Attachment II - Instrument Management and Maintenance Services Performance Work Statement.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Instrument Management and Maintenance Services

U.S. Navy Medicine Readiness and Training Command Guantanamo Bay, Cuba

(USNMRTC GB)

November 16, 2021

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Instrument Management and Maintenance Services.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Instrument Management and Maintenance Services 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 PWS.

1.3 Background: This is new requirement in support of United States Navy Medicine Readiness and Training Command Guantanamo Bay, Cuba (USNMRTC GB) for Instrument Management and Maintenance Services.

USNMRTC GB is a military treatment facility (MTF) that is a part of Navy Medical Forces Atlantic, located in Cuba. The MTF provides surgical, clinical, and dental services to its military members and beneficiaries. The required services mentioned in this document are critical services that help to sustain patient safety while ensuring instrument functionality, which are essential to daily operations of the command.

1.4 Scope: The Contractor shall provide qualified personnel with tools, supplies, transportation for technicians to perform periodic preventive maintenance, corrective maintenance, replace non-serviceable or non-functional equipment, and perform on location repairs for required equipment. The services required include repair and maintenance services for 159 surgical, medical, and dental instrument trays. The contractor will deliver specified services for surgical, medical, and dental equipment and instruments in accordance with this PWS.

1.5 Period of Performance (PoP): The Contractor shall begin services per the Performance Work Statement on 01 October 2026. The period of performance has base period of 01 October 2026 through 30 September 2027, including four optional periods/years.

Option Period 1: 01 October 2027 through 30 September 2028 Option Period 2: 01 October 2028 through 30 September 2029 Option Period 3: 01 October 2029 through 30 September 2030 Option Period 4: 01 October 2030 through 30 September 2031

1.6 Administrative specifications

1.6.1 Place of performance: The work shall be performed at Hospital Point Road, U.S. Navy Medicine Readiness and Training Command Guantanamo Bay, Cuba, as needed.

1.6.2 Recognized Federal holidays: The contractor is not required to perform services on recognized federal holidays or presidential executive orders.

1.6.3 Hours of operation: The Contractor shall be responsible for conducting operations from Friday through Wednesday, 8:00 a.m. to 4:30 p.m., inclusive of weekends. Services are required at all times except during observed Federal holidays or instances when the Government facility is closed due to local or national emergencies, administrative mandates, or other Government-directed closures. The Contractor shall maintain a sufficient workforce to ensure the uninterrupted performance of all tasks described within this PWS during all periods when the facility is operational.

1.7 Travel Requirements:

1.7.1 Contractor Travel: Contractor’s unit pricing shall be inclusive of all associated costs to perform the work including travel, per-diem, lodging, transportation, miscellaneous travel expenses, and shipping of contractor tools, supplies, and misc. equipment. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR). The contractor shall access the Joint Travel Regulations website, https://www.travel.dod.mil/Policy-Regulations/Joint-Travel-Regulations/ to review travel and regulatory guidance.

November 16, 2021

Dates for any site visit is required to be provided to the Sponsor 45 – 60 days prior to each visit. The Contractor shall be responsible for all travel and travel related costs (lodging, airfare, per Diem, and transportation) and accommodations shall be arranged by the Contractor, upon receiving flight information from their sponsor.

1.7.2 The contractor shall acquire access and complete training for the Synchronized Predeployment and Operational Tracker (SPOT) Letter of Authorization (LOA) system. Training for SPOT access and submissions can be obtained through the following: https://spot.dmdc.mil/default.aspx

1.8. Flight Arrangements:

1.8.1 Military Air Travel: While the preferred mode of travel for this contract is MILAIR, the availability of flights is subject to change. Based on this, the Government will facilitate negotiations with the contractor as needed to address any changes related to the availability of flights to and from the place of performance, Guantanamo Bay, Cuba. Travel shall not occur until such time as the travel Contract Line-Item Number (CLIN) identified in the contract is fully funded.

1.8.2 Contractor Authorized Government Services: Synchronized Pre-deployment and Operational Tracker Letter of Authorization (SPOT LOA) requires designation of Contractor Authorized Government Services. The table below identifies those designations.

1.9 Base Access:

1.9.1 The contractor shall complete the Synchronized Predeployment and Operational Tracker (SPOT) Form and 5512 form and provide a copy of their passport/proof of U.S. citizenship. The Contractor shall finalize all travel dates and ensure the SPOT Letter of Authorization (LOA) is fully processed no later than four (4) weeks prior, estimate of (45 days for personnel with dual citizenship), to the scheduled travel date. Typed fonts intended to mimic a signature are not acceptable. A valid digital signature (e.g., CAC-based) or a scanned, handwritten signature is required. Once the form has been approved, the base POC will provide the traveler with signed copy. Strict https://spot.dmdc.mil/default.aspx https://spot.dmdc.mil/default.aspx

November 16, 2021 adherence to documentation accuracy is mandatory; any discrepancies in submitted forms may result in the traveler being denied boarding at the terminal. Once forms are complete, the forms go to the Sponsor for further processing.

1.9.2 Following initial administrative processing, the Government Sponsor shall facilitate the formal endorsement of SECNAV Form 5512/1. Installation Security will conduct a background investigation and provide official endorsement upon favorable determination. Failure to provide accurate and complete information on this form may result in the denial of installation access. The designated lodging facility will endorse the form upon verification of confirmed reservations. The Government Sponsor is responsible for routing and collecting these mandatory endorsements. Upon receipt of the SECNAV Form 5512/1 containing all required endorsements from Installation Security and the designated lodging provider, the Contracting Officer’s Representative (COR) shall initiate the SPOT request. This action will facilitate the formal issuance of the Letter of Authorization (LOA) from the Contracting Office.

1.10 Contractor personnel

1.10.1 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.

1.10.2 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 Commanding Officer (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 4:30 p.m., Friday through Wednesday, except Federal holidays or when the Government facility is closed for administrative reasons.

1.10.3 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.

1.11 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.3. 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 appraise 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.

1.12 Contractor Identification

1.12.1 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. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel. Contractor personnel will be required to attend meetings or otherwise

November 16, 2021 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.

1.12.2 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.

2.0 SPECIFIC TASKS

2.1 The contractor shall provide comprehensive service and maintenance for the entire equipment/instrument inventory utilized by the Department of Surgery (DSS) Main Operating Room (MOR), the Sterile Processing Department (SPD), and the Directory for Dental Services (DDS), in accordance with this Performance Work Statement.

2.2 The Contractor shall inspect all instruments, on location once a year for seven (7) days. The instruments may include General Instruments, Micro Instruments, Orthopedic Instruments, Endoscopic Instruments, Flexible Biopsy Forceps, Vascular Instruments, Hysteroscopy, Cystoscopy and Urology Instruments, Needle Holder TC Insert Replacements, OB-GYN Instruments, Pediatric Instruments, Diamond Dusting, Sterilization Containers, Laparoscopic Instruments, Dental Trays, Dental instruments, and Dental Cassettes.

2.3 The Contractor shall provide instrument management and maintenance services to include inspecting, cleaning and lubricating, repairing, to include alignment, adjustment, pins, sharpening, inserts, laparoscopic shaft insulation, springs and manufactured parts and/or screw replacement.

2.4 The Contractor shall conduct a comprehensive assessment of the MTF’s Surgical Instrument inventory.

2.5 The Contractor shall maintain all surgical instrumentation and medical devices in accordance with Original Equipment Manufacturer (OEM) specifications to ensure clinical readiness.

2.6 The Contractor shall be an Original Equipment Manufacturer (OEM) authorized service provider for V. Mueller surgical instruments

2.7 The Contractor shall conduct an annual on-site visit to the Military Treatment Facility (MTF) to perform a formal review. During this visit, the Contractor shall submit a detailed Surgical Instrument Repair Metrics Report to the Government Representative. This report shall provide an analysis of repair frequencies, maintenance trends, and the overall serviceability status of the surgical instrumentation inventory to ensure continued operational readiness for clinical procedures.

2.8 The Contractor shall make repairs to the extent necessary, as determined by inspection tests or disassembly, to ensure a functional system that will efficiently serve its intended purpose and the technical specification for that equipment as designated by the original equipment manufacturer. Maintenance of all surgical and dental instrumentation shall be conducted in accordance with the Original Equipment Manufacturer (OEM) specifications and guidelines.

2.9 The Contractor shall replace any surgical instrumentation deemed unserviceable or condemned by the Government. Such replacements shall be executed on-site utilizing the Instrument Exchange (I-Exchange) program, subject to an annual Not-To-Exceed (NTE) threshold of $10,000.00. In the event that replacements or returned instrumentation must be transported or shipped to facilitate the exchange, the Contractor shall bear all shipping, packaging, handling, and transit costs. All such shipping actions shall be executed at no additional cost to the Government.

November 16, 2021

2.10 The Contractor’s technician shall be fully qualified in the repair of all equipment. Contractor’s technician shall maintain current qualifications throughout the entire contract period of performance. Qualification includes the certification of all repair technicians and repair facilities by the OEM, training on the equipment and continuous hands-on repair experience with the equipment.

2.11 The Contractor shall provide comprehensive educational training sessions encompassing all aspects of proper equipment management, specialized care, and instrument handling protocols. These instructional presentations must be formally accredited to provide a minimum of one (1) Continuing Education Unit (CEU) credit per session for all attending personnel within the Sterile Processing Department (SPD) / Central Sterile Supply (CSS). All training sessions, associated instructional materials, and CEU credentialing shall be provided at no additional cost to the Government.

2.11 Contractor personnel shall be able to read, write, speak, and understand English.

2.12 The contractor shall complete mandatory training courses on Joint Knowledge Online (JKO) and Aircraft and Personnel Automated Clearance System (APACS) and Isolated Personnel Report (ISOPREP) every six (6) months.

2.13 Contractor personnel shall present a neat appearance commensurate with that required of a professional.

2.14 The Contractor shall provide surgical instrument replacements while instruments are being repaired. The product should be of equal quality to the instrument being repaired.

2.15 The Contractor shall maintain comprehensive insurance coverage for a duration of twelve (12) months, covering the loss, damage, or destruction of any instrumentation while in the care, custody, or control of Contractor personnel.

2.16 Disposal. The Contractor shall dispose of all replaced items in accordance with local command policy at no additional cost to the Government. Specifically, to comply with local installation procedures, the Contractor shall transfer all replaced medical/dental instruments designated for disposal to the Biomedical Engineering (Biomed) Department.

2.17 Corrective Maintenance (Repairs). The contractor shall identify and report Equipment under this PWS that requires corrective maintenance throughout the life of this contract. The Contractor shall provide a report via email to the Contracting Officer Representative (COR). The written report shall include the identification of the equipment (e.g., Serial number, equipment name) that requires corrective maintenance, fault, and corrective maintenance to resolve the fault, including identification of the parts that are required to bring the unit back to working conditions per OEM specifications. The Contractor shall ensure that the original design and functional capabilities will not be changed, modified, or altered unless authorized in writing.

2.18 Phase-Out of Service: Upon expiration or termination of this contract, the Contractor shall provide certification that the instrumentation under this contract meets OEM specifications. If any of the instruments are not in normal operating condition, the Contractor shall provide details of the instrument’s condition/status, and a corrective maintenance report shall be provided at no additional cost to the Government.

2.19 Work Site Maintenance: The Contractor shall maintain a neat and orderly work environment. At the conclusion of the performance period, the Contractor shall remove all proprietary materials and equipment from the facility.

2.20 Equipment Handoff and Biohazard Mitigation: The Government assumes responsibility for initial biohazard mitigation. MTF personnel shall completely sterilize all instruments prior to releasing them to the Contractor for servicing.

2.21 Reports

November 16, 2021

2.21.1 Photographic Documentation: The Contractor shall provide pre- and post-repair photographic evidence for complex repairs or significant findings to document the restorative process.

2.21.2 Observations and Remediation: The Contractor shall record detailed observations during each service visit.

These observations shall be paired with recommended remediation strategies and preventative measures to mitigate the recurrence of identified issues.

2.21.3 Volume Analysis: The Contractor shall provide a comparative analysis detailing the total number of instrument trays serviced against the established preventative maintenance (PM) service volume baseline.

2.21.4 PM Compliance Metrics: The Contractor shall track and report preventative maintenance status, explicitly denoting the percentage of the inventory that is current versus the percentage that is overdue for service.

2.21.5 Non-repairable or non-serviceable items: The Contractor shall provide an aggregate count of all instruments evaluated and deemed non-repairable during the reporting period.

2.21.6 Beyond Repair Standards: The Contractor shall define, document, and consistently apply the specific physical degradation standards utilized as the basis for the condemnation of any instrument.

2.21.7 Technical Quality Tracking: The Contractor shall maintain and report defined quality tracking standards for all technical staff. This shall include tracking capabilities to ensure the workmanship meets established performance requirements.

3.0 GOVERNMENT-FURNISHED PROPERTY AND SERVICES

3.1 Government Responsibility for Damage: The Government shall not be responsible, in any way, for damage to the Contractor employees’ personal belongings brought onto the site.

3.2 Telephones: Government telephone facilities will be made available to the Contractor for official business use only. This includes contacting manufacturers, suppliers, and Government users. Access to outside lines and international calls may be restricted in accordance with USNMRTC and the Joint Task Force Guantanamo Bay policy.

4.0 CONTRACTOR FURNISHED PROPERTY AND SERVICES

4.1 Responsibility: The Contractor shall furnish all supplies, materials, repair or replacement parts, tools, and labor necessary to efficiently and acceptably fulfill the requirements of this contract.

4.2 Damages: The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damage caused by the Contractor’s activities. During performance of services, Contractor shall keep USNMRTC safe, neat, clean, and orderly.

4.3 Contractor Supplies and Equipment: The Contractor supplies and equipment shall comply with Federal, State, municipal, and industry or OEM specifications.