B01-Solicitation-FINAL.pdf

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COMBINED SYNOPSIS/SOLICITATION: HT9425R0002

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information in this notice. Also, this acquisition is being conducted under FAR 13.5, Simplified Procedures for Certain Commercial Items This announcement constitutes the only solicitation; Quotes are being requested and a written solicitation will not be issued. The solicitation number is HT942525R0002. The solicitation is issued as a request for quotation (RFQ).

Provisions and clauses in effect through Federal Acquisition Circular 2025-03 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses https://acquisition.gov/far/index.html. The NAICS code is 811210, with a small business size standard of $34.0M.

Offerors shall submit a quote in response to the requirements of the United States Army Medical Research

Acquisition Activity (USAMRAA) in support of the David Grant Medical Center (DGMC), Travis Air Force Base, CA. USAMRAA requests responses from qualified sources capable of providing the service that can meet the

Governments requirement.

Section B – Supplies/Services and Prices/Costs

AMOUNT

SIMP Repair & Maintenance

FFP

Surgical Instrument Laser & Proactive Repair/Maintenance

FOB: Destination

MFR PART NR: 12 Months

J065

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

0001 1 Each

SIMP Laser Marking

FFP

Surgical Instrument, Case Cart & Surgical Set Laser Marking

FOB: Destination

OPTION SIMP Repair & Maintenance

FFP

Surgical Instrument Laser & Proactive Repair/Maintenance

FOB: Destination

FFP

Surgical Instrument Laser & Proactive Repair/Maintenance

FOB: Destination

0002 6 Each

1001 1 Each

2001 1 Each

FFP

Surgical Instrument Laser & Proactive Repair/Maintenance

FOB: Destination

FFP

Surgical Instrument Laser & Proactive Repair/Maintenance

FOB: Destination

PERFORMANCE WORK STATEMENT

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide comprehensive surgical instrument maintenance, repair and laser marking services at David Grant Medical Center, Travis AFB, CA.

1.2 Description of services/introduction: This Performance Work Statement (PWS) outlines the requirements for a contractor to provide comprehensive surgical instrument maintenance, repair, and laser marking services at David

Grant Medical Center (DGMC), Travis Air Force Base, CA. The contractor shall deliver proactive and ongoing services to ensure surgical instruments and associated equipment are maintained according to Original Equipment

Manufacturer (OEM) specifications, industry standards, and applicable regulatory guidelines. Services include monthly preventive maintenance, instrument repairs, laser engraving of surgical instruments, trays, and case carts, along with continuous maintenance and

3001 1 Each

4001 1 Each integration with DGMC's instrument tracking system. The contractor's efforts directly support the readiness and operational capabilities of DGMC by ensuring all surgical instrumentation remains in optimal condition for patient care.

1.3 Background: David Grant Medical Center (DGMC), located at Travis Air Force Base, CA, is a key component of the 60th Medical Group (60 MDG), providing comprehensive medical services to active-duty military members, their families, retirees, and veterans. To maintain the highest standards of patient safety and quality surgical care, DGMC requires a reliable and effective surgical instrument maintenance and repair program.

The complexity and critical nature of surgical procedures performed at DGMC necessitate strict adherence to

Original Equipment Manufacturer (OEM) standards, Joint Commission (TJC) guidelines, Association for the

Advancement of Medical Instrumentation (AAMI) standards, and Department of Defense (DoD) regulations. An essential element in sustaining DGMC's operational readiness and patient care excellence is ensuring surgical instrumentation is consistently maintained, promptly repaired, properly marked, and accurately tracked through the facility’s instrument management systems.

1.4 Objectives:

• Ensure surgical instruments meet Original Equipment Manufacturer (OEM) specifications through routine maintenance and timely repairs.

• Implement and maintain accurate laser marking of surgical instruments, trays, and case carts for effective tracking.

• Maintain compliance with The Joint Commission (TJC), Association for the Advancement of Medical

Instrumentation (AAMI), and Department of Defense (DoD) standards and regulations.

• Extend the life expectancy of surgical instrumentation by proactive maintenance and repairs.

• Provide ongoing documentation and reporting of all maintenance, repairs, and instrument status updates.

• Offer continuous education and training for DGMC personnel on surgical instrument care, inspection, and handling.

• Support patient safety and surgical readiness by ensuring fully functional, reliable, and compliant surgical instruments at all times.

1.5 Scope: The contractor shall provide surgical instrument maintenance, repair, and laser marking services at David Grant Medical Center (DGMC). The scope of service includes:

Monthly Standard Service

• On-site surgical instrument inspection, sharpening, cleaning, and repair services.

• Preventive maintenance in accordance with Original Equipment Manufacturer (OEM) and industry standards.

• Continuous laser engraving of surgical instruments, trays, and case carts.

• Inspection and re-marking of previously laser-marked instruments and equipment as needed.

• Repair and maintenance of laparoscopic instruments.

• Quarterly inspections of backup surgical instrumentation.

Instrument Tracking System Management

• Ensuring laser marking is compatible with DGMC’s instrument tracking system.

• Verification and entry of laser-marked instruments into DGMC’s tracking system.

• Continuous updating and maintenance of instrument records in the tracking system.

Initial Compliance Service (One-Time Requirement)

• Removal of existing labels, adhesives, and stickers from surgical sets and case carts.

• Application of laser-marked identification tags on up to 75 case carts and 3,500 surgical trays/sets.

• Laser marking of up to 2,000 surgical instruments with 2D data matrix codes.

• Passivation treatment post-laser marking to prevent corrosion.

Documentation and Reporting

• Detailed documentation of instrument conditions pre- and post-service with magnified digital images.

• Submission of electronic reports summarizing maintenance, repairs, and instrument updates.

Training and Education

• Provision of real-time, on-site training to DGMC staff.

• Educational sessions covering instrument inspection, maintenance, and care.

• Minimum of five educational training sessions per year, fulfilling IAHCSMM and CEU requirements.

Dedicated Mobile Repair Facility

• Provision and maintenance of a fully equipped mobile repair lab onsite at DGMC.

• Utilization of advanced equipment, including fiber lasers, 2D scanners, and instrument inspection tools.

Quality and Compliance Assurance

• Implementation of a quality control program within 30 days of the contract start date.

• Adherence to The Joint Commission (TJC), Association for the Advancement of Medical

Instrumentation (AAMI), Department of Defense (DoD), and DGMC-specific guidelines.

Fiscal Responsibility

• Coverage of all shipping costs associated with off-site repairs.

• Provision of loaner instruments during off-site maintenance periods.

• Financial coverage for repairs requiring OEM intervention, up to $9,400 per instance.

1.6 Period of Performance (PoP):

Period Period of Performance

Base Period 10/01/2025 – 09/30/2026

Option Period 1 10/01/2026 – 09/30/2027

Option Period 2 10/01/2027 – 09/30/2028

Option Period 3 10/01/2028 – 09/30/2029

Option Period 4 10/01/2029 – 09/30/2030

1.7 Administrative specifications

1.7.1 Place of performance: All services outlined in this Performance Work Statement shall be performed at the following location:

David Grant Medical Center (DGMC) 101

Bodin Circle

Travis Air Force Base, CA 94535

Specifically, maintenance, repairs, and laser marking activities will be conducted in designated areas within DGMC, utilizing a dedicated mobile repair lab provided by the contractor. Off-site repairs will be coordinated as necessary, with shipping costs and loaner equipment provided by the contractor.

1.7.2 Recognized Federal holidays: Not required

New Year’s Day Labor Day

Martin Luther King Jr.’s Birthday Columbus Day

President’s Day Veteran’s Day

Memorial Day Thanksgiving Day

Juneteenth Day Christmas Day

Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday except

Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.10 Quality

1.10.2 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).

1.12 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 CO. 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 5:00 p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.14 Reporting

1.14.3 Government’s 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 CO 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.

1.14.4 Post award conference/periodic progress meetings: Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The

CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.15 Contractor Identification

1.15.1 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 with whom DHA/Deputy Assistant Director for Acquisition (DAD- A)/Head of the Contracting Activity

(HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel.

Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

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

1.15.3 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.

1.15.4 Legal Authorization to Work in the United States: HCWs performing under this contract must be a

U.S. Citizen or as defined by the Department of Homeland Security, U. S. Citizenship, and Immigration Services, either a noncitizen national of the U.S., lawful permanent resident of the U.S., or alien authorized to work in the

U.S.

1.15.5 Installation Access Procedure: Contract workers shall comply with local installation access requirements at the place of performance.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement

Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual

(DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy

Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction

(DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and

DoDM 5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective

September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the

DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275- 6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

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

AFB Air Force Base

AFI Air Force Instruction

AFMAN Air Force Manual

AIS Automated Information System

AQL Acceptable Quality Level

CDRL Contract Data Requirements List

CEU Continuing Education Unit

CLIN Contract Line Item Number

CO Contracting Officer

COR Contracting Officer’s Representative

COTR Contracting Officer’s Technical Representative

CUI Controlled Unclassified Information

DAFI Department of the Air Force Instruction

DAFMAN Department of the Air Force Manual

DAD-A Deputy Assistant Director for Acquisition

DGMC David Grant Medical Center

DHA Defense Health Agency

DoD Department of Defense

DoDD Department of Defense Directive

DoDI Department of Defense Instruction

DoDM Department of Defense Manual

FDA Food and Drug Administration

FAR Federal Acquisition Regulation

FSO Facility Security Officer

HIPAA Health Insurance Portability and Accountability Act

HCA Head of the Contracting Activity

IAHCSMM International Association of Healthcare Central Service Materiel Management IT

Information Technology

MDG Medical Group

MDGI Medical Group Instruction

MOPA Master Oscillator Power Amplifier (fiber laser type)

MTF Military Treatment Facility

OEM Original Equipment Manufacturer

O&M Operations and Maintenance

PWS Performance Work Statement

PMN Premarket Notification

PoP Period of Performance

PRS Performance Requirements Summary

PSP Personnel Security Program

QA Quality Assurance

QASP Quality Assurance Surveillance Plan

R-Services Support (Professional/Administrative/Management) Services SIMP

Surgical Instrumentation Maintenance Program

TJC The Joint Commission

2D Two-Dimensional (refers to matrix code marking)

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the PWS. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF.

Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil/

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct

DoDI 5400.7-R Freedom of Information Act

DoD 6025.18-R Health Information Privacy Regulation Jan 03

DoDD 8500.1 Information Assurance

DoD 8580.02-R HIPAA Security Rule

DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI

33-332 Air Force Privacy and Civil Liberties Program

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

DFARS 239.7602-2 Required Storage of Data within the United States or Outlying Areas

AFMAN17-1201 User Responsibilities and Guidance for Information Systems

AIR FORCE INSTRUCTIONS/MANUALS

DAFI—Department of the Air Force Instruction

DAFMAN- Department of the Air Force Manual

AFP--Air Force Pamphlet

AF Form--Air Force Form

DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as

Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal

Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

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 provide access to relevant DGMC personnel for coordination of maintenance schedules, training sessions, and instrument tracking integration.

• Oversight and guidance from the Contracting Officer’s Representative (COR) for contract compliance and issue resolution.

3.2 Facilities: The Government:

☒ Will provide designated workspace within DGMC for contractor personnel to perform inspections, repairs, and training.

• Parking space and access for the contractor’s dedicated mobile repair lab on hospital grounds.

3.3 Utilities: The Government:

☒ Will provide access to electrical power, lighting, heating/cooling, and water as required to support contractor operations within DGMC and the mobile lab parking area.

• Internet and/or Wi-Fi access for workstations (if needed and authorized) within DGMC.

3.4 Equipment: The Government:

☒ Will provide government-owned instrument tracking system (e.g., Censitrac or equivalent), including scanning stations and tracking software access.

• Any existing government-furnished forms or templates necessary for documenting repairs, maintenance, and service records.

• Access to DGMC’s government-owned laser engraver for supplemental marking of instruments and equipment.

3.5 Materials: The Government:

☒ Will provide access to government-issued publications, directives, and manuals required to ensure regulatory and procedural compliance.

• Labels, tags, and identification supplies provided by DGMC when necessary for use in conjunction with the hospital’s tracking system.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☒ Will provide the following Furnished Services in support of this contract/task order.

• Monthly on-site surgical instrument maintenance and repair.

• Laser engraving and re-marking of surgical instruments, trays, and case carts.

• Initial compliance service (one-time mass labeling, marking, and cleaning of all trays and carts).

• Preventive maintenance and repair of laparoscopic instruments.

• Quarterly inspection and maintenance of backup instrumentation.

• Education and training for DGMC staff (minimum five sessions/year).

• Documentation and reporting of all services performed, including digital images.

4.2 Facilities and Labor: The Contractor

☒ Will provide the following Facilities and Labor in support of this contract/task order.

• A dedicated mobile repair lab (on hospital grounds) for servicing instruments.

• Fully trained and certified technicians capable of handling surgical instrumentation and laser marking.

4.3 Utilities & Equipment: The Contractor

☒ Will provide the following Utilities and Equipment in support of this contract/task order.

• Precision sharpening and repair tools.

• Magnification and inspection equipment.

• OEM-compatible repair equipment.

• A contractor-furnished laser engraving system, capable of 2D data matrix coding and compatible with

DGMC’s tracking system.

• Fiber laser marking unit, passivation station, and inspection tools (per mobile lab specifications).

4.4 Materials: The Contractor

☒ Will provide the following Materials in support of this contract/task order.

• Contractor-supplied replacement parts and components for routine repairs (excluding those requiring OEM intervention).

• Passivation materials used after laser marking to prevent corrosion.

• Supplies for cleaning/removal of old stickers, labels, and adhesives.

• Loaner instruments when DGMC instruments are sent off-site for OEM repair.

4.5 Transportation & Shipping: The Contractor

☒ Will provide the following Transportation and Shipping in support of this contract/task order.

• All shipping and handling costs associated with off-site repairs.

• Coordination and delivery of any replacement or repaired items.

4.6 Compliance & Documentation: The Contractor

☒ Will provide the following Compliance and Documentation in support of this contract/task order.

• A documented Quality Control Program (delivered within 30 days of contract award).

• Compliance with TJC, AAMI, DoD, and OEM standards.

4.7 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

PART 5

5.0 SPECIFIC TASKS

5.1 Contractor Services

5.1.1 Monthly Standard Service

The contractor shall provide ongoing monthly maintenance and repair services for surgical instruments.

Additionally, the contractor shall provide continuous laser marking services for new instruments, trays and carts and re-mark existing instruments, trays, and carts as needed.

Services include:

• On-site repair, sharpening, and cleaning services for surgical instruments.

• Monthly inspections and preventive maintenance in accordance with OEM and industry standards.

• Documentation and reporting of instrument repairs and replacements.

• Quarterly inspections of backup instruments.

• Data entry into DGMC’s instrument tracking system.

• Repair and maintenance of laparoscopic instruments as part of the service package.

• Engraving new surgical instruments, caskets, and five case carts as needed throughout year.

• Reviewing previously engraved instruments, carts, and caskets, and re-engraving as necessary due to wear and deterioration.

• Maintaining and updating instrument tracking system entries.

• Ensuring all laser marks remain legible and scannable by DGMC’s tracking system.

5.1.2 One-Time Initial Service for Compliance

To bring DGMC’s inventory into compliance with updated tracking and labeling standards, the contractor shall complete the following within three (3) months:

• Removal of all existing tracking system labels, stickers, and adhesives.

• Installation of laser-marked case cart tags on up to 75 case carts.

• Removal of labels, stickers, and adhesives and installation of two (2) laser-marked tray tags on up to 3,500 surgical sets/trays.

• Application of 2D data matrix laser marks on up to 2,000 surgical instruments.

• Verification and entry of all 2D data matrix laser marks into DGMC’s tracking system.

• Post-laser marking passivation treatment to reduce corrosion risks.

• Comprehensive tracking and documentation of all services rendered.

5.2 Contractor Responsibilities

The contractor shall:

• Identify defective instruments and remove them from service to prevent patient liability.

• Use only medical-grade parts and materials for repairs.

• Perform all services in designated areas at DGMC, with an on-site team available Monday through Friday, 0730 to 1630.

• Provide digital photographs (minimum 250X magnification) to document instrument condition pre- and post-repair.

• Maintain compliance with DGMC, DoD, and industry regulations.

• Ensure that all services align with The Joint Commission (TJC) and AAMI standards.

Provide continued support and repairs for obsolete equipment to maximize the life expectancy of instruments.

5.3 Dedicated Mobile Repair Lab

The contractor shall provide a dedicated mobile repair lab at David Grant Medical Center. The mobile lab must be outfitted with the necessary tools, parts, and equipment required to proactively service and laser mark surgical instruments and surgical sets in accordance with the PWS. The repair vendor must provide:

• Laser Marking technician.

• A dedicated, fully functional mobile instrument repair and laser marking lab.

• MOPA fiber laser(s).

• 2D data matrix scanner(s).

• Magnification equipment.

• Channel/lumen inspection equipment.

• Computers (laptops).

• Surgical instrument repair parts, tools, and accessories.

• Surgical instrument inspection materials.

• Safety equipment.

5.4 Surgical Instrument Laser Marking

The repair vendor shall utilize a MOPA fiber laser to apply 2D data matrix codes on surgical instruments for tracking and identification purposes. Surgical instruments laser marked by the repair vendor should function as intended and conform to OEM and/or industry standards. Laser marks must be applied in a manner that does not degrade or damage the instrument(s). The repair vendor must be able to laser mark surgical instruments of all types of materials. Immediately following laser marking, surgical instruments must receive a passivation treatment to remove iron and maximize protection against corrosion. The 2D data matrix codes must be placed in a location that does not alter or change instrument functionality or use.

Laser marks (2D data matrix codes) applied by the repair vendor must be compatible with David Grant Medical

Center instrument tracking system(s) (Currently Censitrac) and readable by tracking system scanners. The purpose of this requirement is to ensure that the 2D data matrix codes that are being applied to our instruments, case carts, etc. are compatible with our operating system; otherwise, the markings are useless. This also goes for the second requirement mentioned, "readable by tracking system scanners." We have scanners that we use in conjunction with

Censitrac; without them, the entire process of adding laser engraved matrix codes would be useless. This requirement ensures that the laser engravings can be read by the scanners and can be processed by the software that we use within the unit. Immediately following laser marking, all 2D data matrix codes must be inspected and verified for readability, then entered in David Grant Medical Center’s tracking system(s). The repair vendor must possess instrument tracking system knowledge to ensure laser marked instruments are identified and cataloged properly in DGMC’s tracking system(s). All instrument laser marking activities must be recorded by the repair vendor and shared with DGMC at the conclusion of all service visits.

The repair vendor must adhere to the following steps to ensure tracking system and laser marking accuracy and accountability:

1. Identify and adhere to tracking system numbering sequence.

2. Understand instrument nomenclature and entry format.

3. Consult with DGMC to identify and correct instrument differences across like surgical sets (scrub count sheets).

4. Apply 2D data matrix code to instrument(s) with MOPA fiber laser.

5. Record 2D data matrix code, surgical instrument, and surgical set information.

6. Passivate surgical instruments to reduce the possibility of corrosion.

7. Scan 2D data matrix code to confirm/verify readability.

8. Enter the 2D data matrix code and instrument information in DGMC’s tracking system(s).

9. Inspect and maintain 2D data matrix code laser marks.

10. Repeat.

5.5 Education & Training

• The contractor shall provide comprehensive, real-time training resulting from the maintenance services of each on-site visit. Training shall include:

• Proper inspection, care, and handling of surgical instruments.

• Techniques for preventing excessive instrument wear and damage.

• Differences between economy and surgical-grade instruments.

• A minimum of five (5) educational programs per year, meeting IAHCSMM and state CEU requirements.

• At least one (1) annual training session that provides a certificate of completion.

• Customized educational modules using digital imagery and technology to demonstrate microscopic defects.

• Training scheduled in coordination with DGMC SPD and OR personnel.

• Training for DGMC SPD personnel on the use of DGMC’s own laser engraving system for newly assigned staff.

5.6 Fiscal Responsibilities

• The contractor shall be responsible for shipping costs associated with off-site repairs.

• The contractor shall provide loaner instruments when off-site repairs are necessary.

• If an original equipment manufacturer (OEM) must be used for a repair, the contractor shall cover up to

$9,400 per instance.

5.7 Service Reporting & Documentation

• The contractor shall provide an end-of-service report summarizing all repairs, laser markings, and maintenance activities.

• Data shall include instrument condition before and after service, any non-repairable items, and tracking system updates.

• Reports must be submitted electronically to the designated DGMC point of contact.

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

PART 7, ATTACHMENT 1 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.

Performance Objective PWS

Reference

ACCEPTABLE

QUALITY LEVEL (AQL)

Method of

Surveillance

PRS #1 Preventive maintenance and on- site repairs meet schedule and technical requirements.

PWS Part 5, Para 5.2

100% of the time 100%

Surveillance

PRS #2 Monthly service reports are submitted on time and are accurate and complete.

PWS Part 5, Para 5.7

100% of the time 100%

Surveillance

PRS #3 Laser engraving is accurate, permanent, and readable by the instrument tracking system.

PWS Part 5, Para 5.4

100% of the time 100%

Surveillance

PRS #4 Contractor provides a minimum of five approved training sessions per year.

PWS Part 5, Para 5.5

100% of the time 100%

Surveillance

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

CDRL A001 – Quality Control

Plan

Within 30 days of task order award

Contractors discretion CDRL

A001 to

CO

All, See PWS

1.10.1

CDRL A002 – Monthly Service

Report

Monthly, by the 5th duty day

Electronic (PDF or

Excel)

COR PWS 5.7

CDRL A003 – Training

Session Log & Attendance

Upon completion of each training

Electronic COR PWS 5.5

CDRL A004 – Laser

Engraving Compliance

Summary

Monthly, with service report Electronic COR PWS 5.4

CDRL A005 – Backup

Instrument Inspection

Report

Quarterly Electronic COR PWS 1.5

CDRL A006 – Initial

Compliance Report (One-

Time)

Within 60 days of task order award Electronic COR PWS 1.5

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

2001 Destination Government Destination Government

3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 30-SEP-2025 TO

29-SEP-2026

N/A 60TH MDSS SGSL - MM

60TH MEDGRP

CP 707 423 7973 101 BODIN CIR BLDG 777

TRAVIS AFB CA 94535-1825

(301) 619-9045

FOB: Destination

HT1102

0002 POP 30-SEP-2025 TO

29-MAR-2026

N/A (SAME AS PREVIOUS LOCATION)

FOB: Destination

HT1102

1001 POP 30-SEP-2025 TO

29-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

FOB: Destination

HT1102

2001 POP 30-SEP-2025 TO

29-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

FOB: Destination

HT1102

3001 POP 30-SEP-2025 TO

29-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

FOB: Destination

HT1102

4001 POP 30-SEP-2025 TO

29-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

FOB: Destination

HT1102

CONTRACT ADMINISTRATION

The point of contact for administrative concerns at United States Army Medical Research Acquisition Activity

(USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702 is Christopher L. Cook 301-619- 2640, christopher.l.cook68.civ@health.mil

COR

1. The COR shall be:

Determined at the time of Award mailto:christopher.l.cook68.civ@health.mil

The COR is the duly authorized representative of the Contracting Officer.

The COR will perform inspection and acceptance of services to be provided. Inspection and acceptance will be performed at the location listed in the contract awarded.

DELIVERY

The Contracting Officer reserves the right to adjust the start date of the contract based on the actual award date. The ordering period shall not exceed sixty (6) months.

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984

52.203-11 Certification and Disclosure Regarding Payments to Influence SEP 2024

Certain Federal Transactions 52.203-12 Limitation On Payments To Influence Certain Federal JUN 2020

Transactions 52.204-7 System for Award Management NOV 2024

52.227-1 Authorization and Consent JUN 2020

52.229-3 Federal, State And Local Taxes FEB 2013

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.247-34 F.O.B. Destination JAN 1991

52.249-2 Termination For Convenience Of The Government (Fixed- APR 2012

Price) 52.249-8 Default (Fixed-Price Supply & Service) APR 1984

252.201-7000 Contracting Officer's Representative DEC 1991

252.203-7000 Requirements Relating to Compensation of Former DoD SEP 2011

Officials 252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022

252.203-7005 Representation Relating to Compensation of Former DoD SEP 2022

Officials 252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7015 Notice of Authorized Disclosure of Information for Litigation JAN 2023

Support 252.204-7016 Covered Defense Telecommunications Equipment or Services DEC 2019

-- Representation 252.204-7017 Prohibition on the Acquisition of Covered Defense MAY 2021

Telecommunications Equipment or Services -- Representation 252.204-7018 Prohibition on the Acquisition of Covered Defense JAN 2023

Telecommunications Equipment or Services 252.204-7024 Notice on the Use of the Supplier Performance Risk System MAR 2023

252.225-7048 Export-Controlled Items JUN 2013

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.244-7000 Subcontracts for Commercial Products or Commercial NOV 2023

Services

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph

(d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM)

(https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

http://www.sam.gov/

(d) Representations. The Offeror represents that--

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The

Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered

(include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered

(include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition--

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3

(see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for…