFU Instructions for Use

MTFs Military Treatment Facilities PCD Process Challenge Devices POC Point of Contact PoP Period of Performance PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

II. General Information

1. Government Available Services

The government will provide the following equipment, supplies and services listed below:

i. Supplies: For the purpose of this contract, the government will furnish all trays (caskets) for sets and all related instrument count sheets.

3.1 CONTRACTOR FURNISHED ITEMS AND SERVICES

The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work under this contract that are not listed as Government Furnished.

APPENDIX A

Applicable Publications and Forms

Publications and forms applicable to this Statement of Work (SOW) are listed below and are mandatory. The contractor shall follow those publications to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) to meet requirements in this PWS.

Applicable publications are located at https://www.e-publishing.af.mil The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up to date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause.

The Contractor will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the Government all issued publications and unused forms.

Publications Code:

AFI--Air Force Instruction AMC-Air Mobility Command DoDI-DoD Instruction MDGI -60th Medical Group Instruction American National Standards Institute/Association for the Advancement of Medical Instruments

(AAMI)

Association of peroOperative Registered Nurses (AORN) Centers for Disease Control and Prevention (CDC) International of Healthcare Central Service Material Management (IAHCSMM) Manufacturer’s Instructions for Use Occupational Safety and Health Administration (OSHA) The Joint Commission (TJC) on Accreditation of Healthcare Organizations

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive

DoDI 3020.37 Continuation of Essential DOD

Contractor Services During Crises

DoDI 5400.7-R DoD Freedom of Information Act Para, C.4.2.1, C.4.4C3.2.1.2 - C3.2-1.9

Air Force Sup DoD Freedom of Information Act

DoDI 5500.7-R Joint Ethics Regulation (JER) https://www.e-publishing.af.mil/

DoDR 6025.18-R Health Information Privacy Regulation

AFI 33-129 Transmission of Information Via the

AMC Sup 1 Transmission of Information via the Internet

AFI 33-201 Communications Security (COMSEC)

AFI 33-332 Air Force Privacy Act Information

AMC Sup 1 Air Force Privacy Act Information

DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework