RFQ. 36C26324R0135 VISN Urinalysis System IDIQ ver 08.28.24.docx

36C26324R0135

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C263-24-AP-0653

10/01/2024

36C26324R0135 08-11-2024 Joseph Bennett 319-688-3633 08-30-2024

12:00 PM

EDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St Suite 300 Coralville IA 52241

X

334516 1000 Employees

N/A

Department of Veterans Affairs Multiple Locations Care of:

VA Midwest Healthcare Network 2805 Dodd Rd., Suite 250 Eagan MN 55121 36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center ***See Admistration Page below ***

TX 78714-9971

See CONTINUATION Page

Request for Proposal, for an IDIQ Base w/4 Ordering Periods.

Cost-Per-Patient-Reportable basis, all inclusive system for the analysis of urine macroscopic and urine microscopy from a single patient specimen

Period of Performance:

Base Year: 10/01/2024 - 09/30/2025 Ordering Period 1: 10/01/2025 - 09/30/2026

Ordering Period 2: 10/01/2026 - 09/30/2027 Ordering Period 3: 10/01/2027 - 09/30/2028

Ordering Period 4: 10/01/2028 - 09/30/2029

Issued under FAR 16 and FAR 13 Simplified Acquisition Procedures.

See CONTINUATION Page Funding will be included per delivery order placed against this IDIQ Contract.

Joseph Bennett

VA-VHA-RPOC-2024-0088

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

The VA Financial Service Center(FSC) uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact the phone numbers or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

· Tungsten e-Invoice set-up information: 877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 877-353-9791

· FSC e-Invoice email: vafsccshd@va.gov

· More information on the FSC electronic invoicing process can be found at

· http://www.fsc.va.gov/einvoice.asp.

5. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

DESCRIPTION / SPECIFICATIONS/ STATEMENT OF WORK

REQUIREMENTS FOR AUTOMATED URINALYSIS SYSTEM:

1. AUTHORITY:

It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 23) to establish an IDIQ (Indefinite Delivery Indefinite Quantity) for an Automated Urinalysis System. The Government will award a CPRR IDIQ to a single Contractor for Automated Urinalysis Instrumentation. Contractor agrees to the following terms of the IDIQ exclusively with the VISN 23 facilities listed below. However, as requirements change, facilities within VISN 23 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market.

2. TERM OF AGREEMENT:

This will be a single award, firm-fixed price IDIQ with one base year and four, one-year ordering periods. VISN 23 intends to establish the base year of the agreement for the period of October 1, 2024 through September 30, 2025.

3. SCOPE:

ORDERING PERIODS: Contract will be a 5 (Five) year contract with a Base Ordering Period and 4 (Four) Ordering Periods of 1 year duration each. Delivery Orders will be place within the appropriate Ordering Period. Any reference to “Option Year/s” shall be interpreted as meaning “Ordering Period/s.”

Contractor shall provide VISN 23 Pathology & Laboratory Medicine Service (PLMS), under a “Cost-per-Patient-Reportable Result” basis, an all-inclusive system for the analysis of urine macroscopic and urine microscopy from a single patient specimen. Cost per Patient Reportable Result (CPRR) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. Ownership of Equipment and Title to the equipment shall remain with the Contractor. The Contractor, upon contract expiration, termination and/or replacement of equipment, shall remove the equipment. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor except when equipment is being replaced to maintain a functional, well operating system. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

All equipment provided must be new.

4. TECHNICAL SPECIFICATIONS:

VISN 23 PLMS is requesting a proposal for an Automated Urinalysis System under a Cost per Patient Reportable Result (CPRR) program. The urine macroscopic and urine microscopy must be from a single vendor and supported by a single vendor for equipment, reagents, calibrators, controls, expendable supplies, service and technical support. All items are to be shipped FOB Destination. The system provided must include the following:

a. The desired instrumentation shall have random access capability (if discrete testing required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

b. Automated Urine Macroscopic – Chemical analysis of urine to include color, clarity, specific gravity, pH and the presence/absence of leukocytes, erythrocytes, nitrates, total protein, glucose, ketone, urobilinogen and bilirubin.

c. Automated Urine Microscopic – Analysis to determine the presence/absence of sediment constituents, e.g. red blood cells, white blood cells, WBC Clumps, bacteria, yeast, waxy casts, hyaline casts, WBC casts, RBC casts, epithelial casts, granular casts, fatty casts, tri-phosphate crystals, calcium oxalate crystals, calcium phosphate crystals, calcium carbonate crystals, uric acid crystals, squamous epithelial cells, transitional epithelial cells, renal epithelial cells, etc. The microscopic analyzer shall be integrated with the macroscopic analyzer for true “walk-away” capabilities.

d. Fully automated integrated analyzer that incorporates an automated urine macroscopic and automated urine microscopy system in one single-step platform. The automated urinalysis sample testing shall be continuous to improve workflow and efficiency, preferably reducing the number of work stations or overall labor required to accomplish the required testing. Patient specimens shall be loaded once on the integrated analyzer for both macroscopic testing and microscopic evaluation.

e. The system must have the capability to reflex urine microscopy if indicated by user-defined urine macroscopic results. The system must also have the ability to not perform microscopic evaluation on samples that do not meet the user-defined criteria.

f. Ability to select either a numeric or semi-quantitative results format (mg/dl or large/4+) and the ability to set user-defined rules/flags for reflex to automated microscopic testing.

g. The system must have load and walk away capability with sufficient capacity to meet volume and service demands.

h. Ability to prioritize STAT testing without compromising existing programmed testing.

i. The system must have the ability to handle small sample volumes.

j. Minimum calibration frequency and long calibration stability is preferred.

k. Two (2) sets of urinalysis macroscopic and microscopic controls shall be included and sufficient to perform quality control analysis in accordance with regulatory and manufacturer recommendations.

l. Capability to detect out of range quality control. A quality control data management system is preferable.

m. Ability to perform dilutions and perform dilution calculations or ability to minimize need for dilutions and manual intervention to obtain accurate results.

n. Minimal carryover.

o. All known interferences must be listed.

p. The vendor shall provide manufacturer verified documentation of sample stability.

q. On board stability sufficient to accommodate both low and high volume use.

r. Minimal reagent, calibrator and control preparation. Vendor shall provide a list to include all reagents, calibrators, and controls needed for testing to include preparation and storage requirements.

s. On board reagent inventory system.

t. The system may have the capability to detect when manual review is required.

u. Minimal daily, monthly, and periodic maintenance.

v. The system must have the capability of auto release of results based on user-defined parameters.

w. Contractor shall provide a system that is interfaced with the VA Vista computer system for reporting patient results to the Computerized Patient Record System (CPRS). See Section 7 – Computer Interfacing Requirements.

x. The system must be capable of data storage (urine macroscopic and microscopic analysis including images) and capable of reporting patient results in the event that the Laboratory Information System (LIS) is down. The system must be capable of retransmitting results to LIS upon restoration of LIS function.

y. Hardware Features:

· A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of the laboratory.

· Monitor/screen that is easily readable.

· A printer that has the capability of printing a patient result with demographic information that includes minimally the accession or unique identifier number (UID).

· An uninterruptable power supply with line conditioner of each instrument provided.

z. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the IDIQ . This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Method performance/comparison shall be at the expense of the Contractor and shall include linearity material and reagents as required or recommended based on manufacturer’s specifications, and be consistent with the current CLSI documents, College of American Pathologists (CAP) standard and Federal regulations. Acceptable accuracy and precision for macroscopic and microscopic urinalysis. Contractors shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

· Upon award of a IDIQ , the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

· Contractors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded IDIQ including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to confirm to the transition period may be considered sufficient cause to terminate IDIQ for cause under the Termination for Cause clause of the IDIQ .

· At the end of 90 days from award of the IDIQ , the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ .

aa. Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) relocation within each site.

5. SDS, HAZARDOUS MATERIALS and WASTE STREAM ANALYSIS:

Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Material Safety Data Sheets (MSDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

· Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

· Waste ignitability (Reference 40CFR261.21)

· Waste corrosivity (Reference 40CFR261.22)

· Waste reactivity (Reference 40CFR261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

· Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

· Solid Waste (Reference 40 CFR 261.2)

· Exclusions (Reference 40 CFR 261.4)

The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 C.F.R 261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 C.F.R 261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerasol and formaldehyde) must be developed and MSDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration / measures of the elements and parameters listed below and must be included with vendor response:

· Barium (Total)

· Cadmium (Total)

· Chromium (Total)

· Copper (Total)

· Cyanide (Total)

· Lead (Total)

· Mercury (Total)

· Nickel (Total)

· Silver (Total)

· Zinc (Total)

· Arsenic (Total)

· Selenium (Total)

· Tin (Total)

· pH

· Flash point (to higher than 200 F)

· BOD; biochemical oxygen demand

The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

6. TRAINING:

The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Training shall include 2 employees per instrument, airfare, room and board for off-site training. One additional on-site training at Government facility, per instrument for each completed year upon request.

Onsite initial training shall also be provided and encompass all laboratory shifts. Initial training will cover, at a minimum, the competency elements specified in the College of American Pathologists Laboratory General Checklists/Joint Commission checklists. These training elements include but are not limited to:

· Routine patient test performance, including patient preparation (if applicable), specimen handling, processing and testing.

· Reviewing test results.

· Demonstration of software to include test result review, quality control records, and preventative maintenance records.

· Instrument maintenance and function checks.

· Troubleshooting and problem solving

7. COMPUTER INTERFACING REQUIREMENTS:

A bi-directional, bar-coded computer interface with ability to read standard barcode format such as Code 128 and Code 39 is required. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Veterans Health Information Systems and Technology Architecture (VistA) hospital information system (HIS) at the time of contract award. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities, the VISN23 facility laboratories currently use Data Innovations systems.

The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

8. MAINTENANCE/SERVICE CALLS:

The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, offered according to the following terms:

a. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

b. On-site equipment repair service shall be provided during core business hours. Core business hours are considered Monday – Friday 0800-1700. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

c. On-site equipment response time shall be no more than 24 hours.

d. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

e. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent for repair, and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

f. Each notification for an emergency repair service call shall be treated as a separate and new service call.

g. When a service Engineer presents at a site for either routine maintenance or repair service, they must follow appropriate facility procedures for check in.

9. UPGRADES:

The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

10. ANCILLARY SUPPORT EQUIPMENT:

The Contractor shall provide, install and maintain through the life of the IDIQ, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

11. COMMERCIAL OFFERINGS:

The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. Microsoft Word document containing procedure manual in CLSI format or an on-line procedure manual in the instrument software.

12. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the Contracting Officer of any recalls of product or other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

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 for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required by the government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

ITEMS AND PRICES:

Participating Facilities:

· VA Black Hills Health Care System, Hot Springs, SD

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Black Hills Health Care System, Ft. Meade, SD

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Black Hills Health Care System, Rapid City, SD

· Not currently included, but may be added in the future.

· If included in the future, would be equivalent or less than Hot Springs above.

· Fargo VA Health Care System, Fargo, ND

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Nebraska-Western Iowa Health Care System, Omaha, NE

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Nebraska-Western Iowa Health Care System, Lincoln, NE

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Nebraska-Western Iowa Health Care System, Grand Island, NE

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· St. Cloud VA Healthcare System, St. Cloud, MN

· 1 fully automated (chemistry & microscopy);

· NO back-up chemistry

· Sioux Falls VA Health Care System, Sioux Falls, SD

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Central Iowa Healthcare System, Des Moines, IA

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· VA Iowa City Healthcare System, Iowa City IA

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· Minneapolis VA Healthcare System, Minneapolis, MN

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

· Twin Ports VA Clinic, Superior, WI

· 1 fully automated (chemistry & microscopy);

· 1 back-up chemistry

This IDIQ does not obligate any funds. The Government is obligated only to the extent of authorized delivery orders actually issued against the IDIQ by authorized individuals.

Prices. The Government is providing the estimated volumes of tests to be performed below which are based on historical data. The estimates are per facility in VA VISN 23. The Government does not guarantee the volumes as listed; they are estimates ONLY.

NOTE: Each laboratory performs 3 macroscopic QCs per day and 2 microscopic QCs per day unless regulatory and manufacturer recommendations indicate differently.

Estimated Annual Volumes by Medical Center Facility

80,050

Offerors Fill in PRICE PER UNIT and BASE YEAR/PERIOD TOTALS here AND on the PRICE/COST SCHEDULE:

Base Ordering Year 10/01/24 – 09/30/25

DESCRIPTION:

CPRR Fully Automated, Integrated Urinalysis System for Single sample Analysis of both:

a) Urine Macroscopy and

b) Urine Microscopy

Ordering Period 1 10/01/25 – 09/30/26

DESCRIPTION:

Urinalysis System for Single sample Analysis of both:

Ordering Period 2 10/01/26 09/30/27

DESCRIPTION:

Urinalysis System for Single sample Analysis of both:

Ordering Period 3 10/01/27 – 09/30-28

DESCRIPTION:

Urinalysis System for Single sample Analysis of both:

Ordering Period 4 10/01/28 – 09/30/29

DESCRIPTION:

Urinalysis System for Single sample Analysis of both:

5 Year total:

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

CPRR Macroscopic As described in the SOW.

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

CPRR Microscopic

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025

CPRR Macroscopic As Described in the SOW Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026

CPRR Microscopic As described in the SOW Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026

CPRR Macroscopic

Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027

CPRR Microscopic

Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027

CPRR Macroscopic

Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028

CPRR Microscopic

Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028

CPRR Macroscopic

Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029

CPRR Microscopic

Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029

B.4 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the…