CUI//PROCURE

CUI//PROCURE

CUI//PROCURE

PART 1

1.0 GENERAL INFORMATION

1.1 This is a supply contract to provide Hematology Automation Line with Testing Agreement. The requirement is a lease of a complete Hematology Automation Line capable of providing complete blood cell counts (CBC) with advanced RBC and Body Fluid Software Applications, & Differential Remote Review Software Teams Edition (5 concurrent licenses) in a Cost-Per-Reportable-Result 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 installation, validation, and implementation of the complete Hematology Automation Line as defined in this Statement of Work (SOW) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this SOW.

1.3 Background: NMCP is a Level II Trauma Center and the primary military medical facility for the Hampton Roads region. The Hematology laboratory services:

· Oncology inpatients receiving active myelosuppressive chemotherapy regimens

· Bone marrow transplant (BMT) patients in engraftment monitoring periods

· Immunocompromised active-duty personnel and beneficiaries

· ICU patients that at risk for sepsis, where early neutrophil left-shift detection is a life-critical

· finding

· Patients with suspected or confirmed hematologic malignancies (AML, MDS, CLL, ALL) requiring diagnostic-quality automated differentials

These patient populations present with blood samples that are fundamentally different from routine outpatient specimens. They contain low cell counts, dysplastic morphology, treatment-related artifacts, and abnormal cell distributions that stress the limitations of standard impedance-based technology.

To provide the expected standard of care for those who receive their healthcare services at Naval Medical Center Portsmouth (NMCP); there must be capability of providing certain in-house laboratory tests that are ordered on a routine basis. A Complete Blood Count (CBC) is one such test. The CBC is a test panel that is requested by a credentialed provider which provides information about the cells in a patient's blood. A clinical laboratory scientist/technician performs the requested testing and provides the requesting provider with results of the patient’s CBC. The CBC includes a white blood cell count, red blood cell count, hemoglobin, hematocrit, red blood cell indices (information on red blood cell size and hemoglobin content), a platelet count as well as a white blood cell differential (neutrophils, lymphocytes, monocytes, basophils, immature granulocytes, and eosinophils are enumerated). Due to the large CBC workload experienced daily, CBC analyzer automation is necessary to ensure consistent, standardized and timely CBC test results are provided to the ordering providers.

1.4 Objectives: The Naval Medical Center Portsmouth (NMCP) and its affiliated Branch Health Clinics (BHCs) are responsible for providing the U.S. Navy, other military branches, and their military families with reliable quality health care. In addition to maintaining status as one of the nation’s premier care providers, NMCP is responsible for preparing for deployable support of operational forces, as well as shaping the future of military medicine through education, training and research. The requirement is for a reliable analyzer capable of automated identification and enumeration of pathologic cell populations specifically immature granulocytes (IG), blast cells, abnormal lymphocytes, and platelets within a high-acuity oncology and immunocompromised patient population, at a throughput and accuracy level that supports real-time clinical decision-making without excess manual review delays.

NMCP’s patient population requires an analyzer capable of:

· High sensitivity/specificity detection and flagging of abnormal cells, including blasts, variant lymphocytes, and immature granulocytes.

· Reliable automated differential performance in pathologic samples, not only normal samples

· Accurate reticulocyte and immature reticulocyte fraction (IRF) quantification

· Reduction in false-negative flags that would otherwise require additional manual review and delay clinical decision-making

· Capability to determine true platelet count in the presence of certain disease states.

The vendor shall supply a lease agreement for a complete Hematology Automated System capable of providing complete blood cell counts (CBC) with advanced RBC and Body Fluid Software Applications, direct platelet detection technology & Differential Remote Review Software Teams Edition (5 concurrent licenses) in Cost-Per-Reportable-Result Agreement, Consumables (reagents) and Maintenance Support Services for Naval Medical Center Portsmouth.

1.5 Scope: The requirement is for a lease of duplicate Hematology analyzers incased within its own automation line to also include Advanced RBC and Body Fluid Software Applications, &Teams Edition (5 concurrent licenses) in Cost-Per-Reportable-Result (CPRR) Agreement, Consumables (reagents) and Maintenance Support Services for Naval Medical Center Portsmouth. All analyzer and accessories technology, testing methodologies, quality control, consumables, spare parts used in routine user maintenance, and reagents used onboard the analyzers will be approved by and compliant with the U.S. Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment and reagents shall be in compliance with OSHA requirements. Services include all list in Part 5. The contractor shall accomplish all items listed in Parts 3 and 4.

1.6 Period of Performance (PoP): 01 June 2026 – 31 May 2027 + 4 Option Years and optional 6 month extension.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Naval Medical Center Portsmouth, Virginia.

1.7.2 Recognized Federal holidays:

Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business, between the hours of 0700-1700 Monday thru 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 SOW when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

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 Quality

1.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

1.9 Contractor personnel

1.9.1 DBIDS 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 DBIDS 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 SOW. A DBIDS is the standard identification for eligible DoD contractor personnel.

1.9.2 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.10 Reporting

1.10.1 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.

1.10.2 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.

1.11 Contractor Identification

1.11.1 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.

1.11.2 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.

1.11.3 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.

1.12 Base Access

1.12.1 Vendors and contractors will apply for, and maintain, base access. This can be done at https://dbids-global.dmdc.mil/home/.

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 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.

2.1.8 Defective Service: A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

2.1.10 Key Personnel: Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the SOW. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.11Physical Security: Actions that prevent the loss or damage of Government property.

2.1.12 Quality Assurance: The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.13 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.14 Quality Control: All necessary measures taken by the Contractor to assure that the quality of an end product or service meet contract requirements.

2.1.15 Subcontractor: One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.16 Work Day: The number of hours per day the Contractor provides services in accordance with the contract.

2.1.17 Work Week: Monday through Friday, unless specified otherwise.

2.2 Acronyms:

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

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

3.1 Services: The Government:

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

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

3.2 Facilities: The Government:

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

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

3.3 Utilities: The Government:

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

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

Water Source_______________________________________________________________ Electricity _________________________________________________________________

3.4 Equipment: The Government:

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

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

3.4 Materials: The Government:

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

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

Standard Operating Procedures and Policies As Needed

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

The contractor shall provide services for instrument analyzer hardware, providing instrument reagents, controls and consumables, providing additional instrument accessories, providing middleware functionality, instrument training, tech support, and install all while maintaining current hematology functionality.

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:

· All equipment, supplies, parts, tools, and labor to perform this contract.

· The Contractor must act in accordance with commercial practices.

· The Contractor must include Medical Liability clauses for non-personal medical services.

· All sub-contracted referral facilities used by the Contractor shall also meet the above requirements.

· The Contractor must call the originator regarding clarification of work submitted or questions about specific requirements. Unusual terminology and non-standard test requests must be verified with the originator when unclear.

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

PART 5

5.0 SPECIFIC TASKS

5.1 Basic Services: The contractor shall provide services for instrument analyzer hardware, providing instrument reagents, controls and consumables, providing additional instrument accessories, providing middleware functionality, instrument training, tech support, and install all while maintaining current hematology functionality.

5.1.1 Analyzer Hardware:

Be compatible with and maintain bi-directional interface with HL7, TCP/IP, and the DOD Laboratory Information System, MHS Genesis.

Be capable of reading specimen Code 39 barcode labels.

Must provide a full CBC test panel using an FDA-approved fluorescence flow cytometry methodology. This CBC panel will include White Blood Cell (WBC) count, Red Blood Cell (RBC) count, RBC indices (measured or calculated), directly measured platelet count, and six-part WBC differential.

Must utilize fluorescent flow cytometry to analyze RNA and DNA content and intracellular cellular structures to provide differentiation of white blood cell populations and improved identification of immature and abnormal cells, including blasts, atypical lymphocytes, and immature granulocytes. In addition, will provide an automated reticulocyte count, nucleated RBC (NRBC) enumeration, Immature Granulocytes, IG Absolute count, nRBC Absolute count, and Immature Platelet Fraction.

Must be capable of providing a NRBC count without interfering with the WBC count triggering a correction to the WBC count.

Provide an immature granulocyte count which will provide an actual quantitative measurement of promyelocytes, myeloctyes and metamyelocytes.

Must provide a low end Body Fluid WBC and low end Body Fluid RBC linearity range for the NMC analyzers. Body Fluid WBC range should extend from 0.005x10(3)/µL to 10.00(3)/µL and a Body Fluid RBC linearity range should extend from 0.002x10(6)/µL to 5.00x10(6)/µL.

Possess onboard approved FDA methodology, e.g. fluorescent technology, for the measurement of platelets to confirm the accuracy of low platelet counts and to provide an accurate platelet count in the presence of interferences (such as RBC fragments).

Have a WBC and platelet linearity range to facilitate accuracy of testing on patients with very high WBC counts or platelet counts as seen in various disease states. The WBC linearity range should extend from 0.03x10(3)/µL to 440x10(3)/µL with a larger range desired if offered. The platelet linearity range should extend from 2.00x10(3)/µL to 5,000x10(3)/µL.

Have a closed, open and capillary specimen sampling/testing mode. A small specimen volume requirement is desired due to the large population of neonatal, pediatric and geriatric patients referred to and treated by the client; desirable specimen aspiration size: No more than 100µL for the open and closed sampling modes. Test at least 200 CBC specimens per hour.

Must include an integrated automated QC module capable of holding, retrieving, storing, performing, evaluating, and documenting quality control without user intervention at defined intervals and maintain traceability of all records in accordance with accreditation guidelines.

Must provide platelet counts using a technology that is not susceptible to interference from small RBCs or RBC fragments.

Analyzers must directly measure the hematocrit with a linearity of at least 75%.

Analyzers must be able to provide correct white count in the presence or absence of NRBCs data both for the CBC and the differential for the presence of NRBCs without requirements of correction or rerun in the patient sample.

Analyzers must be able to provide a first-pass NRBC.

Provide an FDA-cleared red cell distribution width SD and CV.

No pretreatment requirement of the specimen, additional preparation of the analyzer (including the additional of more reagents), or the need for additional quality control materials to perform reticulocyte counts and body fluid counts.

Analyzers must possess specimen clot detection capabilities.

Analyzers must possess a walk-away shut down and re-start capability.

Analyzers must combine flagging information from multiple channels to optimize diagnostic information.

Analyzers must offer customized suspect flag settings to optimize review rates.

Use standardized operational software among all analyzer model platforms to make training and operation of the analyzers efficient, simple and as transparent as possible for the staff members. Staff members rotate in and out of the hematology section and are called to cover other clinics with.

If necessary, the contractor will offer customized tables to hold the analyzer units.

Each analyzer unit will be supplied with an uninterruptible power supply (UPS).

Each analyzer system will be supplied with a printer.

5.1.2 Reagents, Controls and Consumables:

Reagents, Controls and Consumables

The contractor will provide all analyzer automation, necessary reagents, quality control, spare parts for user level maintenance, and consumables in support of in-house CBC and associated testing at NMCP and its affiliated clinics. Additionally, services include recurring shipment of materials and reagents at no cost.

The contractor will provide standardized reagents and quality control material that can be used interchangeably between different analyzer models of the same manufacturer for the purpose of improving supply ordering, easing supply maintenance, lessening the storage of a variety of different reagents and quality control materials and to facilitate the ease of sharing reagents between sites until supply replenishment as necessary.

The contractor will provide reagents with at least a six month shelf life.

Reagents and controls shall be FDA-cleared for their intended use.

Reagents shall be 100% compatible with proposed hematology analyzers.

Reagents shall have shelf-life that is sufficient to support operations without excessive waste.

The system shall provide onboard reagent storage.

Reagent packs must perform at least 500 tests per container.

A single quality control material must provide measurements for all parameters on the system namely CBC panel and reticulocytes to lessen the need for and the use of multiple QC materials.

The contractor will provide quality control materials with a shelf life lot stability of at least 80 days which will place less of a burden on NMCP of having to constantly evaluate new quality control lots and performing correlation studies to confirm new control lot performance.

The contractor will perform all analyzer calibrations and provide all calibration materials at no cost to NMCP or its affiliated clinics.

5.1.3 Other Accessories to Accompany Hematology Analyzers:

Capable of performing automated scheduling for QC levels, frequency of QC runs, and when to run on specific instruments.

Capable of ensuring proper QC storage and material handling and directly integrate into laboratory workflow.

Capable of providing guided troubleshooting and analysis of failed QC runs.

Capable of providing an automated digital cell morphology packages for Body Fluids, Advanced Red Cell Morphology, and performing Differential Counts with technical support/consultation on using digital cell morphology applications.

Capable of providing an automated peripheral slide maker and stainer package with technical support/consultation on the use of this slide maker and stainer.

Capable of providing an automated specimen distribution track to distribute specimens to available analyzers and slide maker/stainers to lessen technician transit between analyzer systems. Also, have the ability to add turn units and other modular components that will minimize additional construction.

Capable of providing an automated Cell Imaging Analysis Module that is designed to automate and standardize the smear review process. This module includes the cell imaging system, PC, and all other parts to connect it to the Hematology automation line. The image analyzer will be interfaced to the Laboratory information system (LIS) through the vendors Middle Ware software.

Capable of providing a Tube Sorter Module that is designed a hands free pre- and post-analytical Hematology Automation Line solution. The vendor’s Middle Ware Software will drive the integrated sample processing, routing, and tracking of specimens both on and off the Automated Hematology Track.

Capable of providing a Streamlined Reagent Management Module that dilutes concentrated diluent to create ready-to-use reagent. This will allow user to have fewer reagent changes providing greater instrument availability and improved workflow. Also, provide the Reagent Grade Water System that meets or exceeds the manufactures water requirements.

Capable of providing all necessary modules and parts to provide an optimally functioning Automated Hematology System (AHS). All connections to automation lines must be proven and reliable. The AHS must connections to the all major vendors Total Automation Line. Together these systems will provide optimal pre- analytical, analytical, and post-analytical management of hematology patient samples. Data Management and patient results reporting will be handled together by the AHS system Middle Ware and the “Command Center” of the Laboratory Automation Line.

Capable of providing an internet-based quality control program.

Capable of providing standardized offerings (standing orders for reagents and controls).

Capable of providing automatic notification and documentation of required calibration verification procedures.

Capable of offering remote support capability for analyzer troubleshooting purposes.

Capable of providing self-paced instrument on-line training with CEU’s at no charge.

Capable of providing centralized data management and analysis of QC processes.

Capable of connecting with middleware and command center components for integrated total lab automation.

Capable of providing an FDA-approved lab automation connection with laboratory automation line solution.

Provide Professional Services (SPS) to expedite project implementation timeline.

Quick Quality Installation, which saves time and improves efficiency (Automation lines are set up and tested prior to customer shipment).

5.1.4 Maintaining Current Hematology Capabilities:

To maintain current operation capabilities and lessen the impact of having to change and update large numbers of hematology policies and procedures it is optimal for the Hematology Testing Automation Line to have the following characteristics.

System shall be able to provide a fully automated and reportable Complete Blood Count (CBC), 6-part differential, nucleated red cell count, and reticulocyte analysis with blood film preparation and staining, blood film differential, tube sorting, HbA1c analysis, and auto-verification capabilities without operator intervention

System shall provide physically connected and integrated slide making/staining to reduce technician handling and improve workflow.

System shall provide the ability to connect directly to a digital imaging device to reduce technologist handling of sample tubes, blood, and slides thereby improving turn-around time of results to physicians.

System shall offer fully reportable, FDA cleared immature granulocyte enumeration providing a 6-part differential to provide more specific cellular information and to help reduce manual differentials

System shall offer fully reportable, FDA cleared secondary on board platelet methodology to reduce manual reviews of flagged samples and platelet estimates.

System shall offer fully reportable, FDA cleared reticulocyte hemoglobin measurement to assist with anemia management.

System shall provide the most up to date, complete and FDA approved anemia management parameters such as those described in the VA/DoD Practice Guidelines for the Management of Chronic Kidney Disease, for the purpose of efficiently screening for anemia.

System shall offer fully reportable, FDA cleared immature platelet fraction to assist with thrombocytopenia determinations.

System shall provide enhanced body fluid testing capabilities with the lowest possible linearity.

System shall provide enhanced body fluid testing capabilities fully reportable, FDA cleared 2-part WBC body fluid differential.

System shall provide reagent concentrate and dilution system to reduce reagent changes and inventory requirements.

System shall not require more than 5 control vials for daily quality control runs for complete blood count, 6-part differential, reticulocyte, nucleated red cell and body fluid counts.

System shall not require more than 100µl sample aspiration volume to perform Complete Blood Count (CBC), white blood count differential, nucleated red cell count, and reticulocyte analysis as a way to reduce redraws and allow for maximized test utilization and efficiency.

Preventative maintenance of system should be self-contained and automated to increase laboratory productivity.

System shall offer standardized reagents, technology, and quality control across all offered solutions.

System shall provide vendor completed calibration adjustments and verifications in accordance with accreditation requirements.

All current menu of test parameters to be maintained and FDA approved on new hematology system.

Hematology system must be compatible and able to connect to multiple vendor CC/IA track automation lines

Middleware shall be be included.

System shall have the ability to add turn units and other modular components that will minimize additional construction.

5.1.5 Capability of Providing a Middleware Functionality with the Following Criteria:

Key Functionality:

· Comprehensive rule creation capability for instrument flags, linearity, delta results and critical test results.

· Auto-validation and manual validation features.

· Vendor must provide consultant to facilitate Auto-Validation through MHS Genesis LIS.

· Manual differential keyboard and morphology result reporting.

· Management of patient results from multiple instruments in one consolidated view.

· Management of peripheral blood and body fluid analysis.

· Management of HbA1c testing analyzer and the management of the patient testing data reports (If desired to bring online with Hematology system).

· Online, real-time access to patient data for at least two years.

· Provide technical support/consultation for the use of Middleware.

Intra-hospital Network, Middleware Must Provide:

· Connectivity for all hospital labs, clinics into a single database system for data management across IHN system.

· Ability to integrate multiple laboratory information systems (LISs) as required.

Interfacing: Middleware Architecture Must Be Able to Support:

· HL7/TCP-IP interface for best practices data integration and interfacing capabilities.

· Reflex orders management capability through interfacing without manual intervention by user.

· Seamless integration between LIS and middleware so that user does not need to switch between middleware and LIS. All work must be able to be performed in the middleware system.

· Must have extensive LIS interfacing experience.

· Must be compatible with DOD’s MHS Cerner-Genesis.

Information Systems Security: All Navy Medicine IT systems must maintain an appropriate level of confidentiality, integrity, authentication, non-repudiation, and availability. The Business-To-Business (B2B) Gateway provides confidentiality, integrity, authentication, non-repudiation, and availability to Navy Medicine Enclaves. The B2B Gateway is the solution to be used by Navy MTFs to provide remote connectivity to MHS Business Partners. The B2B Gateway is designed to provide MHS Business Partners with a securely managed, single point of entry into Navy Medicine Enclaves. The B2B Gateway is sponsored by TIMPO and is managed by DISA.

The Contractor’s responsibilities must include some or all of the following:

· Provides network information.

· Procures and installs B2B Gateway compatible VPN/encryption device.

· Procures Tier I or Tier II Internet Service Provider for connectivity.

· Provides qualified on-site touch labor support technical support to help resolve telecommunications and support routine maintenance activities.

· Provide technical support/consultant and training slot for LIS staff for the use of Middleware.

· Vendors solution must have RMF approval to allow for “Remote Service Monitoring” of proposed analyzers, middleware and automation.

· Ensures personnel have appropriate security qualifications.

· Ensures personnel complete annual Information Awareness Training.

· Reports all problems to the MHS Help Desk.

· Provides 24/7 on-call technical points of contact to assist with problem resolution.

· Provides configuration management of B2B Gateway Questionnaire.

5.2 Cost-Per-Result-Reportable Charges

5.2.1 CPRR – Billings will be for patient reportable results only. A reportable is considered one cycle of the instrument that increments the run counter, excluding repeats, controls and calibrators.

5.2.2 190,000 reportables annually for the Base Year and each Option Year for Complete Blood Count (CBC) tests.

5.3 Special Qualifications: RESERVED.

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

6.2 RESERVED.

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: RESERVED.

6.4 Training: RESERVED.

6.5 Cybersecurity Requirements for Non-DoD IT or Covered Contractor IS: RESERVED.

6.6 Risk Management Framework (RMF) for DoD IT: RESERVED.

6.7. Facility Related Control Systems: RESERVED.

6.8. System Communications: RESERVED.

6.9 MHS Demilitarized Zone (DMZ) Medical Community of Interest (MedCOI) Business-to-Business (B2B) Gateway

6.9.1 If there is an external system connection to a DoD IS required, then the contractor shall, in accordance with contract requirements, connect to the DHA B2B Gateway via a contractor procured Internet Service Provider (ISP) connection.

6.9.2 The contractor shall assume all responsibilities for establishing and maintaining their connectivity to the B2B Gateway. This shall include acquiring and maintaining the circuit used to connect to the B2B Gateway and the acquisition of a Virtual Private Network (VPN) device maintenance agreement and license compatible with the MHS VPN device. The list of compatible devices are detailed in the DHA B2B/MedCOI Gateway questionnaire.

6.9.3 The contractor shall submit a completed current version of the DHA B2B Gateway questionnaire to their Contracting Officer or COR within 10 calendar days after new requirements have been provided to the contractor.

6.9.4 The contractor shall provide information specific to their connectivity requirements, proposed path for the connection and last mile diagram.

6.10 Contractor Provided IT Infrastructure

6.10.1 Platforms shall support HyperText Transfer (Transport) Protocol (HTTP), HyperText Transfer (Transport) Protocol Secure (HTTPS), web-derived Java Applets, and Secure File Transfer Protocols (SFTPs) (e.g., STFP, Secure Socket Layer/Transport Layer Security), and all software that the contractor proposes to use to interconnect with DoD facilities.

6.10.2 The contractor shall configure their networks to support access to Government systems (e.g., configure ports and protocols for access).

6.10.3 The contractor shall provide full time connections to a TIER 1 or TIER 2 ISP. Dial-up ISP connections are not acceptable. All IP addresses need to be publicly routable. Private address space using Network Address Translation will not be permitted.

6.10.4 The contractor shall maintain a valid maintenance contract and pertinent licenses for all devices connecting to the MHS B2B Gateway.

6.11 System Authorization Acess Request (SAAR), Defense Department (DD) Form 2875

6.11.1 The contractor shall submit the most current version of DD Form 2875, “System Authorization Access Request (SAAR), in accordance with CO guidance for all contractors that use the DoD Gateways to access Government IT systems and/or DoD applications shall. A DD Form 2875 shall be completed for each contractor employee who will access any system and/or application on a DoD network. The DD Form 2875 shall clearly specify the system and/or application name and justification for access to that system and/or application.

6.11.2 The contractor shall submit the completed DD Form 2875 to the DHA IT Security for verification of Tier I or Tier II Designation. The DHA Personnel Security will verify that the contractor employee has the appropriate background investigation completed or a request for background investigation has been submitted to the Office of Personal Management (OPM). Acknowledgment from OPM that the request for a background investigation has been received and that an investigation has been scheduled will be verified by the DHA Personnel Security prior to access being approved.

6.11.3 Upon approval, DHA will notify the user of the ID and password via secure/encrypted e-mail upon the establishment of a user account. User accounts will be established for individual use and may not be shared by multiple users or for system generated access to any DoD application. Misuse of user accounts by individuals or contractor entities will result in termination of system access for the individual user account.

6.11.4 The contractor shall conduct a monthly review of all contractor employees who have been granted access to DoD IS’/networks to verify that continued access is required

6.11.5 The contractor shall provide the DHA DPCLO with a report of the findings of their review by the 10th day of each month following the review. Reports identifying changes to contractor employee access requirements shall include the name, DoD ID number from CAC, Company, IS/network for which access is no longer required and the date access will be terminated.

6.12 MHS Systems Telecommunications

6.12.1 The primary communication links shall be via encrypted tunnels (i.e., Secure Internet Protocol (IPSEC), GetVPN, or Secure Socket Layer) between the contractor’s primary site and the MHS B2B Gateway.

6.12.2 The contractor shall place the VPN appliance device outside the contractor’s firewalls and shall allow full management access to this device (e.g., in router access control lists) to allow Central VPN Management services provided by DHA or other source of service as designated by the MHS to remotely manage, configure, and support this VPN device as part of the MHS VPN domain.

6.12.3 The contractor shall procure and configure for operation an auxiliary VPN device for backup purposes to minimize any downtime associated with problems of the primary VPN.

6.12.4 The contractor shall send devices to the MHS VPN management authority (e.g., DHA) via postage paid and include prepaid return shipping arrangements for the devices(s).

6.12.5 The MHS VPN management authority (e.g., DHA) will remotely configure and manage the VPN appliance once installed by the contractor.

6.12.6 The contractor shall be responsible for the maintenance and repair of contractor procured VPN equipment.

6.12.7 The Government will be responsible for the troubleshooting of VPN equipment.

6.13 Establishment of Telecommunications

6.13.1 Telecommunications shall be established with the MHS through coordination with DHA.

6.13.2 The contractor and DHA Program Office shall identify their requirement(s) for the establishment of telecommunications with the MHS and/or other Government entities.

6.13.3 The DHA/MedCOI B2B Gateway Questionnaire (provided by DHA) identifies the required telecommunication infrastructure between the contractor and the MHS systems. This includes all Wide Area Network, Local Area Network, VPN, Web DMZ, and B2B Gateway access requirements.

6.13.4 The contractor shall complete their applicable portion of the questionnaire and shall return it to the DHA designated POC for review and approval.

6.13.5 The contractor shall, Upon Government request, provide technical experts to provide any clarification of information provided in the questionnaire. DHA will review and process the questionnaire when it is accepted.

6.13.6 DHA will coordinate any requirements for additional information with the POC and schedule any meetings required to review the Questionnaire. Upon approval of the Questionnaire, DHA will coordinate a testing meeting with appropriate stakeholders.

6.13.7 DHA will notify the contractor POC of the meeting schedule. The purpose of the testing meeting is to complete a final review of the telecommunication requirements and establish testing dates.

6.14 Contractors Located On Military Installations

6.14.1 The contractor(s) shall coordinate/obtain the connections with the local MTFs/ Enhanced Multi-Service Markets (eMSMs) and Base/Post/Camp communication personnel located on a military installation who require direct access to Government systems.

6.14.2 These connections will be furnished by the Government.

6.14.3 Contractors located on military installations that require direct connections to their networks shall provide an isolated IT infrastructure. They shall coordinate with the Base/Post/Camp communications personnel and the MTF/eMSM in order to get approval for a contractor procured circuit prior to installation to ensure the contractor is within compliance with the respective organizational security policies, guidance and protocols.

Note: In some cases, the contractor may not be allowed to establish these connections due to local administrative/security requirements.

6.14.4 The contractor shall be responsible for all security certification documentation as required to support DoD IA requirements for network interconnections.

6.14.5 The contractor shall provide, on request, detailed network configuration diagrams to support IA accreditation requirements.

6.14.6 The contractor shall comply with IA accreditation requirements. All network traffic shall be via Transmission Control Protocol/Internet Protocol using ports and protocols in accordance with current Service security policy. All traffic that traverses MHS and/or military Service Base/Post/Camp security infrastructure is subject to monitoring by security staff using Intrusion Detection Systems.

Part 7

7.0 Points of Contact

LTJG Justin Washington - Laboratory Manager justin.a.washington6.mil@health.mil 757-953-1541

Kristen Cote - COR Kristen.e.cote.civ@health.mil 757-953-1494

CUI//PROCURE

CUI//PROCURE

1CUI//PROCURE

DHA PWS Template V13 November 16, 2021