S02 36C24623Q0004.pdf

PAGE 1 OF1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

See pg. 2

36C24623Q0004 08-29-2022

Isaac.Hernandez@va.gov (910) 488-2120 x: 5862 09-12-2022

10AM EDT

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301

X

334516

1000 Employees

Net 30 N/A

X

See Delivery Schedule Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971

512-460-5049 512-460-5221

X

See CONTINUATION Page

This is a firm-fixed-priced, cost-per-test solicitation for Microbial Identification analyzer, see statement of work below.

Period of Performance: 10/1/2022 - 9/30/2023

See CONTINUATION Page See pg. 2

X X

X 1

Isaac Hernandez Contracting Officer

Requisition No.’s: 659-23-1-064-0001, 652-23-1-096-0068, 658-23-1-039-0018, 590-23-1-023- 0018, 637-23-1-167-0023, 565-23-1-049-0003

Accounting and Appropriation Data: 637-3630160-167-822300-2631 010022300, 652-3630160- 096-822300-2633 010022300, 658-3630160-039-822300-2341 010022300, 590-3630160-023- 822300-2631 010022300, 659-3630160-064-822300-2560 010022300, 565-3630160-049- 822300-2560 010022390

36C24623Q0004

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

B.5 IT CONTRACT SECURITY

B.6 SPECIAL CONTRACT REQUIREMENTS

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2021)

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

C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

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

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.2 INSTRUCTIONS TO OFFERORS

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

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 36C246 Isaac Hernandez

Department of Veterans Affairs

Network Contracting Office 6

201 Hay Street, Suite 304

Fayetteville NC 28301

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in arrears

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

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

SCOPE:

Selected VISN6 Medical Centers are seeking a one-year contract for the identification and detection of vaginitis/bacterial vaginosis using automated DNA direct probe detection method for our female patient population with results available in under one hour.

Instrument /equipment and supplies shall be provided to each Medical Center per the projected volumes provided in the Statement of Work. Participating VISN 6 Medical Centers are located as follows:

VAMC Asheville, 1100 Tunnel Road, Asheville, NC 28805

VAMC Fayetteville, 2300 Ramsey Street, Fayetteville, NC 28301

VAMC Hampton, 100 Emancipation Drive, Hampton, VA 23667

VAMC Salem, 1970 Roanoke Blvd, Salem, VA 24153

VAMC Salisbury, 1601 Brenner Ave., Salisbury, NC 27144

VAMC Richmond, 1201 Broad Rock Blvd., Richmond, VA 23249

TYPE OF CONTRACT

Firm-Fixed Price

PERIOD OF PERFORMANCE

October 1, 2022, through September 30, 2023

PRICES AND TERMS:

If the vendor fails to perform in a manner satisfactory to the CO, this agreement may be canceled with thirty (30) days written notice to the Vendor by the CO. VISN 6 intends to establish the base year of the agreement for the period of October 1st, 2022, through September 30th, 2023.

The Government anticipates award of a purchase order using the quantities stated in appendix A, VISN-6 Vaginitis Estimates to provide the vendor a basis of calculating their pricing. Quantities are estimates based upon prior history of actual volumes and are intended to provide the vendor a basis for calculating their pricing. Pricing shall be based on a schedule of items offered and per item cost. The Government estimates the volumes per facility but does not guarantee volumes; they are ESTIMATES ONLY.

The vendor will provide each participating facility with Food and Drug Administration (FDA) approved testing equipment, reagents and consumables necessary for conducting testing and producing a result.

The vendor will ensure that all reagents/supplies received have at least a six-month expiration date.

STATEMENT OF WORK/SERVICES TO BE PROVIDED:

1. GENERAL REQUIREMENTS:

1.1. The awarded reagent rental agreement or cost-per-test agreement shall be limited to the VISN 6 facilities listed above. N ew or additional VISN 6 facility requests to be included in this agreement will require a new solicitation and award.

1.2. The purpose of this contract is for the Government to obtain the greatest overall benefit in response to the requirements.

1.3. The vendor shall provide each participating facility with Food and Drug Administration (FDA) approved reagents, controls, disposables and any consumable part necessary for testing and must include the capabilities listed under section 2-System Requirements.

1.4. The vendor’s equipment must be able to meet the volume and match or improve the turnaround time requirements of the using-facilities.

2. SYSTEM REQUIREMENTS:

2.1. System Requirements:

2.1.1. The vendor shall ensure that each facility is provided with and maintains a fully operational FDA approved microbial identification test for the detection of vaginitis/ bacterial vaginosis using an automated DNA direct probe detection method for the simultaneous detection and differentiation of Gardnerella vaginalis, Candida species and Trichomonas vaginalis from a single vaginal specimen as agreed under the terms of that agreement.

2.1.2. The vendor shall ensure software, hardware, reagents, consumables, and analyzers are standardized throughout the participating facilities.

2.1.3. The system shall be a rapid automated processing microbial identification system and provide final results within one hour from start to finish.

2.1.4. The system shall be able to identify infections caused by multiple organisms.

2.1.5. The system shall be user-friendly requiring minimal hands-on time with walk-away capability and present clear visible results for interpretation by the user.

2.1.6. The system shall not be affected by interfering substances such as vaginal lubricants.

2.1.7. The system shall include a specimen transport system that is stable for at least 72 hours at ambient temperature for those specimens collected at outpatient clinics and remote sites requiring an extended transport time.

2.1.8. The system shall have the ability to perform batch testing. Facility requests for additional instruments would require a new contract solicitation and award.

2.1.9. The vendor’s system shall include a quality control program that meets College of American Pathologists (CAP) and The Joint Commission regulatory guidelines and ensures proper test performance including but not limited to 1) internal quality control with each test performed, and 2) external quality.

2.2. Instrumentation and Software:

2.2.1. The vendor shall complete with their proposal the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI & T) for the facility for any medical devices that will be connected to the VA information network. The vendor then shall provide evidence of VA approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place.

2.2.2. The vendor shall supply all equipment (to include as required for testing, specimen processor/s and incubator/ heating block unit/s), reagents, and disposables required for operating the microbial identification system and producing quality results.

2.2.3. Requests for additional instrumentation due to excessive instrumentation/ test kit failures/malfunctions, breakdowns, or service calls will be evaluated as needed by the facility laboratory with communication to the vendor and the Government’s Contracting Officer for modification of the contract. A high incidence of problems with any instrumentation/ test kits supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/ test kits that can produce the required criteria of this contract satisfactorily to the user.

2.2.4. The vendor shall provide upgrades to equipment hardware at no additional charge to the Government.

2.2.5. The vendor shall provide users with utility requirements (electrical, guidelines for disposal of waste and hazardous reagents, etc.). Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

2.2.6. The vendor shall promptly notify the Government of any changes to environmental requirements (heat/cool, humidity, lighting, etc.) for instrument operation and reagent storage.

2.2.7. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this contract.

3. INSTALLATION AND VALIDATION: In the event of instrument replacement under the vendor’s service plan, the vendor shall provide technical assistance with replacement equipment validation. This shall include at least 72 tests (3 kits at 24 tests each) to be used in the validation process, organism recommendations, and evaluation of correlation data sufficient to satisfy accreditation requirement.

4. SUPPORT SYSTEMS (SERVICE, PREVENTIVE MAINTENANCE AND

SHIPPING OF SUPPLIES):

4.1. Vendor shall continue to provide service sufficient to meet the needs of the facilities Monday through Friday 8:00am to 4:30pm through their service plan which will at a minimum, provide a replacement instrument. The vendor shall make every effort to ensure replacement equipment is shipped with intent to deliver to the Government facility within 24 hours from notification of equipment failure.

4.2. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support through one contractor. All calls shall be answered within one hour via telephone.

4.3. The vendor shall provide at no charge all parts necessary for the operation of the system.

4.4. The vendor’s service is to include all parts for repair or replacement and labor.

4.5. The vendor shall provide service agreements that includes replacement or repair of all ancillary equipment (i.e. processors, incubators/heating blocks).

4.6. The vendor shall provide all necessary Safety Data Sheet (SDS) records.

4.7. Frequency of shipments: The vendor shall cooperate with the Government’s requests for on demand or standing weekly/monthly/quarterly shipments based on current use and maintain the capacity to fill emergency order requests pending the confirmation of fund appropriation by facility.

4.8. The vendor shall pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional testing supplies be required. The vendor shall pay for all expedited shipping fees for all supplies, consumables, and equipment for product fulfilment issues (i.e., backorders, product failure, etc.) or equipment failures that occur at the fault of the vendor or the vendor’s equipment. The Government shall pay for any expedited shipments that occur at the fault of the Government.

5. TRAINING AND PROCEDURES:

5.1. The vendor shall continue to provide education/training on site during installations or update to the equipment. Training shall include staff on all shifts, basic operation, quality control, interpretation and reporting of results, required user performed maintenance, and troubleshooting. The vendor shall provide a documented record of training (training checklist) completed for all trained staff before leaving site following any installation at any Government facility covered by this agreement.

5.2. The vendor shall continue to supply all necessary procedure manuals, troubleshooting manuals and operator manuals (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. The vendor shall provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility.

6. Table of Estimated Test Volumes

Facility Estimated Annual Test Volume

Asheville VAMC 336 Fayetteville VAMC 960

Hampton VAMC 936 Richmond VAMC 1,464 Salem VAMC 504 Salisbury VAMC 1,440

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 YR __________________ __________________

Asheville VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0001AA 336.00 EA __________________ __________________

Test Kits Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0001AB 400.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0002 1.00 YR __________________ __________________

Fayetteville VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0002AA 960.00 EA __________________ __________________

Test Kits Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0002AB 1,200.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0003 1.00 YR __________________ __________________

Hampton VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0003AA 936.00 EA __________________ __________________

Test Kits

Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0003AB 900.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0004 1.00 YR __________________ __________________

Richmond VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0004AA 1,464.00 EA __________________ __________________

Test Kits Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0004AB 1,400.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Cost-per-Test, Open Market

0005 1.00 YR __________________ __________________

Salem VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0005AA 504.00 EA __________________ __________________

Test Kits Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0005AB 500.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0006 1.00 YR __________________ __________________

Salisbury VAMC - Provide Microbial Identification Analyzer IAW the SOW Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None Cost-per-Test, Open Market

0006AA 1,440.00 EA __________________ __________________

Test Kits Contract Period: Base

POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

0006AB 1,500.00 EA __________________ __________________

Collection Devices Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Cost-per-Test, Open Market

GRAND TOTAL __________________

B.4 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: Asheville VAMC 1100 Tunnel Rd.

Asheville, NC 28805

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Karen Jones 828-298-7911 Ext. 2292 Karen.Jones4@va.gov

0001AA SHIP TO: Asheville VAMC 1100 Tunnel Rd.

Asheville, NC 28805

336.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Karen Jones 828-298-7911 Ext. 2292 Karen.Jones4@va.gov

0001AB SHIP TO: Asheville VAMC 1100 Tunnel Rd.

Asheville, NC 28805

400.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Karen Jones 828-298-7911 Ext. 2292 Karen.Jones4@va.gov

0002 SHIP TO: Fayetteville VAMC 2300 Ramsey St.

Fayetteville, NC 28301

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Penny Creech 910-488-2120 Ext. 5582 Penny.Creech@va.gov

0002AA SHIP TO: Fayetteville VAMC 2300 Ramsey St.

Fayetteville, NC 28301

960.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Penny Creech 910-488-2120 Ext. 5582 Penny.Creech@va.gov

0002AB SHIP TO: Fayetteville VAMC 2300 Ramsey St.

Fayetteville, NC 28301

1,200.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Penny Creech 910-488-2120 Ext. 5582 Penny.Creech@va.gov

0003 SHIP TO: Hampton VAMC 100 Emancipation Dr.

Hampton, VA 23667

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Mary Petty

(757) 722-9961 Ext 3632 mary.petty@va.gov

0003AA SHIP TO: Hampton VAMC 100 Emancipation Dr.

Hampton, VA 23667

936.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Mary Petty

(757) 722-9961 Ext 3632 mary.petty@va.gov

0003AB SHIP TO: Hampton VAMC 100 Emancipation Dr.

Hampton, VA 23667

900.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Mary Petty

(757) 722-9961 Ext 3632 mary.petty@va.gov

0004 SHIP TO: Richmond VAMC 1201 Broad Rock Blvd.

Richmond, VA 23249

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Wayne Stevens

804.675.5000 ext.5889 Wayne.Stevens@va.gov

0004AA SHIP TO: Richmond VAMC 1201 Broad Rock Blvd.

Richmond, VA 23249

1,464.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Karmen Purdel

804.675.5000 ext.5889 Wayne.Stevens@va.gov

0004AB SHIP TO: Richmond VAMC 1201 Broad Rock Blvd.

Richmond, VA 23249

1,400.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Karmen Purdel

804.675.5000 ext.5889 Wayne.Stevens@va.gov

0005 SHIP TO: Salem VAMC 1970 Roanoke Blvd Salem, VA 24153

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Kristaen Cooper

(540) 982-2463 Ext. 2196 Kristaen.Cooper@va.gov

0005AA SHIP TO: Salem VAMC 1970 Roanoke Blvd Salem, VA 24153

504.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Kristaen Cooper

(540) 982-2463 Ext. 2196 Kristaen.Cooper@va.gov

0005AB SHIP TO: Salem VAMC 1970 Roanoke Blvd Salem, VA 24153

500.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Kristaen Cooper

(540) 982-2463 Ext. 2196 Kristaen.Cooper@va.gov

0006 SHIP TO: Salisbury VAMC 1601 Brenner Ave.

Salibsury, NC 27144

1.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Samuel Welty 704-638-9000 x 15421 Samuel.Welty@va.gov

0006AA SHIP TO: Salisbury VAMC 1601 Brenner Ave.

Salibsury, NC 27144

1,440.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Samuel Welty 704-638-9000 x 15421 Samuel.Welty@va.gov

0006AB SHIP TO: Salisbury VAMC 1601 Brenner Ave.

Salibsury, NC 27144

1,500.00 POP: 10/1/2022 -

9/30/2023

MARK

FOR:

Samuel Welty 704-638-9000 x 15421 Samuel.Welty@va.gov

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 2 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law…