36C25521Q0105.docx

36C25521Q0105

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25521Q0105 12-2 -2020 Esperanza Roberts Esperanza.Roberts@va.g ov 913-946-1979 1- -2020

5PM

CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 334516 1,000 employees N/A X Department of Veterans Affairs VISN 15 - See delivery schedule Kansas City MO 64128-2226 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page This is a solicitation to establish a Blanket Purchase Agreement (BPA) for VISN 15 laboratories. The BPA will be for Cost per Test for automated hematology testing for:

VA Medical Center 800 Hospital Drive, Columbia MO 65201 VA Medical Center 6211 E Waterford Blvd,Evansville

IN 47715

VA Medical Center 4801 E Linwood Blvd, Kansas City MO 64128 VA Medical Center 1 Jefferson Barracks Dr, St Louis MO 63125 VA Medical Center 4101 S 4th St, Leavenworth KS 66048 VA Medical Center 2401 W Main St, Marion IL 62959 VA Medical Center 1500 Westwood Blvd, Poplar Bluff MO 63901 VA Medical Center 915 Grand Blvd, St Louis MO 63106 VA Medical Center 2200 Gage Blvd, Topeka KS 66622 VA Medical Center 5500 E Kellogg Ave, Wichita KS 67218 See Section B - Delivery Schedule for more detail See Att. A - Hematology Annual Estimated Workload See CONTINUATION Page X X X Esperanza Roberts 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 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

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.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX

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

Page 1 of

B.2 Statement of Requirements VISN 15- Heartland Network Clinical Laboratory Hematology Instrumentation

INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a contract for Automated Hematology Instrumentation. The Government will award a CPRR to a single Contractor for Hematology instrumentation, reagents, and service. Contractor agrees to the following terms of the agreement exclusively with the VISN 15 facilities listed by Attachment A herein and awarded in the final agreement.

As requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the award as new technology becomes available on the market.

VISN will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. CPRR price will include all components (reagent, equipment, data manager system, hardware, software, service, etc.) necessary to allow for release of a test result into the VISTA computer system.

VISN 15 intends to establish the base year of the agreement for the period of 4/1/2021 through 3/31/2026.

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCOPE OF PROCUREMENT:

The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument 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).

Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

Preferred analyzer(s) shall be able to simultaneously perform the complete panel as defined by each facility in Attachment A.

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

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 or technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/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 Attachment A.

Special handling for emergency orders of supplies: 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.

Need validation of new equipment completed 60 days before end of previous contract (March 31, 2021).

DEFINITIONS:

Cost per Patient Reportable Result (CPRR): 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 a reportable patient result. 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. The per patient reportable result price shall also encompass all costs associated with repeat and confirmatory testing required to produce 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.

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/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.

Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

Parameter definitions CBC- Complete Blood Count WBC- White Blood Cell Count Diff- Automated Differential RBC- Red Blood Cell Count MCH- Mean Corpuscular Hemoglobin MCV- Mean Corpuscular Volume MCHC-Mean Corpuscular Hemoglobin Concentration RDW- Red Cell Distribution Width MPV-Mean Platelet Volume PLT – Platelet Count Complete Blood Count (CBC) and White Blood Cell (WBC) Automated Differential (DIFF) and Reticulocyte.

CBC with five-part WBC Diff shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, PLT, MCH, MCV, MCHC, RDW, and MPV. Five-part WBC Diff shall include at a minimum: % neutrophils, % lymphocytes, % monocytes, % eosinophils, and % basophils.

CBC with six-part WBC Diff shall include the following parameters at a minimum: % neutrophils, % lymphocytes, % monocytes, % eosinophils, % basophils, and % immature granulocytes.

Reticulocyte count shall include the following parameters at a minimum: Absolute Reticulocyte count, Reticulocyte Count, Immature Reticulocyte Fraction.

Test Menu: Refer to Attachment A for desired test menu and estimated annual volumes.

GENERAL REQUIREMENTS:

Primary Analyzer(s): Base equipment offered shall fully support the scope of operations. Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, two mirror-image analyzers to act equally as primary analyzers are required to meet the productivity specifications defined herein.

Operational Features- The instrumentation offered shall have the following:

The capability of performing analysis on 100% of the tests listed in Attachment A.

Ability to perform either a five (5) or six (6) part differential.

Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

The accuracy of the barcode reading must have less than a 1% failure rate.

Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrent.

Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric depending on site.

Ability to prioritize STAT testing without compromising existing programmed testing.

Minimal daily, monthly, and periodic maintenance.

Ability to store, retrieve and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents.

No requirements for sample pre-treatment.

Capability to detect out of range quality control.

Ability to accept various types of sample containers.

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

On-board QUALITY CONTROL data management system with a minimum storage capacity of 11 Quality Control files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

Analyzer must have the ability to document on analyzer Quality Control review and corrective action documentation.

Remote monitoring capabilities to include instrument monitoring (and appropriate notification to site of issues/concerns with analyzer functionality) and Quality Control upload and management. This option must have National ISA/MOU approval with documentation for analyzer being proposed. Remote monitoring must be currently in use by other VA facilities.

Analyzer must have the ability to perform testing on Body Fluids. This process must be FDA approved.

On board reagent inventory system.

Only one mode calibration required for all functions of the analyzer.

Minimal carryover.

Calibration stability for a minimum of 6 months.

Hardware Features- The instrumentation shall have the following:

A main computer backup system must be provided.

A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. The size limitations for this is 12 feet by 4 feet for sites receiving two primary analyzers and 15 feet by 4 feet for sites receiving two primary analyzer and slide maker stainer.

An on-board monitor/screen that is easily readable.

A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession number or unique identifier number (UID).

An uninterruptible power supply with line conditioner for each instrument provided, including replacement of batteries.

An auto sampling system that includes cap piercing closed tube aspiration, auto- loader, and auto-mixing.

Primary tube sampling.

Clot detection.

Manual sampling mode that reads barcode label; ideally both closed and open manual sampling modes is desirable.

Slide maker/stainer option available for sites that listed on Attachment A.

Ability for laboratory to customize rules for differential or morphology review.

If system runs on Windows, ability to run Windows 10.

Interface Requirements 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 (see Attachment A).

The vendor shall provide assistance with setting up Autoverification through Data Innovations Work with the Laboratory LIMs to interface VISTA LIS with vendor provided instruments Provide remote or onsite guidance on validation techniques and assist troubleshooting Provide support and guidance during modifications of final Autoverification build. For example, modifying rules logic cutoff based on evolving SOP’s.

The Contractor shall provide any and all necessary software support for ensuring 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

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.

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.

Contractor shall provide copies of current ISA/MOU and BAA with the VA that are applicable for remote connection to the interface system used to manage the testing system.

Method Performance/Validation Requirements Method performance/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.

Correlation studies for each analyte. A minimum of 20 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 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, ROC analysis, and meet current standards defined by CLSI.

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. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

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.

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

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

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:

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 at each VISN 15 location to verify the manufacturer’s range. Any apparent outliers should be omitted, and new specimens obtained to provide a statistically valid verification.

If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference 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.

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

Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

Internal Barometer Check. If the instrument has an internal barometer, its function should be checked by comparing its values to a reliable independent measurement on installation and per the manufacturer’s guideline. This check should be performed by the vendor.

Support Features Commercial marketing. 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 are not acceptable.

Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format at no cost to the Government.

Training. The Contractor shall provide instrument training program that is coordinated with and timely to the equipment installation and appropriate for the size and scope of the facility’s services. This shall include detailed, hand-on training on the operation of the system, data management, maintenance, quality control, limitations of tests, data manipulation, and basic troubleshooting and repair. When training occurs on-site, all operators performing testing will be trained by the contractor. When such training occurs off-site, it will include two operators per analyzer in the first year. Thereafter, the Contractor shall provide off-site training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. There shall be no difference in the detail of training provided on-site and off-site.

Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

Service Requirements 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 1 hour.

Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. 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.

Equipment repair response time shall be no more than 24 hours.

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

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.

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

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 agreement; however, it does refer to significant changes in the hardware operational capability.

Ancillary support equipment - the contractor shall provide, install and maintain through the life of the agreement , as indicated, any and all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. carts or stands to support/house the analyzer, 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, line conditioners, UPS and UPS Batteries etc.

Reports: The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the agreement. Attachment C may be used as a template to provide these quarterly reports.

Waste Stream Specifications 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, 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 make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) 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 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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation must include, but not be limited to the concentration/measures of the elements and parameters listed below:

pH Flash point (to higher than 200F) 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 the waste from each device can legally be disposed of via the sewerage system Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than days after the award of the agreement. this timeline is based on a reasonable attempt of the contractor to complete all the necessary implementation requirements within the stated timeframe. contractor 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 an agreement, the transition period for the awarded agreement to have all equipment and peripherals installed and operational by January 1, 2021. during this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

Contractor shall provide with its quotation an implementation plan for installation of new equipment. contractor’s submitted plan shall project for the transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations with a start date of April 1, 2021. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate agreement for cause under the Termination for Cause clause of the agreement.

On April 1, 2021, the awarded Contractor shall have full and sole responsibility for services under the awarded agreement.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

Columbia VAMC 800 Hospital Drive, BLDG D218 Columbia, MO 65201 5275

ALL

Evansville VA Health Care Center 6211 E. Waterford Blvd Evansville, IN 47715

ALL

Kansas City VAMC 4801 Linwood Blvd Kansas City, MO 64128 2226

ALL

St Louis VAMC, Jefferson Barracks 1 Jefferson Barracks Drive, BLDG 8 Saint Louis, MO 63125 63125 4199

ALL

Leavenworth VAMC 4101 S. 4th Street, BLDG 41 Leavenworth, KS 66048 5014

ALL

Marion VAMC 2401 W Main Street Marion, IL 62959 1188

ALL

Poplar Bluff VAMC 1500 N Westwood Blvd Poplar Bluff, MO 63901 3318 0.00

Saint Louis VAMC, John Cochran 915 N Grand Blvd, BLDG 1 Saint Louis, MO 63106 1621

ALL

Topeka VAMC 2200 Gage Blvd., Warehouse Building 20 Topeka, KS 66622 0001

ALL

Robert J. Dole VA Medical Center 5500 East Kellogg, BLDG 34 Wichita, KS 67218 1607

ALL

B.5 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.6 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

B.7 PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer. This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.

3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.

B.8 OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 60 days before the BPA expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.

B.9 GENERAL SUPPLY ORDERS

A properly appointed Department of Veterans Affairs Contracting Officer will request a quote from the Contractor based upon the requirements of the individual calls/orders, usually in the form of a Statement of Work (SOW). The information provided to the Contractor will include the place of performance, required period of performance, and other particular task requirements. Travel may be required (reimbursement of travel expenses will be IAW applicable Federal travel regulations). The vendor will reply within 5 business days with a quote depending on the details required by the SOW. The Contractor may offer additional spot discounts on any order, as they deem appropriate. All subcontractor activity must be clearly identified in each new order proposal as applicable.

B.10 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach /per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.11 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.12 PERIOD OF PERFORMANCE

This BPA expires on or such later ending date as determined by the exercise of any option.

B.13 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

Dept. of Veterans Affairs facilities-VISN 15

B.14 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.

B.15 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4)…