SOR Automated UA NMCP 18Aug25.docx

Statement of Requirement

PART 1

1.0 GENERAL INFORMATION

1.1 This is a supply contract to provide a fully Automated Urinalysis Platform for Cost-Per-Reportable-Result (CPRR).

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 a fully Automated Urinalysis Platform 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: In order to provide the expected standard of care for patients 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. The laboratory provides essential diagnostic services in support of inpatient and outpatient care across multiple clinical specialties. Urinalysis testing plays a critical role in evaluating renal function, detecting infection, and monitoring a wide range of medical conditions. On average, the laboratory processes over 48,000 urinalysis components annually, including both urine chemistry and urine microscopic sediment analysis.

1.4 Objectives: To maintain diagnostic continuity, improve efficiency, and meet projected testing volumes for FY 2026 and beyond, the laboratory requires a modern, fully automated urinalysis analyzer. The new system must be compatible with existing laboratory infrastructure, including Cerner LIS, Instrument Manager middleware. It should also support integrated digital imaging and automated result classification and release. 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.

1.5 Scope: This requirement is for a lease of a fully Automated Urinalysis Cost-Per-Reportable- Result (CPRR) testing platform. The analyzer should feature automatic loading, automatic unloading, automated chemistry strip readers, automated microscopic particle analyzers, automated particle classification and all components necessary to support continuous loading and high-throughput processing with minimum processing of 200 samples per hour for urine chemistry and 100 samples per hour for microscopics in the form of a CPRR Agreement with Consumables (all reagents, controls and calibrators necessary to operate the system) 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 October 2025 – 30 September 2025 + 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 PWS 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 PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

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

1.9 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 PWS. 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 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.

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

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

2.1.9 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 PWS. 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.

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

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

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

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

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

2.1.15 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 urinalysis 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 PWS.

1. Duplicate Automated Urinalysis Systems

2. Reagents, Controls and Consumables

3. Monitors

4. Keyboards

5. UPS (uninterrupted power supply)

6. Cords

7. Software

8. Waste Containers

9. Tube Racks

10. Calibration Tools

11. (2) Maintenance kits

12. Manuals

13. IFUs (Instructions for Use)

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 urinalysis 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 fully automated urinalysis system capable of performing both urine chemistry and urine microscopy in a single integrated platform using FDA approved methodologies.

Must not require any centrifugation for analysis.

Must drastically minimize the need for microscopic review by incorporating automated particle imaging and classification through AI algoritihims and user defined rules or equivalent technology.

Shall produce a standard urinalysis report that includes: urine color, clarity, specific gravity, pH, protein, glucose, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase, and blood.

Shall enumerate and classify formed elements under microscopy to include, but not limited to: RBCs, WBCs, epithelial cells, bacteria, crystals, casts, and mucus.

Must provide a fully automated imaging system that captures high-resolution images of urine sediment with ability to transmit to LIS or archive for retroactive review.

Must support continuous loading and high-throughput processing with minimum processing of 200 samples per hour for urine chemistry and 100 samples per hour for microscopics, with supporting growth in volume for over 50,000 test/year.

Must possess onboard sample management features that positively IDs specimens by barcode and supports walk-away operations.

Possess onboard approved FDA methodology, e.g. fluorescent flow technology or comparable digital imaging for the measurement of cellular components.

Contractor must supply delivery, on-site installation, and implementation/validation support.

Contractor must supply initial and refresher training as needed for laboratory personnel. All training and support must be provided at no additional cost.

Must provide a quality control monitor for automated urinalysis quality control that defines QC out of limits and provides reports base on shift activity.

Must provide assistance with autoverification rule configuration and implementation.

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.

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

Through a Cost-Per-Reportable-Result (CPRR) contract, the contractor will provide all analyzer automation, necessary reagents, quality control, spare parts for user level maintenance, and consumables in support of in-house urinalysis testing 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.

A single quality control material must provide measurements for all parameters on the system

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.

Reagent and Supply Delivery All supplied items and reagents shall be certified for use with the equipment provided by the selected vendor.

All supplied items and reagents that require special handling (e.g. refrigeration, time sensitivity, immediate open, etc.) will be marked in an explicit manner with a label that is easily read, understandable, and a minimum of 3 inches x 3 inches (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies or items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

The contractor shall provide deliveries to the delivery point identified below:

Naval Medical Center Portsmouth 620 John Paul Jones Circle Portsmouth, VA 23708

5.1.3 Equipment must be from an Original Equipment Manufacturer authorized dealer/distributor/seller for any service, software, warranty, or maintenance requirements. All Parts, Service. Software, Vendor, Warranty, and Maintenance must be of OEM, original vendor quality and not third party re-furbished parts, services, or equipment.

5.1.4 Replacement Parts/Updates

The vendor shall have ready-access to unique and/or high-mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional charge to the Government.

The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

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

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

The vendor shall install software revisions and updates (field service changes) that are required by FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional charge to the Government. Updates and revisions shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, the vendor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

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

5.1.5 Government Furnished Property, Materials and Services

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

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

The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Vendor supplies, materials, or for the personal belongings brought onto Government property by Vendor’s personnel.

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

5.1.6 Training

The contractor shall provide on-site operator training for Government personnel upon initial implementation for the base year and for each option year exercised. The training shall include initial automation system user training for twenty-three (23) staff members, and user training for a minimum of two (2) staff members for each additional option year.

On-site assistance during system validation shall be provided.

5.1.7 Maintenance

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

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

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

5.1.8 Preventive Maintenance Services

Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. EST. Vendor shall provide full-service preventive maintenance.

Preventive maintenance shall be performed in accordance with OEM recommendations.

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

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

5.1.9 Corrective Maintenance

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

A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours. Equipment shall be operational within forty-eight (48) hours of the initial trouble call.

Government request for corrective maintenance will be placed by NMC Portsmouth Biomedical Engineering Division (BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract.

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

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

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

5.2.0 Other Accessories/Capabilities to Accompany Urinalysis Analyzers:

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

Capable of performing analysis without centrifugation.

Capable of using fluorescent flow imaging or comparable digital imaging technology. Must include digital imaging capabilities with ability to automatically classify particles from urine sediment with a high degree of accuracy and provide output for review.

Capable of providing an automated specimen distribution track to distribute specimens to available analyzers and imagers to lessen technician transit between analyzer systems. Also, have the ability to add 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 microscopic review process. This module includes the cell imaging system, PC, and all other parts to connect. The image analyzer will be interfaced to the Laboratory information system (LIS) through the directy or though vendor Middleware.

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 remote support services if ATO is available or currently in the process of approval for remote services.

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).

5.2.1 Maintaining Current Urinalysis Capabilities:

To maintain current operation capabilities and lessen the impact of having to change and update large numbers of urinalysis policies and procedures it is optimal for the Urinalysis Testing Platform to have the following characteristics.

System shall be able to provide a fully automated and reportable urinalysis chemistry and microscopic with accurate automate classification, and auto-verification capabilities without operator intervention.

System shall provide physically connected and integrated imaging system to reduce technician handling and improve workflow.

System shall not require more than 3 control vials for daily quality control runs

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 urinalysis system.

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

Middleware shall be be included.

5.2.2 System Requirements

Equipment must occupy the current placement of existing analyzer, no facility or structural adjustments will be required. If found non-compatible this will cause a delay if infrastructure, electrical specifications, and water/waste requirements dictates differentially.

Current equipment is stationary with space available occupied by a duplicate automated urinalysis system. Approximate space available is 10ft x 8 ft.

5.2.3 Envoirnomental Factors

Regulated room temperature of 18-28 degrees Celsius is required. Instrument must be capable of continuous functioning at humidity between 20- 80%.

5.2.4 Voltage and Electrical Requirements

Current voltage and electrical requirement are regular 90-240-VAC. (2) Automated Urinalysis Workcell analyzers will be plugged into an individual UPS appropriate of handling interrupted or unexpected power conditions. Monitor will require between 100-240 VAC.

Electrical power requirement Microscopy module 90-240 VAC, 50-60 Hz, 2.5 A Monitor 100-240 VAC, 50-60 Hz , 1.7 A Chemistry module 100-240 VAC, 50-60 Hz

5.2.5 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 urinalysis specimens.

· 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.

· Capable of supporting autoverification rules and flags based on laboratory needs for workflow standardization with result verification without additional software.

Information Systems Security: All DHA network 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 DHA network Enclaves. The B2B Gateway is the solution to be used by DHA 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 DHA network 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.

5.3 Monthly Charges

5.3.1 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.

5.3.2 24,828 reportables per year for Urine Chemistry Tests.

5.3.3 23,736 reportables per year for Urine Microscopic Tests.

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 MHS Systems Telecommunications

6.11.1 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.

6.11.2 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.

6.11.3 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.

6.11.4 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).

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

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

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

6.12 Establishment of Telecommunications

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

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

6.12.3 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.

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

6.12.5 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.

6.12.6 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.

6.12.7 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.

Part 7

7.0 Points of Contact

Cynthia Sivells- Clinical Core Lab Manager cynthia.m.sivells.civ@health.mil 757-953-1705 LTJG Justin Washington- Chemistry Lab Division Officer justin.a.washington6.mil@health.mil 757-953-1541 Kristen Cote- COR Kristen.e.cote.civ@health.mil 757-953-1494