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36C25519Q0582

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

TBD

36C25519Q0582 07-02-2019 Zaritz, Larry | larry.zaritz@va.gov 913-946-1977 07-10-2019 10:00 am 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 325413 1250 Employees N/A X Department of Veteran Affairs VISN 15 Facilities

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 The purpose of this requirement is to establish a contract for Point of Care(POC) Testing for Creatinine with eGFR (Estimated Glomerular Filtration Rate) See Section B. Statement of Requirements (SOR) for details $0.00 See CONTINUATION Page

TBD

X X X One(1) Zaritz, Larry

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 STATEMENT OF REQUIREMENTS4
B.3 PRICE/COST SCHEDULE15
ITEM INFORMATION15
DELIVERY SCHEDULE16
SECTION C - CONTRACT CLAUSES17
C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)17
C.2 52.216-18 ORDERING (OCT 1995)17
C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)17
C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)18
C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)18
C.6 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)19
C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)19
C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)20
C.9 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)21
C.10 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)21
C.11 VAAR 852.246-71 REJECTED GOODS (OCT 2018)21
C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)21
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS29
SECTION E - SOLICITATION PROVISIONS30
E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)30
E.2 52.233-2 SERVICE OF PROTEST (SEP 2006)30
E.3 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)31
E.4 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)31
E.5 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)32
E.6 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)32
E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT 2018)33

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:

Offeror DUNS #:

Company Name and Address:

Point of Contact:

Phone Number:

Email Address:

b. GOVERNMENT: Contracting Officer 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Leavenworth, KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System For Award Management.

3. INVOICES: Shall be submitted in arrears Monthly

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

B.2 STATEMENT OF REQUIREMENTS

0. INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a Blanket Purchase Agreement (BPA) for Point of Care testing for Creatinine with eGFR (Estimated Glomerular Filtration Rate). The BPA shall be under open market Cost Per Reportable (CPRR). The Government will award a CPRR BPA to a Contractor for point of care testing reagents and analyzer service. Vendor will also supply a CPT price for reagent, service and data manager support for existing analyzers in select VISN 15 Laboratory Sites. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment A herein and awarded in the final BPA. However, 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 BPA as new technology becomes available on the market.

0. ORDERS: The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

0. PRICES AND TERMS: VISN 15 will provide an estimated volume by test as reflected in Attachment B for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume for each facility. The Government estimates the volumes per facility as listed in Attachment B but does not guarantee volumes as listed; they are estimates ONLY.

0. TERM OF AGREEMENT: This will be a single vendor award, firm-fixed price BPA with one base year and four, one-year options. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 15 intends to establish the base year of the agreement for the period of 8/1/2019 through 7/31/2024.

0. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable BPA Number. BPA identification numbers are assigned through the VHA

0. ORDERING METHOD: The participating facilities in Attachment A may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1. SCOPE OF PROCUREMENT:

0. 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).

0. If Contractor offers a family of analyzers, VISN 15 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

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

0. 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/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 B.

0. 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.

1. DEFINITIONS:

1. 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 dilution; 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.

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/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. 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.

1. MOU - The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection.

1. 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. Parameter definitions- (Name Brand or Equivalent references used) System should be FDA approved that allows for reading of the following:

5. Creatinine

5. eGFR (Calculated using MDRD Equation)

5. pH

5. Carbon Dioxide, Partial Pressure (pCO2)

5. Oxygen, Partial Pressure (pO2)

5. Sodium

5. Potassium

5. Ionized Calcium

5. Chloride

5. Glucose

5. Lactate

5. Creatinine

5. Actual Bicarbonate (cTCO2 calculated)

5. Total Carbon Dioxide (cHCO3 calculated)

5. Base Excess of Extra Cellular Fluid (BE(b) calculated)

5. Oxygen Saturation (cSO2 calculated)

5. Hemoglobin (cHgb calculated)

5. Estimated Glomerular Filtration Rate (eGFR calculated)

5. Estimated Glomerular Filtration Rate if African American (eGFR-a calculated)

5. Anion Gap (AGAP calculated)

5. Anion Gap , Potassium (AGapK calculated)

1. GENERAL REQUIREMENTS: Contractor should provide CPT pricing for sites with existing equipment. CPT pricing will include reagents, service and maintenance of analyzers and data manager systems. CPRR pricing will provided if the solution presented does not allow for use of existing equipment. CPRR will include all components (reagent, equipment, data manager system, service, etc.) necessary to allow for release of a test result into the VISTA computer system.

6. Operational Features- The instrumentation offered shall have the capability to perform;

0. Creatinine testing.

0. eGFR result must be calculated on board the analyzer at the time of testing

0. Calculation for eGFR must be performed using MDRD Equation.

0. Creatinine testing must a method that has calibration traceable to an IDMS reference measurement procedure. Methods based on either enzymatic or Jaffe method principles should have calibration traceable to IDMS.

0. Cards must allow for testing of both venous and arterial blood sources.

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

0. Meters must be portable or singlehanded use

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

1. Testing cannot be High Complexity testing by CLIA definitions.

1. Operator and patient identification tracking.

1. Products must be compatible with the wireless EPOC point of care analyzers in place at Kansas City VAMC.

1. Expired operator, failed quality control and invalid lot number instrument lock out.

1. Ability to detect poor reagent or strip integrity.

1. Capillary, arterial and venous sample options.

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

1. Capability to add user configurable comments.

1. Maintenance for end users should be minimal and easily documented.

1. Vendor should supply documentation detailing maintenance requirements.

1. Ability to correlate Creatinine values with main laboratory instrumentation within +/- 20%.

6. Data Manager

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

2. Data Manager will assist with transmission of results to VISTA for posting in patient records.

2. The Data Manager system should allow coordinators to monitor end user access and/or competency from desk top.

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

2. An MOU/ISA is required for vendor access into data manager systems.

2. The Data Manager should have ability to support a virtual environment.

6. Interface Requirements

3. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface.

3. 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

3. 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.

3. 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.

3. 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.

6. Hardware Features- The instrumentation shall have the following:

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

4. Existing equipment as specified in Attachment C.

4. The contractor shall provide full maintenance both remotely and onsite to include all replacement parts, software updates, labor, travel expenses, tools, test equipment and other incidentals necessary to maintain or restore the existing data manager to operating specifications which meet or exceed the manufacturers’ specifications for existing equipment.

4. If existing equipment malfunctions, the contractor will be contacted by the facility to provide a replacement unit as part of this agreement.

4. Any and all parts used must be new or factory rebuilt for that model and type of device.

4. If any action requires replacement of a hard drive or other storage media, the contractor shall not remove the hard drive/storage media from the VA premises and must turn over said device to the facility.

4. All services for this contract must meet manufacturers’ performance and technical specifications, Federal Regulations, FDA device certification and other specifications that may apply such as National Electric Code (NEC), Life Safety Code (LSC), the Joint Commission (JC), and VA Regulations.

4. Contractor must provide the appropriate service documentation at no additional expense. Contractor shall provide hardcopy proof, upon request of COR, that contracting entity is a certified manufacturer service provider ant that technicians are current in device certification training.

4. Contractor service representative shall report to the Engineering Offices upon arrival on station to be issued a temporary VA Contractors ID badge and shall wear the VA issued ID badge above the waistline at all times while on the premises.

4. Rechargeable batteries should be included.

4. If device functions utilizing wireless technology, the device must have FIPS-140-2 certification.

4. Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15:

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

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

4. FIPS-140-2 Certification for Wireless technology

4. MOU/ISA for Data Management systems that will require vendor access.

6. Method Performance/Validation Requirements

5. 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.

5. 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 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.

5. 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

5. 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.

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.

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

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. 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:

7. A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 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.

7. 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.

7. 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.

1. Support Features

8. 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.

8. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/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 of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

8. 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 and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. 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/or laboratory personnel.

8. Service Requirements

3. Equipment Preventative Maintenance/Repair Service. 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, e.g. water system, offered according to the following terms:

3. 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.

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

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

3. 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.

8. Upgrades - The Contractor shall provide upgrades to the equipment hardware, bidirectional interface 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 if sites are interested. 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 BPA; however, it does refer to significant changes in the hardware operational capability.

8. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and 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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

CLIN
DESCRIPTION OF SUPPLIES/SERVICES
QNTY
UNIT
UNIT PRICE
AMOUNT
0001
Kansas City

Estimated Annual Usage-See Attachment B in Section D Contract Period: Base POP Begin:

POP End:

1.00
YR
____________
___________
0002
Wichita

Estimated Annual Usage-See Attachment B in Section D Contract Period: Base POP Begin:

POP End:

1.00
YR
____________
___________
1001
Kansas City

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 1 POP Begin:

POP End:

1.00
YR
____________
___________
1002
Wichita

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 1 POP Begin:

POP End:

1.00
YR
____________
___________
2001
Kansas City

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 2 POP Begin:

POP End:

1.00
YR
____________
___________
2002
Wichita

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 2 POP Begin:

POP End:

1.00
YR
____________
___________
3001
Kansas City

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 3 POP Begin:

POP End:

1.00
YR
____________
___________
3002
Wichita

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 3 POP Begin:

POP End:

1.00
YR
____________
___________
4001
Kansas City

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 4 POP Begin:

POP End:

1.00
YR
____________
___________
4002
Wichita

Estimated Annual Usage-See Attachment B in Section D Contract Period: Option 4 POP Begin:

POP End:

1.00
YR
____________
___________
GRAND TOTAL
___________

DELIVERY SCHEDULE

DELIVERY LOCATIONS:
QUANTITY
DELIVERY DATE

Department of Veteran Affairs Kansas City VA Medical Center Kansas City, MO 64128 2226

ATTN; TBD

ANNUAL
IAW Option Period of Performance

Department of Veterans Affairs Wichita VAMC 5500 E Kellogg, Bldg 34 Wichita, KS 67218 1607

ATTN; TBD

ANNUAL
IAW Option Period of Performance

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS 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.1 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):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR Number
Title
Date
52.204-4
PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER
MAY 2011
52.204-7
SYSTEM FOR AWARD MANAGEMENT
OCT 2018
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
DEC 2013

(End of Clause)

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the Effective Date through Expiration of any executed Option Periods.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than TBD, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of TBD;

(2) Any order for a combination of items in excess of TBD; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 2 Business Days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after / beyond the normal delivery schedule.

(End of Clause)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 Days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 120 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.6 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses or veteran-owned small businesses proposed as subcontractors in accordance with 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more service-disabled veteran-owned small businesses or veteran-owned small businesses for subcontract work of the same or similar value.

(End of Clause) C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.9 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee's authority. A copy of the designation shall be furnished to the contractor.

(End of Clause)

C.10 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.11 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause) (End of Addendum to 52.212-4)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

[] (ii) Alternate I (NOV 2011) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (JAN 2011) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[] (ii) Alternate I (NOV 2011).

[] (iii) Alternate II (NOV 2011).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

[] (ii) Alternate I (Oct 1995) of 52.219-7.

[] (iii) Alternate II (Mar 2004) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JAN 2017) of 52.219-9.

[] (v) Alternate IV (AUG 2018) of 52.219-9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).

[X] (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)).

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15 U.S.C. 637(m)).

[] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[X] (26) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2018) (E.O. 13126).

[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (28)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

[X] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or…

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