RFQ 36C25723Q0055.pdf

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Attached to: 6550--NEW - CTX Urinalysis CPRR BPA
Solicitation number: 36C25723Q0055
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

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

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25723Q0055 10-28-2022

Delphia Schoenfeld 210-694-6310 11-18-2022

15:00 EST

36C257

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

325413

1250 Employees

N/A

Department of Veterans Affairs

Central Texas Veterans Healthcare System

Laboratory

1901 Veterans Memorial Dr.

Temple TX 76504

36C257

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for the procurement of Urinalysis CPRR testing for the Central Texas Veterans Healthcare System.

Ordering Periods:

Ordering Period 1 - 2/1/2023-1/31/2024

Ordering Period 2 - 2/1/2024-1/31/2025

Ordering Period 3 - 2/1/2025-1/31/2026

Ordering Period 4 - 2/1/2026-1/31/2027

Ordering Period 5 - 2/1/2027-1/31/2028

See CONTINUATION Page

X X

X 1

Delphia Schoenfeld

Contracting Officer

36C25723Q0055

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) .. 79

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL

ITEMS (APR 2020)

C.8 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.9 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

C.10 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.11 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.2 INSTRUCTIONS TO OFFERORS

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

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 36C257

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] 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.

This is accomplished through the Tungsten Network, located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: CPRR Urinalysis Contract

2. Scope of Work: Contractor shall provide, under a “reagent rental” or “Cost-per-Reportable Test” basis, all equipment, installation, reagents, calibrators, controls (Contractor shall provide controls manufactured for QC use with his/her instrumentation. Contractor shall provide integrated backup analyzers / redundancy for the Olin E Teague VAMC Laboratory. Contractor will be required to provide

3rd party controls (in case manufacture controls do not meet Lab’s requirements), consumable supplies, linearity testing materials, interface to VA VistA system including hardware, software, licensing, costs for the DI water system (if required), training of end users, and system maintenance

(including parts, labor, travel) and all shipping costs with inside delivery to the clinical laboratory at all sites. During the term of this agreement to support urinalysis analyzers that are provided under this

BPA. Contractor shall provide enough reagents sufficient to perform testing at each location for a minimum of 90 days.

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 with no shipping expenses.

The contractor will remove the equipment from VA premise within 60 days of the expiration of the BPA. Equipment will not be repaired or refurbished at VA expense so that it may be returned to the contractor in the same condition as received. Contractor shall retain ownership and title to the equipment.

NOTE: All equipment provided must be new. All back-up equipment must use the same reagents and provide the same reference range as the base analyzer.

3. Background: The CTVHCS requires a Cost Per Reportable Results (CPRR). The CPRR program should include the equipment, service and maintenance, training, all reagents, controls, calibrators, consumables, reagent strips, calibration strips, cleaning solutions, diluent solutions, and sheath fluid necessary to operate the contractor’s equipment.

The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (TJC). System must be capable of performing urine chemistry strip testing to include Urine Color, Appearance, Glucose, Bilirubin, Ketones, Specific Gravity, Blood, PH, Protein, Urobilinogen, Nitrite, and Leukocyte Esterase, clarity. Automated Microscopic analysis to recognize and identify 13 urine sediment particles RBC, WBC, WBC Clumps, Squamous Epithelial Cells, Non-Squamous Epithelial cells, Hyaline Casts, Unclassified Casts, Crystals, Bacteria, Yeast, Sperm and Mucus.

In addition, must be able to subclassify Unclassified Cast: Granular, Cellular, Waxy, Broad, RBC, WBC, Epithelial Cells and Fatty Cast, Crystals: Calcium Phosphate, Uric Acid, Calcium Carbonate, Leucine, Cystine, Tyrosine, Amorphous Calcium Oxalate, Triple Phosphate, and place other particles as questionable for tech to identify and quantify to complete the report. System should be able to evaluate if microscopic is needed or not when the chemistry strip is negative. It should have user define capability to define the reporting format. Bidirectional With host query interface compatible with current Data Innovation Middleware, Vista and CPRS systems to include Cerner.

4. Performance Period: This is for a Base + 4 option year with the base starting on 2/1/2023-1/31/2024 with four option years going through 2028.

5. Type of Contract: This is a Firm-Fixed-Price Contract.

B. GENERAL REQUIREMENTS

The Contractor shall provide an automated urinalysis systems (see configurations) of automated urine chemistry analyzers and automated urine sediment analyzers to the Central Texas Veteran’s Healthcare System (CTVHCS) at the following locations:

Olin E Teague VA Medical Center Pathology and Laboratory Medicine Services (113) Hematology Building 163 Room 1D102 1901 S. Veterans’ Memorial Blvd Temple, TX 76504 2 Analyzers

Doris Miller VA Medical Center

Pathology and Laboratory Medicine Services Building 4W RM 1A157J1 4800 Memorial Dr.

Waco, TX 76711 1 Analyzer

Austin VA Outpatient Clinic (AOPC) Pathology and Laboratory Medicine Services Building 7901 RM 2B105 7901 Metropolis Dr.

Austin, TX 78744 1 Analyzer

All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

The annual patient test estimates are:

Olin E Teague VA Medical Center: Urine Chemistries are approximately 84,000 annually.

Urine Microscopies are approximately 42,000 annually.

Doris Miller VA Medical Center: Urine Chemistries are approximately 18,000 annually.

Urine Microscopies are approximately 9,000 annually.

Austin VA Outpatient Clinic (AOPC): Urine Chemistries are approximately 24,000 annually.

Urine Microscopies are approximately 12,000 annually.

Automated Urinalysis Analyzer Specifications:

• General instrument characteristics must include automated dipstick reader and automated microscopic, a fully automated bench to analyzer in one platform.

• Physical Characteristics, Not to exceed (NTE) o Weight - 400 lbs. for each unit.

o Dimensions –

▪ Olin E Teague VAMC:12 ft x 43 in x 6 ft (L/W/H)

▪ Doris Miller VAMC: 10 ft x 43 in x 6 ft (L/W/H)

▪ Austin VA OPC: 10 ft x 43 in x 6 ft (L/W/H)

• Electrical Characteristics 100-120 VAC for each module, 50/60 Hz, 250 watts max.

• Backup analyzers must have the same specifications as primary analyzers and be integrated into one continuous automated system.

• Automated Urine Microscopic- must include analysis to determine the presence/absence of sediment constituents, such as but not limited to red blood cells, white blood cells, casts, crystals, bacteria, etc.

Instrument must be able to display particle images to provide high confidence in the classification of such elements.

• Automated Urine Macroscopic – must include chemical analysis of urine to include color, clarity, specific gravity, pH and the presence/absence of leukocytes esterase, nitrites, total protein, glucose, blood/hemoglobin, ketone, ascorbic acid, urobilinogen, and bilirubin.

• Provisions for waste: Waste to be pumped to a cup sink behind the bench.

• The systems must be barcode driven, random access, and have a precision delivery system.

• The systems must deliver well established, standout performance on proficiency surveys.

• The systems must handle high volume workloads with short turnaround times, at least 200 samples per hour.

• The system must provide state of the art digital images and auto particle recognition software that provides the most extensive and accurate quantification of urine particles and rigorously tested and accurate urine chemistry assays. Technology that assays urine chemistry and urine sediment/microscopic testing with

Fluorescent Flow cytometry technology and digital imaging and a reliable chemistry back-up analyzer.

• UA analyzer with digital imaging which yields microscope- quality images with accurate sediment classification and cell identification for fewer screen review.

• Reduced carryover with user adjustable carryover rinse cycle settings to eliminate interference.

• Analytical Measurement Range for WBC of greater than 5,000/µL and greater than 10,000/µL for RBC to reduce dilution requirements and operator intervention.

• Easily standardized with accurate particle differentiation, bacteria quantification, and enhanced detection down to <0.5 um.

• On-Board Warmer that dissipates urates and phosphate material thus eliminating an additional step to reduce amorphous interference. This will help tremendously in analyzing samples from CBOCs.

• The system must strive to eliminate manual microscopy and provide unmatched quality and accuracy.

• The system must have an automated tube decapper to aid in less specimen handling to promote employee safety.

• System must come with a cart, wagon, or table for analyzers to sit on and capable of housing reagents for the primary analyzers.

• Urine Chemistry analyzers should have RFID or similar labelled test strips with auto humidity checks to ensure strip integrity.

• Urine Chemistry analyzers should have automatic color correction, thereby reducing potential for false positives.

• Utilize Fluorescent Flow Cytometry methodology in identifying and quantifying cells. Utilizing side scatter detection technology to differentiate similarly sized crystals and RBC.

• Minimal maintenance <30 minutes with walkaway capability and minimize staff hands-on and free technologists for more critical tasks.

• The system must not require monitoring during a run and should be 100% “walk-away” system.

• Contractor shall provide quality control material at a minimum of two levels: normal and elevated / abnormal levels.

• The system must be LIS compatible with Data Innovations.

• The system must be capable of rules based resulting of which the operator is notified when incongruent results are reported between the urine chemistry analyzer and the urine microscopy analyzer.

• Be able to print results and/or interface to Vista LIS system or any LIS system that the VA may use in the future.

• All models shall perform satisfactorily at any laboratory temperature between 59- and 86-degrees F (15 and

30 degrees Celsius).

• All models shall perform satisfactorily at any laboratory relative humidity between 30 - 80%.

• An electronic operator’s manual must be furnished with each model supplied.

• Provide calibration and assisted calibration verification and set up reference ranges.

• Provide any ancillary printers, monitors, computers, and scanners required by the system to provide a printed or electronic report.

• Scalable design for unique workflows and configuration.

• Single screen to review all analyzer results and individual module status.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below and in B.3 Price/ Cost Schedule within the performance period stated in this SOW.

2. Deliverable: See B.3 Price/ Cost Schedule for item numbers and quantities.

D. SCHEDULE FOR DELIVERABLES

1. The contractor shall complete the delivery date for all deliverables (reagents and consumables) for the cost per reportable result.

E. PERFORMANCE REQUIREMENTS

1. Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

• Inventory and recording of systems components.

• Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

• After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.

• Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

• Remote access for service-related issues.

• Provide uninterruptable power supply, printer.

• Computer interfacing-fully operational/bi-direction interface. Provide LIS connections and drivers for interfacing.

2. Repairs and support

• Technical support: Support Personnel will be available by telephone from 0730 to 1600 each business day.

• On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

• For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

• Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

• Contractor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g., upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

• Contractor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Contractor shall indicate which tasks are user level and which are service level.

• 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.

3. Training: The contractor will provide two operator training slot per year and two mobile learning opportunities.

4. Contractor shall provide/install/train users on any data management system with either off site or in house training.

5. Contractor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals

(also available on computer disk format). Procedures shall be in the Clinical and Laboratory Standards

Institute (CLSI) format.

6. Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

7. Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications.

Deviations from the performance specifications shall be corrected by the contractor.

• All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation.

F. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

G. CONTRACTOR SECURITY REQUIREMENTS

This contractor requires no access to CTVHCS or any VA information system. The analyzer will be interfaced to the CTVHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

The C&A requirements do not apply. A Security Accreditation Package is not required.

H. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to

Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.

I. OTHER

1. The contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this agreement but not until the completion of new contractor's equipment installation inclusive of completed cross over studies. Contractor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer.

2. If the any consumable, reagent, or other necessary item 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 shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the contractor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

3. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria satisfactorily to the user.

4. If any consumable, reagent, or other necessary item 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 shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the contractor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

J. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

K. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

L. CONTRACTOR SECURITY CONTRACT REQUIREMENTS

This order is for test kits and supplies only; vendor requires no access to Central Texas Veterans Healthcare System (CTVHCS) or any VA information system.

None of the information in this contract includes Protected Health Information (PHI) or Individually Identifiable

Information (III).

The C&A requirements do not apply, and that a Security Accreditation Package is not required.

ALL DATA AND ELECTRONIC MEDIA WILL NOT LEAVE THE VA.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

NARA RM Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C Chapter 21, 29, 31, and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part

1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting

Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The

Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

References:

VHA Directive 6300

VA Handbook 6300.1

Central Texas VA Medical Center Policy

VA Directive 6500

36 CFR Part 1222.32 (b)

B.3 PRICE/COST SCHEDULE

This is Single Award, Firm Fixed-Price, Indefinite Delivery Indefinite Quantity (IDIQ) Contract.

The guaranteed minimum award amount for this contract is $100.00. The maximum aggregate value of orders that can be placed under this contract is $2,000,000.00. The Government does not guarantee that it will place any orders in excess of the guaranteed minimum award amount.

Ordering Period 1 – February 1, 2023 through January 31, 2024

Ordering Period 2 – February 1, 2024 through January 31, 2025

Ordering Period 3 – February 1, 2025 through January 31, 2026

Ordering Period 4 – February 1, 2026 through January 31, 2027

Ordering Period 5 – February 1, 2027 through January 31, 2028

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Urine Chemistry

Ordering Period 1 POP Begin: 02-01-2023 POP End: 01-31-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): N/A

Central Texas VA Urinalysis CPRR

0001AA

84,000.00 EA __________________ __________________

Temple

0001AB

18,000.00 EA __________________ __________________

Waco

0001AC

24,000.00 EA __________________ __________________

Austin

Ordering Period 1 POP Begin: 02-01-2023

POP End: 01-31-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): N/A

Urine Microscopic

0002AA

42,000.00 EA __________________ __________________

0002AB

9,000.00 EA __________________ __________________

12,000.00 EA __________________ __________________

Ordering Period 1 POP Begin: 02-01-2023 POP End: 01-31-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): N/A

0003AA

21.00 EA __________________ __________________

UF-Control

MANUFACTURER PART NUMBER (MPN): BE740265

(Brand Name or Equal)

0003AB

22.00 EA __________________ __________________

CELLCLEAN for Urinalysis (50ml)

MANUFACTURER PART NUMBER (MPN): 83401621

0003AC

6.00 EA __________________ __________________

UF-Fluorocell CR

MANUFACTURER PART NUMBER (MPN): CE919553

0003AD

UF-Fluorocell AR

MANUFACTURER PART NUMBER (MPN): AG792864

0003AE

UF-CELLPACK SF

Ordering Period 1

POP Begin: 02-01-2023 POP End: 01-31-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): CE604532

Central Texas VA Urinalysis CPRR

0003AF

UF-CELLPACK CR

MANUFACTURER PART NUMBER (MPN): CB505392

0003AG

103.00 EA __________________ __________________

UF-CELLSHEATH UCS-900A

MANUFACTURER PART NUMBER (MPN): ZA900007

0003AH

15.00 EA __________________ __________________

Clinitek Atlas Control Strips

MANUFACTURER PART NUMBER (MPN): 10311124

0003AJ

Clinitek Atlas Neg Control Strips

Central Texas VA Urinalysis CPRR

0003AK

5.00 EA __________________ __________________

Clinitek Novus Calibrator

MANUFACTURER PART NUMBER (MPN): 10697753

0003AL

98.00 EA __________________ __________________

Clinitek Novus 10 Cassette 450

MANUFACTURER PART NUMBER (MPN): 10634643

0003AM

3.00 EA __________________ __________________

Clinitek Novus Rinse Additive

MANUFACTURER PART NUMBER (MPN): 10697754

0003AN

MANUFACTURER PART NUMBER (MPN): BE740265

0003AP

Ordering Period 1

POP End: 01-31-2024

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): 83401621

Central Texas VA Urinalysis CPRR

0003AQ

MANUFACTURER PART NUMBER (MPN): CE919553

0003AR

MANUFACTURER PART NUMBER (MPN): AG792864

0003AS

MANUFACTURER PART NUMBER (MPN): CE604532

0003AT

MANUFACTURER PART NUMBER (MPN): CB505392

0003AU

MANUFACTURER PART NUMBER (MPN): ZA900007

0003AV

MANUFACTURER PART NUMBER (MPN): 10311124

0003AW

MANUFACTURER PART NUMBER (MPN): 10311135

0003AX

MANUFACTURER PART NUMBER (MPN): 10697753

0003AY

Ordering Period 1 POP Begin: 02-01-2023 POP End: 01-31-2024

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): 10634643

Central Texas VA Urinalysis CPRR

0003AZ

MANUFACTURER PART NUMBER (MPN): 10697754

0003BA

MANUFACTURER PART NUMBER (MPN): BE740265

0003BB

MANUFACTURER PART NUMBER (MPN): 83401621

0003BC

MANUFACTURER PART NUMBER (MPN): CE919553

Urinalysis Reagents - Waco

MANUFACTURER PART NUMBER (MPN): N/A

0004AA

0.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): BE740265

0004AB

CELLCLEAN for Urinalysis (50 ml)

MANUFACTURER PART NUMBER (MPN): 83401621

0004AC

UF-Fluorocell SF

MANUFACTURER PART NUMBER (MPN): CE919553

0004AD

Central Texas VA Urinalysis CPRR

0004AE

4.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): CE604532

0004AF

MANUFACTURER PART NUMBER (MPN): CB505392

0004AG

48.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): ZA900007

0004AH

MANUFACTURER PART NUMBER (MPN): 10311124

0004AJ

Ordering Period 1

POP End: 01-31-2024

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): 10311135

Central Texas VA Urinalysis CPRR

0004AK

MANUFACTURER PART NUMBER (MPN): 10697753

0004AL

42.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): 10634643

0004AM

1.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): 10697754

Urinalysis Reagents - Austin

MANUFACTURER PART NUMBER (MPN): N/A

0005AA

8.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): BE740265

0005AB

MANUFACTURER PART NUMBER (MPN): 83401621

0005AC

MANUFACTURER PART NUMBER (MPN): CE919553

0005AD

MANUFACTURER PART NUMBER (MPN): AG792864

0005AE

Ordering Period 1 POP Begin: 02-01-2023 POP End: 01-31-2024

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): CE604532

Central Texas VA Urinalysis CPRR

0005AF

MANUFACTURER PART NUMBER (MPN): CB505392

0005AG

52.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): ZA900007

0005AH

11.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): 10311124

0005AJ

MANUFACTURER PART NUMBER (MPN): 10311135

0005AK

MANUFACTURER PART NUMBER (MPN): 10697753

Central Texas VA Urinalysis CPRR

0005AL

56.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): 10634643

0005AM

2.00 EA __________________ __________________

MANUFACTURER PART NUMBER (MPN): 10697754

Ordering Period 2 POP Begin: 02-01-2024 POP End: 01-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

1001AA

1001AC

1002AA

Ordering Period 2 POP Begin: 02-01-2024 POP End: 01-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro…

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File details come from the government source that posted it. Updated Oct 28, 2022.