36C26319Q0538-001.pdf

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

36C26319Q0538

JOSH IMDACHA 3193397017 07-08-2019

4PM

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

X

334516

1000 Employees

N/A

X

MULTIPLE SEE DELIVERY SCHEDULE

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 x

IDIQ a “Cost-per-Patient-Reportable Result” basis, an all-inclusive system for the analysis of urine macroscopic and urine microscopy from a single patient specimen.

Questions are due 72 hours PRIOR to closing date and time.

(Late questions will NOT be answered.)

Questions can be directed to JOSHUA.IMDACHA@va.gov

* Failure to follow the instructions found in the solicitation may result in your offer being removed from the competition. The Government will make no assumptions.

**This solicitation will use Trade-offs. Non-cost factors may or may not be traded off for cost or price.

CONTRACTOR MUST FURNISH ALL REQUESTED ITEMS OR QUOTE MAY

BE CONSIDERED "NON-RESPONSIVE"

X X

6/13/2019

36C26319Q0538

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SPECIFICATIONS/ STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

B.4 DELIVERY SCHEDULE:

SECTION C - CONTRACT CLAUSES

C.1 AUTHORIZED LIMITS

C.2 52.216-18 ORDERING (OCT 1995)

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

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

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.6 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS

(NOV 2018)

C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

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

2018)

C.9 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

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

ITEMS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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 36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

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] UPON ACCEPTANCE

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

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 SPECIFICATIONS/ STATEMENT OF WORK

REQUIREMENTS FOR AUTOMATED URINALYSIS SYSTEM:

5 Ordering Periods (up to 60 months total)

The contractor must provide catalog information, specifications, etc. to prove that their product meets the minimum requirements of the Government. Failure to provide the information will result in the quote not being considered for an award.

GREY MARKET ITEMS: The Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM.

The vendor shall provide new items ONLY; no remanufactured or "grey market" items. All items must be covered by the manufacturer's warranty. The offeror shall provide evidence of its authority to distribute the proposed equipment/system at the time of submission of its quote/offer. Please note that such evidence is subject to verification by the Contracting Officer at his/her discretion.

1. AUTHORITY:

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

2. TERM OF AGREEMENT:

This will be a single award, firm-fixed price IDIQ with one base year and four, one-year ordering periods. This IDIQ is not a contract. VISN 23 intends to establish the base period of the agreement for the period of October 1, 2019 through September 30, 2020.

3. SCOPE:

Contractor shall provide VISN 23 Pathology & Laboratory Medicine Service (PLMS), under a “Cost-per-Patient- Reportable Result” basis, an all-inclusive system for the analysis of urine macroscopic and urine microscopy from a single patient specimen. Cost per Patient Reportable Result (CPRR) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution;

repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

All equipment provided must be new.

4. TECHNICAL SPECIFICATIONS:

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

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

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

c. Automated Urine Microscopic – Analysis to determine the presence/absence of sediment constituents, e.g. red blood cells, white blood cells, casts, crystals, etc. The microscopic analyzer shall be integrated with the macroscopic analyzer for true “walk-away” capabilities.

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

e. The system must have the capability to reflex urine microscopy if indicated by user-defined urine macroscopic results.

The system must also have the ability to not perform microscopic evaluation on samples that do not meet the user-defined criteria.

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

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

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

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

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

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

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

m. Ability to perform dilutions and perform dilution calculations is preferable.

n. Minimal carryover.

o. All known interferences must be listed.

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

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

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

s. On board reagent inventory system.

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

u. Minimal daily, monthly, and periodic maintenance.

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

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

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

y. Hardware Features:

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

Monitor/screen that is easily readable.

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

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

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

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

Contractors shall provide with its quotation an implementation plan for installation of new equipment.

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

IDIQ

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

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

5. MSDS, HAZARDOUS MATERIALS and WASTE STREAM ANALYSIS:

Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements.

Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Material Safety Data Sheets (MSDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

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

• Waste ignitability (Reference 40CFR261.21)

• Waste corrosivity (Reference 40CFR261.22)

• Waste reactivity (Reference 40CFR261.23)

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

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

• Solid Waste (Reference 40 CFR 261.2)

• Exclusions (Reference 40 CFR 261.4)

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

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

• Barium (Total)

• Cadmium (Total)

• Chromium (Total)

• Copper (Total)

• Cyanide (Total)

• Lead (Total)

• Mercury (Total)

• Nickel (Total)

• Silver (Total)

• Zinc (Total)

• Arsenic (Total)

• Selenium (Total)

• Tin (Total)

• pH

• Flash point (to higher than 200 F)

• BOD; biochemical oxygen demand

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

6. TRAINING:

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

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

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

Reviewing test results.

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

Instrument maintenance and function checks.

Troubleshooting and problem solving

7. COMPUTER INTERFACING REQUIREMENTS:

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

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

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

The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established.

Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

8. MAINTENANCE/SERVICE CALLS:

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

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

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

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

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

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

• date and time notified

• date and time of arrival

• serial number, type and model number of equipment

• time spent for repair, and

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

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

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

9. UPGRADES:

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

10. ANCILLARY SUPPORT EQUIPMENT:

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

11. COMMERCIAL OFFERINGS:

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

12. RECALLED AND DEFECTIVE PRODUCTS

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

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

B.3 PRICE/COST SCHEDULE

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

Participating Facilities:

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

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

• Fargo VA Health Care System, Fargo, ND

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

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

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

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

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

• VA Central Iowa Healthcare System, Des Moines, IA

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

Prices and Terms VISN 23 will provide an estimated volume of test performed as reflected for each individual medical center. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed; they are estimates ONLY.

NOTE: Total patient reportable results are estimated and are based upon historical data from FY2018. Each laboratory performs 3 macroscopic QCs per day and 2 microscopic QCs per day unless regulatory and manufacturer recommendations indicate differently.

Estimated Annual Volumes by Medical Center Facility

O m ah a

Li nc ol n

G ra nd I sl an d

S io ux F al ls

S t

C lo ud

Fa rg o

H ot

S pr in gs

Fo rt

M ea de

D es

M oi ne s

V

IS

N t ot al

Total Volume 17,000 9,000 12,000 30,000 8,373 20,781 4,753 10,334 33,739 146,043

Microscopic 8,000 4,500 5,500 8,012 3,721 8,314 1,684 4,530 9,794 54,055

Estimated Patient

Tests/Per Year Unit

Unit CPRR Price Each

Total

CLIN 0001 CPRR Macroscopic 146,043 $ $

Base Period CPRR Microscopic 54,055 $ $ CPRR Fully Automated, Integrated

Urinalysis System for single sample Analysis of both:

a) Urine Macroscopic and

b) Urine Microscopy

CLIN 1001 CPRR Macroscopic 146,043 $ $

Option Period 1 CPRR Microscopic 54,055 $ $ CPRR Fully Automated, Integrated

Urinalysis System for single sample Analysis of both:

a) Urine Macroscopic and

b) Urine Microscopy

CLIN 2001 CPRR Macroscopic 146,043 $ $

Option Period 2 CPRR Microscopic 54,055 $ $ CPRR Fully Automated, Integrated

Urinalysis System for single sample Analysis of both:

a) Urine Macroscopic and

b) Urine Microscopy

CLIN 3001 CPRR Macroscopic 146,043 $ $

Option Period 3 CPRR Microscopic 54,055 $ $ CPRR Fully Automated, Integrated

Urinalysis System for single sample Analysis of both:

a) Urine Macroscopic and

b) Urine Microscopy

CLIN 4001 CPRR Macroscopic 146,043 $ $

Option Period 4 CPRR Microscopic 54,055 $ $ CPRR Fully Automated, Integrated

Urinalysis System for single sample Analysis of both:

a) Urine Macroscopic and

b) Urine Microscopy

ESTIMATED GRAND TOTAL $

(base + 4 ordering periods)

B.4 DELIVERY SCHEDULE:

Fargo VA Health Care System 2101 Elm Street Fargo, ND 58102

VA Black Hills Health Care System - Hot Springs Campus 500 N 5th St Hot Springs, SD 57747

VA Black Hills Health Care System - Fort Meade Campus 113 Comanche Road Fort Meade, SD 57741

Des Moines Division - VA Central Iowa Health Care System

***MINIMUM TOTAL VALUE IS $100,000.00

PERIOD TOTAL

PERIOD TOTAL

PERIOD TOTAL

PERIOD TOTAL

PERIOD TOTAL

3600 30th Street Des Moines, IA 50310-5774

Omaha Division - VA Nebraska Western Iowa Health Care System 4101 Woolworth Avenue Omaha, NE 68105

Lincoln, NE 68510

Grand Island, NE 68803

St. Cloud VA Health Care System 4801 Veterans Dr Saint Cloud, MN 56303

Sioux Falls VA Health Care System 2501 W. 22nd Street PO Box 5046 Sioux Falls, SD 57117-5046

Lincoln VA Community Based Outpatient Clinic 600 South 70th Street

Grand Island VA Community Based Outpatient Clinic 2201 No. Broadwell Avenue

SECTION C - CONTRACT CLAUSES

C.1 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual IDIQ Orders placed against this contract may reach $100,000.00. 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 TBD over the period covered by the contract; 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.

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.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 10/1/2019 through 9/30/2024.

(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 $500.00, 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 $1,000,000.00;

(2) Any order for a combination of items in excess of $1,000,000.00; or

(3) A series of orders from the same ordering office within 3 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 10 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 the end of the contract unless extended.

(End of Clause)

C.5 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.6 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE

MANUALS (NOV 2018)

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) all applicable. The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities.

The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

(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 852.246-71 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)

C.10 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/

(End of Clause)

FAR

Number

Title Date

52.212-4 OCT 2018

52.203-17 APR 2014

52.204-4 MAY 2011

52.204-13 OCT 2018

52.204-18 JUL 2016

52.232-40 DEC 2013

52.237-3 JAN 1991

CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

SYSTEM FOR AWARD MANAGEMENT MAINTENANCE

COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

CONTINUITY OF SERVICES

(End of Addendum to 52.212-4)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS

(JAN 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:

[] (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.)

[] (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).

[] (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.

[] (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.

[] (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).

[] (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)).

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

[x] (26) 52.222–19, Child Labor—Cooperation…