PWS NHP Offsite Sterilization Services 05 June 2026 DRAFT.docx

Department of Defense Defense Health Agency – Performance Work Statement –

Off Site Sterile Processing Services

Sterile Processing Department (SPD)

Naval Hospital Pensacola

Version:

Date: 05 June 2026

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide sterile processing for Naval Hospital Pensacola (NHP). The contractor shall be responsible for the transport of government-owned property—specifically surgical instrumentation and trays—between the contractor’s offsite facility and NHP, located at 6000 HWY-98, Pensacola, FL 32512.

Contract operations include the delivery of sterile instruments and trays to the Main Operating Room and the collection of items from the Sterile Processing Department. All logistical access to the facility shall be conducted via the loading dock located behind Building 2268."

The contractor shall utilize the loading dock located behind Building 2268 at Naval Hospital Pensacola (6000 HWY-98, Pensacola, FL 32512) to facilitate the delivery of instruments to the Main Operating Room in Room 4058 on the fourth floor and the collection of items from the Sterile Processing Department in Room 2012 on the second floor.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform Offsite Reprocessing Center (ORC) and Instrument Maintenance Service (IMS) as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this performance work statement.

1.3 Background: NHP requires sterile processing services for the Department of Surgery in support of patient care. NHP's fixed facility SPD is unable to provide the sterile processing required. This contract will support the full sterile processing required to support NHP's healthcare mission. This contract will serve to support the hospital until NHP's fixed facility SPD can complete the actions required to ensure sterile processing meets all regulatory and patient safety requirements.

1.4 Objectives: The primary objective is to provide sterile processing and instrument maintenance services to the operating room, clinics and sterile processing department (SPD) within NHP.

1.5 Scope: The Contractor shall provide all personnel, vehicles, equipment, tools, materials, supervision and other items necessary to perform the sterile processing and maintenance of surgical medical instrumentation as described in this PWS. The Contractor shall have the tools and expertise to provide sterile processing services. Services include Offsite sterile processing and instrument maintenance.

1.6 Period of Performance (PoP): Base year plus 3 option years.

1.7 Administrative specifications

1.7.1 Place of performance: All medical surgical instrument trays and peel packs processed under this contract shall be picked up/dropped off Tuesday and Friday or as coordinated with the SPD Department. There will be only one pick up site, NHP, (Sterile Processing Department - Receiving Area). The Contractor may coordinate with the COR to determine the best times to pick up and deliver. Daily Pick-up and Drop-off times shall be an afternoon pick-up no earlier than 1400 CST and 1800 CST. If there is a cancellation of any pickup, the Government will notify the Contractor 12 hours before the scheduled pick-up time. Communication for cancellation must be emailed to a provided list of Contractor contacts. The Contractor and the Government will review, discuss, and agree upon the pick-up and delivery times for routine pick-up and deliveries scheduled on a Federal Holiday.

1.7.2 Recognized Federal holidays: The contractor is not required to perform services on holidays.

Independence Day

1.8 Quality Assurance / Quality Control

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 that 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 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’s QC program is the means by which the work complies with stated requirements. Within 30 calendar days after contract award, one copy of a comprehensive written QCP shall be submitted to the COR and within five (5) working days when changes are made thereafter. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

The Contractor shall have a plan to keep Trays segregated and returned to NHP in accordance with their inspection status, such as accepted, rejected, set aside for re-cleaning, and awaiting decision by the COR, to prevent intermixing and unauthorized use.

The Contractor shall have an inspection system covering all the services required by this contract which must specify the areas to be inspected on either a scheduled or unscheduled basis, how often inspection will be accomplished and documented, and the name and title of the individual who will perform the inspection.

The Contractor shall establish methods of identifying and preventing defects in the quality of service performed before the level of performance becomes unacceptable. This will include procedures for a method of inspection to assure proper temperatures, chemical rinses, detergents and other additives are adhered to.

The Contractor shall maintain records of all quality control inspections conducted by the Contractor and corrective action taken to prevent continued reoccurrence of deficiencies. This documentation shall be made available to the COR or Contracting Officer during the term of the contract.

1.8.3 Contractor Acceptable Quality Levels (AQLs)

The contractor's performance will be measured against the following strict quality thresholds:

1.8.3.1 Production and Delivery (Turnaround Time): The contractor shall process and return collected surgical trays to the Government within the 72-hour timeframe established in Section 5.1.3 of this PWS.

1.8.3.2 Quality and Defect Rate: The contractor shall maintain a maximum allowable defect rate of 5% or below, calculated by dividing the total number of confirmed defects by the total tray volume. Defects include, but are not limited to:

· Collection or Delivery Errors

· Damaged Wrap / Pack or Wet Packs

· Dirty Items / Bioburden presence

· Incorrect Assembly, Labeling, or Missing Items

Defect Resolution and Tracking: The Government will document discrepancies in real-time via Service Reports (SR) using the designated inventory tracking software. The contractor shall evaluate the SR against the physical tray upon its return to the Offsite Reprocessing Center (ORC) and document remedial actions for 100% of reported defects.

Critical Sterilization and Assembly Standards The contractor shall perform all reprocessing tasks in strict compliance with ANSI/AAMI ST79 standards. The following specific quality standards carry a Zero Deviation threshold due to their direct impact on patient safety:

See Part 7 for additional performance objectives under the Performance Requirements Summary and their associated AQLs.

1.9 CONTRACTOR REPAIR AND/OR REPLACE REQUIREMENTS

The contractor shall maintain the following organizational qualifications and adhere to the repair workflows outlined below:

1.10 BASE ACCESS AND VISITOR SECURITY REQUIREMENTS

The contractor’s personnel (specifically delivery drivers) do not require Common Access Cards (CACs) or integration into the Defense Health Agency (DHA) network. Instead, the contractor shall ensure that all personnel and delivery drivers comply with the standard physical security and visitor access requirements of Naval Hospital Pensacola.

1.11 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.12 Key control: RESERVED

1.13 Lock combinations: RESERVED

1.14 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30 p.m., Monday through Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.15 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA Contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The Contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.16 Government COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.16 Contractor Identification and Meetings

1.16.1 Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities.

1.16.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this contract. Contractor personnel shall make their contractor status known during introductions.

1.16.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

PART 2

2.0 DEFINITIONS AND ACRONYMS

2.1 Definitions

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

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

2.1.3 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.

2.1.4 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 quality assurance surveillance plan 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:

2.3 Applicable Publications / Instructions

The Contractor shall ensure the facility, sterilization and repairs meets all the standards found in the following, as amended:

· American National Standards Institute sterilization guidelines

· Association for the Advancement of Medical Instrumentation

· Occupational Safety and Health Administration (OSHA)

· The Joint Commission (TJC) guidelines

· Center of Disease Control and Prevention

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below: provide

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 General: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform work listed under this PWS.

PART 5

5.0 SPECIFIC TASKS

5.1 Task

5.1.1 The Contractor shall provide sterilization, tracking, pick-up, and delivery for medical surgical instrumentation trays and peel packs. The Contractor will provide sterile processing services (tracking, cleaning, decontamination, assembly, and sterilization) for all instrumentation and trays at their Original Reception Center (ORC) in accordance with the terms and conditions set forth in this PWS.

5.1.2 The Contractor will collect trays from and deliver trays processed to locations specified in Part 1 of this PWS, the collection and delivery points mutually agreed upon in by both parties.

5.1.3 The Contractor shall pick up approximately 150 trays per week at the NHP SPD receiving area. The Contractor is responsible for transporting these trays to their facility to process and sterilize all provided medical surgical instrumentation trays, returning them to the NHP SPD receiving area once sterilized. Upon pickup, surgical instruments shall be returned to NHP SPD within 72 hours for Tuesday and Friday pickups, and no greater than 72 hours for Friday pickup and Tuesday delivery.

5.1.4 Pickups and deliveries, based on the volume of 150 trays per week, will be coordinated with the SPD department personnel and/or the Contract COR. The Government will be responsible for purchasing new trays and for maintaining, repairing, and replacing trays unless otherwise contracted to do so with Contract Repair Services.

5.1.5 The Government will, upon delivery or reasonably thereafter:

(i) inspect all delivered Trays to ensure that they are in accordance with the delivery receipt and that they are visually acceptable (e.g. dry, packaging intact, wraps not torn or damaged, labels not missing or incomplete, and seals not broken).

(ii) check the external sterilization indicators. Any visual indicators identified as unacceptable by the Government during this inspection will be returned to Contractor. The Government will complete a Service Report, providing full details of the issue.

Government Inspection, Discrepancy Reporting, and Non-Chargeable Errors, when Trays are opened for use, and before the start of all procedures, the Government will conduct an inspection to confirm that Trays processed by Contractor are complete and fit for use and the Government will check all internal and external sterility indicators and labels. Any discrepancies will be reported immediately to Contractor by the Government by completing an electronic Service Report using the Contractor Software as designated in PWS section 5.4.1.

Contractor will not charge for Trays that are verified Contractor errors and are deemed unusable for surgery or cause a delay or cancellation of a scheduled surgery. Non-chargeable errors include, but are not limited to, the following:

· Bioburden: Shall be reported to Contractor through a Service Report as soon as possible of the finding. The Government will not spray the Tray with enzymatic solution or clean the bioburden prior to returning the Tray to the ORC for inspection and root cause analysis.

· Patient impacting case delay or cancellation: Shall be reported to Contractor through a Service Report as soon as possible of the finding.

· Unusable Tray due to lack of sterility: Shall be reported to Contractor through a Service Report as soon as possible of the finding.

· Unserviceable items that are not deemed repairable must be brought to the attention of NHP and the SPD Department Head and COR.

· Unserviceable items due to sterilizer machine malfunction, or any other damage or loss done at the sterile processing facility shall be replaced at Contractor's expense.

5.1.6 The Contractor shall ensure each tray is sterile and meets all the criteria for sterile processing per the guidelines of the publications designated in 2.3 of PWS.

5.1.7 The Contractor shall ensure that the trailer or truck used to transport soiled or clean instruments meets requirements outlined in ANSI/AAMI, OSHA and TJC guidelines with respective to keeping sterilized instrumentation separate from contaminated instrumentation.

5.1.8 The Contractor shall maintain a system of records as to work performed sufficient to respond to request by the Government.

5.1.9 The contractor shall monitor the temperature and humidity in the transport vehicle when transporting sterile instrumentation in accordance with ANSI/AAMI standards.

5.1.10 The contractor shall package and sterilize all instrumentation. Many instruments may be identified for clinic use outside of NHP. Contractor will coordinate and maintain live inventory of all materials and instruments through existing and suitable electronic Software tracking systems currently in use by or acceptable to the Government.

5.1.11 The contractor shall peel pack and sterilize any excess instrumentation discovered during the Quality Assurance/Quality Control (QA/QC) process.

5.1.12 The contractor shall allow all instrumentation to cool as recommended by ANSI/AAMI standards before being bagged and placed into transport carts.

5.1.13 The Contractor will provide sterilization services offsite at its ORC for trays used by the Government at the Government's facilities.

5.1.14 The Contractor will schedule meetings as needed, to be held virtually or in-person at the Government's facilities, prior to the effective date to evaluate various processes and provide guidance to the Government for best practices for the transition from onsite processing to offsite processing.

5.1.15 The Contractor will be responsible for the transportation of used trays between the collection and delivery points to the ORC and transportation of processed Trays from the ORC to the collection and delivery points specified in Part 1 of this PWS.

5.1.16 The Contractor shall assist the Government in developing and implementing a standardized process for generating, printing, and affixing barcode tags to trays. The Government does not currently possess an internal electronic tracking system, the Contractor shall upload Government-provided set lists into the Contractor's electronic system and generate the necessary barcodes to ensure complete asset tracking.

5.1.17 The Contractor will provide transfer carts needed for transferring Trays to and from the ORC.

5.1.18 The Contractor will not transfer any clinical waste on behalf of the Government.

5.1.19 The Contractor will scan the transfer carts at the collection and delivery points using their software to record collection and delivery of the transported trays.

5.1.20 The Contractor shall clean, decontaminate, assemble, and sterilize trays in strict accordance with the most current Association for the Advancement of Medical Instrumentation (AAMI) guidelines—specifically ANSI/AAMI —as well as the respective Instrument and Sterilizer Manufacturers' written Instructions for Use (IFU).

Trays shall be wrapped or containerized (where compliant rigid containers are provided by the Government). Individual or small supplementary instrument packs shall be sealed in medical-grade peel packs or approved similar materials. All packaging, sealing, and sterilization processes shall be executed in accordance with both the packaging manufacturer's IFUs and AAMI standards to ensure the maintenance of sterility until the point of use.

5.1.21 The Contractor will perform instrument return quality audits to validate Government adherence to the Instrument Return Protocol and all other requirements of this PWS. During these inspections, the Contractor shall provide a detailed report identifying if instruments are damaged or require replacement. In the event of any deviations, the Contractor will generate a Government Service Report within the software to record findings for Government attention and subsequent corrective actions.

5.2. Tray/Pack Deliveries

5.2.1 Pick-Up/ Delivery Procedures. The Contractor shall perform a joint inventory of medical surgical instrument trays and peel packs prior to taking custody of items to be sterilized. The Contractor shall annotate the number of medical surgical instrument trays and peel packs received for sterilizing with concurrence from the requiring activities representative. All medical surgical instrument trays and peel packs processed under this contract shall be picked up/dropped off Tuesday and Friday or as coordinated with the SPD Department. There will be only one pick up site, NHP, (Sterile Processing Department - Receiving Area) as annotated in Part 1. The Contractor may coordinate with the COR to determine the best times to pick up and deliver.

5.2.2 Daily Pick-up and Drop-off times shall be an afternoon pick-up no earlier than 1400 CST and latest 1800 CST. If there is a cancellation of any pickup, the Government must notify the Contractor 12 hours before the pick-up scheduled time. Communication for cancellation must be emailed to a provided list of Contractor contacts. The Contractor and the Government will review, discuss, and agree upon the pick-up and delivery times for routine pick-up and deliveries.

5.3 Schedule

5.3.1 SPD's Hours of Operations: 8 hours a day - 5 days a week from 0600 to 1400.Monday through Friday. Late stay personnel for the Main Operating Room/SPD available from 1400-2000.

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holiday that is declared by Presidential Executive Order shall be observed in the same manner as the standard federal holidays listed above. If SPD is closed on any day other than the holidays noted above, SPD shall notify the Contractor at least a two-day notice of the closure date. Closures of the installation due to inclement weather or other such acts of God, shall be handled in the same manner.

5.4 Documentation and Tracking

5.4.1 Data requirements for Sterile Processing Services: Prior to the Commencement Date, the Government and Contractor shall establish the protocol to be followed by each Party regarding inventory data to be uploaded to Contractor's software system, brand name or equal to SynergyTrak ("Software"). The format of the inventory data will be consistent with the content and format detailed required by the Contractor's software to track all trays.

5.4.2 After the Parties have confirmed and validated that this data is complete and correct, the Contractor will upload the agreed upon Product inventory data into their software.

5.4.3 After entry into the Contractor's software, the Government shall verify and confirm that the data uploaded into the software is complete and correct. If Government has instrument tray barcodes are compatible with the Contractor's software, no additional barcoding will be required. Otherwise, the Government will attach identification barcode tags to trays to be processed by the Contractor. The Parties agree that if additional barcoding is required, the barcodes shall be attached prior to the effective start date of the contract. The Contractor shall assist Government with the attachment of identification barcode tags.

5.4.4 The Contractor shall provide and maintain access to live inventory tracking of items via existing government assets, to support the tracking of all sterilization trays to be completed and agreed upon by both parties prior to effective date. In order to effectively process and return trays in their correct condition, it is essential that tray build sheets accurately reflect the contents, tray set up and include any appropriate details and/or processing instructions relevant to that tray, thereby removing any misunderstanding and/or ambiguity regarding the actual contents and processing requirements of the trays during the decontamination, inspection and packing process. Contractor provided layouts are necessary in order to accurately load instruments and other relevant information into the software. At a minimum the Contractor shall provide a completed and verified inventory management acknowledgement of items received and delivered.

5.4.5 The Contractor with Government concurrence shall perform count sheet audits and rectify tray inventory count sheets prior to completing data transfer to the ORC SynergyTrak or brand name equivalent software system.

5.4.6 The Contractor shall provide Training & Education as required in the use of the Hospitals inventory management system to all the identified Government employees on how to use the SynergyTrak, name brand or equivalent system and ensure the Government's SPD Team have been trained on the identification and preparation of tray process.

5.4.7 The software systems shall provide Quality Control Reports and Infection Control Reports throughout the duration of this contract.

5.5 Instrument Management Services

5.5.1 Contractor shall provide preventative maintenance, repairs, and testing of all surgical instruments, including, but not limited to orthopedic, ophthalmic, genitourinary, dental, neurological, laparoscopic, vascular, otolaryngological, gynecological, bariatric, gastrointestinal and insulated items.

5.5.2 All instruments shall be repaired and maintained in proper operating conditions, as specified by the original manufacturer.

5.5.3 The contractor shall be required to test instruments for accurate alignment, sharpness, insulation integrity, and calibration per manufacturer’s instructions for use (IFU). All returned, inspected, and repaired instruments shall be stain free and in compliance with regulatory standards and guidelines.

5.5.4 All single instruments and surgical trays picked up/delivered by the contractor shall be properly listed for accountability verification.

5.5.5 The contractor shall provide documentation for the specific work that is performed. Upon completion of services the contractor must provide a summary document/end of day report (PowerPoint or equivalent) which contains the following information: date of repair, instrument type, tray description, department, status of instrument repair or resolution, and type of repair rendered. Instruments that are non-repairable shall be annotated in this log.

5.5.6 If the contractor identifies a single instrument beyond refurbishment and/or repair, the contractor shall replace the surgical instruments with the same quality and likeness to ensure the completion of surgical trays. As applicable, all replacement instruments shall be procured through the Government Mandatory Source – Defense Logistics Agency (DLA).

5.5.7 Repairs shall be completed at the respective facilities listed herein, in the contractor’s mobile repair vehicle, or offsite at the contractor’s repair facility.

5.5.8 Contractors shall have 1S0 9001 and 1S0 13485 (Medical Device) certifications.

PART 7

7.0 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

7.1 The contractor service requirements are summarized into performance objectives that relate directly to mission-essential items. The Acceptable Quality Level (AQL) describes the minimum acceptable levels of service required.

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