HT940625R0011.pdf

Section A - Solicitation/Contract Form

COMBINED SYNOPSIS/SOLICITATION

COMBINED SYNOPSIS/SOLICITATION HT940625R0011

Lease of High-Volume Nucleic Acid Amplification Testing Analyzer System

Cost-Per- Test/Reagents/Maintenance Service Naval Medical Center Portsmouth, VA (NMCP)

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, 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 HT940625R0011. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2024-03 (published 23 February 2024) 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 size standard of $6M. This requirement is being procured via full and open competition.

The Naval Medical Center Portsmouth, VA (NMCP) has a requirement for non-personal services requirement including software license, service, support, and maintenance of a high volume molecular microbiological nucleic acid amplification testing instrument system including a software interface program that connects results to the MHS Genesis electronic health record system . The solicitation will result in one (1) firm fixed price contract.

The estimated periods of performance are outlined below:

Base Period: 01 July 2025 to 30 June 2026 Option Period 1: 01 July 2026 to 30 June 2027 Option Period 2: 01 July 2027 to 30 June 2028 Option Period 3: 01 July 2028 to 30 June 2029 Option Period 4: 01 July 2029 to 30 June 2030 6-month Extension (FAR 52.217-8): 1 July 2030 – 31 December 2030

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

Materials: (SEE ATTACHMENTS ) Product List for high volume molecular nucleic acid amplification testing system.

Equipment: (SEE ATTACHMENTS ) High volume molecular nucleic acid amplification testing system.

NOTE: Only need a proposal for one of the Product list NOT both.

ADMINISTRATIVE INFORMATION

Contracting Officer: Melissa Peregrino-White

Contract Specialist: Kimberly Bunn

The evaluation criteria can be found in ADDENDUM to 52.212-2 – EVALUATION –

COMMERCIAL ITEMS

INSTRUCTIONS TO OFFERORS

**Addendum to FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services (Mar 2023)**

1. GENERAL INSTRUCTIONS AND NOTICES

This requirement is being solicited in accordance with FAR Part 12 and FAR Part

13.5. In addition to FAR 52.212- 1, this section specifies the format and content that Offerors shall use in responding to this Request for Proposal (RFP). The intent is to ensure a certain degree of uniformity in the format in the response for evaluation purposes. The proposal should be legible and comprehensive enough to provide the rating standards for a sound evaluation by the Government.

Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. If the proposal does not provide, at a minimum, that which is required in this solicitation it may be determined to be substantially incomplete and not warrant any further consideration. The offer shall also be compliant with all requirements as stated in the Performance Work Statement (PWS).

The Offeror’s initial proposal should contain the Offeror’s best terms from a cost or price and technical standpoint.

All offer information is subject to verification by the Government. Falsification of any offer submission, documents, or statements may subject the Offeror to civil or criminal prosecution under Section 1001 of Title 18 of the United States Code.

The Offeror shall comply with FAR 52.204-7, System for Award Management (SAM). In complying with this clause, the Offeror shall ensure that all representations and certifications contained in this solicitation are completed and uploaded to its SAM record at http://www.sam.gov by the date specified for receipt of the proposal. If the Offeror does not have an active SAM record or has a record that does not include all representations and certifications required in this solicitation, they may be considered ineligible for award.

Any data previously submitted in response to another solicitation to DHA SEM- CD or another agency shall be assumed to be unavailable during this proposal evaluation and source selection process. The Government will not reimburse the Offeror for costs incurred as a result of preparation and submission of an offer in response to this solicitation.

SUBMISSION OF PROPOSALS: A proposal shall be submitted and received no later than 30 May 2025 by 9:00AM Eastern Time. The proposal shall be submitted electronically, via e-mail, to Kimberly Bunn, Contract Specialist at Kimberly.p.bunn.civ@health.mil.

QUESTIONS: All questions shall be addressed in writing and submitted electronically to Kimberly Bunn Contract Specialist at Kimberly.p.bunn.civ@health.mil. Questions shall be submitted no later than 10 May 2025 by 4:00PM Eastern Time.

Files shall not contain classified data. The use of hyperlinks in proposals is prohibited.

ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission shall include four (4) separate parts: (1) Technical Approach, (2) Past Performance (3) Price and (4) Business. Volume 1 – Technical Approach may include items such as brochures or pictures. Volume 2 - Past Performance shall be submitted in MS Word 2000 or searchable PDF format.

Volume 3 – Price shall be submitted in MS Excel 2000 or higher, but not greater than MS Excel 2007 format. Volume 4 - Business may be submitted in MS Word 2000 or searchable PDF format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

The Offeror’s proposal shall consist of four separate volumes. Each volume shall be separate and complete, so that the evaluation of each one may be accomplished independently and concurrently with evaluation of the others. Each Volume shall be an independent document, labeled accordingly. The volumes are:

Volume 1 – Technical Approach

Volume 2 – Past Performance

Volume 3 – Price

Volume 4 - Business

*No pricing information shall be included in Volume 1 – Technical Approach, Volume 2 – Past Perfromance, or Volume 4 – Business.

(a) The Government will award one contract resulting from this solicitation to the offeror whose proposal, conforming to the solicitation, offers the best value to the Government, technical approach, past performance, price and business considered.

(b) The factors are listed in descending order of importance. Factor 1 is significantly more important than Factor 2. Factor 2 is more important than Factor 3. Factor 3 is more important than Factor 4.

Factors 1 and 2 when combined are more important than Factors 3 and 4.

The Contracting Officer has broad discretion in determining which awardee shall receive a contract and reserves the right to pay a premium for past performance benefiting the Government.

Basis for Award

Award of this requirement will be made on a best value basis, technical approach, past performance, price, and business considered. The Government intends to award without discussions. The Government reserves the right to hold discussions if deemed necessary. The Offeror MUST provide their best complete proposal upon initial submission.

The Government evaluator(s) will not assume the Offeror possesses any capability or knowledge unless it is specified in the proposal. If Technical Approach received an individual rating of “unacceptable” the collective overall rating will also be “unacceptable.” Only a proposal receiving an overall rating of “acceptable” will be further considered for award.

Factor 1: Technical Approach

Technical Approach will be evaluated to the degree to which the Offeror demonstrates overall ability to perform the services and their understanding of the requirements set forth in Statement of work

(SOW)

Ratings Description Acceptable Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is low.

Unacceptable Proposal does not meet requirements of the solicitation, and thus, contains one or more deficiencies, and/or risk of unsuccessful performance is high.

Factor 2: Past Performance

Past Performance Evaluation Methodology. Past performance will be based on the CPARS reports. Remaining offerors will be assigned an overall Performance Confidence Assessment (PCA), see below, which is based on an integrated assessment of the offeror’s relevant past performance. The resulting PCA represents an overall evaluation of offeror performance. Offerors without a record of relevant past performance or for whom information on past performance is so sparse that no meaningful confidence assessment rating can be reasonably assigned will not be evaluated favorably or unfavorably on past performance and, as a result, will receive a "Neutral Confidence" rating for the Past Performance factor.

*The Government reserves the right to use information from the CPARS, as well as information obtained from other sources available to the Government, to include, but not limited to, Federal Awardee

Performance and Integrity Information System (FAPIIS), or other databases; interviews with Program Managers, Contracting Officers, and commercial sources and/or non- Government sources.

Relevancy Assessment: An assessment of the past performance information will be made to determine if it is relevant. To be relevant, the contract/task order must be for services and must be non-personal services and not inherently governmental or closely associated inherently governmental. Services performed by offeror personnel that supplement existing Government personnel and completed no more than three years prior to the closing date of this solicitation are considered relevant. Clinical (direct patient care), advisory and assistance, information technology, housekeeping or facility management services are not considered relevant.

Examples of services considered not relevant include hands on, direct patient care services performed in a clinical setting. Task orders that are determined to be not relevant will not be further evaluated.

Performance Confidence Assessment (PCA): The Government will consider the performance quality of relevant efforts and assign an overall PCA. Offerors with experience providing services in a higher number of FTEs may be rated more favorably. The confidence ratings noted in the table below will be used. For each relevant contract/task order reviewed, the performance quality of the work performed will be assessed using the, CPARS to obtain information rearding past performance as it relates to providing the services required under this solicitation, including but not limited to recruiting and retaining qualified contract employees. The Government is not restricted from evaluating and considering other relevant past performance information in its possession. Past performance information may be obtained from any other source available to the Government.

PERFORMANCE CONFIDENCE ASSESSMENTS

RATING DESCRIPTION

SUBSTANTIAL CONFIDENCE Based on the offeror’s relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

SATISFACTORY

CONFIDENCE

Based on the offeror’s relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

LIMITED CONFIDENCE Based on the offeror’s relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

NO CONFIDENCE Based on the offeror’s relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

NEUTRAL CONFIDENCE No relevant performance record is available, or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned. The offeror may not be evaluated favorably or unfavorably on the factor of past performance

In the case of offerors for which there is no information on past performance or where past performance is not available, the offeror may not be evaluated favorably or unfavorably on the factor of past performance. In this case, the offeror’s past performance is unknown and assigned a performance confidence rating of “Neutral.”

Factor 3: Price

i) Price will be evaluated separately from Technical Approach, Past Performance and Business. Price will be evaluated in accordance with FAR 12.209 and 13.106-3 for fair and reasonableness in terms of:

Pricing is proposed based on level of effort within the solicitation Pricing is proposed for all CLINs

ii) Price will be evaluated for:

Reasonableness: The degree to which the proposed prices (base period and option periods) compare to the prices a reasonably prudent person would expect to incur for the same or similar services. An offeror with pricing that is determined to be questionable for reasonableness (for any period of performance) may not be further considered for award.

This includes all required pricing for the base period and all option periods. In the event that any of the pricing is incomplete, the Contracting Officer may exclude the offeror’s proposal from further evaluation.

Factor 4: Business The Business volume will be evaluated on a pass/fail basis. Evaluation of the business volume will consist of verifying all documentation has been received and completed, to include acknowledgement of solicitation and all amendments, Offeror’s representations and certifications are complete and accurate, and the offeror has a valid SAM registration.

(a) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options will not obligate the Government to exercise the option(s).

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

POINTS OF CONTACT

VENDOR TO COMPLETE THE FOLLOWING:

COMPANY NAME: ______________________

CAGE: ___________________

UEI: ___________________

Vendor POC: ____________________ Phone: ____________________ Fax: ____________________ Vendor email: _________________________________

Defense Health Agency Contracting Activity (DHACA)

POC:

Phone:

Email:

Product/Services for: Naval Medical Center Portsmouth VA 620 John Paul Jones Circle Portsmouth VA 23708-2297 Department:

Phone:

Vendor to reference RFQ Number: HT940625R0011 on all inquiries.

PAYMENT INFORMATION

Payment in Arrears (Check One): Monthly Quarterly Semi-Annually Annually *Please ensure that quoted price matches the choice above and is evenly divisible depending on the selection

PROMPT PAYMENT

For Prompt Payment Act Purposes, this contract is:

Subject to the 7-calender day constructive acceptance period.

DISCOUNTS

The vendor's initial response to this RFQ should reflect the Vendors' best price including all allowable discounts that are available to the Federal Government. Please identify all discounts that are being offered as part of the vendor's quote submission. The government does not intend to go out for a best and final offer.

EMAIL QUOTES/PROPOSALS TO: kimberly.p.bunn.civ@health.mil DO NOT forward via U.S. Mail service. It is the Contractor’s responsibility to confirm receipt of quote/proposal.

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months FY 25 Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services FOB: Destination

PURCHASE REQUEST NUMBER: 0012198802

NET AMT

1002 12 Months FY 26 Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services FOB: Destination

1003 12 Months FY 27 Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services

1004 12 Months FY 28 Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services

1005 12 Months FY 29 Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services

1006 6 Months Analyzers, Lab Molecular Assay

FFP

Analyzers, Lab Molecular Assay Maintenance Support Services 6 month extension

Section C - Descriptions and Specifications

STATEMENT OF WORK

Department of Defense Defense Health Agency Performance Work

Statement

Lease of High-Volume Nucleic Acid Amplification Testing Analyzer System Cost-Per- Test/Reagents/Maintenance Service Naval Medical Center Portsmouth- Microbiology Department

DCSS

Microbiology Laboratory Department

PART 1

1.0 GENERAL INFORMATION

GENERAL: The requirement is for Lease of two (2) High-Volume Nucleic Acid Amplification Testing Analyzer and one (1) High volume aliquoting Processing System, Cost-Per- Test Agreement, Consumables (reagents) and Maintenance Support Services for Naval Medical Center Portsmouth.

1.1 This is a non-personal services contract to provide Lease of High-Volume Nucleic Acid Amplification Testing Analyzer

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 the lease of two (2) High-Volume Nucleic Acid Amplification Testing Analyzer Systems 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: Vendor has previously provided lease of two (2) High-Volume Nucleic Acid Amplification Testing Analyzer System and one (1) High Volume aliquoting Processing System, which includes a Cost-Per-Test Agreement to include consumables and maintenance support services for the Naval Medical Center Portsmouth Microbiology Department. The Analizer and aliquoting systems were initially implemented as an emergency response for high-volume molecular testing for the COVID-19 Pandemic. However, the analyzer and aliquoting system are now being utilized for high-volume molecular testing for Women’s Health assays, as originally proposed pre-pandemic.

1.4 Objectives: The vendor will supply a lease agreement for two (2) Analyzer Systems and one (1) aliquoting Processing System including Chlamydia/Gonorrhea testing, Trichomonas testing, HPV testing, HPV genotype testing, Bacterial Vaginosis testing, Candida vaginitis testing, and consumables. The lease agreement will be implement as a Cost-Per-Test basis.

1.4.01 The vendor will supply a lease agreement for two (2) Analyzer Systems, one (1) Aliquing systems sample processing system, and consumables.

1.4.02 Supplied equipment shall be for the use of the Naval Medical Center Portsmouth

(NMCP) Microbiology Laboratory

1.4.03 Vendor to provide initial shipment of equipment and install on site (unless currently installed). Installation to be limited to the actual installation of equipment. In the event that utilities upgrades are required, the Government will be responsible for all utilities upgrades

1.4.04 Equipment shall remain the sole property of the selected vendor. Vendor to provide labeling of equipment to identify as vendor property. NMCP shall have no right to attach any liens, security interest or other encumbrance to any supplied equipment

1.4.05 Equipment supplied must be certified for use in US Hospitals adhering to UL and or JACHO requirements as required.

1.4.06 In the event of technology upgrades vendor may substitute equal or better items / equipment.

The Government shall maintain the final determination of deciding equal / better. The decision of equal / better shall be made by the Director of the NMCP Main Lab or their authorized agent

1.5 Scope: The Vendor will supply a lease agreement for two (2) Analyzer Systems and one (1) aliquoting Processing System. The Cost-Per-Test Agreement is to include Consumables and Maintenance Support Services for Naval Medical Center Portsmouth.

1.6 Period of Performance (PoP): The period of performance shall be for one (1) Base Year of 12 months and four (4) 12- month option years. The Period of Performance reads as follows:

Base Year 01 July 2025 to 30 June 2026 Option Year I 01 July 2026 to 30 June 2027 Option Year II 01 July 2027 to 30 June 2028 Option Year III 01 July 2028 to 30 June 2029 Option Year IV 01 July 2029 to 30 June 2030 6 month extension 01 July 2030 to 31 December 3030

1.7 Administrative specifications

1.7.1 Place of performance: The work to be performed under this contract will be performed at the government facility, Naval Medical Center Porsmouth.

1.7.2 Recognized Federal holidays: Contractor will not be required to deliver on Holidays. New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Independence Day Christmas Day Independence Day

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

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

1.8 Contractor travel: Contractor shall be authorized travel expenses consistent with the cost principles and procedures in Federal Acquisition Regulation (FAR) Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR).

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): 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).

1.11 Contractor personnel: N/A

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

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.

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).

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 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 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 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.

1.14 Reporting

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.

1.15 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 (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). 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.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D- Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R- Services)

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

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

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

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.7 Additional Definitions:

2.1.7.01 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.7.02 CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.7.03 DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.7.04 DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.7.05 WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.7.06 WORK WEEK. Monday through Friday, unless specified otherwise.

2.2 Acronyms:

AIS

APL

AQL

ARRT

ATO

B2B

CAC

CAP

CCEVS

CDI CE

CDRL

CIO

CJCSM

CMMC

CMR

CNSSI

CO

CONUS

COR

COTR

CSP

CSSP

CUI

DAD-A

DC3

DD Form 254

DB

DBB

DFARS

DHA

DISA

DoD DoDD DoDI DSAs

DSAA

DMZ

DoDM

DPCLO

DUA

Automated Information System Approved Products List APL Acceptable Quality Level Acquisition Requirements Roadmap Tool Authority to Operate Business-2-Business Common Access Card Cloud Access Point Common Criteria Cybersecurity Evaluation and Validation Scheme Covered Defense Information Computer Environment Contract Data Requirement List Chief Information Officer Chairman of the Joint Chiefs of Staff Manual Cybersecurity Maturity Model Certification Contractor Manpower Reporting Committee on National Security Systems Instruction Contracting Officer(s) Continental United States (excludes Alaska and Hawaii) Contracting Officer Representative Contracting Officer's Technical Representative Cloud Service Provider Cyber Security Service Provider Controlled Unclassified Information Deputy Assistant Director for Acquisition DoD Cyber Crime Center Department of Defense Contract Security Requirement List (if applicable) Design-Build Design-Bid-Build Defense Federal Acquisition Regulation Supplement Defense Health Agency Defense Information System Agency Department of Defense Department of Defense Directive Department of Defense Instruction Data Sharing Agreements Data Sharing Agreement Application Demilitarized Zone Department of Defense Manual DHA Privacy and Civil Liberties Office 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

P-ATO

P&R

PGI

PDT

PHI

PII

PIT

PK

PKI

POA&M

Office of the Secretary of Defense Personal Authorization to Operate Personnel and Readiness Procedures, Guidance and Information Project Delivery Team Protected Health Information Personally Identifiable Information Platform Information Technology Public Key Public Key Infrastructure 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

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

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

3.1 Services: The Government:

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

☐ WILL provide Government Furnished Services required in support of this contract/task orders.

These Services are described below: provide

3.2 Facilities: The Government:

☐ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below: Access to the Laboratory Microbiology Department Located at the Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth VA, 23708

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

The government will provide electrical to support the equipment while in use.

3.4 Equipment: The Government:

☐ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

The Government will provide a specific bench area location where the instrument will reside within the Microbiology Laboratory and in compliance with the power requirements by the manufacturer.

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP. The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee- landing/. Access to PIEE/GFP Module application training materials and in-depth information applicable to the contractor’s responsibilities regarding GFP can be found at the following website:

https://dodprocurementtoolbox.com/.

Contracting Office Responsibilities:

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

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

Contractor Responsibilities:

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

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

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

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

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

4.1.01 Equipment:

4.1.02 The vendor will supply a lease agreement for two (2) Analyzer Systems one (1)

Aliquoting sample processing system, and consumables.

4.1.03 Supplied equipment shall be for the use of the Naval Medical Center Portsmouth

(NMCP) Main Laboratory

4.1.04 Vendor to provide initial shipment of equipment and install on site (unless currently installed). Installation to be limited to the actual installation of equipment. In the event that utilities upgrades are required, the Government will be responsible for all utilities upgrades

4.1.05 Equipment shall remain the sole property of the selected vendor. Vendor to provide labeling of equipment to identify as vendor property. NMCP shall have no right to attach any liens, security interest or other encumbrance to any supplied equipment

4.1.06 Equipment supplied must be certified for use in US Hospitals adhering to UL and or JACHO requirements as required.

4.1.07 In the event of technology upgrades vendor may substitute equal or better items / equipment.

The Government shall maintain the final determination of deciding equal / better. The decision of equal / better shall be made by the Director of the NMCP Main Lab or their authorized agent

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

4.2.01 Training Requirements

4.2.02 Vendor to provide onsite / offsite training to include but not limited:

4.2.03 Vendor to provide on-site assistance in the set-up and daily operation and maintenance of all supplied equipment

4.2.04 Vendor to provide upon initial installation: off-site training of a minimum of 2 technicians / operating personnel

4.2.05 Training shall include at no charge to the Government all training materials, airfare, and room and board in accordance with JTR and shall include all training materials, airfare, and room and board.

4.2.06 Vendor to provide annual training: off-site training of a minimum of 1 technician / operating personnel.

4.2.07 Training shall include at no charge to the Government all training materials, airfare, and room and board in accordance with JTR and shall include all training materials, airfare, and room and board.

4.4 Materials: (SEE ATTACHMENTS ) Product List for high volume molecular nucleic acid amplification testing system.

4.5 Equipment: (SEE ATTACHMENTS ) High volume molecular nucleic acid amplification testing system.

PART 5

5.0 SPECIFIC TASKS

5.1 Services:

5.1.01 Defense Health Agency Contracting Activity shall be responsible for the normal operation of supplied equipment.

5.1.02 Only qualified personal shall use supplied equipment.

5.1.03 All supplied equipment shall be used as designed by the OEM.

5.1.04 Vendor shall not be responsible for any abuse or neglect as a result of operation by NMCP personnel or its agents.

5.1.05 In the event of abuse / neglect vendor; to contact NMCP Contracts Office prior to performance of any repairs that will incur additional expense to the Government.

5.1.06 Prior notification will be required to ensure proper compensation for repairs.

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified

6.2.1 TIER II: Non-critical sensitive position

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: (Contractor to maintain and follow guidelines that include all PII/PHI, and Federal information requirements to include DoDI 5400.11, DoD Privacy and Civil Liberties Programs if applicable) (Refer to Clause Section, Attachments 1 and 2 of DHA Procedures, Guidance and Information 224.90, Personally Identifiable Information (PII), PHI), and Federal Information Requirement) (Adherence to DHA Administrative Instruction-110, Safeguarding Procurement Sensitive Information, is required.)

6.3.1. Data Sharing Agreements (DSAs): Contractors requiring access to PII, which includes PHI, or access to de-identified data, are subject to the DHA Privacy and Civil Liberties Office (DPCLO) (Privacy Office) Data Sharing Program. This program requires DHA to enter into DSAs with parties outside the MHS who use or create MHS data. A DHA contract may use the term Data Use Agreement (DUA) rather than DSA. DSAs assure that outside parties protect MHS data in accordance with the Privacy Act and the HIPAA Rules. To apply for a DSA, the contractor submits a Data Sharing Agreement Application (DSAA) to the DHA DPCLO. The contractor submits the DSAA even if a subcontractor will be the party accessing MHS data.