36C24218Q0250-002.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 73

36C24218Q0250 02-25-2018

Cavalieri, Tina 914-737-4400 x2065 03-26-2018

3PM

36C242

Department of Veterans Affairs

Network Contracting Office 2

James J. Peters VA Medical Center

130 West Kingsbridge Road

Bronx NY 10468-3904

X

325413

1250 Employees

N/A

X

Multi Site

36C242

Department of Veterans Affairs

James J. Peters VA Medical Center

Network Contracting Office 2

130 West Kingsbridge Road

Bronx NY 10468-3904

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

/veterans-affairs

See CONTINUATION Page

This solicitation is for the Indefinite Delivery, Indefinite

Quantity (IDIQ) contract for PCR Molecular testing for the

VISN 2 Down State facilities.

This is an all or nothing solicitation and you MUST be able to provide all testing on one platform.

The evaluation factors spelled out in great detail need to be thoroughly addressed in your proposal documents.

The awarded IDIQ contract shall be for five years from the date of award.

Award will be made to the vendor offering the best value to the Government. All documentation to support the capability of providing all requirements listed in the Statement of

Work shall be included in response to the RFQ.

The 6550 form and MDS sheet are attached and all vendor proposals shall include these two completed forms with their proposal package.

See CONTINUATION Page

X X

X 1

Sherin Rabadi

Division Chief

36C24218Q0250

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

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS

VISN 2 Downstate

STATEMENT OF WORK (SOW)

B.1 Price Cost Schedule

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.216-18 ORDERING (OCT 1995)

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

C.4 52.216-21 REQUIREMENTS (OCT 1995)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

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

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 28

C.9 52.246-2 INSPECTION OF SUPPLIES—FIXED-PRICE (AUG 1996)

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 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.216-1 TYPE OF CONTRACT (APR 1984)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(SEP 2018)

E.5 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Sherin Rabadi/Contracting Officer 36C242

Tina Cavalieri/Contract Specialist for administrative purposes

Department of Veterans Affairs

Network Contracting Office 2/FDR Campus

2094 Albany Post Road

Montrose, NY 10548

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 [Invoice 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.

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 (SOW)

PCR (Polymerase Chain Reaction) MOLECULAR DIAGNOSTICS

1. SCOPE:

The purpose of this SOW is to provide VISN 2 Downstate Laboratories with and IDIQ contract for a

Polymerase Chain Reaction (PCR) Molecular Diagnostics Testing Platform that enables a comprehensive menu of tests inclusive of tests depicted in the Workload Data table attached. A single analyzer platform is required due to staffing deficits, space availability, cost savings/avoidance, staff safety and learning curve. A second analyzer platform will be required at Bronx VAMC and Northport

VAMC, to allow testing of one or two assays during the evening and night tours, when the Molecular

Department is closed

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).

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 PCR Molecular testing for the generation of Cost Per Test (CPT) services for VISN 2 Downstate laboratories. The Contractor will provide analyzers and supplies to each facility in accordance with Attachment B Workload Data.

Participating VISN 2 laboratories are located as follows:

• Bronx VAMC

• East Orange VAMC

• New York Harbor Healthcare System

• Northport VAMC

The Government shall award a Contract to a single Contractor for cost per test PCR Molecular testing and subcontracting is not authorized. The Contractor shall provide a continuously stocked inventory of reagents, test kits, standards, controls, supplies, consumables, and any other materials required to properly perform tests on their equipment such that equipment operations are not interrupted. All items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. The expiration date must be clearly marked on reagents, standards, and control containers. Unexpected changes in methodology and technology shall be at the expense of the Contractor and shall not be done without providing ninety

(90) days written notice to the Government. Notification of any delays in shipment as well as any or all technical advisories, recalls, and alerts, prior to or simultaneously with field alerts shall be forwarded to the

COR’s who shall be identified at the time of the contract award.

The Contractor shall be able to provide all the tests listed in the schedule below with deliveries when required and provide firm fixed price for all required tests. Multiple awards will not be made and subcontracting is not authorized. The respective awarded contract is subject to funds availability. The total minimum amount for Ordering period 1 will be obligated after award of the IDIQ through purchase orders.

All invoicing shall be accomplished against the purchase orders.

Schedule of tests: The Contractor shall provide the tests in accordance with the pricing terms and conditions contained herein:

2. DEFINITIONS:

Cost Per Test (CPT): The per test cost shall include the use of the analyzer, all reagents, standards, controls, supplies, consumable/disposable items, patient specimen collection device or kit, 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. This also includes a dedicated printer and toner. This CPT price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI). The VA requires a minimum of two (2) preventive maintenance services per year per site. The VA requires a service contract to be included in the cost (detailed below). Contractors are required to provide delivery and installation of equipment at no additional cost.

3. PRICING SCHEDULE:

VISN2 DOWNSTATE will provide an estimated volume of tests performed as reflected on the attached spreadsheet for each individual medical center. Pricing shall be based on the average daily test volume per analyzer/analyzer. The Government estimates the volumes listed in the attached spreadsheet per facility, but does not guarantee volumes as listed; they are ESTIMATES ONLY.

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

Contract Pricing: Offerors shall provide pricing for each test in accordance with the CPT definition contained above, that can be performed on their quoted analyzer. The CPT shall include all costs for:

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

b. All validation materials required prior to live testing.

c. All consumables, reagents, standards, controls, supplies, and patient specimen collection device or kit

d. All quality control organisms and materials.

e. A dedicated printer and replacement of toner/ink, as needed.

f. Inter-laboratory Quality Control comparison program.

g. All validation materials required to meet CLSI guidelines throughout the life of the contract.

h. The inclusion of a Service Agreement (see detail below).

i. A minimum of two (2) preventive maintenance services per year per site.

j. Initial training for two (2) VISN 2 DOWNSTATE personnel, for each facility, operating equipment at Contractor’s facility and at least one (1) training slot per year for the life of the contract.

k. On-site training by Contractor’s experts for initial training of all staff.

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

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

4. TERMS OF AGREEMENT:

The awarded contract shall be in effect from date of award with five (5) additional Option Periods.

5. SPECIFICATIONS:

A. The Contractor shall provide FDA approved automated PCR Molecular testing systems/analyzers for the laboratories listed above. Remanufactured or discontinued models are unacceptable for the awarded contract.

1) The VA requires the performance of the following tests on a single platform on the primary analyzer:

a) Methicillin Resistant Staphylococcus Aureus (MRSA)

b) Clostridium difficile with identification of 027 strain

c) Influenza A, B, RSV

d) Chlamydia trachomatis/Neisseria gonorrhea

e) Mycobacterium tuberculosis complex

f) Streptococcus pyogenes

g) Trichomonas Vaginalis

h) Carbapenemase producing organism identification with differentiation among the major families of resistant genes

i) MRSA/SA Blood Culture Identification

2) The VA requires the performance of the following tests on a secondary analyzer:

a) Clostridium difficile with identification of 027 strain

b) Influenza A, B, RSV

3) If a test is reformulated during the contract period, The VA requires the implementation of the reformulated test at no additional charge.

4) If a new test is introduced during the contract period, The VA requires the option to evaluate the new test, and add to our testing menu, if it meets our needs.

5) The VA requires the ability to program the software to alert the user when epidemic strains of organisms are detected

6) The VA requires the analyzer to have the ability to scan the bar code of patient samples and testing cartridges.

7) The Contractor shall include in the CPT all supplies and services necessary to perform each test as described herein to the participating VAMC facilities.

8) The Contractor shall provide a complete document detailing the electric and data requirements of the proposed analyzers/system.

9) If the analyzer/system requires deionized water (DI), The VA requires the inclusion of a DI water system including maintenance of the DI system throughout the life of the contract.

10) The VA requires 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.

B. INTERFACING:

1) Analyzers proposed shall be capable of bi-directional, bar-coded, computer interface with VA

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).

2) Contractor shall provide bi-directional interface for Data Innovations middleware, if required for

VistA interface.

3) 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 insuring 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.

4) The VA requires the system to be able to hold completed results during interface down-time to enable the result to be re-transmitted to the host computer once interface is re-established.

C. SERVICE AND SUPPORT

1) As this service is critical to the support of providing excellent care to our nation’s Veterans, service and support to ensure continuous quality of care is needed. The Contractor will detail the level of support available at the time of submission. The level of support will include but is not limited to customer service phone support (“hotline”), remote dial-in instrument monitoring, and in-person field service support.

2) The Contractor will detail the specific time-frame for on-site support for each instrument system and middleware proposed (i.e. Business Hours, 24/7, days of week, etc.). Help desk personnel, field technicians, and access to this support are a critical element of this acquisition.

3) Service Expectations

Service for a malfunctioning analyzer and middleware is an essential component of maintaining testing readiness at all times.

a) The VA requires call-back from Customer Service or Field Service Engineer within one hour of first call for service for a non-functioning analyzer or middleware.

b) If on-site service is needed, The VA requires the arrival of Field Service Engineer within 4 hours of first call.

c) The VA requires the availability for Customer Service hotline 24 hours per day 7 days per week.

d) The VA requires detailed Service Reports for each service call.

4) Service Agreements

a) The VA requires a Service Agreement included in the CPT for all analyzers and middleware proposed.

b) Vendor shall clearly state the cut-off time once the first service call is placed for same-day service arrival. A cut-off time of no earlier than 3:00 pm is preferred. Include service details for weekends and holidays.

5) Uninterrupted Power Supply

The VA requires Uninterrupted Power Supply (UPS) systems for all analyzers and middleware hardware proposed. Maintenance, repair and/or replacement of each UPS is required thru the life of the contract.

6) Peripheral Hardware

The VA requires the inclusion and maintenance of all peripheral hardware required to run the analyzers and middleware proposed thru the life of the contract. This includes, but is not limited to connectors, cables, Plantronics box, and other items deemed essential by the

Contractor.

7) Remote Monitoring

Remote monitoring into analyzers is preferred to diagnose system problems and facilitate troubleshooting and maintenance. Clearly state availability of remote monitoring.

8) Information Technology (IT) Support

The VA requires on-site IT support until communication is established and patient result upload is validated in our Computer Patient Record System (CPRS). The VA requires the provision of all necessary drivers needed to send and receive orders.

(PLEASE NOTE: The VA, in conjunction with the DOD, is in the process of developing a new laboratory information system package; implementation date to be determined. In the event this package is implemented during the life of the contract, Contractor will provide IT support on site until communication is established and patient results uploaded into CPRS for each analyzer/system in use).

D. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES

1) DELIVERY OF SUPPLIES. Shall be in accordance with Statement of Work.

2) Any unexpected changes in methodology/technology shall be at the expense of the Contractor, including all reagents and supplies needed for full validation of test. The VA requires notification of any change at least 60 days prior to the change.

3) 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.

4) SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES: If 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.

5) SUPPLIES: Each site will notify the Contractor monthly, or more often if needed, of the reagents, standards, controls, supplies, consumable/disposable items, patient specimen collection device or kit, parts, accessories and any other item required to perform testing. The VA requires an invoice for each order placed. The VA requires the provision of a dedicated printer and toner/ink, as needed.

E. TRAINING

1) The VA requires initial training for two (2) VISN 2 DOWNSTATE personnel, for each facility, operating equipment at Contractor's facility and at least one (1) training slot per year for the life of the contract.

2) 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.

3) The Contractor will provide on-site initial operator training for all applicable personnel who will run analyzer.

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

F. SITE PREPARATION:

1) 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.

2) 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.

3) All questions regarding the requirements and terms and conditions of this solicitation shall be addressed to the Contracting Officer. Any information obtained by the offeror that did not come from the Contracting Officer shall not be considered a change in the solicitation requirement and offerors reliance on such information shall be at offerors own detriment.

G. IMPLEMENTATION PLAN

The Contractor shall provide an implementation plan for the complete transition of all services under the awarded IDIQ contract 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 90 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.

H. 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. The VA requires 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.

ATTACHMENT A

Northport VA Medical Center

Dolores M Grant, Laboratory Manager/Chairperson

631-261-4400 ext. 2885

Dolores.Grant@va.gov

Beth LeMaitre, Microbiology/Serology/Molecular Supervisor

631-261-4400 ext. 2022

Beth.LeMaitre@va.gov

Mary Creed, Lead Technologist Microbiology/Serology/Molecular

631-261-4400 ext. 2890

Mary.Creed@va.gov

Bronx VA Medical Center

Reynaldo Ortiz, PCR Molecular Supervisor

718-584-9000 ext. 6292

Reynaldo.ortiz@va.gov

Idamary Perozo, PCR Molecular Medical Technologist

718-584-9000 ext. 2691

Idamary.Perozo@va.gov

New York Harbor VA Health Care System/Manhattan Campus

Edlira Tafani, Microbiology Supervisor

212-686-7500 x3420

Edlira.Tafani@va.gov

New Jersey VA Health Care System

Kalpana Suwarna, Microbiology Supervisor

973-676-1000 ext. 1284

Kalpana.Suwarna@va.gov mailto:Dolores.Grant@va.gov mailto:Beth.LeMaitre@va.gov mailto:Mary.Creed@va.gov mailto:Reynaldo.ortiz@va.gov mailto:Kalpana.Suwarna@va.gov

ATTACHMENT B

PCR Molecular Workload Data:

Bronx:

secondary analyzer: an average of 10% for Influenza (during flu season) and 1% of C. difficile, if there is an outbreak of norovirus.

Northport: testing on a secondary analyzer: an average of 25% for FLU/RSV (during flu season)

Shipping – All Delivery Orders placed against the awarded IDIQ are to be shipped FOB Destination.

Invoices – The obligation of funds will occur at the Delivery Order level. Each Delivery Order will have a corresponding Purchase Order. To receive payment, the Contractor must invoice against the Purchase

Order associated with the corresponding Delivery Order. Invoices must be submitted electronically through the Tungsten Network against the correct Purchase Order Number.

CLIN Description of Services Guaranteed Minimum Maximum Amount

Ordering Period: June 1, 2019 through May 31, 2024

0001 PCR Molecular Testing

$10,000 $7,000,000.00

Baseline Configurations

TEST NAME NYHHS

FY17

NJHCS

FY18

NORTHPORT

FY18

BRONX

FY18

MRSA 10,170 5,500 2,400 3,360

C.DIFFICILE 1,090 500 350 550

Flu Screening

(XPRESSFLU/RSV)

500 1,000 800 1,397

CT/NG 2,590 1,600 1,200 1,790

Carbapenemase resistance 500 120 80 450

MTB/RIF 1,000 180 95 300

Strep A 200 250 145 120

T.vaginalis 2,590 420 165 120

MRSA Bld Culture 100 100 50 100

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:

- MacAfee Virus Scan Enterprise

- McAfee Host Intrusion Prevention (HIPS)

- McAfee ePolicy Agent

- System Center Configuration Manager Client (SCCM)

- BigFix

- SNMP

- ENCASE

The attached 6550 forms and the attached Manufacturer Disclosure Statement (MDS) for Medical

Device Security form must be completely filled out and submitted with your proposal.

B.1 Price Cost Schedule

Item List:

The quantities listed in the Price/Cost Schedule are estimates only and are not to be considered minimum or maximum. The guaranteed minimum contract amount, including the base year and any option years exercised, is $10,000. A task order will be issued at the start of each performance period. Please see

SOW for breakdown by site. Offerors are encouraged to submit a discounted quote based on VISN volume.

Base Year: June 1, 2019 through September 30, 2019

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

Clostridium difficile/027 PCR testing. 830

Influenza A, B and respiratory syncytial virus PCR testing

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

Carbapenemase producing gene PCR testing 383

Mycobacterium Tuberculous/Rifampin PCR testing

Streptococcus A PCR testing 238

Trichomonas Vaginalis PCR testing

Methicillin Resistant Staph Aureus (isolated from blood culture bottles) PRC testing

Total for all tests

Option Year One: October 1, 2019 through September 30, 2020

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

21,430

Clostridium difficile/027 PCR testing. 2,490

Influenza A, B and respiratory syncytial virus PCR testing

3,697

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

7,180

Carbapenemase producing gene PCR testing 1,150

Mycobacterium Tuberculous/Rifampin PCR testing

1,575

Streptococcus A PCR testing 715

3,295 from blood culture bottles) PRC testing

Option Period two: October 1, 2020 through September 30, 2021

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

21,430

Clostridium difficile/027 PCR testing. 2,490

Influenza A, B and respiratory syncytial virus PCR testing

3,697

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

7,180

Carbapenemase producing gene PCR testing 1,150

Mycobacterium Tuberculous/Rifampin PCR testing

1,575 from blood culture bottles) PRC testing

Option Year Three: October 1, 2021 through September 30, 2022

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

21,430

Clostridium difficile/027 PCR testing. 2,490

Influenza A, B and respiratory syncytial virus PCR testing

3,697

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

7,180

Carbapenemase producing gene PCR testing 1,150

Mycobacterium Tuberculous/Rifampin PCR testing

1,575 from blood culture bottles) PRC testing

Option Year Four: October 1, 2022 through September 30, 2023

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

21,430

Clostridium difficile/027 PCR testing. 2,490

Influenza A, B and respiratory syncytial virus PCR testing

3,697

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

7,180

Carbapenemase producing gene PCR testing 1,150

Mycobacterium Tuberculous/Rifampin PCR testing

1,575 from blood culture bottles) PRC testing

Option Year Five: October 1, 2023 through May 31, 2024

Description/Part Number Quantity/

Est. # of tests

CPT

Price

Total Estimated

Cost

Methicillin Resistant Staphylococcus Aureus

PCR testing

14287

Clostridium difficile/027 PCR testing. 1660

Influenza A, B and respiratory syncytial virus PCR testing

Chlamydia trachomatis/Neisseria gonorrhea

PCR testing

Carbapenemase producing gene PCR testing 767

Mycobacterium Tuberculous/Rifampin PCR testing

Streptococcus A PCR testing 477 from blood culture bottles) PRC testing

SECTION C - CONTRACT CLAUSES

C.1 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, 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 points 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 Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the

Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the

Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in

32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31

U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts;

18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety

Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-

Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the

EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the

Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of award through December 30, 2024.

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

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

(End of Clause)

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

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than N/A Requirements Contract, the Government is not obligated to purchase, nor is the

Contractor obligated to furnish, those supplies or services under the contract.

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

(1) Any order for a single item in excess of N/A Requirements Contract;

(2) Any order for a combination of items in excess of N/A Requirements Contract; or

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

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

(b) of this section.

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

(End of Clause)

C.4 52.216-21 REQUIREMENTS (OCT 1995)

(a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the

Government's requirements do not result in orders in the quantities described as "estimated" or

"maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the

Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order…