36C26025Q0118 VISN 20 WBG Testing.docx

36C26025Q0118

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

01-06-2025 Eric Lingenfelter 360-852-9891 01-200-2025 17:00

PST

36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

X

325413 1250 Employees

N/A

Department of Veterans Affairs Veterans Integrated Service (VISN) 20

1601 East Fourth Plain Blvd Vancouver WA 98661 36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

Dept of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

See CONTINUATION Page

a. Location: Veterans Integrated Service Network (VISN) 20.

b. Supplies Being Requested: Whole Blood Glucose Testing

Devices, interfaceable middleware (as applicable), Supplies, reagents, and consumables to perform testing.

c. Period of Performance:

Ordering Period One (1): 2/1/2025 - 1/31/2026 Ordering Period Two (2): 2/1/2026 - 1/31/2027 Ordering Period Three (3): 2/1/2027 - 1/31/2028 Ordering Period Four (4): 2/1/2028 - 1/31/2029 Ordering Period Five (5): 2/1/2029 - 1/31/2030

d. B.2 PRICE / COST SCHEDULE to be filled in.

e. VA POC for this Solicitation: Eric Lingenfelter, eric.lingenfelter@va.gov, 360-852-9891

f. This will be awarded as an Indefinite Delivery Indefinite

Quantity (IDIQ) Contract, with a minimum guarantee of

$5,000.00 and a total contract capacity of $600,000.00

Quantity (IDIQ) Contract.

See CONTINUATION Page

One 1

Jose Ronstadt Contracting Officer

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:

b. GOVERNMENT: Contracting Officer 36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

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 following hyperlink contains information for invoicing e-Invoice Program - VA-FSC Internet https://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

Background

The VA Northwest Health Network, Veterans Integrated Service Network (VISN) 20, is responsible for providing health care to Veterans in the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county in Montana. The VISN 20 sites listed under the Places of Performance require Point of Care Whole Blood Glucose monitoring for inpatient setting at the patient bedside and outpatient clinic locations.

Scope

This BPA will provide VISN 20 with Point of Care Whole Blood Glucose Testing devices, interfaceable middleware (as applicable), supplies, reagents, and consumables required to properly perform required testing.

1.Description and Specifications

1.1. Specifications

1.1.1. The instruments shall have capability to perform testing 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).

1.1.2. If Contractor offers a family of analyzers, VISN technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.3. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in 1.5 Places of Performance.

1.1.4. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology shall be at the expense of the Contractor. Notification of any delays in shipment as well as any or all technical advisory, recalls and alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Estimated volumes of testing can be found in Price Cost Schedule.

1.1.5. Special handling for emergency orders of supplies: If 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 and routine supplies delivery.

1.2. Definitions

1.2.1. Cost per Test (CPT)- As defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5-year equipment use; (2) all reagents, standards, quality controls, supplies, consumable items, disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result: (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 are required to provide delivery, installation, and removal of equipment at no additional charge.

1.2.2. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems, to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.

1.2.3. Parameter definitions-

1.2.3.1. Point of Care Whole Blood Glucose – Blood glucose monitoring in inpatient setting at the patient bedside and at outpatient clinic locations.

1.3. General Requirements: CPT pricing will include reagents, service and maintenance of analyzers and data manager systems necessary to allow for release of a test result into the electronic medical record computer system. VISN20 is in the middle of converting to a new electronic medical record system. The vendor will need to be able to provide an interfaceable middleware for both VISTA and CERNER.

1.3.1. Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

1.3.1.1. Ability to perform testing at locations that are remote from the laboratory. This may include hospital inpatient ward, hospital clinic, emergency department, operating room, or Community Based Outpatient Clinic locations.

1.3.1.2. Testing must be Waived Complexity by CLIA 88’ definitions

1.3.1.3. Strip Requirements:

1.3.1.3.1. Capillary and venous sample options.

1.3.1.3.2. No requirement for micropipette for application of blood for capillary test option.

1.3.1.3.3. Ability to detect poor reagent or strip integrity.

1.3.1.3.4. Interfering substances must be minimal. (Vendor should supply documentation detailing interfering substances).

1.3.1.3.5. Measurement range should span range of 10 – 600 mg/dl

1.3.1.3.6. Vendor should supply studies that show that data across an entire reportable range meets acceptance criteria of greater than or equal to 95% of individual values within ±12 mg/dL of the reference values at glucose concentrations below 100 mg/dl and within ±12.5% of the reference values of glucose concentrations at or above 100 mg/dL. (Reference: CLSI POCT 12-A3:2013 Point of Care Blood Glucose Testing in Acute or Chronic Care Facilities)

1.3.1.3.7. Testing strips should be stable until expiration date on container without adjustment of expiration date after opening.

1.3.1.3.8. Supplies (strips, controls, and linearity material) must have a shelf life sufficient to provide system stability for 12 months.

1.3.1.3.9. Quantities of a single lot number should be available to allow sites to maintain the same lot number per minimum shipment of one year of workload.

1.3.1.4. Instrument Requirements:

1.3.1.4.1. Downloader and rechargers must be provided if required as part of the testing system.

1.3.1.4.2. Sturdy design with ergonomic features to afford ease of use (singlehanded used by operators with various sized hands).

1.3.1.4.3. Scanning capability for patient armbands, controls, and test strips, operator ID barcodes with capability of manual entry as a backup system.

1.3.1.4.4. Ability to easily read on a horizontal surface.

1.3.1.4.5. Meter and software must be capable of displaying at least five user’s configurable comments for use with critical results.

1.3.1.4.6. Ability must exist to clear patient data from the meter prior to returning meter to the vendor for replacement.

1.3.1.4.7. Meter must be easy to disinfect and have a simple procedure to avoid contamination when testing patients. They should be able to withstand commercially available cleaning and disinfecting wipes. Vendor should provide documentation of cleaning procedure for the meter.

1.3.1.4.8. Meter must include a sturdy carrying case. Replacement carrying cases will be provided free of charge.

1.3.1.4.9. Maintenance must be simple and easily documented by the end user.

1.3.1.4.10. Replacement meters must be free of charge and readily available.

1.3.1.4.11. Rechargeable batteries should be included.

1.3.1.5. Data Manager Requirements:

1.3.1.5.1. Data Manager will be provided to monitor and evaluate test and quality control results.

1.3.1.5.2. Data Manager will assist with transmission of results to electronic medical record (using either Cerner or VISTA – specific to each site) for posting in patient records.

1.3.1.5.3. The Data Manager system should allow for tracking of competency assessment and notification of end users and supervisors when competency is expiring.

1.3.1.5.4. The Data Manager will allow coordinators to manage reagent lot numbers as applicable to the system.

1.3.1.5.5. The Data Manager System should have the ability to lock out users for any of the following scenarios:

1.3.1.5.5.1. Expired operator training and competency

1.3.1.5.5.2. Invalid operator

1.3.1.5.5.3. Failed quality control

1.3.1.5.5.4. Expired reagents

1.3.1.5.5.5. Invalid lot number of reagents

1.3.1.5.6. Capability must exist to add user configurable comments.

1.3.1.5.7. The Data Manager must have the ability to handle ADT feeds for positive patient identification.

1.3.1.5.8. Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 20:

1.3.1.5.8.1. MDS2 - Manufacturer Disclosure Statement for Medical Device Security.

1.3.1.5.8.2. VA Directive 6550 Appendix A- Pre-Procurement Assessment

1.3.1.5.8.3. FIPS-140-2 Certification for Wireless technology

1.3.1.5.8.4. MOU or ISA for Data Management systems that will require vendor access.

1.3.1.5.9. Vendor must have the ability to supply servers for all VISN 20. Costs for these servers and connectivity must be included in the quote.

1.3.1.5.10. The Data Manager must have the ability to handle data for other point of care analyzers. Vendor should supply a list of point of care analyzers that can be connected to the system.

1.3.1.5.11. Vendor must supply the servers that are required for the project.

1.3.1.6. Method Performance & Validation Requirements:

1.3.1.6.1. Method performance and comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations.

1.3.1.6.2. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall provide technical support specialist to assist with studies and to analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

1.3.1.6.3. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method

1.3.1.6.4. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum.

1.3.1.6.5. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied.

1.3.1.6.6. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

1.3.1.6.7. Testing will not be implemented at the individual facilities for the selected system if the validation fails statistical studies as determined by the facility Pathology & Laboratory Service Chief.

1.3.1.7. Reference Range - A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

1.3.1.7.1. A verification of the manufacturer’s suggested reference range may be performed if 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 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

1.3.1.7.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

1.3.1.7.3. If a laboratory is currently using the proposed instrument and reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems prove to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

1.3.2. Added Value:

1.3.2.1. The following would be of added value to the award:

1.3.2.1.1. The meters should have performance evaluation for use in critically ill patients.

1.3.2.1.1.1. This factor will be evaluated after the technical factors defined in the General Requirements section.

1.3.2.1.1.2. Vendor should supply documentation of performance evaluation for all FDA approved blood sample types. (i.e., venous, capillary, and arterial.)

1.3.3. Support Features-

1.3.3.1. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment is not acceptable.

1.3.3.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable items, disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance and Validation section above and report data in an organized, clearly comprehensible format.

1.3.3.3. 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 being supported. This shall include training on the operation of the system, maintenance, quality control, limitations of the test, data manipulation, and basic trouble shooting and repair, as applicable, to nursing, pharmacy, and laboratory personnel, to include Community Based Outpatient Clinic staff at their work locations.

1.3.3.4. Equipment Maintenance and Repair Service. The Contractor shall be able to provide replacements on all instrumentation and any incremental support equipment, e.g., charging bases, and rechargeable batteries, offered according to the following terms:

1.3.3.4.1. Service Requirements

1.3.3.4.2. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with maximum call back response time of 1 hour.

1.3.3.4.3. The contractor shall provide the necessary information to replace an inoperable device.

1.3.3.4.4. This replacement shall include meters, charging bases, and rechargeable batteries at no additional cost.

1.3.3.4.5. A minimum acceptable service shall also include replacement delivery of items to be replaced with overnight service, but no longer than one (1) business day from the time-of-service ticket confirmation.

1.3.3.5. Upgrades - The Contractor shall provide upgrades to the equipment hardware 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 contract: however, it does refer to significant changes in the hardware operational capability.

1.3.3.6. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the contract, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., rechargeable batteries. 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, etc.

1.4. Characterization of waste

1.4.1. 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, Safety Data Sheets (SDS) 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 decide if the waste is hazardous waste or otherwise regulated.

1.4.2 The determination and description shall address the following:

1.4.2.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

1.4.2.2. Waste ignitability (Reference 40 CFR §261.21)

1.4.2.3. Waste corrosivity (Reference 40 CFR §261.22)

1.4.2.4. Waste reactivity (Reference 40 CFR §261.23)

1.4.2.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

1.4.2.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

1.4.2.7. Solid Waste (Reference 40 CFR §261.2)

1.4.2.8. Exclusions (Reference 40 CFR §261.4)

1.4.3. 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.

1.4.4. 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 CFR §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 CFR §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, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration and 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

1.4.5. The documentation the contractor provides will be used to work with the Medical Center and the public to determine whether the waste from each device can legally be disposed of via the sewerage system.

1.5 Places of Performance

· Alaska VA Healthcare System

· Colonel Mary Louise Rasmuson Campus 1201 North Muldoon Road Anchorage, AK 99504

· Fairbanks CBOC 2555 Phillips Field Road Fairbanks, AK 99709-3933

· Soldotna CBOC 237 West Rockwell Avenue Soldotna, AK 99669-7412

· Matanuska-Susitna (MAT-SU) CBOC 865 N. Seward Meridian Parkway Wasilla, AK 99654-7241

· Juneau CBOC 709 West 9th Street, Federal Building, Suite 150 Juneau, AK 99801-1807

· Alaska Domiciliary Care for Homeless Veterans 3001 C. Street Anchorage, AK 99503

· Boise VA Medical Center

· Boise VA Medical Center 500 West Fort Street Boise, ID 83702

· Eastern Oregon VA Clinic 635 Highway 20 North Hines, OR 97738

· Mountain Home CBOC 815 North 6th Street East Mountain Home, ID 83647

· Caldwell CBOC 713 Haystack Way Caldwell, ID 83605

· Twin Falls VA Clinic 260 2nd Ave. East Twin Falls, ID 83301

· Salmon CBOC 705 Lena St.Salmon, ID 83467

· Portland VA Health Care System

· Portland VA Medical Center 3710 SW US Veterans Hospital Rd Portland, OR 97239

· Vancouver VA Medical Center 1601 East 4th Plain Blvd. Vancouver, WA 98661

· Portland VA Clinic 308 Southwest 1st Ave, Community Resource & Referral Center (CRRC), Lawrence Bldg., Suite 155 Portland, OR 97204

· Fairview VA Clinic 1800 Northeast Market Drive Fairview, OR 97024

· Hillsboro VA Clinic 1925 Northeast Stucki Ave, Suite 300 Hillsboro, OR 97006

· Loren R. Kaufman VA Clinic 704 Veterans Drive The Dalles, OR 97058

· North Coast VA Clinic 91400 Neacoxie Street, Bldg. 7315 Warrenton, OR 97146

· Robert D. Maxwell VA Clinic 2650 Northeast Courtney Drive Bend, OR 97701

· Salem VA Clinic 1750 McGilchrist Street Southeast, Suite 130 Salem, OR 97302

· West Linn VA Clinic 1750 Southwest Blankenship Rd., Suite 300 West Linn, OR 97068

· VA Puget Sound Health Care System

· Edmonds VA Clinic 21616 76th Avenue West, Professional Center, Suite 112 Edmonds, WA 98026-7512

· Mount Vernon VA Clinic 307 South 13th Street, Suite 200 Mount Vernon, WA 98274-4100

· Olympia VA Clinic 500 Lilly Road Northeast, Suites 201 and 202 Olympia, WA 98506-5197

· North Olympic Peninsula VA Clinic 1114 Georgiana Street Port Angeles, WA 98362-4212

· Puyallup VA Clinic 11216 Sunrise Boulevard East, Suite 209, Building 3 Puyallup, WA 98374-8848

· Silverdale VA Clinic 9177 Ridgetop Boulevard NW Silverdale, WA 98383-8519

· Seattle VA Medical Center 1660 South Columbian Way Seattle, WA 98108-1532

· American Lake VA Medical Center 9600 Veterans Drive Southwest Tacoma, WA 98493-0003

· Mann-Grandstaff VA Medical Center

· Coeur d’Alene VA Clinic 915 West Emma Avenue Coeur d'Alene, ID 83814-2531

· East Front Avenue VA Clinic 624 East Front Avenue, Suite 201 Spokane, WA 99202-2139

· Mann-Grandstaff VA Medical Center 4815 North Assembly Street Spokane, WA 99205-6185

· Spokane VA Homeless Veterans Health 504 East 2nd Avenue Spokane, WA 99202-1406

· Spokane Valley CBOC 12509 E Mirabeau PKWY Spokane, WA 99216

· Elwood “Bud” Link VA Clinic 2530 Chester Kimm Road Wenatchee, WA 98801-8130

· Jonathan M. Wainwright Memorial VA Medical Center

· Jonathan M. Wainwright Memorial VA Medical Center 77 Wainwright Drive Walla Walla, WA 99362

· Yakima CBOC - 1211 Ahtanum Ridge Drive, Union Gap, WA, 98903

· Richland CBOC - 825 Jadwin Ave Ste 250 2nd Floor, Richland, WA, 99352-3589

· Morrow County PTCOC - 2 Marine Dr Suite 103, Boardman, OR, 97818

· Lewiston CBOC - 1630 23rd Avenue Building 2, Lewiston, Suite 301 and 401, ID, 83501-6350

· La Grande CBOC - 202 12th ST, LaGrande, OR, 97850-1186

· Wallowa County PTCOC - 401 Northeast 1st Street Suite A, Enterprise, OR, 97828-1186

· VA Southern Oregon Healthcare System

· White City VA Medical Center8495 Crater Lake Highway White City, OR 97503-3011

· Grants Pass VA Clinic 1877 Williams Highway Grants Pass, OR 97527

· Klamath Falls VA Clinic 2225 North Eldorado Boulevard Klamath Falls, OR 97601-6417

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

PERIOD 1 CONTROLS SOLUTION

Ordering Period: Period 1 POP Begin: 02-01-2025 POP End: 01-31-2026

PERIOD 1 LINEARITY KIT

PERIOD 1 TEST STRIPS

PERIOD 2 CONTROLS SOLUTION

Ordering Period: Period 2 POP Begin: 02-01-2026 POP End: 01-31-2027

PERIOD 2 LINEARITY KIT

PERIOD 2 TEST STRIPS

PERIOD 3 CONTROLS SOLUTION

Ordering Period: Period 3 POP Begin: 02-01-2027 POP End: 01-31-2028

PERIOD 3 LINEARITY KIT

PERIOD 3 TEST STRIPS

PERIOD 4 CONTROLS SOLUTION

Ordering Period: Period 4 POP Begin: 02-01-2028 POP End: 01-31-2029

PERIOD 4 LINEARITY KIT

PERIOD 4 TEST STRIPS

PERIOD 5 CONTROLS SOLUTION

Ordering Period: Period 5 POP Begin: 02-01-2029 POP End: 01-31-2030

PERIOD 5 LINEARITY KIT

PERIOD 5 TEST STRIPS

B.4 DELIVERY SCHEDULE

Vancouver, WA 98661

USA

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery…