36C24824Q0188.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. 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

36C24824Q0188 11-03-2023

Robert R. Edwards 787-641-7582 15:00 11-20-2023

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

X

334516

1000 Employees

N/A

X

36C672

Department of Veterans Affairs VA Caribbean Healthcare System Pathology & Laboratory Medicine Services 10 Casia Street San Juan PR 00921

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Solicitation for Blanket Purchase Agreement for Automated Urine Analyzer (Cost Per Test) for Caribbean VA Health Care System located in San Juan, PR.

See Section B.2 to quote items.

$0.00 See CONTINUATION Page

X X

X 1

36C24824Q0188

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 STATEMENT OF WORK

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2022)

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

EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

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

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

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

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.212-1 INSTRUCTION TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (MAR 2023)

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV

2021)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) 56

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY

NOTICE (FEB 2023)

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:

b. GOVERNMENT: Contracting Officer: Jessica M Kiser, jessica.kiser@va.gov Contract Specialist: Robert R. Edwards, robert.edwards2@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

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 in Arrears.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 http://www.tungsten-network.com/US/en/veterans-affairs/

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

mailto:jessica.kiser@va.gov mailto:robert.edwards2@va.gov http://www.tungsten-network.com/US/en/veterans-affairs/

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov

See https://www.fsc.va.gov/einvoice.asp for more information.

6. CONTRACT MODIFICATIONS: The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the point of contact has the authority to make changes that will affect. contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions shall be formalized by the proper contractual document executed by the Contracting Office.

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

AMENDMENT NO DATE

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

0.00 MO __________________ __________________

Automated Urine Analyzers Cost Per Test (CPT) for the Caribbean VA Healthcare System - San

Juan, PR. (Rental, Service and Maintenance Support)- Reference Section B.1 Price Cost Schedule and Statement of Work.

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

0001AA

2.00 EA __________________ __________________

Urine Chemistry Analyzer

Contract Period: Base POP Begin:

POP End:

0001AB

Urine Particle analyzer

Contract Period: Base POP Begin:

POP End:

0001AC

Urine Digital Microscopic Analyzers

Contract Period: Base POP Begin:

POP End:

0001AD

12.00 MO __________________ __________________

Re-Agents and Consumables

Contract Period: Base POP Begin:

POP End:

0001AE

8,600.00 MO __________________ __________________

Automated Urine Analyzers Cost Per Test

Contract Period: Base POP Begin:

POP End:

Automated Urine Analyzers Cost Per Test (CPT) for the Caribbean VA Healthcare System - Ponce Outpatient Clinic: Ponce, PR. (Rental, Service and Maintenance Support)- Reference Section B.1 Price Cost Schedule and Statement of Work

Contract Period: Base

POP End:

0002AA

1.00 EA __________________ __________________

Contract Period: Base POP Begin:

POP End:

0002AB

Contract Period: Base POP Begin:

POP End:

0002AC

Contract Period: Base POP Begin:

POP End:

0002AD

Contract Period: Base POP Begin:

POP End:

0002AE

1,200.00 MO __________________ __________________

Contract Period: Base POP Begin:

POP End:

AAutomated Urine Analyzers Cost Per Test (CPT) for the Caribbean VA Healthcare System -

Mayaguez Outpatient Clinic: Mayaguez, PR. (Rental, Service and Maintenance Support)- Reference Section B.1 Price Cost Schedule and Statement of Work.

Contract Period: Base POP Begin:

POP End:

0003AA

Contract Period: Base POP Begin:

POP End:

0003AB

Contract Period: Base POP Begin:

POP End:

0003AC

Contract Period: Base POP Begin:

POP End:

0003AD

Contract Period: Base POP Begin:

POP End:

0003AE

Contract Period: Base POP Begin:

POP End:

Contract Period: Option 1

POP End:

1001AA

Contract Period: Option 1 POP Begin:

POP End:

1001AB

Contract Period: Option 1 POP Begin:

POP End:

1001AC

Contract Period: Option 1 POP Begin:

POP End:

1001AD

Contract Period: Option 1 POP Begin:

POP End:

1001AE

Contract Period: Option 1 POP Begin:

POP End:

POP End:

1002AA

Contract Period: Option 1

POP End:

1002AB

Contract Period: Option 1 POP Begin:

POP End:

1002AC

Contract Period: Option 1 POP Begin:

POP End:

1002AD

Contract Period: Option 1 POP Begin:

POP End:

1002AE

Contract Period: Option 1 POP Begin:

POP End:

POP End:

1003AA

Contract Period: Option 1 POP Begin:

POP End:

1003AB

POP End:

1003AC

Contract Period: Option 1 POP Begin:

POP End:

1003AD

Contract Period: Option 1 POP Begin:

POP End:

1003AE

Contract Period: Option 1 POP Begin:

POP End:

Contract Period: Option 2

POP End:

2001AA

Contract Period: Option 2 POP Begin:

POP End:

2001AB

Contract Period: Option 2 POP Begin:

POP End:

2001AC

POP Begin:

POP End:

2001AD

Contract Period: Option 2 POP Begin:

POP End:

2001AE

Contract Period: Option 2 POP Begin:

POP End:

POP End:

2002AA

Contract Period: Option 2 POP Begin:

POP End:

2002AB

Contract Period: Option 2 POP Begin:

POP End:

2002AC

Contract Period: Option 2 POP Begin:

POP End:

2002AD

Re-Agents and Consumables Contract Period: Option 2 POP Begin:

POP End:

2002AE

Contract Period: Option 2 POP Begin:

POP End:

POP End:

2003AA

Contract Period: Option 2 POP Begin:

POP End:

2003AB

Contract Period: Option 2 POP Begin:

POP End:

2003AC

Contract Period: Option 2 POP Begin:

POP End:

2003AD

Contract Period: Option 2 POP Begin:

POP End:

2003AE

Contract Period: Option 2 POP Begin:

POP End:

Contract Period: Option 3

POP End:

3001AA

Contract Period: Option 3 POP Begin:

POP End:

3001AB

Contract Period: Option 3 POP Begin:

POP End:

3001AC

Contract Period: Option 3 POP Begin:

POP End:

3001AD

Contract Period: Option 3 POP Begin:

POP End:

3001AE

POP End:

POP End:

3002AA

Contract Period: Option 3 POP Begin:

POP End:

3002AB

Contract Period: Option 3 POP Begin:

POP End:

3002AC

Contract Period: Option 3 POP Begin:

POP End:

3002AD

Contract Period: Option 3 POP Begin:

POP End:

3002AE

Contract Period: Option 3 POP Begin:

POP End:

POP End:

3003AA

Contract Period: Option 3 POP Begin:

POP End:

3003AB

Contract Period: Option 3 POP Begin:

POP End:

3003AC

Contract Period: Option 3 POP Begin:

POP End:

3003AD

Contract Period: Option 3 POP Begin:

POP End:

3003AE

Contract Period: Option 3 POP Begin:

POP End:

Contract Period: Option 4

4001AA

Contract Period: Option 4 POP Begin:

POP End:

4001AB

Contract Period: Option 4 POP Begin:

POP End:

4001AC

Contract Period: Option 4 POP Begin:

POP End:

4001AD

Contract Period: Option 4 POP Begin:

POP End:

4001AE

Contract Period: Option 4 POP Begin:

POP End:

POP End:

4002AA

Contract Period: Option 4

4002AB

Contract Period: Option 4 POP Begin:

POP End:

4002AC

Contract Period: Option 4 POP Begin:

POP End:

4002AD

Contract Period: Option 4 POP Begin:

POP End:

4002AE

Contract Period: Option 4 POP Begin:

POP End:

POP End:

4003AA

Contract Period: Option 4 POP Begin:

POP End:

4003AB

POP End:

4003AC

Contract Period: Option 4 POP Begin:

POP End:

4003AD

Contract Period: Option 4 POP Begin:

POP End:

4003AE

Contract Period: Option 4 POP Begin:

POP End:

GRAND TOTAL __________________

***INCLUDED IN THE COST FOR CPT PROVIDED: INSTRUMENTS, SERVICE, ALL REAGENTS,

CONTROLS, CONSUMABLES FOR CPT TESTING*** ESTIMATED QUANTITIES***

B.3 STATEMENT OF WORK

Automated Urine Analyzer (Cost Per Test)

1. PURPOSE:

The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 8, VA Caribbean Healthcare System (VACHS) Medical Center Pathology and Laboratory Medicine Service Chemistry Section San Juan P.R.

is requesting a cost per test (CPT) contract for an Automated Urinalysis Instrumentation for the VA Caribbean Healthcare System Pathology and Laboratory Service in San Juan and the Ponce Outpatient Clinic (POPC) and Mayaguez Outpatient Clinic (MOPC).

This will be a Brand Name or Equal Requirement.

2. TERMS OF AGREEMENT:

The government contemplates awarding a five-year- cost per test (CPT) result agreement with one base of 12 months and four 12-month options.

The decision to exercise all options will be at the sole discretion of the government.

3. DEFINITIONS

Cost per Test (CPT)- pricing is established by determining the total tests necessary to produce one patient result.

Throughput: The speed at which the equipment processes and operates reported in units per hour.

VistA: VistA is the Hospital Information System (HIS) developed by the Department of Veterans Affairs. VistA is used by clinical staff in every phase of the healthcare delivery process. VistA Imaging is the image-enabling component of the VistA HIS. VistA Imaging is a controlled image management and storage system. No system is permitted to interface with VistA Imaging except through a defined interface that has been validated by the VistA Imaging process. The VistA Imaging Program maintains a list of validated third-party devices that interface with VistA Imaging on the VistA Imaging DICOM page at www.va.gov/imaging/DICOM.asp.

DB-9 is an analog 9-pin plug of the D-sub miniature (D-sub) connector plug and socket family for computer and communication devices.

RJ45 stands for Registered Jack-25. Refers to a cable termination specification that specifies physical male and female connectors and pin assignments.

RS232 is a standard protocol used for serial communication.

ASTM is a bidirectional protocol that is used to connect clinical devices.

POC is Point of Contact.

4. SCOPE OF PROCUREMENT

The analyzer must include an automated urine chemistry instrument to perform measurements of urine chemical constituents utilizing test strips and an automated urine microscopy analyzer. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to 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).

The cost per Test (CPT) 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 Cost per Test 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.

https://vaww.aams.ecms.va.gov/AAMS_Production/DAV/mw-vyybjynyjwxyy/www.va.gov/imaging/DICOM.asp

5. GENERAL INSTRUMENTS REQUIREMENT

The contractor shall provide an automated system for the chemistry and the automated microscopic analysis of urine specimens in San Juan in addition to a backup system of the same model. Also, the same model analyzers will be provided for the Ponce Outpatient Clinic (POPC) and Mayaguez Outpatient Clinic (MOPC). The contractor must provide new instrumentation that meets all the laboratory requirements. Discontinued models are not acceptable.

The chemistry system performs analysis for the following analytes: glucose, protein, bilirubin, pH, blood, urobilinogen, ketones, nitrite, leucocytes, specific gravity, turbidity, and color.

The microscopic analyzer shall detect using fluorescent flow cytometry and digital imaging microscopy, which provides higher sensitivity and specificity to aid in particle detection and identification of the following elements present in a specimen: WBC (White Blood Cell), RBC (Red Blood Cells), Epithelial cells, Crystals, bacteria, yeast, pathological casts, sperm, and mucus. Using imaging analysis alone means we must look at the images of a high volume of the samples. By combining urine flow cytometry with digital imaging, the lab will have a highly standardized and more efficient process for urine sediment analysis.

The instrument shall maximize efficiency and productivity through a digital imaging device that increases clinical confidence by eliminating subjective result interpretation and repeat testing.

The instrumentation must ensure seamless urinalysis workflow and reduced manual microcopies. The manual microscopic test (which involves centrifuging samples, decanting, serving, and examining under the microscope) is a time-consuming task that interrupts the testing workflow and increases the test turnaround time, causing a delay in the results for the physicians. An increase in this type of analysis (manual microscopic) could lead to an increase in the number of staff to perform the Urinalysis tests. Therefore, the instrument shall minimize the risk of procedural errors through standardization and reduction of manual processes.

The specimens must be loaded into one of the instruments, and the sample racks are transferred automatically from the chemistry analyzer to the microscopic analyzer.

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

The instrument should have a specimen warming function, in addition to the reagent, that dissipates interfering amorphous urate and phosphate material.

The instrumentation offered shall have sufficient capacity and throughput to meet the volume and service demands.

• Chemistry Analyzer throughput of 240 samples/hour

• Automated Microscopy throughput of over 100 samples/hour

The instrument shall have minimal daily, monthly, and periodic maintenance.

The urine sample mixing is automatic. The instrument shall use primary tube for sampling.

The instrument shall use reagents with RFID tags for traceability.

The instrument shall provide a means of backup or system restoration.

A LaserJet printer and a UPS (uninterruptible power supply) shall be provided for each instrument.

The instrument must have a sample loader with the capacity to load at least 80 patients in one time which fits our heavy daily workload.

It includes all necessary reagents, thermal papers, printers, filters, calibrators, and controls to perform analysis.

The instrument shall be FDA-approved.

The instrument shall have the capacity of automated monitoring of reagent levels.

A patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

6. INSTRUMENT SOFTWARE

The instrument shall have a Software or Data Manager program that supports auto-validation of results through rule-based judgments, as well as quality control management.

The instrument’s software must have the capability to provide monthly Levey-Jennings graphs.

The instrument must have the capability to record, store, and print the following information:

• Required QC and instrument maintenance information.

• On-board reagent inventory system.

The instrument’s software must have the capability to detect and alert the operator when Quality Control (QC) needs to be performed or has exceeded acceptable limits via flagged results on QC printout and visual alerts on the display monitor.

Quality Control (QC) for each location is as follows.:

• VA Caribbean Healthcare System San Juan:

Once every 24-hours, Chemistry every eight-hour shift, Microbiology once every 24-hour shift.

• Mayaguez Outpatient Clinic:

At the beginning of the day, Chemistry and Microbiology at the beginning of the day.

• Ponce Outpatient Clinic:

At the beginning of the day, Chemistry and Microbiology at the beginning of the day.

The ability to detect and alert the operator of low reagent levels and the potential of depletion, as well as the capability to load and unload consumables from the equipment during operation without interrupting testing in progress.

The instrument software must have the capability to alert the operator of patient results with anomalies via flagged results on printouts and visual alerts on the display monitor.

7. INTERFACE

The contractor shall provide instrumentation that is compatible with VistA or interfaces directly with Data Innovations and Instrument Manager, the most recent version.

The contractor will supply a system and/or software that is compatible with the VISTA Hybrid Lower-Level Protocol Receiver/Sender M routine Interface for Health Level 7 (HL7) version 1.6 used at the VA for Laboratory Information Systems, also compatible with Data Innovations/ Instrument Manager for bidirectional automatic interphase and Auto Verification.

The contractor must provide a completed copy of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) and VA Form 6550.

The contractor shall provide all hardware, software, lines, adapters, and devices required to connect all Laboratory instruments to the Middleware, including, but not limited to, Lantronix devices or equivalent that are capable of converting DB9 serial to RJ45 Ethernet following RS232 or ASTM protocols.

The contractor shall provide 24/7 technical support for all hardware and software connections.

The contractor shall utilize the VA national site-to-site VPN or work with the VA Officer of Cyber and Information Security and Information Security Officers to establish a client-based VPN.

The contractor must ensure all proposed instruments/systems that requires Remote Connection capability shall be included under the current active MOU interconnection Security Agreement.

The contractor shall provide a secure communication from the analyzer to contractor servers using a high-speed, outbound internet connection via VPN. This powerful tool is the analyzer’s data link, feeding a variety of innovative tools and services. The tools and services include proactive analyzer support, remote calibration verification, reagent inventory management, error monitoring, and analyzer maintenance.

The contractor shall provide an Orders connection and a Results connection to our Laboratory Information System (LIS) systems. If more than two (2) connections are required, the contractor shall provide all connections to our

LIS.

The contractor is responsible for providing hardware and software support to the LIS interface including patches, updates, enhancements, and new versions of software and drivers. Information Technology (IT) support is included to provide management, consultation, or troubleshooting to any problem and/or situation within a reasonable time frame at no cost to the government.

8. INSTALLATION AND IMPLEMENTATION

8.1. Space Requirements, System Specifications, etc.:

Configuration of the proposed equipment shall be able to conform to the space previously allotted for this function. System specifications shall all be disclosed in the proposed space. Crossover from current to new instrumentation shall be performed timely with no interruption in patient care and laboratory service.

Installation shall not require extensive renovations to allocated space in all laboratory locations.

8.2. Dimensions of each location’s space requirements

• VA Caribbean Healthcare System San Juan 168 inches X 96 inches

• Mayaguez Outpatient Clinic 71 inches x 29 inches (current analyzer dimensions)

• Ponce Outpatient Clinic 109 inches X 48 inches

8.4. Installation:

a) The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order, connections of all equipment, and interconnecting wiring and cabling, if applicable, in coordination with the facility biomedical engineer. Upon receipt of notice to proceed with installation, it shall be the contractor’s responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once the installation is completed. If the progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until the cause of delay has been eliminated and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

b) The installation must include configuring test parameters, calibrators, controls, and verification of system operation and performance by multiple trial sample runs.

c) The contractor will provide Technical Services for validation studies in San Juan (including linearities, correlations, sensitivity limits, and reference range validations).

d) Upon completion of installation the equipment shall be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from the date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government will accept installation with a guaranteed date commencing ten calendar days after installation.

e) Before leaving the site, the following must be provided: a certified copy verifying the analyzer’s operation performance, and all required operating manuals.

f) The contractor shall provide equipment relocation and installation at no cost if the equipment is required to be moved due to construction or laboratory redesign at VACHS.

g) The contractor will remove instruments when a replacement or termination occurs and will be responsible for all packing and shipping required.

8.5. Implementation and Transition:

The contractor shall provide with its quotation an implementation plan for the installation and validation of the instrument. The contractor shall provide a certified, dedicated project manager equipped with project management tools to design and implement system configuration and installation. This would include such items as start-up team, regularly scheduled meetings, monitoring and tracking of project tasks, critical path, and oversight of project to completion. The contractor will ensure a smooth transition with an existing company (as applicable) and provide as few interruptions as possible in-patient services and reporting of results. The contractor shall provide a plan of implementation detailing this transition, including timelines.

This would include, but are not limited to the following:

a) Shipment of the new analyzers (depends on availability of inventory or if needs to be manufactured).

b) Deinstallation of old analyzers, this is done by the current vendor (this includes Biomed).

c) Installation of the new analyzers, done by the new vendor.

d) Validation of the new analyzers, done by the new vendor.

e) Validation of the Auto verification process done by the VA Laboratory Information Manager, during this process, the LIM verifies that results are transmitting correctly.

f) Train all laboratory staff that will use the new analyzer, done by the new vendor.

g) Go live timeframe.

8.6. Hours of Operation:

Normal business hours are 7:00 AM to 4:30 PM Monday thru Friday, excluding Federal Holidays. Work completed outside this time shall be requested through the Point of Contact.

VA Caribbean Healthcare System San Juan:

24 Hour operation with three shifts, Morning, Evening and Night.

Mayaguez Outpatient Clinic:

Monday to Friday 7:00 AM to 4:30 PM.

Ponce Outpatient Clinic:

Monday to Friday 7:00 AM to 4:30 PM.

Unless specifically authorized in writing by the Contracting Officer, no services will be provided, and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

New Year’s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day Washington’s Birthday Veterans' Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

9. VALIDATION STUDIES

The contractor shall perform, to the satisfaction of the Government, all installation, implementation, and validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format.

10. EQUIPMENT PREVENTATIVE MAINTENANCE / REPAIR SERVICE REQUIREMENT

The contractor must provide analyzer preventive maintenance (P.M.) as per manufacturer specifications which includes labor and the non-consumable parts used during the P.M. in order to maintain instruments in good operating conditions.

Onsite service shall be provided 8:00 a.m. - 5:00 p.m. during weekdays. (not to exceed 24 hours of the time of malfunction notification). Service reports will be provided upon completion and repair of equipment.

The contractor shall provide all upgrades to equipment hardware and operating system software without additional charge. These enhancements to the contractor equipment shall be delivered to the government site and installed by the contractor within sixty days of their issuance or date of first commercial availability.

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 the software, correction of a hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc.

11. 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 key operator training shall include training on the operation of the system, data manipulation, and basic troubleshooting repair for the instruments.

Therefore, the contractor shall provide training for a minimum of one operator per facility per year at the discretion of the Government for each model of instrumentation placed. The VA and the Contractor shall mutually agree on utilizing the training slots. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

The contractor shall provide basic operator training for no less than 3 operators.

The contractor shall provide supplemental operator training without additional charge to the government upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

11.1 Operator Procedure Manuals:

Operator and Service manuals, along with CLSI-compliant procedures, shall be furnished. Technical assay procedures shall be provided for the Automated Urinalysis System, and the contractor shall assist in transferring these procedures to the VACHS template to ensure that procedures are complete and available prior to implementation.

12. STANDARD AND ACCEPTANCE OF PERFORMANCE

This paragraph establishes a standard of performance that shall be met before any equipment listed on the delivery order is accepted by the government. This also includes replacement, substitute equipment, and instruments that are added or field modified after a system has completed a successful performance period.

The performance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any contract at an effectiveness level of 99% or more. Operational use time for performance testing for a system is defined as the accumulated time during which the instrument is in actual use. System failure downtime is that period when any instrument in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

13. CHARACTERIZATION OF WASTE

The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

a) Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b) Waste ignitability (Reference 40 CFR §261.21)

c) Waste corrosivity (Reference 40 CFR §261.22)

d) Waste reactivity (Reference 40 CFR §261.23)

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

f) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR

§261.33)

g) Solid Waste (Reference 40 CFR §261.2)

h) Exclusions (Reference 40 CFR §261.4)

The contractor shall 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

The contractor shall provide a description of all wastes, and the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), and State and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosivity, reactivity, and toxicity as defined in 40 CFR §261 shall be determined and documented. Any mercury-containing reagents shall be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K, and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal, and formaldehyde) shall be developed and SDS sheets shall 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 shall be included with contractor response:

Barium (Total) Zinc (Total) Cadmium (Total) Arsenic (Total) Chromium (Total) Selenium (Total) Copper (Total) Tin (Total) Cyanide (Total) Potential of Hydrogen (pH) Lead (Total) Flashpoint (to higher than 2000F) Mercury (Total) Biochemical Oxygen Demand (BOD) Nickel (Total)

The documentation the contractor provides will be used to work with the OVAHCS 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.

B.4 IT CONTRACT SECURITY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance.

National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S.

defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the POC.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information, and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program).