B.08 Attachment 1 1449 - W81K0426QA025.pdf

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SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect 8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

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CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8(A)

ECONOMICALLY

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NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

calls)

Solicitation/Contract Form Continuation

CBC Testing Equipment and Accessories and SuppliesInstrument Name:

W81K0426QA025

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Item Supplies/Service Quantity Unit Unit Price

Amount

0001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 4/01/2026 -9 /30/26 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

31,250 Each

0002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 4/01/2026 -9/30/26 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

600 Each

0003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 4/01/2026 -9/30/26 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

180 Each

0004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 4/01/2026 -9/30/26 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

6,000 Each

0005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 4/01/2026 -9/30/26

6,000 Each

Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

1001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/26 -9/30 /27 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

62,500 Each

1002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/26 -9/30/27 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

1,200 Each

1003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/26 -9/30/27 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

360 Each

1004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 10/1/26 -9/30/27 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

12,000 Each

1005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 10/1/26 -9/30/27 Product Service Code: 6550

12,000 Each

System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

2001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/27 -9/30 /28 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

62,500 Each

2002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/27 -9/30/28 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

1,200 Each

2003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/27 -9/30/28 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

360 Each

2004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 10/1/27 -9/30/28 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

12,000 Each

2005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 10/1/27 -9/30/28 Product Service Code: 6550

12,000 Each

Pricing Arrangement: Firm Fixed Price

3001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/28 -9/30 /29 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

62,500 Each

3002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/28 -9/30/29 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

1,200 Each

3003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/28 -9/30/29 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

360 Each

3004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 10/1/28 -9/30/29 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

12,000 Each

3005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 10/1/28 -9/30/29 Product Service Code: 6550

12,000 Each

Pricing Arrangement: Firm Fixed Price

4001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/29 -9/30 /30 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

62,500 Each

4002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/29 -9/30/30 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

1,200 Each

4003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/29 -9/30/30 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

360 Each

4004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 10/1/29 -9/30/30 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

12,000 Each

4005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 10/1/29 -9/30/30 Product Service Code: 6550

12,000 Each

Pricing Arrangement: Firm Fixed Price

5001 Complete Blood Count w/Differential - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/30 -3/31 /31 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

31,250 Each

5002 Reticulocyte Count Panel -Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/30 -3/31/31 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

600 Each

5003 Body Fluid Cell Count - Womack Army Medical Center, Fort Bragg, NC Delivery Dates: 10/1/30 -3/31/31 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

180 Each

5004 Complete Blood Count w/Differential - Clark Clinic Fort Bragg, NC, 28310 Delivery Dates: 10/1/30 -3/31/31 Product Service Code: 6550 North American Industry Classification System (NAICS): 334516 Pricing Arrangement: Firm Fixed Price

6,000 Each

5005 Complete Blood Count w/Differential - Robinson Clinic, Fort Bragg, NC Delivery Dates: 10/1/30 -3/31/31 Product Service Code: 6550

6,000 Each

Pricing Arrangement: Firm Fixed Price

Continuation of Description

1. SCOPE OF WORK

1.1. The contractor shall provide services to include, but not limited to, all personnel, equipment, transportation, tools, materials, supervision, training, and other items and services necessary to provide hematology automation systems and reagents. The contract pricing shall be an all-inclusive price within the Cost Per Kit (CPK) or Cost Per Reportable Result (CPRR).

The contractor shall perform to the standards of this Statement of Work (SOW). The contractor selected is responsible for equipment and services at the following facilities:

- Womack Army Medical Center (WAMC), Fort Bragg, NC

- Clark Health Clinic Laboratory, Fort Bragg, NC

- Robinson Health Clinic Laboratory, Fort Bragg, NC

1.2. For the purposes of this SOW, the automation system includes at a minimum:

- All analyzers for each location

- Peripherals (e.g., Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units (CPUs), printers, barcode scanners, terminals, monitors, etc.

1.2.1 Automation system to include (2) two automated CBC analytical systems, (1) one slide maker/Stainer, (1) one digital cell imager, and middleware shall be delivered and installed at the primary location: Womack Army Medical Center (WAMC), Fort Bragg, NC.

1.2.2 Two identical automated CBC analytical systems that are identical to WAMC's CBC analytical system shall be delivered and installed at each of the following secondary locations:

- One system shall be delivered and installed at Clark Health Clinic

- One system shall be delivered and installed at Robinson Health Clinic.

Womack Army Medical Center, Building 4-2817, Room BG0800, 2817 Rock Merritt Ave, Fort Bragg, NC 28310. Space available for all equipment and its operation is 16' by 5' at the main lab.

Clark Health Clinic, Building 5-4257, Bastogne Road, Fort Bragg, NC 28310. Space available for all equipment and its operation is 6' by 4' at Clark Clinic.

Robinson Health Clinic, Building C-1722 Tagaytay Street, Fort Bragg, NC 28310. Space available for all equipment and its operation is 6' by 4' at Robinson Clinic.

1.3 Normal Hours of operation:

- Womack Army Medical Center: 24/7

-Clark and Robinson Health Clinics: 5 days a week 0730-1700 M-F, no weekends or federal holidays.

Delivery Periods

Validation 01 01 March 2026 through 31 March 2026

Base Period 01 01 April 2026 through 30 September 2026

Delivery Period 1 01 October 2026 through 30 September 2027

Delivery Period 2 01 October 2027 through 30 September 2028

Delivery Period 3 01 October 2028 through 30 September 2029

Delivery Period 4 01 October 2029 through 30 September 2030

Delivery Period 5 01 October 2030 through 31 March 2031

2. TESTING SYSTEM

2.1. All testing systems shall be manufactured, sold, and supported by one Contractor. All testing systems shall be serviced and supported by the awarded Contractor. This includes all on-site and off-site training, Information Technology (IT) management, IT implementation services, phone support, on-site and off-site services, as well as any future Food and Drug Administration (FDA) approved testing that can be performed on contractor supplied testing systems. All testing systems shall be capable of interfacing with the military hospital computer system, i.e., the MHS Genesis. The Contractor shall have an established driver compatible for interfacing the analyzer with the MHS Genesis. The interface between MHS Genesis and the analyzer shall be bi-directional.

2.2. All testing systems shall include a data management system for control of the operation of the analyzers, management of the quality control (QC) program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer to produce hard copy of patient reports and other reports generated via the data management system.

2.3. All equipment displays and supporting literature shall be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and QC materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA)/College of American Pathology (CAP) guidelines and analyzer removal within 30 days after the termination of the contract.

2.4. All analyzers shall be fully automated with at least 50 tests per hour to include Retic, Body fluids, and Complete Blood Count with Differential with continuous access for samples, a true walk-away system, automatic shut-down/start up of the system, and barcode reading for all reagents and samples for the WAMC location.

2.5 The CBC analyzer shall be fully automated with at least 50 test per hour to include Retic and Complete Blood Count with automated Differential with continuous access for samples, a true walk away system, automatic shut down/start up of the system and barcode reading for all reagents and samples for the Clark and Robinson clinic locations.

2.6. All analyzers and associated parts and accessories shall be new. Neither used, refurbished, or like-new equipment will be provided in support of this contract at any time.

2.7 All testing systems shall include a dedicated stand for analyzers, accessories, and supplies in use for storage for each site location listed in section 1.

2.8 The testing system shall have the capabilities to drain either into a sink or collection container for non-hazardous waste disposal for Clark and Robinson testing sites.

2.9 The testing system shall have the capabilities to drain into a central drain for non-hazardous waste products for the WAMC location.

2.10 The testing system shall have the capability to have one control center for central management of all analyzers at the WAMC location and a separate control center for each site location listed in section 1.

2.11 The testing system shall be connected in a continuous automated line from initial to reflex testing to include digital imager for cell identification for the WAMC location.

2.12 The contractor is responsible for maintaining printers, peripherals, CPU, and other accessories throughout the duration of the contract period for each site location listed in section

2.13 All testing systems shall come equipped with UPS capable of providing all necessary electrical power to each analyzer system, to operate the data management and testing system for at least 15 minutes. The contractor shall support the maintenance and replacement batteries to the UPS as needed.

2.14 Contractor shall provide updates and upgrades of all testing systems upon availability at no charge. The Contractor and Contracting Officer's Representative (COR) shall agree upon a date of installation of updates and upgrades.

3. INFORMATION MANAGEMENT

3.1 Contractor Information Systems (IS)/Network that are involved in the operation of systems in support of WAMC shall operate in accordance with controlling laws, regulations, Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF), and local policy. DHA CyberLOG requirements are detailed in Appendix 2, titled Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF) Requirements, 5 January 2022.

3.2 The data management system shall offer software management features with rules capable of preparing data for auto validation prior to host transmission. The software shall have following capabilities:

- To write and validate user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user

- To write and validate user defined order /request rules

- To support patient delta checks as part of the auto-verification process

- To support rules that recognize linearity limits, repeat for critical value tests, review for specimen integrity and delta checks on previous patient results etc.

- To support specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test shall be able to transmit to the host along with the appropriate comment.

3.3 All Contractor systems that wish to communicate with Department of Defense (DoD) systems and deployed vendor systems will need to initiate Business to Business (B2B) gateway approval through DHA, if not already approved. For all Web applications, Contractors will connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone

(DMZ).

3.4 The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data and compliance with Health Insurance Portability and Accountability Act (HIPAA) of 1996, to ensure the confidentiality, integrity, and availability of data. As a minimum, this shall include provisions for personnel security, electronic security and physical security.

3.5 The Contractor shall provide a Thin Client-type data management system that allows for control of the analyzer system, review and management of the QC program, review of on-instrument useful life of the reagents/reagent packs, and management of patient results.

3.6 All software and software licenses, interfaces, and hardware (e.g., servers, printers, monitors, UPS, CPUs, barcode scanners, etc.) shall be included with cost of hardware required.

3.7 The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage.

3.8 The Data Management system shall have a comprehensive, fully integrated QC software module that stores and evaluates QC results. Results can be viewed in a variety of formats including Levy-Jennings charts and statistical summaries. The application will validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred.

3.9 The QC software shall have a large capacity to store graphics and results, cumulative patient reports and QC files with statistics - all available to user. The QC software will provide the capability to write user defined Westgard QC Rules. In addition, it will integrate with the result manager for auto-verification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall include the ability to apply Westgard QC result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4. ANALYZERS

4.1 The Contractor shall provide a fully automated, continuous sample loading CBC analyzer system capable of performing all of the required assays listed in Appendix 1 for Womack Army Medical Center, Clark, and Robinson Health Clinics. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

4.2 The analyzer systems and all reagents shall be FDA approved for clinical use. All analyzers and associated parts and accessories will be new. Neither used, refurbished, nor like-new equipment will be provided in support of this contract at any time.

4.3 All analyzers shall have the ability to import reagent and quality control with ranges, expiration dates, lot numbers, etc. from the ease of scanning barcode information.

4.4 All systems shall come equipped to perform continuous, random and statistical analysis;

capable of real time or on-line Quality Control. Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot#s, means, ranges, SD, and CVs%.

4.5. All CBC analyzers shall have the capabilities to differentiate between neutrophils, lymphocytes, monocytes, basophils, and eosinophils in absolute and relative values and a way to detect immature granulocytes and alert the tech for reflex testing.

4.6 All CBC analyzers shall provide specimen analysis technology with demonstrated performance that corrects for interfering substances, such as: NRBCs, platelet aggregation, cold agglutinins, fragmented RBC's, extreme sickle cell, ABN RBC fragility, and spherocytosis.

4.7. All analyzer systems shall have an interface that is compatible to the government system MHS Genesis. All analyzers shall be able to recognize a variety of generated bar-code labels (code 128) on primary sample tubes.

4.8. All CBC analyzers shall determine WBC, PLT, RBC, and hemoglobin by direct measure analysis.

4.9. All CBC analyzers shall provide for the direct measure of individual leukocyte population

(vs. calculated parameters) and shall analyze leukocytes in their near-native state so as not to physically or biochemically alter their morphology.

4.10.All analyzers shall have cap piercing capabilities with multiple vacutainer tube sizes with a minimal volume of 1mL. .

4.11. All CBC analyzer systems shall provide surface plots to review WBC differential populations, NRBC and Retic populations.

4.12 All analyzers shall have the capabilities to use pediatric tubes to include the BD microtainer tubes and Griener minicollect tubes.

4.13. The Slidemaker/stainer analyzer shall prepare microscope slides automatically or flags problems for slide prep.

4.14. All CBC analyzers shall have the capability to perform automatic NRBC differential and automatic correction of the white blood cell count, and capable of enumerating Nucleated Red Blood Cells (NRBCs) accurately.

4.15. The digital cell analyzer shall have the capability of performing digital Red cell morphology and WBC differentials in an automated fashion and integrated in the automated line system located at the WAMC site.

4.16. The CBC analyzer located at WAMC shall be FDA approved for performing automated cell counts on body fluids (CSF, synovial, pleural and peritoneal) to include WBC, RBC, and a two part differential count. .

4.17. All CBC analyzers system shall provide users with rapid, reliable test results that are critical for patient care. These CBC analyzer systems shall be capable of performing in low, medium, and high-volume work periods to produce results that are accurate and precise throughout the manufacturer's stated linearity/analytic measurement range.

4.18. All CBC analyzers at minimum actual through-put shall be 50 whole blood counts per hour, and/or 10 reticulocyte counts per hour with both open mode (manual sampling) and closed mode sampling to include micro sampling for "pedi-tubes" and microtainer tubes used for NICU patients.

4.19. All analyzers initial startup from the shutdown state shall not exceed 20 minutes.

4.20. All CBC analyzers shall perform platelet count by size, impedance, and/or alternate method, And include Mean platelet volume (MPV). Analyzer shall be Capable of detecting platelet clumping, enlarged platelets, and can differentiate between a large platelet and small red blood cell.

4.21. All analyzers shall have the on-board ability to maintain reagents at the proper storage temperatures. The instrument shall have on-board reagent monitoring which shall include on board open reagent expiration, available volume, and number of tests remaining. The analyzers shall have non-interrupted loading of reagents and consumables.

4.22 All analyzers shall also be able to generate an on-board maintenance record and tracker.

4.23 All CBC analyzers shall have the capability to automatically run, repeat, and/or reflex specimens without operator interventions, by the use of user defined decision rules.

4.24 Any item/part/supply excluded by the contractor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.

5. REAGENTS

5.1. The Contractor shall provide all of the tests listed in exhibits, to include reagents and calibrators. These products shall be manufactured by the Contractor and not by a third party.

The testing system and all assays shall be FDA approved for clinical use. All reagents provided will be identical to those used in the FDA approval application. For reagents with hazardous constituents, Contractor shall provide a mechanism for the Laboratory to meet local discharge requirements. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alerts and notifications of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the Contracting Officer Representative (COR), Hematology Supervisor, OCMH Supervisors, and/or Quality Assurance Coordinator. All equipment displays and supporting literature shall be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and QC materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA) / Clinical and Laboratory Standards Institute (CLSI) guidelines and analyzer removal at the termination of the contract.

5.2. The Contractor shall also estimate the volume of user-replaceable maintenance items that will be required to support all analyzers, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks at the level of volume specified in Appendix

1. The contractor shall provide the operator level maintenance tool/spare parts kits and replenish all expended items. Replenishment will be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3. Delivery of the reagents shall be on an as needed basis or delivery schedule based on workload and usage. Individual orders will be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel will be provided to the Contractor.

5.4. The workload listed in the exhibits is an estimate based on projected annual volume.

Orders of required items will be called or emailed to the Contractor. Deliveries shall arrive within five working days after the order is placed. No deliveries shall be accepted on weekends or federal holidays. Emergency orders placed before 2:00 PM Eastern Standard Time (EST) will be delivered within 24 hours after the order is placed.

5.5. All reagents/reagent packs shall be provided as follows:

Be provided by the manufacturer of the equipment.

Be marked with the required storage temperature.

Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

5.6. The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality shall be acceptable to satisfy proficiency testing standards of CAP and the Joint Commission (JC). The Proficiency Test Program standards are used as Minimum Acceptable Standards (MAS) for assay performance.

In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment or the contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 24 hours once the issue has been brought to the contractor's attention, at no cost to the Government. The Contractor shall reimburse the government for any costs/supplies related to tests performed by another contractor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

5.7. Safety Data Sheets (SDS). For all products the contractor shall provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide one set of paper copy and two electronic copies on Compact Disk (CD) of SDS of all reagents and consumables to be used on the system.

5.8 The contractor shall pay for the delivery charges for shipping and handling of the reagents.

Any additional costs such as Industrial funding fees, special shipping and handling fees, or any other fee or charges shall be included in CPRR.

5.9 Any item/part/supply/reagent excluded by the contractor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.

5.10 The Contractor shall provide quality control materials sufficient to run every 8 hours and to be used as needed for troubleshooting. This includes third-party controls where requested /required by the laboratory. These controls and calibrators shall be at no cost to the government.

6. INSTALLATION AND INITIAL SET UP

6.1. Prior to reporting to the laboratory, the contractor or contractor's representatives shall report to and obtain a visitor badge from the HTMB (Health Technology Medical Branch) for all facilities listed in section 1. The badge shall be returned to the department prior to departing the facility.

6.2 Within 10 working days after contract award, Contractor shall coordinate and conduct a post-award site visit for the purpose of coordinating schedule for equipment installation.

Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to the government.

6.3. The Contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the contract and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice from the COR, an agreed date will be established to proceed with installation. It shall be the Contractor's responsibility to inform the COR of any problems which may be anticipated in connection with installation or those that will affect optimum performance once installation is completed. If changes are required to facility infrastructure to facilitate installation vendor will be responsible for costs to make changes necessary for installation of analyzers. The Contractor will provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g., EP Evaluator(r)), to provide technical assistance for the method validation studies. The Contractor will provide a dedicated team of project management professionals who are experienced in delivering on time installations. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the COR as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

6.4 The Contractor shall provide an Information Technology Project Manager (IT PM) for implementation of the instrument interface and middleware. The IT PM will have demonstrated working knowledge of Information Security Requirements specific to DHA installations as detailed in Section 3 of this SOW. The IT PM will have a demonstrated working knowledge and competency in the uses of and configuration options for instrument middleware. The IT PM will work with Department of Defense (DoD) subject matter experts (SMEs) to configure and test the instrument interface with MHS Genesis. The IT PM will be actively engaged in all aspects of this SOW. The IT PM will also actively collaborate with Laboratory SMEs to configure the system's middleware to optimally meet medical treatment facility (MTF) requirements.

6.5 The Contractor shall assist in the current water system (e.g. filtered, deionized etc.)

connection, if required by the analyzer and provide specification for the water line for all sites listed in section 1 and coordinate with medical maintenance and facilities.

6.6 The contractor shall specify all electrical requirement and work with facilities to ensure the appropriate power is available for all sites listed in section 1.

6.7 The contractor shall specify all waste drained requirement and work with facilities to ensure the appropriate drains are available and coordinate for connections at all sites listed in section

1.2.2 of this document.

6.8 During the initial implementation, a technical representative shall be available on site throughout the entire implementation period, ensuring the installation and validations be completed within 90 days of equipment arrival. The same technical representative (or contractor designated replacement) shall be available throughout the entire implementation;

there shall be documentation of information "hand off" between the different Technical Representatives.

6.9 Upon completion of installation, on-site training, method validation studies, and analytical measurement range/linearity verification shall be performed by Contractor personnel within the validation period to ensure that equipment is fully operational as negotiated.

6.10 Method Validation will be conducted in accordance with method validation protocols established by CLSI and/or required by CAP. Method Validation will include but not be limited to, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and establishment or verification of QC ranges. All reagents, QC materials, calibrators and linearity materials used in the Method Validation Study shall be provided by the Contractor at no cost to the Government.

These materials will not be used in the analysis of specimens for patient care.

6.11 Contractor shall assist all validation studies at no cost to the government, to include manpower, linearity material and reagents, calibrators, controls and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

Correlation studies shall include a minimum of 30 samples, spanning the reportable range, shall be run by the present and the new method. Contactor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

Linearity analysis shall be performed on new contracted instrument for each analyte to determine reportable range using statistical tool in accordance with CLSI.

Precision study shall be performed utilizing normal an abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls or patient samples.

Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Contractor shall provide interpretation of raw data and validate no carryover exists within the testing system.

Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood and urine container are evaluated for interfering substances for each method performed.

Reference Range: Determine a reference range for each test following CLSI guideline C-23A.

Samples used for the reference range study shall be representative of the patient population being tested. Reference range assessment shall be performed for each lab. A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 30 reference individuals shall be used to verify the manufacturer's range. Any apparent outliers shall be discarded, and new specimens obtained to provide a statistically valid verification.

If the suggested manufacturer's range is not appropriate for the patient population, a reference range shall be established. Establishing a reference shall follow CLSI-28A guidelines. This requires a minimum of 100 reference individuals be used to establish a reference range.

Therapeutic range validation studies shall be performed by contractor for applicable analytes.

6.12 The Contractor shall provide statistical reports of method validation study and all result print outs, package inserts of materials used for method validation study in an organized fashion to the hematology supervisor before using the analyzer systems for patient testing. In addition to the hard copy, the Contractor will provide method validation study results and reports electronically. The Contractor will provide instrument settings and other configurations on a paper as well as electronically.

6.13 In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be modified until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

7. MAINTENANCE AND SERVICES

7.1. Prior to performing maintenance and repair work, the contractor or contractor's representative shall report to and obtain a visitor badge from the HTMB of the facility. The badge shall be returned to the department prior to departing the facility.

7.2. The Contractor shall provide a list of maintenance options. The Contractor shall provide a full preventative maintenance service during the lease period of all analyzers at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems.

7.3. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor personnel in accordance with requirements as specified in the Contractor's instrument manual. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation. Completing the installation of the analyzers will mark the starting point for determining the timelines for the performance of the periodic services mentioned above.

7.4. If any deficiencies are found due to negligence of the service representative, the Contractor shall correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government. During the contract period, shall the repair record of any laboratory equipment reflect a downtime of more than 72 continuous hours in one calendar month, a determination will be made by the COR to replace the initial laboratory equipment with new equipment.

7.5 Repair:

The Contractor shall provide direct customer hotline telephone service and support, 24 hours/7 days a week, and on-call emergency repair service support, to assist operators in correcting equipment problems. The Contractor shall respond to telephonic requests for unscheduled repair within 1 hour for the main hospital and same working day for Clark and Robinson Health Clinics.

Upon the failure of any analyzer the Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours. The equipment shall be repaired and operational within a minimum of 48 hours after initial response by the Contractor.

Emergency Services and unscheduled services outside contractor's regular working hours, on weekends, and on Federal Holidays will be identified in contractor's proposal. The Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair in the event of single instrument failure) within 24 hours. The equipment shall be repaired and operational within a minimum of 48 hours after initial response by the Contractor. Estimated emergency visits per year are six.

Shall both instruments at the Womack Army Medical Center, or both instruments in Clark and Robinson Health Clinics become inoperable, the Contractor's technical specialist shall be on-site within four hours of initial notification of emergency repair. The repair of at least one analyzer shall be completed within 24 hours of initial notification. If at least one analyzer cannot be repaired within 24 hours of the initial notification, and if deemed necessary by COR, the contractor will arrange for the pickup and delivery of all critical specimens to a CAP accredited clinical laboratory of the Government's choice for testing. During the period when both analyzers are inoperable, each patient report shall include the testing laboratory's reference range for the test being performed. The Contractor will pay all costs associated with the provision of this service, including those for delivery of hard copy patient results by express courier, for as long as both analyzers remain inoperable, at no additional cost to the Government.

If any of the leased equipment cannot be repaired, a replacement instrument shall be provided within 72 hours.

All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government. During the contract period, shall the repair record of any laboratory equipment reflect a downtime of 10% or more working days in one calendar month, a determination will be made by COR to replace the initial laboratory equipment with new equipment.

Within one working day after completion of service, the contractor shall furnish the copy of a service report for all services performed to the Hematology supervisor and Clinic supervisor.

7.6 The report shall be in English, and a copy shall be given to the Laboratory representative for the location where the work is performed. The report shall contain, at a minimum, the following information:

Nomenclature and serial number.

Date.

Description of services performed (i.e., preventive maintenance service, or unscheduled repair service).

Location and services performed.

Duration of performance (hours).

List of parts replaced or other actions taken to restore operability of the instrument.

Name of Technician.

8. TRAINING

The Contractor shall provide initial on-site operator training for up to 20 government technicians. In addition, the Contractor shall provide training for 10 primary operators at the Contractor's training site (6 Primary site, 4 outlying clinics). The Contractor will also provide 2 training slots per contract year, at the Contractor's training site (one per site of analyzers). The off-site training cost shall include all funding travel, i.e., transportation (air and ground), room and board. The contractor shall identify this cost in exhibits.

9. SPECIAL TASKS

9.1. The Contractor will provide one paper and one electronic copy of the Operator and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified as non- Government owned equipment are serviced and maintained by the Contractor.

9.2. The Contractor will provide one paper and one electronic copy of Standard Operating Procedures (SOPs) for each, and every methodology included under the Proposal. The SOPs will include all relevant technical information regarding the methodology and shall be provided in Microsoft Word, capable of being customized/modified by the end user.

9.3 In addition to performing linearity studies initially during the validation period, the contractor shall perform, assist, and/or be available for the linearity studies on all of the measured parameters performed on all of the analyzers provided by the contractor for every lot change that is required for linearity studies. The contractor shall provide the technical representative to perform, assist and/or be available for the study and the linearity materials needed for the study at no additional cost to the Government. The representative will analyze the linearity study data and provide the statistical reports to the technical supervisor for review.

9.4. New Test Method/s or Generation change of current test reagent/s: The contractor shall perform all validation studies including installation/set-up, linearity, precision, accuracy, and correlation studies when new test(s) that are not listed in the exhibits are added to the current test menu or new generation of reagent/s are placed in use at no additional cost to the Government. The contractor shall provide reagents and materials needed for the validation studies. The validation studies shall be completed, and statistical reports shall be presented for evaluation before placing new test/reagents in use.

9.5. Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional cost to the Government.

These enhancements to the Contractor's equipment shall be delivered to the Government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

9.6. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures /malfunctions, breakdowns, etc., or service calls will be evaluated as needed with communication to the contractor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user at no additional cost to the Government. Removal of instrument by the contractor shall be performed within 60 days after request at no additional cost to the Government.

10. ADDITIONAL REQUIREMENTS

10.1 The automated testing system located at WAMC shall have the capability to connect to the current automation line located in the laboratory to provide a single point of specimen entry for the routine analysis of all required tests and move specimens bi-directionally/uni-directionally.

There shall be an optional ability to directly load specimens onto the analyzer for priority analysis of STAT specimens or during times the automation line is unavailable.

10.2 Reagents shall have a minimum shelf life of three (3) months, and controls will have a minimum shelf life of four (4) weeks upon receipt by the Government.

10.3 The contractor shall be willing to assist in the connection to the automation line when it becomes available for the WAMC analyzers to connect if not available before the installation time frame and work with all parties to accommodate this request by the timeline provided by the Laboratory Director.

APPENDIX 1 (This appendix is to assist in determining in the amount of maintenance that will be required based on workload.)

LOCATION TEST YEARLY WORKLOAD

Womack Army Medical Center CBC w/Differential 62,500

Womack Army Medical Center Retic 1,200

Womack Army Medical Center Body Fluids 360

Clark Clinic CBC…