Performance Work Statement (PWS).docx

Department of Defense Defense Health Agency Performance Work Statement

Ventilator Maintenance Services for Biomed Department

Naval Medical Readiness Training Center Portsmouth, VA (NMRTC) Materials Management Department

Date: 08APR2025

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide preventative maintenance and on- site repairs for Ventilators located at Naval Medical Readiness Training Center Portsmouth, VA (NMRTC Portsmouth).

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide full maintenance and repair support for the items listed in Section 1.5 and all support items / components as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.3 Background: The Respiratory, ICU, NICU, ER and PICU department of Naval Medical Readiness Training Command Portsmouth in Portsmouth, VA has a requirement for a service and maintenance plan for Hamilton ventilators and their components. This equipment was purchased C1 13OCT2023, C6 06SEP2022, G5 28JUL2014, MR1 26JUN2019, T1 28OCT2023.

1.4 Objective: This contract shall provide annual preventative maintenance services in accordance with the Original Equipment Manufacturers (OEM) recommendations. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); routine preventive maintenance services to Department of Defense owned equipment. All maintenance provisions shall apply to firmware, and software updates, as applicable, unless otherwise stated. Additionally, contractor must have ready access to parts inventory of OEM replacement parts required for preventive maintenance.

1.5 Scope: Uninterrupted operation of the Hamilton ventilator units is vital to support of the Navy mission. An annual service contract is required to support the installed equipment located within the Respiratory, ICU, NICU, ER and PICU departments. The service contract would include access to technicians via phone, text, or email, technical phone support during procedures, on-site preventative maintenance once every 12 months, and as needed on-site emergency service and repair for malfunctioning equipment. Service will include full coverage on parts/travel/labor charges, full coverage on replacement consoles/parts, hardware and all software updates, shipping to ensure parts are available to on-site technicians during service and maintenance, and a 24 hr response time for preventative maintenance. The contractor shall make a best effort to schedule and complete annual preventive maintenance services once a year by the 15th of October, but no later than the last day of the month for all equipment listed below and their subcomponents.

1.6 Period of Performance (PoP):

BASE Year (18-FEB-2026 TO 17-FEB-2027) Option Year 1 (18-FEB-2027 TO 17-FEB-2028) Option Year 2 (18-FEB-2028 TO 17-FEB-2029) Option Year 3 (18-FEB-2029 TO 17-FEB-2030) Option Year 4 (18-FEB-2030 TO 17-FEB-2031)

1.6.1 Transition: N/A

1.6.1.1 Transition-in period: N/A

1.6.2 The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide calibration support for the items listed and all support items / components as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.6.2.1 The Contractor shall be qualified / authorized by the Original Equipment Manufacturers (OEM) (IE: Certified Agent of the OEM) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and throughout contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. In the event that a sub-contractor is used for this requirement, the sub-contractor must be a Certified Agent of the OEM. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally, contractor must have ready access to parts inventory of OEM replacement parts.

1.6.3 Corrective Maintenance

1.6.4 Government request for corrective maintenance will be placed by BME, to the Contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract. (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays).

1.6.5 The Contractor shall assign a unique Log/Reference Number to each Government request for Corrective Maintenance.

1.6.6 Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor Field Service Engineer (FSE). Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of an FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

1.6.7 Contractor’s pricing shall be inclusive of all cost including parts, labor, travel, and shipping.

1.6.8 The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

1.6.9 This contract shall provide all corrective maintenance services in accordance with the Original Equipment Manufacturers (OEM) recommendations. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); routine preventive maintenance services to Department of Defense owned equipment. All maintenance provisions shall apply to firmware, and software updates, as applicable, unless otherwise stated. Additionally, contractor must have ready access to parts inventory of OEM replacement parts required for preventive maintenance. The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. The vendor shall be required to provide documentation from the manufacturer stating the vendor is an authorized service provider on the required equipment/system. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at the Respiratory, ICU, NICU, ER and PICU departments Lab department at Naval Medical Readiness and Training Command Portsmouth (NMRTC-P) located at 620 John Paul Jones Cir, Portsmouth, VA 23708.

1.7.2 Recognized Federal Holidays: The Contractor will not be required to perform services on the day of observance of Federal Holidays.

DHA PWS Template V13 November 16, 2021

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Juneteenth Day Independence Day

Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday between 8:00 A.M. to 4:00 P.M 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.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Other Direct Costs (ODC):

1.9 Quality

1.9.1 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. 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. See Part 7, Technical Exhibit 1 - CDRL A001.

1.9.2 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).

1.9.3 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.

1.9.4 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 42.5. 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.

1.9.5 During normal duty hours: Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. (Biomedical Engineering located in Build-250 1st floor; 757-953-5336). The Contractor FSEs shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Contractor FSE’s shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor) and the systems operator designated by BME.

1.9.6 The Contractor shall provide to BME a full-service report within two (2) days after completion of all service performed. Additionally, contractor will be required to affix a tag on equipment upon the completion of a calibration. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed.

1.14.7 The Contractor shall provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.

1.9.7 Contractor Identification: 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.

1.9.8 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.

1.9.9 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, 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.

2.1.7

2.2 Acronyms:

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

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:

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office and requested within the PIEE/GFP Module system.

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government, or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

The contractor shall report semi-annually 100% inventories, reconciliations, and final disposition of GFP provided by the government. Final invoices will not be paid pending GFP reconciliation. Contractors shall be aware of and ensure compliance with applicable FAR Part 45, DFARS 245 and 252.245, Defense Pricing and Contracting Policies, Procurement Integrated Enterprise Environment Standards, DHA Administrative Instruction 094 and DHA Guidance.

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 Services: The Contractor:

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

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

4.2 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

5.0.1 Preventive Maintenance Services: This contract shall provide annual preventative maintenance services in accordance with the Original Equipment Manufacturers (OEM) recommendations. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); routine preventive maintenance services to Department of Defense owned equipment. All maintenance provisions shall apply to firmware, and software updates, as applicable, unless otherwise stated. Additionally, contractor must have ready access to parts inventory of OEM replacement parts required for preventive maintenance.

5.0.2 Corrective Maintenance Services: This contract shall provide corrective maintenance services in accordance with the Original Equipment Manufacturers (OEM) recommendations. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); routine preventive maintenance services to Department of Defense owned equipment. All maintenance provisions shall apply to firmware, and software updates, as applicable, unless otherwise stated. Additionally, contractor must have ready access to parts inventory of OEM replacement parts required for corrective maintenance. Equipment must be repaired back to factory OEM condition upon completion of service.

5.1 Special Qualifications:

5.1.1 When using education/certification in conjunction with labor categories, the COR in coordination with the CO must establish a review process of contractor personnel to ensure labor category requirements are met.

5.1.2 The contractor shall make a best effort to schedule and complete annual preventive maintenance services once a year by the 15th of October 2025, but no later than the last day of the month for all equipment listed below and their subcomponents.

5.2.3 The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor’s expense and shall be inspected to the satisfaction of the Contracting Officer or appointed representative.

5.2.4 During each scheduled preventive maintenance visit performed during the Base and each Option Year, the Contractor shall replace all worn or defective parts as required to complete the preventive maintenance with Original Equipment Manufacturer (OEM) parts.

5.2.4.1 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacturer of test equipment) and shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards.

5.2.4.2 An annual service contract is required to support the installed equipment located within the Respiratory, ICU, NICU, ER and PICU departments. The service contract would include access to technicians via phone, text, or email, technical phone support during procedures, on-site preventative maintenance once every 12 months, and as needed on-site emergency service and repair for malfunctioning equipment. Service will include full coverage on parts/travel/labor charges, full coverage on replacement consoles/parts, hardware and all software updates, shipping to ensure parts are available to on-site technicians during service and maintenance, and a 24 hr response time for preventative maintenance. The contractor shall make a best effort to schedule and complete annual preventive maintenance services once a year by the 15th of October, but no later than the last day of the month for all equipment listed below and their subcomponents.

PART 6, 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 (The Service required—usually a shall statement from Part 5)

could possibly be “Zero deviation from standard”) Method of Surveillance

Performance Requirements Summary (PRS) # 1.

Maintain and repair For Ventilators Maintenance for NMRTC Portsmouth.

preventive maintenance is performed within 30 days of the due date.

100% of all periodic, preventive maintenance is performed within 60 days of due date.

Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

PRS # 2

The Contractor shall inspect, maintain, and test Ventilators, if needed repairs and software updates shall be completed.

What: Repairs and software updates for Ventilators How: 100% IAW manufacturer’s Manual, Customer feedback trouble reports, Field Service Reports Who: Users, Technical engineers Incentive: $100 deduct for out of compliance documentation $50 deduct for failure to perform preventive maintenance on schedule.

Standard(s): Incentive applies to standard (a) and (b) only Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

PRS # 3

The Contractor shall conduct preventive maintenance for all equipment listed in the PWS of the contract.

a) Preventive maintenance performed IAW the manufacturer's manual 100% of the time

b) Meets all warranty requirements What: Preventive Maintenance for Ventilators How: Preventive maintenance performed IAW the manufacturer's manual, On-site periodic inspections, and all completion documents shall be sent to Biomed Who: Vendor’s Technician Incentive: $100 deduct for each PM procedure not performed IAW manufacturer manuals Standard(s): Inspection applies to all standards Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

PRS # 4

The Contractor shall assure parts availability for continuous operation.

Deliverables:

A02 Parts Inventory List

a) Sufficient parts are available to support the required Ao and the mandated parts list AQL: Ao is maintained Mandated Parts List is complete 98.8% of the time What: Parts Inventories Availability Records How: Records and Visual Inspection On-site periodic inspections Frequency: After completion of each inventory Who: COR for Ao Mechanics Staff for parts Standard(s): Inspection applies to all standards Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

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