HT940624R0001 Combined Synopsis Coagulation Hemostasis Analyzer NMC Portsmouth.pdf

HT940624R0001

COMBINED SYNOPSIS/SOLICITATION HT940623R0014

Coagulation Hemostasis Analyzer

DCSS/Laboratory Naval Medical Center Portsmouth Readiness and Training Center

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice and FAR 13, Simplified Acquisition Procedures.

This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HT940624R0001. The solicitation is issued as a Request for Proposal (RFP).

Provisions and clauses in effect through Federal Acquisition Circular 2024-01 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at:

https://www.acquisition.gov/.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of $1,000. This requirement is being procured via full and open competition.

The Naval Medical Center Portsmouth, VA (NMCP) has a requirement for a firm fixed price contract the Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support Services. The solicitation will result in one (1) firm fixed price contract.

The estimated period of performance is outlined below:

Base Period: 01 April 2024 to 31 March 2025 Option Period 1: 01 April 2025 to 31 March 2026 Option Period 2: 01 April 2026 to 31 March 2027 Option Period 3: 01 April 2027 to 31 March 2028 Option Period 4: 01 April 2028 to 31 March 2029

The scope of the requirement is listed in the Performance Work Statement (PWS). Naval Medical Center Portsmouth, VA (NMCP) requests responses from qualified sources capable of providing services outlined in the Performance Work Statement (PWS).

ADMINISTRATIVE INFORMATION

Contracting Officer: Lorri J. Loveland, lorri.j.loveland.civ@health.mil

Contract Specialist: Peggy Suever, margaret.a.suever.civ@health.mil

The closing date of the solicitation can be found in ADDENDUM to 52.212-1 – INSTRUCTIONS TO OFFERORS

– COMMERCIAL ITEMS

The evaluation criteria can be found in ADDENDUM to 52.212-2 – EVALUATION – COMMERCIAL ITEMS https://www.acquisition.gov/ mailto:lorri.j.loveland.civ@health.mil mailto:margaret.a.suever.civ@health.mil

Department of Defense Defense Health Agency

Performance Work Statement

Coagulation Hemostasis Analyzer DCSS/Laboratory

Naval Medical Center Portsmouth Readiness and Training Center

Solicitation Number: HT940624R0001

Version: 1 Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide the Lease of two (2)-Coagulation/Hemostasis Systems, Cost- Per-Reportable Agreement, Consumables (reagents) and Maintenance Support Services for Naval Medical Center 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 perform [for Lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable Agreement, Consumables (reagents) and Maintenance Support 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: The Laboratory performs Hemostatic testing. These tests help identify patients with hemostatic defects that could cause excessive bleeding. Screening tests are available for each of the three phases of hemostasis:

coagulation (fibrin clot formation), platelet plug formation, and fibrinolysis.

1.4 Objectives: Contractor to provide lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services for Naval Medical Center Portsmouth- Coagulation Laboratory Department for an estimated test volume to be defined as PT test of 23,064 and PTT test of 16,044.

1.5 Scope: lease of two (2)-Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services. The contractor shall provide lease of two (2)- Coagulation/Hemostasis Systems, Cost-Per-Reportable agreement to include Consumables and Maintenance Support Services for Naval Medical Center Portsmouth- Coagulation Laboratory Department for an estimated test volume to be defined as PT test of 23,064 and PTT test of 16,044.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform delivery, install, analytical validation and technical support as defined in this Performance Work Statement (PWS).

Contactor to warrant that all supplied items are free of manufacturer defects. Contractor shall repair / replace any unsatisfactory items at Contractor’s expense.

Contractor price shall be inclusive of all cost including lease of equipment, maintenance of equipment, reagents, shipping and handling.

1.6 Period of Performance (PoP):

Base Period: 01 April 2024 to 31 March 2025 Option Period 1: 01 April 2025 to 31 March 2026 Option Period 2: 01 April 2026 to 31 March 2027 Option Period 3: 01 April 2027 to 31 March 2028 Option Period 4: 01 April 2028 to 31 March 2029

1.6.1 Transition: Transition-in/transition-out period

1.6.1.1 Transition-in period: Full performance start date is 01 April 2024. Transition-in begins once the contract is awarded, when the awardee shall commence to implement the contract with minimal issues or disruptions to the agency, including extended delay to scheduling services. During the transition-in period, the Contractor shall prepare to meet all contract requirements and ensure incoming personnel are functionally trained and qualified on the full performance start date except cybersecurity requirements, which must be fully adhered during transition and full performance periods. The remaining incoming personnel shall be trained and qualified within 7 days.

1.6.1.1.1 The contractor shall comply with transition-in requirements of the DHA, as listed in paragraph 1.11.1, for contractors needing to be issued Common Access Card (CAC) identification, including Department of Defense (DoD) and DHA-directed training and forms submission, prior to network access. N/A

1.6.1.2 Transition-out period: The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract.

1.6.1.2.1 The contractor shall comply with transition-out requirements of the DHA for contractors who have been issued a CAC or who generate “records”, as defined by DoD (records manual), including DoD-directed disposition of records, and others displayed on the In/Out (I/O) Processing Portal.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at

Naval Medical Center Portsmouth Attn: Hematology Laboratory Department 54 Lewis Minor Street

BLDG. 250

Portsmouth, VA 23708-2297

1.7. Recognized Federal holidays: The Contractor is not required to perform services on the day of observance of Federal Holidays.

1.7.3 Hours of operation: The contractor is responsible for conducting business 0700 -1700 Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours. In this instance, NMCP contracting officer shall be engaged to determine if an emergency Purchase Order is required before services are requested or not provided by Contractor.

1.8 Contractor travel: None

1.9 Other Direct Costs (ODC): N/A

1.10 Quality

1.10.1 Quality Control (QC): N/A

1.10.2 Quality assurance (QA): N/A

1.11 Contractor personnel

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2. N/A

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note:

Public Key Infrastructure (PKI)-restricted, printed versions available). N/A

1.11.2.4 DHA’s new employee handbook at Part 7 Section 7.1.4

N/A

1.11.3 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.

1.11.4 Key control: The contractor shall establish and implement methods of making sure all keys/key cards issued to the contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE:

All references to keys include key cards. No keys issued to the contractor by the Government shall be duplicated.

The contractor shall develop procedures covering key control that shall be included in the Quality Control Plan (QCP). Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the CO.

1.11.4.1 In the event keys, other than master keys, are lost or duplicated, the contractor shall, upon direction of the Contracting Officer (CO), re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the contractor. In the event a master key is lost or duplicated, all locks and keys for that https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx system shall be replaced by the Government and the total cost deducted from the monthly payment due the contractor.

1.11.4.2 The contractor shall prohibit the use of Government issued keys/key cards by any persons other than the contractor’s employees. The contractor shall prohibit the opening of locked areas by contractor employees to permit entrance of persons other than contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the CO.

1.11.5 Lock combinations: The contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations.

These procedures shall be included in the contractor’s QCP.

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

N/A

1.13 Data rights: N/A

1.14 Reporting: N/A

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

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

The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance;

maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.14.4 Post award conference/periodic progress meetings: 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.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

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

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

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI)

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

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

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

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

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

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

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

2.1.3 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.4 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the 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:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business CAC Common Access Card CAP Cloud Access Point CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer CJCSM Chairman of the Joint Chiefs of Staff Manual CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DC3 DoD Cyber Crime Center

DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build

DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement eMSM Enhanced Multi-Service Markets EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring IV&V Independent Verification & Validation MedCOI Medical Community of Interest MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personal Management OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate

P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TOS Terms of Service US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

2.3 Applicable Publications, DHA Administrative

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

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:

Not Applicable

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 N/A.

PART 5

5.0 SPECIFIC TASKS

System Support:

5.1 The Contractor shall provide system installation, validation, and correlation.

5.2 The Contractor shall provide validation of the equipment following installation with assays that met the Six

Sigma Analysis quality performance as approved by the FDA for testing methodologies.

5.3 Contractor shall provide overlap equivalent to a (3) month timeframe to allow validation either in comparison equipment due to upgrades and or new Contractor.

5.4 Contractor shall provide at no cost to Government the moving and/or relocation of equipment due to renovation and upgrades to the laboratory department.

5.5 The Coagulation system shall be currently authorized (Authority to Operate) as capable with Military Health

System (MHS) Genesis.

5.6 The contractor shall provide on-site operator training for Government personnel upon initial implementation for the base year and for each option year exercised. The training shall include initial system user training for all staff members, and user training for a minimum of two (2) staff members for each additional option year.

5.7 The contractor shall provide yearly off-site training for key operator staff excluding travel, lodging, meals, expenses, and incidentals.

5.8 On-site assistance during system validation shall be provided.

Maintenance:

5.9 The Contractor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and English-speaking personnel. The Contractor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance (CM).

5.10 The Contractor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking systems operator shall be made available to answer technical questions regarding system operations and applications.

5.11 Equipment listed in this contract shall be maintained to meet and retain the OEM’s specifications and/or equipment certification.

Preventive Maintenance and Corrective Maintenance Services:

5.12 Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00

P.M. EST. Contractor shall provide full-service preventive maintenance.

5.13 Preventive maintenance shall be performed in accordance with Original Equipment Manufacturer recommendations.

5.14 Contractor shall perform preventive maintenance service checks at the OEM’s recommended intervals at a date and time mutually agreed upon by the Contractor and the Government throughout the life of the contract.

5.15 All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with The Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

5.16 Contractor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. EST, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

5.17 A Contractor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours. Equipment shall be operational within forty-eight

(48) hours of the initial trouble call. Government request for corrective maintenance will be placed by NMC Portsmouth Biomedical Engineering Division (BIOMED) personnel, to the Contractor. Corrective maintenance shall be completed during the hours specified in the contract. The 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 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE); and 4) should identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM.

The Contractor's pricing shall be inclusive to include all parts, consumables, labor, travel, and shipping associated with performing corrective maintenance on the system as well as any other costs associated with performing corrective maintenance on equipment that utilizes water and or sewage, including the cost of water utilized by Contractor during corrective maintenance and any drainage costs associated with that water.

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

Uptime:

5.18 Equipment shall be returned to operational condition within 48 hours after telephone notification from

BIOMED. The Contractor shall maintain an overall uptime rate of 95% or better for all equipment. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MTBF).

5.19 Uptime Calculation: Uptime is calculated on a rolling 6-month basis. Until the Contractor has at least 6 months of performance experience at NMC Portsmouth, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

5.20 Variables Definitions: U= Possible Equipment Uptime (100%) H= Hours of Coverage per day H1= Begin Coverage Time during each day H2= End Coverage Time during each day A= # of covered days of the week W = Weeks of Coverage in a Year C= Uptime Commitment (95%) Known (for this contract):

H1= 0001 hours H2= 2359 hours A= 7 days per week W= 52 weeks per year C = 95%

5.21 Downtime hours shall fall within the Contractor’s hours of coverage as defined by this contract. Downtime hours outside of the coverage timeframe shall not be calculated as a metric of Contractor performance.

Downtime ends once the system is available for full clinical use.

Replacement Parts/Updates:

5.22 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 replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional charge to the Government.

5.23 The Contractor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. The contractor shall be an Original Equipment Manufacturer authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such as OEM warranty and service are provided and maintained by the OEM.

5.24 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.

5.25 All replacement parts shall be new, non-refurbished, and certified as OEM replacement parts.

5.26 The Contractor shall install software revisions and updates (field service changes) that are required by FDA-or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional charge to the Government. Updates and revisions shall be performed as soon as possible after release, 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, the Contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

5.27 With approval from the Contracting Officer, the Contractor may perform hardware/software upgrades as they become available.

5.28 The government will be responsible for maintaining the proper environment, including utilities and site requirement necessary for the system to function properly as specified by the OEM.

5.29 The Government will operate the system in accordance with the instruction manual provided by the OEM.

5.30 The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of

Contractor supplies, materials, or for the personal belongs brought onto Government property by Contractor’s personnel.

Contractor Qualifications/Considerations:

5.31 The Contractor shall provide all service literature, reference publications, laptop computers, and diagnostic software to be used by the Contractor Field Service Engineer as required for the completion of the services in accordance with this contract.

5.32 During normal duty hours, Contractor FSE personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. The Contractor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Contractor FSEs shall notify the Officer of the Day Desk and the Duty BIOMED personnel.

5.33 The Contractor shall provide a full-service report to BIOMED within two (2) days of completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

Name of Contractor Contract Number Name of field service technician performing service Contractor log/control number Date, time (beginning and ending), and hours on-site for service call Description of problem reported by user Equipment identification factors to include manufacturer, make, model, serial number, and Facility Equipment Control Number (ECN) Itemized description of service performed to include parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

Problem resolution or pending action Signatures:

Field Service Technician performing services BMET verifying service rendered (Identify Medical Treatment Facility) 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).

5.34 Software and/or hardware must be an approved product by the Defense Health Agency (DHA) and authorized to be used on the DHA network. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

PART 7

7.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

7.1 The following forms are to be completed by the FSO/Security POC, or COR once the contractor is granted the proper background investigation. N/A

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 5)

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 ensure adequate uptime of systems

PWS Part 5. Section 5.18 Overall uptime rate of 95% Surveillance will be done by monthly observations and a log of down time and trouble tickets.

PRS #2 The Contractor shall provide a full-service report to BIOMED within two (2) days of completion of all services performed

PWS Part 5 Section 5.33 95% Submission of report

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

Transition-in, Transition-out CDRLs if a Government requirement for this contract.

Transition-in:

Transition-out: 6 months prior to close of contract or unexercised option.

1.6.1.1 and 1.6.1.2.

Perform preventive maintenance service checks

Mutually agreed upon by the Contractor and the Government throughout the life of the contract

NMC Portsmouth 5.14

Deliverable Frequency Medium/Format Submit To Applicable to:

Service Technician Response time

Within two hours after receipt of trouble call via telephone BIO Med Department 5.17

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Consumable and Reagents FY24

FFP

FOB: Destination

NET AMT

1001 1 Job OPTION Consumable and Reagents FY25

FFP

2001 1 Job OPTION Consumable and Reagents FY26

FFP

3001 1 Job OPTION Consumable and Reagents FY27

FFP

4001 1 Job OPTION Consumable and Reagents FY28

FFP

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-APR-2024 TO

31-MAR-2025

N/A NAV MED CNT PORTSMOUTH VA - MM

NAV MED CNT PORTSMOUTH VA - MM

ATTN SUPPLY OFFICER BLDG 250

54 LEWIS MINOR STREET

PORTSMOUTH VA 23708-2297

HT0242

1001 POP 01-APR-2025 TO

31-MAR-2026

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-APR-2026 TO

31-MAR-2027

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-APR-2027 TO

31-MAR-2028

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-APR-2028 TO

31-MAR-2029

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.204-26 Covered Telecommunications Equipment or Services-- Representation.

OCT 2020

52.209-7 Information Regarding Responsibility Matters OCT 2018 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

SEP 2023

52.212-2 Evaluation - Commercial Items NOV 2021 52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

DEC 2022

52.217-5 Evaluation Of Options JUL 1990 52.222-41 Service Contract Labor Standards AUG 2018 52.222-42 Statement Of Equivalent Rates For Federal Hires MAY 2014 52.222-50 Combating Trafficking in Persons NOV 2021 52.229-11 Tax on Certain Foreign Procurements--Notice and

Representation

JUN 2020

52.242-15 Stop-Work Order AUG 1989 52.245-1 Government Property SEP 2021 52.245-9 Use And Charges APR 2012 52.247-34 F.O.B. Destination NOV 1991 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7001 Prohibition On Persons Convicted of Fraud or Other Defense- Contract-Related Felonies

JAN 2023

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

JAN 2023

252.211-7007 Reporting of Government-Furnished Property MAR 2022 252.225-7001 Buy American And Balance Of Payments Program--Basic JAN 2023 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.245-7001 Tagging, Labeling, and Marking of Government-Furnished

Property

APR 2012

252.245-7002 Reporting Loss of Government Property JAN 2021 252.245-7003 Contractor Property Management System Administration APR 2012 252.245-7004 Reporting, Reutilization, and Disposal DEC 2017

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

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

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

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

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

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

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

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

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

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

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

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

(e) Disclosures.

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

(i) For covered equipment--

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

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

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

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

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

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

(i) For covered equipment--

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

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

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

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors…