S02 - Solicitation Attachment - 36C24221Q0220.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 68

36C24221Q0220 12-11-2020

Wilmen Joa (718) 526-1000 x2784 12-28-2020

11 am EST

36C242

Department of Veterans Affairs

Network Contracting Office 2

St. Albans Community Center

179-00 Linden Blvd

Jamaica NY 11425-0001

X

325413

1250 Employees

N/A

See Delivery Schedule

36C242

Department of Veterans Affairs

St. Albans Community Center

Network Contracting Office 2

179-00 Linden Blvd

Jamaica NY 11425-0001

Tungsten Network http://www.tungsten-network.com/us/en

/veterans-affairs

See CONTINUATION Page

VISN 2 Bacterial Identification and Susceptibility testing.

See Statement of Work

Award will be made on a price and other factors basis. As such, vendor responses shall include all documentation to support the capability of providing all requirements listed in the Statement of Work.

Base plus four annual ordering periods.

See CONTINUATION Page

X 1

Kendall Jones

36C24221Q0220

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 FSS ORDER INTRODUCTORY LANGUAGE

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.3 52.216-18 ORDERING (AUG 2020)

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

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

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2020)

C.10 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.11 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) . 38

C.12 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) 40

E.2 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG

2020)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

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

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (OCT 2020)

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 36C242 Kendall Jones / Wilmen Joa Admin

Department of Veterans Affairs

Network Contracting Office 2

St. Albans Community Center

179-00 Linden Blvd

Jamaica NY 11425-0001

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 [X]

b. Semi-Annually []

c. Other []

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.

Tungsten Network http://www.tungsten-network.com/us/en

/veterans-affairs

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

AMENDMENT NO DATE

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS

VISN 2 Downstate

STATEMENT OF WORK

CLINICAL LABORATORY Microbiological System

For Identification and Antibiotic Susceptibility of Microorganisms

1. SCOPE:

The purpose of this contract to provide VISN 2 Downstate facilities with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VISN 2 Downstate facilities in accordance with the terms and conditions stated herein. The analyzers shall 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).

Our goal is for the Veterans Administration to obtain the greatest overall benefit in response to the requirements. A listing of estimated yearly quantities by participating facilities to be provided under this agreement is located in Attachment B. Quantities as listed are estimated based upon prior history of actual volumes and are not a guaranteed minimum.

This contract will include an identification and susceptibility system and an identification system such as Matrix-Assisted Laser Desorption/Ionization - Time of Flight Mass

Spectrophotometer (MALDI-TOF).

The Contractor shall propose the suggested/recommended equipment/reagents for all sites that meet the requirements of each facility as each facility is unique in its needs.

All offers must include an identification and susceptibility system for:

• Hudson Valley Healthcare System

All offers must include a susceptibility system and, an identification system (used as needed) for the following sites:

• East Orange VAMC

• New York Harbor Healthcare System/Manhattan campus only

• Northport VAMC

All offers must include MALDI-TOF system in their offering for the following sites:

• East Orange VAMC

• New York Harbor Healthcare System/Manhattan campus only

• Northport VAMC

The Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, and any other item required for the proper operation of its' contractor owned organism identification (ID) and antimicrobial susceptibility

(AST) analyzer for Microbiology and peripherals necessary for the generation of Microbiology

Testing services for VISN 2 Downstate. The Contractor will provide analyzers and supplies to each facility in accordance with Attachment B.

2. DEFINITIONS:

Cost Per Kit: The cost per kit pricing shall detail the number of tests in each kit, and based on testing volume found in Attachment B, the proposed number of kits that will be required by each site. The cost per kit price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result and the kits required to perform quality control, and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI).

3. PRICING SCHEDULE:

VISN2 DOWNSTATE will provide an estimated volume of tests performed as reflected on the

Attachment B for each site. Pricing shall be based on the average daily test volume per analyzer systems proposed. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed; they are ESTIMATES

ONLY.

All offers shall reflect pricing based on the requirement of each site, and not spread cost across all sites.

Offers must include a schedule of kits and supplies offered and per item cost with any tiered pricing for volumes and/or percentage of use in the Schedule of Pricing.

The Contractor will detail if the cost per kit will include the use of the analyzer systems, all reagents, saline, standards, controls, supplies, consumable/disposable items (for example plastic tubes), parts, accessories and any other item required for the proper operation and maintenance of the contractor’s equipment and necessary for the generation of a patient reportable result; a dedicated printer and toner; a minimum of two (2) preventive maintenance services per year per site; a repair service for each piece of equipment proposed delivery and installation of equipment at no additional cost.

The Contractor shall provide pricing for each kit and supplies in accordance with the cost per kit definition contained above, or other option for pricing, that can be performed on the quoted analyzer. The cost per kit shall include all costs for:

a. The use of the analyzer for the life of the contract.

b. All validation materials required prior to live testing.

c. All consumables, reagents, standards, controls and supplies.

d. All quality control organisms and materials.

e. Inter-laboratory Quality Control comparison program.

f. All validation materials required for the use of new or change of panels to meet CLSI guidelines throughout the life of the contract.

g. On-site training by contractor’s experts for initial training of all staff.

h. Contractor will provide training for any updates throughout the life of the contract.

i. Delivery and installation of equipment at no additional cost.

j. Pricing will be fixed price for the duration of the contract in accordance with the terms and conditions of the contractor’s Federal Supply Schedule Contract and FAR Part 13.303.

An alternative shall be cost per kit and supplies and cost for lease of equipment. The

Contractor will detail the Lease Buy-Back policy available at the end of the contract term.

4. TERMS OF AGREEMENT: The contract shall be in effect from the date of award to

September 30th of the award year, unless specified by the contracting officer, with four (4) additional Option Years and one six-month extension.

5. GENERAL REQUIREMENTS:

a. The contractor shall provide all supplies and services as described herein to the participating VAMC facilities.

b. The contractor shall provide a complete document detailing the electric and data requirements of the proposed analyzers/system.

c. If the analyzer/system requires deionized water (DI), we require the inclusion of a DI water system including maintenance of the DI system throughout the life of the contract.

d. We require the inclusion of an Uninterruptable Power System (UPS) for each analyzer proposed and the inclusion of maintenance and replacement, if needed, throughout the life of the contract.

e. Clinical laboratory assays currently performed at the VISN 2 Downstate facilities shall include, but not limited to, the following assays:

• Automated Organism Identification

• Automated Antimicrobial Susceptibility

• Detection of antibiotic resistance

• Rules for Unusual ID & AST results

• Software to prepare site specific reports

f. The contractor shall provide to each facility a copy of operating procedures in Clinical and

Laboratory Standards Institute (CLSI) (Microsoft Office WORD) format.

g. We require the system to be capable of bar-code scanning for specimens, panels, and quality controls materials.

h. Quality Control materials shall be included in the contract for all tests in use.

i. We require the inclusion of the cart/table/stand if necessary, to house each analyzer systems if it is not a floor model

6. TECHNICAL REQUIREMENTS

A. IDENTIFICATION and SUSCEPTIBILITY

1) The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers with the capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. Remanufactured or discontinued models are unacceptable for this contract.

2) The system shall be FDA approved to identify Candida auris: Candida auris is a multidrug-resistant yeast that causes invasive infections and persists in the environment. Correct identification of Candid auris is crucial to treating patients and preventing infections. We require instrumentation that will identify Candida auris to the genus and species level, so we are not required to send yeast to a reference laboratory for further identification.

3) Offered models of organism identification and antimicrobial susceptibility analyzers for clinical microbiology laboratory shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum testing capabilities without excessive malfunctions, breakdowns, or service calls.

4) The system shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal.

5) The system shall have a comprehensive and extensive data base of bacteria, anerobic bacteria and yeast that is consistent with CLSI guidelines and FDA approved.

6) System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc.

B. MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization - Time of Flight Mass

Spectrophotometer)

1) MALDI-TOF is required as an additional faster bacterial identification system. The device must analyze material from microbial cultures to provide organism identification within minutes.

2) The analyzer must include an FDA-approved broad library of gram positive, gram negative, anaerobic bacterial organisms as well as yeast, fungi and mycobacteria to limit the amount of work needed on self-validation/verification studies.

3) The analyzer must be FDA 21 CFR Part 11 Compliant.

4) A preparatory apparatus and equipment must be provided for specimen preparation, and there must be an easy method for securely linking specimen information to each spot on the target slide.

1)5) The analyzer must be fully integrated with the antimicrobial susceptibility testing platform in place with automatic linking of organism identification to sensitivity.

2)6) The system shall be FDA approved to identify Candida auris: Candida auris is a multidrug-resistant yeast that causes invasive infections and persists in the environment. Correct identification of Candid auris is crucial to treating patients and preventing infections. We require instrumentation that will identify Candida auris to the genus and species level, so we are not required to send yeast to a reference laboratory for further identification.

7. DATA MANAGEMENT

a. The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organism’s isolated and antimicrobial profiles and allow for manual modification of susceptibility breakpoints to comply with new

CLSI guidelines until such time as the contractor applies necessary software updates.

b. The contractor shall provide hardware and operating system software upgrades necessary to maintaining the integrity of the system at no additional charge to the Government during the lifetime of the analyzer. These enhancements shall be delivered and installed at each participating VISN 2 facility within 60 days of issuance to the commercial market. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner.

c. A printer for each analyzer shall be provided by the Contractor and the provision of toner throughout the life of the contract.

d. The analyzer/system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime.

e. Analyzers proposed shall be capable of bi-directional, bar-coded, computer interface with

Vista (at a minimum shall be capable of downloading patient demographics from host computer, integrating this information with test results and uploading to the host computer).

f. Provide bi-directional interface for Data Innovations middleware or whichever middleware the facilities are using.

g. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA Vista hospital information system at the time of award and includes all medical center facilities. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established with these systems. Specific requirements for the communication of the data streams shall be unique to the analyzer system involved and dictated by the manufacturer itself.

h. Ability to recall and re-transmit test results to host computer.

8. SOFTWARE

a. Contractor shall provide software upgrades at no charge when CLSI guidelines change or are updated, or when there are changes in bacterial nomenclature.

b. We require the system to be able to retrieve previously completed results and store these results for a minimum of two years.

c. We require the system to store quality control results for reagents and panels tested.

d. We require the system to alarm/flag repeat testing of unusual isolates, susceptibilities, and drug-bug combination. We require the system to flag an alert to the operator of isolates that are defined as public health risks and isolates that should be reported to the public health department.

e. We require the system to detect and alert the operator of analyzer problems and insufficient reagent.

f. We require the ability to define rules to alarm/flag reflex testing to confirm unusual results per CLSI & FDA guidelines.

g. We require the system to notify the operatory of the on-board sample capacity and when capacity is reached.

h. We require the ability to review Quality Control and patient results directly on the system.

i. We require the system to continue to process quality control and patient testing during LIS downtime. If needed, we require the ability to print a patient result during downtime. Once

LIS function is restored, we prefer the ability to upload all completed testing.

j. If middleware is needed to accomplish any or all the above, we require the inclusion of the middleware and all related software, hardware, and licenses to be included in the CPT.

k. If available, we prefer the inclusion of remote connection of the system to the contractor to assist in troubleshooting.

9. MAINTENANCE AND REPAIR:

a. We require the inclusion of a Service and Maintenance agreement for the full term of the contract to include all analyzer systems, software and hardware, seven days per week during business hours. Enhanced service options should be included in the proposal to enable each site to select the level of service to meet their needs.

b. We require the inclusion of the performance of a minimum of one preventive maintenance service per year per analyzer system prosed for each site.

c. The Contractor shall detail the level of service offered and the cost associate with each level of service, and if the service and maintenance costs are included in the cost per kit and supplies, or in the lease payment.

d. The Contractor shall detail their policy for emergency service and repair and the expected

a. arrival time for the field service engineer after the initial call is placed.

e. A technical assistance or support center shall be available by telephone hotline 24/7 days/week with a maximum call back response time of 1 hour, and on-site service (if required) within 4 hours following the determination that site service is required. (this can be a service level option).

f. We require a full detailed service report after each repair and each preventive maintenance.

g. The contractor shall not leave a service call open pending verification that repairs completed by the contractor’s maintenance personnel. For each analyzer provided the contractor shall treat each notification for an emergency/repair service call from the

Government as a separate and new service call.

10. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES

a. DELIVERY OF SUPPLIES. Shall be in accordance with National Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor.

b. ALERT/NOTIFICATION OF DELAYS. In shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the department supervisor, lab chiefs, and the VISN 2 DOWNSTATE clinical systems program office manager.

c. SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES: In the event that the consumables 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 routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the Government.

d. QUALITY OF SUPPLIES: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other material or commonly stocked parts required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision/reproducibility and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of

American Pathologists (CAP), Clinical Laboratory Standards Institute (CLSI) and the Joint

Commission on Accreditation (JC).

11. IMPLEMENTATION PLAN

The Contractor shall provide an implementation plan for the complete transition of all services under the awarded CPT including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 60 days after the award of the CPT. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe.

12. SITE PREPARATION:

a. The Contractor shall assess each site for placement of the new analyzer systems. The contractor shall review daily workflow at each site to facilitate the proposal of the most cost-effective solution.

b. Specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications.

c. The Contractor shall assess the laboratory department where the testing will be performed in each facility to ensure the right size equipment is provided based on space and test volume. Contractors will use the contact list (ATTACHMENT A) to make an appointment to inspect the site where equipment will be placed and where services will be performed.

13. COMPARISON AND VALIDATION OF ANALYZER

The Contractor shall perform at each site current to new analyzer comparison studies and quality control verification studies at no cost. We require the contractor to provide a written copy of all completed studies. This process shall be completed within four (4) weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

14. TRAINING

a. We require the inclusion of initial training for two key operators from each site for each analyzer system proposed, and for one key operator from each site annually for the remainder of the contract term.

b. The training on the operation of the system shall include data manipulation, preventative maintenance and basic trouble shooting and repair. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

c. The contractor will provide on-site initial operator training for all applicable personnel who will run analyzer.

d. A training and competency checklist shall be provided by the Contractor for all on-site training.

15. PAST PERFORMANCE

a. Past performance will be evaluated based on a defined questionnaire queried to current users provided by the contractor.

b. Contractor shall provide, as part of its offer, a list of VA and non-VA sites currently using interfaces for the analyzer offered.

ATTACHMENT A

Northport VA Medical Center

Hudson Valley VA Health Care System

New York Harbor VA Health Care System/Manhattan Campus

New Jersey VA Health Care System

ATTACHMENT B

PRODUCT

DESCRIPTION

Northport Hudson Valley

NY Harbor Manhattan

New Jersey

TOTAL

Gram Negative Identification Card

1360 866 4620 3400 10246

Gram Positive Identification Card

400 616 3520 1800 6336

Gram Negative Susceptibility Cards

1560 1069 4620 4800 12049

Gram Positive Susceptibility Card

1360 1083 3520 2400 8363

Neisseria Identification Card

40 40 580 0 660

Yeast Identification 60 0 240 400 700

Susceptibility Card 160 0 320 0 480

Anaerobe Identification Card

60 0 180 0 240

Mold 40 0 0 0 40

Mycobacteria 20 0 0 0 20

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

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.

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 onsite 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 COTR.

LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $_TBD___ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least

3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

Department of Veteran Affairs Baseline Configurations

Microsoft Windows Server

The following versions are approved, with baseline compliance, for enterprise use:

- 2008 R2 (SP1)

- 2008 R2 (SP1) Core

- 2012

- 2012 Core

- 2012 R2 (Update)

- 2012 R2 (Update) Core

Approved with listed constraints:

- 2008 x86 (non-core) is approved for SCCM 2007 infrastructure only. No new non-SCCM installations.

- 2003 is approved for existing installs only. No new installations without approved waiver.

- 2003 R2 is approved for existing installs only. No new installations without approved waiver.

Microsoft Windows Desktop and Laptop

- Windows 7

Microsoft Windows Medical Device Protection Program (MDPP)

- Windows 7

Macintosh Mac OS Workstation and Laptop

- Mac OS 10.10.X - Yosemite

- Mac OS 10.11.X - El Capitan

Linux

- Red Hat Enterprise Linux 6

Database Platforms

SQL

- SQL Server 2012

- SQL Server 2014

Oracle

- Oracle 11g

- Oracle 11.2g

- Oracle 12c

Server Virtualization (Virtual Machines)

With full virtualization the hypervisor is installed directly onto server hardware. Full virtualization has no underlying Operating System (OS). In Host-based virtualization the hypervisor is installed on the host OS. Moving forward, host-based virtualization is not authorized in VA.

The Visibility to Servers (V2S) Application Suite is not to be installed on virtual server hosts;

however, Visibility to Everything (V2E) requires a Simple Network Management Protocol

(SNMP) configuration be in place on server hosts. VA does require guest Virtual Machines

(VM’s) have the V2S Application Suite installed:

- McAfee Virus Scan Enterprise

- McAfee Host Intrusion Prevention (HIPS)

- McAfee ePolicy Agent

- System Center Configuration Manager Client (SCCM)

- BigFix

- SNMP

- ENCASE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

1.00 EA _______________

This 2237 is to establish a BPA for Cost Per Kit for VISN 2 South at Hudson Valley, New Jersey, NY Harbor Manhattan and Northport laboratories for Microbiological System for Identification and Antibiotic Susceptibility of Microorganisms.

The anticipated base year is FY2021 October 1, 2020 through September 30, 2021. The total amount for all sites is estimated at $473,950.00 for base year for 39,100 tests per year. Northport has estimated amount of $122,600.00 for 5,000 test per year. Attention CO Wilmen Joa

GRAND TOTAL _______________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

1.00

SECTION C - CONTRACT CLAUSES

C.1 FSS ORDER INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all task or delivery orders issued under the contract. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of an order issued under the contract that are not a part of the applicable FSS contract will govern.

In the event of an inconsistency between the terms and conditions of a task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence.

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The

Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims

Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the

Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the

Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting

Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the…