DRAFT PWS for Cardiology Equipment Nov 2026.docx

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Request for Information: Cardiology Equipment Preventative Maintenance and Service Agreement for Naval Medical Center Portsmouth
Solicitation number
12467230
Issued by

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This is a Draft Performance Work Statement (PWS) for preventive maintenance and service of cardiology equipment at Naval Medical Center Portsmouth, a Defense Health Agency (DHA) facility located in Portsmouth, Virginia. The contract consolidates services previously performed under two separate contracts (N0018320P0613 and N0018321P0527) and covers comprehensive maintenance, repair, and support services for three equipment systems: the LabSystem Pro Recording System (BARD, priced at $30,900 annually), the MicroPace Stimulator (BARD EPS320, priced at $12,300 annually), and the Angiojet Recording System/Ultra EverCare (MEDRAD, priced at $8,500 annually). The period of performance spans from January 1, 2027, through December 31, 2029, consisting of a base year (2027) and two option years (2028–2029).

The contractor must be an Original Equipment Manufacturer (OEM) certified service provider with current certifications maintained throughout the contract period and must provide annual preventive maintenance scheduled by June 15th at the latest, 24/7 technical support via toll-free response center, corrective maintenance with telephone response within 4 hours and on-site service within 48 hours during normal business hours (Monday–Friday, 8:00 a.m.–4:30 p.m. EST), and all replacement parts, labor, travel, and shipping costs inclusive in pricing. The contractor must supply trained personnel, calibrated test equipment compliant with Joint Commission and FDA standards, Field Service Reports within two days of service completion, and software updates at no additional cost. Preventive maintenance must be performed in accordance with OEM specifications with a 100% acceptable quality level, and corrective maintenance response times include best-effort targets of 72 hours for equipment operability. Work is performed at Naval Medical Center Portsmouth, Building 2 (Cardiac Cath Lab) and Building 250 (Biomedical Department), with contractor personnel required to report to and coordinate through the Biomedical Engineering Department.

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Department of Defense Defense Health Agency Performance Work Statement

Preventive Maintenance and Service for Cardiology Equipment

PART 1

1.0 GENERAL INFORMATION

1.1. Description of Service/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other non-personal services necessary to perform comprehensive maintenance, repair, and support services for cardiology equipment located at Naval Medical Center Portsmouth, 620 John Paul Jones Cir, Portsmouth, VA 23708.

1.2. Background: This requirement consolidates services previously performed under contract numbers N0018320P0613 and N0018321P0527. The Cardiology Department and Cardiac Cath Lab at Naval Medical Center Portsmouth have an ongoing need for comprehensive maintenance and service plans for critical cardiology equipment, including the LabSystem™ Pro Recording System, MicroPace™ Stimulator, and Angiojet™ Recording System. In the past, some of this equipment was serviced through warranties and contracts that have since expired, necessitating a new, consolidated service contract to ensure continued operational readiness and patient safety.

1.3. Period of Performance (PoP): 01 January 2027 – 31 December 2029

Base Year
01 January 2027 – 31 December 2027
Option Year 1
01 January 2028 – 31 December 2028
Option Year 2
01 January 2029 – 31 December 2029

1.4. Objectives: The primary objective is to ensure all listed cardiology equipment is maintained to meet OEM specifications for both functional performance and safety. This includes regular preventative maintenance, timely corrective repairs, and system calibrations to minimize equipment downtime and support the delivery of high-quality cardiovascular care.

1.5. Scope: This contract covers comprehensive annual services for the Electrophysiology and Angioplasty Systems. This service contract will include maintenance service, emergency service, routine preventative maintenance, access to a Technician Service Center, 24/7 Technical Support during patient procedures, and full coverage on parts, travel, and labor charges as specified in Part 3.

1.6. Federal Regulations: The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall implement procedures to identify, prevent, and ensure the non-recurrence of defective services.

1.7. Geographical Location: The work shall be performed at Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth, VA 23708. Specific locations include Building 2 (2nd floor, Cardiac Cath Lab, Lab #1) and Building 250 (Biomed Dept).

1.8. 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.

1.8.1. Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.9. Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the Contracting Officer (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 regarding 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.

1.10. 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.

1.10.1. The contractor shall report Biomedical Engineering, Building 250, 1st floor, located at 54 Lewis Minor St, Portsmouth, VA 23708, to ensure a clear understanding of the requirements and to be escorted to the required location before any services are performed under this contract.

1.10.2. After services are completed, the contractor shall report to Biomedical Engineering to provide a Field Service Report (FSR) and verify that the work has been completed before departure.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions: N/A

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:

AISAutomated Information System
APLApproved Products List APL
AQLAcceptable Quality Level
ARRTAcquisition Requirements Roadmap Tool
ATOAuthority to Operate
B2BBusiness-2-Business
CACCommon Access Card
CAPCloud Access Point
CCEVSCommon Criteria Cybersecurity Evaluation and Validation Scheme
CDICovered Defense Information
CEComputer Environment
CDRLContract Data Requirement List
CIOChief Information Officer
CJCSMChairman of the Joint Chiefs of Staff Manual
CMMCCybersecurity Maturity Model Certification
CMRContractor Manpower Reporting
CNSSICommittee on National Security Systems Instruction
COContracting Officer(s)
CONUSContinental United States (excludes Alaska and Hawaii)
CORContracting Officer Representative
COTRContracting Officer's Technical Representative
CSPCloud Service Provider
CSSPCyber Security Service Provider
CUIControlled Unclassified Information
DAD-ADeputy Assistant Director for Acquisition
DC3DoD Cyber Crime Center
DD Form 254Department of Defense Contract Security Requirement List (if applicable)
DBDesign-Build
DBBDesign-Bid-Build
DFARSDefense Federal Acquisition Regulation Supplement
DHADefense Health Agency
DISADefense Information System Agency
DoDDepartment of Defense
DoDDDepartment of Defense Directive
DoDIDepartment of Defense Instruction
DSAsData Sharing Agreements
DSAAData Sharing Agreement Application
DMZDemilitarized Zone
DoDMDepartment of Defense Manual
DPCLODHA Privacy and Civil Liberties Office
DUAData Use Agreement
eMSMEnhanced Multi-Service Markets
EULAEnd User License Agreement
EVMEarned Value Management
FARFederal Acquisition Regulation
FCIFederal contract information
FEFacilities Enterprise
FedRAMPFederal Risk Authorization and Management Program
FISMAFederal Information Security Modernization Act
FRCSFacility Related Control Systems
FSOFacilities Security Officer
HAHealth Affairs
HIPAAHealth Insurance Portability and Accountability Act
HCAHead of the Contracting Activity
HITHealth Information Technology
IGCEIndependent Government Cost Estimate
IAInformation Assurance
IOInitial Outfitting
I/OIn/Out Processing Portal
IPvInternet Protocol Version
ISInformation System
ISPInternet Service Provider
ITInformation Technology
ISCMInformation Security Continuous Monitoring
IV&VIndependent Verification & Validation
MedCOIMedical Community of Interest
MHSMilitary Health System
MIL-STDMilitary Standard
MTFsMilitary Treatment Facilities
NCRNational Capitol Region
NDANon-Disclosure Agreement
NIAPNational Information Assurance Partnership
NISTNational Institute of Standards and Technology
OCONUSOutside Continental United States (includes Alaska and Hawaii)
ODCOther Direct Costs
OPMOffice of Personal Management
OSDOffice of the Secretary of Defense
P-ATOPersonal Authorization to Operate
P&RPersonnel and Readiness
PGIProcedures, Guidance and Information
PDTProject Delivery Team
PHIProtected Health Information
PIIPersonally Identifiable Information
PITPlatform Information Technology
PKPublic Key
PKIPublic Key Infrastructure
POA&MPlan of Action and Milestones
POCPoint of Contact
PMOProgram Management Office
PoPPeriod of Performance
PPPersonal Property
PPSMPorts, Protocols, and Services Management
PRSPerformance Requirements Summary
PSPPersonnel Security Program
PWSPerformance Work Statement
QAQuality Assurance
QAPQuality Assurance Program
QASPQuality Assurance Surveillance Plan
QCQuality Control
QCPQuality Control Plan
RFPRequest for Proposal
RFQRequest for Quotation
RMFRisk Management Framework
SPSpecial Publication
SPRSSupplier Performance Risk System
SRMSustainment, Restoration and Modernization
SRGSecurity Requirements Guides
STIGSecurity Technical Implementation Guides
TOSTerms of Service
USUnited States
UFCUnified Facilities Criteria
VPNVirtual Private Network
XMLExtensible Markup Language

PART 3

3.0 SPECIFIC TASK

3.1. Service Agreement for Annual Preventative Maintenance and Corrective Maintenance

This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, normal working hour coverage; emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

3.2. PLAN: EP LabSystem Pro EverCare Plus (120 Channel Amp)

ECN
Serial #
Nomenclature
Manufacturer
Model
Pricing for Each Year
160907
1E872805
MONITORING SYSTEM, PHYSIOLOGIC, CARDIAC ELECTROPHYSIOLOGY
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
LAB SYSTEM PRO
$30,900.00

Subcomponents:

111130
VNB3L11167
PRINTER, COMPUTER/NETWORK, LASER
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
P2035
146312
3167490
WORKSTATION, COMPUTER, CPU/MONITOR/KEYBOARD
HEWLETT-PACKARD CO (MEDICAL PRODUCTS)
XW4600
111133
43076040
MONITOR, VIDEO
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
52433WH
111134
43138040
MONITOR, VIDEO
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
52433WH
111135
43140040
MONITOR, VIDEO
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
52433WH
111137
MP3114
MONITOR, VIDEO, MEDICAL
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
EPS320

3.2.1. Preventive maintenance: The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of designated month, but no later than the last day of the month. Shall be performed once a year in accordance with the Original Equipment Manufacturers (OEM) recommendations. The contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the service and 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( original equipment manufacturer) 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.

3.2.1.1. This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, if an FSE is in the geographic area. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of June, but no later than the last day of the month. Vendor shall report to Biomedical Engineering Bldg. 250 1st floor located at 54 Lewis Minor St. Portsmouth, VA 23708. The contact number is 757-953-5336. The FSE shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, contractor FSEs shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor).

3.2.1.2 The contractor shall provide BME a Field Service Report (FSR) within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents/sub-contractor’s are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally, contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. 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. FSR will be emailed to BME distribution email at usn.hampton-roads.nmrtc-portsmouth-va.list.nmcp-dfabiomed@health.mil.

3.2.1.3 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission (JC) Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

3.2.1.4 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. If one is available in the geographic area.

3.2.1.5 The contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. The contractor points of contact (POC). Service calls shall be placed 24 hours a day, 7 days a week by calling a vendor supplied toll free response center. Qualified service reps are required to make a “best effort” to call back within 4-hours during normal business hours (8:00am – 4:30pm EST Monday – Friday excluding Federal Holidays) to schedule service visit.

3.2.2 Corrective Maintenance: Normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 4 hours after receipt of trouble call and make a best effort to provide on-site service within 48 hours of call and a best effort to have all equipment operational within 72 hours of initial on-site response.

3.2.2.1 In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates and negotiated and approved by a Contracting Officer prior to services rendered. 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.

3.2.3 Replacement Parts: The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, Joint Commission (JC), manufacturer’s certifications or any other certifications as they apply.

3.2.3.1 The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items.

3.2.3.2 Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

3.2.3.3 Contractor’s pricing shall be inclusive of all costs including parts, labor, travel and shipping, unless otherwise indicated.

3.2.3.4 Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the contractor.

3.2.4 Software: The contractor must include software revisions and updates (field service changes or technical service updates (TSUs)), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

3.3 PLAN: EP MicroPace TotalCare

ECN
Serial #
Nomenclature
Manufacturer
Model
Pricing for Each Year
111131
2082
STIMULATOR, ELECTRICAL, CARDIAC
BARD ELECTROPHYSIOLOGY DIV CR BARD INC
EPS320
$12,300.00

3.3.1. Preventive maintenance: The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of designated month, but no later than the last day of the month. Shall be performed once a year in accordance with the Original Equipment Manufacturers (OEM) recommendations. The contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the service and 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( original equipment manufacturer) 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.

3.3.1.1. This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, if an FSE is in the geographic area. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of June, but no later than the last day of the month. Vendor shall report to Biomedical Engineering Bldg. 250 1st floor located at 54 Lewis Minor St. Portsmouth, VA 23708. The contact number is 757-953-5336. The FSE shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, contractor FSEs shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor).

3.3.1.2 The contractor shall provide BME a Field Service Report (FSR) within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents/sub-contractors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally, contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. 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. FSR will be emailed to BME distribution email at usn.hampton-roads.nmrtc-portsmouth-va.list.nmcp-dfabiomed@health.mil.

3.3.1.3 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission (JC) Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

3.3.1.4 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. If one is available in the geographic area.

3.3.1.5 The contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. The contractor points of contact (POC). Service calls shall be placed 24 hours a day, 7 days a week by calling a vendor supplied toll free response center. Qualified service reps are required to make a “best effort” to call back within 4-hours during normal business hours (8:00am – 4:30pm EST Monday – Friday excluding Federal Holidays) to schedule service visit.

3.3.2 Corrective Maintenance: Normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 4 hours after receipt of trouble call and make a best effort to provide on-site service within 48 hours of call and a best effort to have all equipment operational within 72 hours of initial on-site response.

3.3.2.1 In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates and negotiated and approved by a Contracting Officer prior to services rendered. 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.

3.3.3 Replacement Parts: The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, Joint Commission (JC), manufacturer’s certifications or any other certifications as they apply.

3.3.3.1 The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items.

3.3.3.2 Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

3.3.3.3 Contractor’s pricing shall be inclusive of all costs including parts, labor, travel and shipping, unless otherwise indicated.

3.3.3.4 Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the contractor.

3.3.4 Software: The contractor must include software revisions and updates (field service changes or technical service updates (TSUs)), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

3.4 PLAN: PI Ultra EverCare (POST)

ECN
Serial #
Nomenclature
Manufacturer
Model
Pricing for Each Year
109160
U3957
ANGIOPLASTY SYSTEM, ATHEROTOMY
MEDRAD, INC.
105650
$8,500.00

3.4.1. Preventive maintenance: The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of designated month, but no later than the last day of the month. Shall be performed once a year in accordance with the Original Equipment Manufacturers (OEM) recommendations. The contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the service and 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( original equipment manufacturer) 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.

3.4.1.1. This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, if an FSE is in the geographic area. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of June, but no later than the last day of the month. Vendor shall report to Biomedical Engineering Bldg. 250 1st floor located at 54 Lewis Minor St. Portsmouth, VA 23708. The contact number is 757-953-5336. The FSE shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, contractor FSEs shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor).

3.4.1.2 The contractor shall provide BME a Field Service Report (FSR) within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents/sub-contractors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally, contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. 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. FSR will be emailed to BME distribution email at usn.hampton-roads.nmrtc-portsmouth-va.list.nmcp-dfabiomed@health.mil.

3.4.1.3 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission (JC) Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

3.4.1.4 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. If one is available in the geographic area.

3.4.1.5 The contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. The contractor points of contact (POC). Service calls shall be placed 24 hours a day, 7 days a week by calling a vendor supplied toll free response center. Qualified service reps are required to make a “best effort” to call back within 4-hours during normal business hours (8:00am – 4:30pm EST Monday – Friday excluding Federal Holidays) to schedule service visit.

3.4.2 Corrective Maintenance: Normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 4 hours after receipt of trouble call and make a best effort to provide on-site service within 48 hours of call and a best effort to have all equipment operational within 72 hours of initial on-site response.

3.4.2.1 In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates and negotiated and approved by a Contracting Officer prior to services rendered. 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.

3.4.3 Replacement Parts: The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, Joint Commission (JC), manufacturer’s certifications or any other certifications as they apply.

3.4.3.1 The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items.

3.4.3.2 Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

3.4.3.3 Contractor’s pricing shall be inclusive of all costs including parts, labor, travel and shipping, unless otherwise indicated.

3.4.3.4 Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the contractor.

3.4.4 Software: The contractor must include software revisions and updates (field service changes or technical service updates (TSUs)), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

3.5 Removal of Government Property: Whenever the repair of equipment cannot be performed at the Government site as determined by the contractor, the contractor shall notify BME who will make arrangements for the contractor to remove the item to the contractor’s designated site. The contractor may be required to sign a Government form accepting responsibility for the Government equipment. The contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

3.5.1 All charges resulting from a contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the contractor.

3.6 Equipment Modification Upgrades: The contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the contractor installation of any modification, alteration, or upgrades.

3.6.1 The contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

3.6.2 The Government shall not alter the system without prior notification to the contractor.

3.6.3 The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

3.7 Service beyond the Scope of the Contract: The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the contractor considers they are not responsible for under the terms of this contract.

3.7.1 At the same time of the notification, the contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the contracting Officer to be outside the scope of this contract shall not be covered under this contract but shall be ordered under a separate purchase order.

PART 4

4.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

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

4.1. 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

4.2. 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:

The Government will provide all necessary utilities, including electricity and lighting, at the worksite for the contractor’s use in the performance of tasks outlined in this PWS.

4.3. 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 5

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

5.1. 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

Except for those items specified as Government-furnished in Part 4, the contractor shall furnish all personnel, equipment, tools, materials, supervision, and other items necessary to perform the maintenance and repair services as defined in this PWS.

5.2. General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 2 of this PWS.

5.3. Materials: The contractor shall furnish all replacement parts, diagnostic software, specialized tools, test phantoms, and calibrated test equipment necessary to meet the maintenance and repair requirements under this PWS. All test equipment must have current calibration certification compliant with OEM and federal standards.

5.4. Equipment: The contractor shall furnish all replacement parts, diagnostic software, specialized tools, test phantoms, and calibrated test equipment necessary to meet the maintenance and repair requirements under this PWS. All test equipment must have current calibration certification compliant with OEM and federal standards.

5.5. Facilities: The contractor shall perform tasks at Building 2 (2nd floor, Cardiac Cath Lab, Lab #1) and Building 250 (Biomed Dept).

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 3)

PWS Reference
Acceptable Quality Level (AQL) (This is the maximum error rate. It could possibly be “Zero deviation from standard”)
Method of Surveillance

Performance Requirements Summary (PRS) # 1.

The contractor shall inspect, maintain, test, and repair all listed systems and subcomponents.

Part 3
All maintenance, repairs, and software updates shall be performed IAW the manufacturer's manual 100% of the time. Field Service Reports (FSRs) must be submitted within 48 hours of service completion, 100% of the time.
100% inspection of FSRs and validated customer complaints by the COR. A $100 deduction may apply for out-of-compliance documentation.

PRS # 2

The Contractor shall conduct annual preventive maintenance (PM) for all applicable equipment.

Part 3
Preventive maintenance shall be performed IAW the manufacturer's manual 100% of the time, meeting all warranty requirements.
On-site periodic inspections and review of completion documents by the COR. A $50 deduction may apply for failure to perform PM on schedule, and a $100 deduction may apply for procedures not performed IAW the manual.

DHA PWS, FEB 2024

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File details come from the government source that posted it. Updated .