36C24526R0021_1.docx

36C24526R0021

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24526R0021 01- 7-2026

ALISON KLEIN

304-623-3461 X 4143 03-03-2026

12:00PM

EST

Department of Veterans Affairs Louis A Johnson, VAMC Contracting Office (90C) 1 Med Center DR Clarksburg WV 26301-4199 X 621511 $41.5 Million N/A X See Delivery Schedule

19ACQ

Department of Veterans Affairs Louis A Johnson, VAMC Contracting Office (19ACQ) 1 Med Center DR Clarksburg WV 26301-4199

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135 x X

ALISON KLEIN

Table of Contents

E.7 52.209-12 CERTIFICATION REGARDING TAX MATTERS (OCT 2025)

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 36C245 Department of Veterans Affairs Louis A Johnson, VAMC Contracting Office (90C) 1 Med Center DR Clarksburg WV 26301-4199

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

3. INVOICES: Invoices shall be submitted 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:

B.2 Schedule of Supplies/Services

The contractor agrees to provide Supplies/Services attachment(s) Western Region or Eastern Region Line Items in accordance with the terms, conditions, and provisions stated herein at the prices specified in the Schedule of Supplies/Services attachment(s).

The guaranteed minimum contract amount for all 5 years is $15,000.00 and the maximum contract amount, including the base year and any option years exercised, shall not exceed $45,000,000. Task orders shall be issued by a warranted NCO 5 Contracting Officer.

ESTIMATED QUANTITIES: The quantities listed in the attached ATTACHMENT 2 EASTERN REGION LINE ITEMS and ATTACHMENT 2 WESTERN REGION LINE ITMES are estimates only and are not to be considered a minimum or maximum. These estimates do not create any obligation to purchase any specified amount of services under this contract, and the Government will only be obligated to make payment for services requested and received in the quantities and the quality requested. The Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contact.

The Government is allowed to place task order up to 9/30/2031 and contractors are required to deliver tests 180 days after expiration of contract(s).

B.3 Statement of Work - Reference Laboratory Services

The Contractor(s) shall provide all labor, supplies, equipment, maintenance, information technology, and supervision to provide Reference testing laboratory services to include the following:

1. Specimen preparation and storage

2. Transportation of specimens to its laboratory

3. Pre-analytic processing

4. Analysis

5. Reporting of analytic results

6. Consultation regarding:

a. Selection

b. Collection

c. Transportation

d. Result interpretation.

A listing of test descriptions under this contract are in attachment labeled:

Clarksburg and Huntington schedule or VAMHCS Martinsburg Beckley DC LineItems

The Contractor(s) shall provide services to the following facilities:

Western Region:

· Louis A. Johnson VAMC, Clarksburg, WV

· Huntington VAMC, Huntington, WV

Eastern Region:

· Martinsburg VAMC, Martinsburg, WV

· VA Maryland Health Care System, Baltimore, MD

· Washington DC VAMC, Washington, DC

· Beckley VAMC, Beckley, WV

Government reserves the right to add or remove supporting facilities as necessary.

Period of Performance: 5 years Contract Type: Two Single Award Firm Fixed Price Indefinite Quantity contract(s)

I. Qualifications:

i. Licensing and Accreditation

1. Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/Subcontractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP) or The Joint Commission (TJC), or any other licensing and/or Accreditation in order to perform the required testing listed in this SOW and comply with the Limitation of Subcontracting. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer (CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification.

3. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

4. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA)

0. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the contract within 24 hours of notification of an investigation or suspension

0. Contractor Personnel:

1. The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide access via website or email upon request a copy of the renewed licenses/certificates before expiration.

1. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or American Board of Bioanalysis, certified Bio-analyst.

1. The Contractor shall have at least three years of experience providing laboratory services and shall have at least one-year experience in transporting biomedical materials.

2. CLIA certifications shall include:

0. Histocompatibility (010)

0. Bacteriology (110)

0. Mycobacteriology (115)

0. Mycology (120)

0. Parasitology

0. Virology (140)

0. Syphilis Serology (210)

0. General Immunology (220)

0. Routine Chemistry (310)

0. Urinalysis (320)

0. Endocrinology (330)

0. Toxicology (340)

0. Hematology (400)

0. Immunohematology ABO Group & Rh type (510)

0. Immunohematology Antibody Detection (transfusion) (520)

0. Immunohematology Antibody Detection (non-transfusion) (530)

0. Immunohematology Antibody Identification (540)

0. Immunohematology Compatibility Testing (550)

0. Histopathology (610)

0. Oral Pathology (620)

0. Surgical Pathology

0. Molecular Biology

0. Cytology (630)

0. Radiobioassay (800)

0. Cytogenetics (900)

1. The Contractor shall provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

1. The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s).

II. Specimen Preparation and Storage for Reference Testing Specimens

1. The contractor(s) shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

1. Contractor(s) shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory.

1. Each individual VISN 5 medical center, the contractor shall provide the preparation, storage, packaging, and transport of specimens.

1) The Contractor(s) shall provide staff to function as a specimen processor for the medical center.

2) This service shall be provided to the government within the price of the test.

1. If a medico-legal specimen is submitted, the Contractor(s) shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose. Contractor’s testing personnel who performed the analysis may be required to provide Court testimony. Contractor(s) testimony shall be provided as required at no additional expense to the Government.

1. Contractor(s) shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

III. Transportation Services for Reference Testing Specimens A. Routine transportation services shall occur once per day, Monday-Friday, from the Government facilities listed in the SOW. STAT transportation services shall occur within one (1) hour of notification. Weekend transportation services shall be available, upon request. Specimen pick-up times will be negotiated at the Order level with the COR. Specimen pickup shall occur within the laboratory service not the loading dock.

B. The Contractor(s) shall provide transport services and not rely on ground commercial transportation services via FedEx, UPS, USPS, DSL, etc.

C. The Contractor(s) shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1. Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

1. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

1. Test request forms, preprinted with the appropriate Shipping Section details and account information.

1. Test request forms for specialized testing (i.e., TB testing, cytogenetics, tissue, etc.).

1. Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract.

IV. Specimen Testing

1. The Contractor(s) and/or subcontractor(s) shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to include all required tests as annotated in Attachment A – Reference Lab Tests. Contractor shall make available the following test information:

1. Requisition form requirements

1. Alphabetized test name list

1. Test order code

1. Specimen collection and preservation requirements

1. Test method employed (indicate if testing performed in duplicate) and interpretations.

1. Test reference intervals adjusted for age, sex or race, when required.

1. Test specific sensitivity, specificity, and interferences, when required.

1. Result code

1. Test critical values with policy for critical value notification.

1. CPT coding

1. Test turn-around times (TAT), where the turn-around time is defined as the time between collection of specimens by the Contractor(s) and receipt of results by the Government. TAT starts when the specimen is collected not when the contract lab has received the specimen.

Routine turn-around time (TAT) within 2-3 days.

Stat turn-around (STAT) time within 4 hours.

1. Schedule of test performance (specific days of week indicated)

1. Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab, name, and address of secondary (sub-contracted) laboratory. Any new test(s) not listed in Attachment A must be added to the contract through modification by the government Contracting Officer.

1. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

1. The Contractor(s) shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

1. The Contractor(s) shall notify the government of any changes to the test menu. (Change in test name or CPT code, removal of test name, additional/new test name, etc.)

1. Negotiated/Miscellaneous Line Item: For testing not specified. This line item shall be used for any work within scope that is not pre-priced in the price breakout schedule.

IV. Specimen Retention

1. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication.

V. Reporting of Results

1. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor(s) as part of the test information.

1. A report of laboratory testing results must be issued either as a printed final copy or through the host to host electronic transmission of the test results. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery is not possible, the Contractor(s) shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor(s) by the VA. Delivery by electronic mail, i.e., MS Outlook, etc. is prohibited.

Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in Section B3.IX., Telecommunication Requirements below.

1. Each test report shall, at minimum, include the following information:

1. Patient's full name

1. Patient’s identification number, e.g., social security number (SSN)

1. Physician’s name (if supplied)

1. Government laboratory unique identification number (UID) (if supplied)

1. Submitting facility name

1. Submitting facility account number

1. Patient's location (clinic/ward) (if supplied)

1. Test(s) ordered

1. Date/time of specimen collection (when available)

1. Date/time test completed

1. Test result

1. Reference intervals (adjusted for age, sex or race, when appropriate)

1. Toxic and therapeutic ranges, if applicable

1. Flagged abnormal results

1. Reference laboratory accession number

1. Name and address of testing laboratory

1. Any other information the laboratory has that may indicate a questionable validity of test results.

1. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

1. Test results determined by the Contractor(s) to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

VI. Customer Service

1. Contractor(s) shall provide customer service that is accessible by toll-free telephone service 24 hours per day; 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

1. Upon award, the Contractor(s) shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

1. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

1. Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

1. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

c. Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

1. Result interpretation inquiries shall be addressed within four business hours of initial call.

3) Consultative services, where information is required regarding the clinical significance of tests, shall be addressed within twenty-four business hours of the initial call.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g., test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

1. The Contractor(s) shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

1. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

C. Contractor(s) shall provide on-site specimen processing services. Contracted employee(s) shall complete all necessary paperwork and training required by VA.

VII. Consultative Services/Utilization Reports

1. Contractor(s) shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

1. Contractor(s) shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

1. Contractor(s) shall provide a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, quarterly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures.

1. A copy of the report shall be delivered electronically to the Contracting Officer, COR, and each Government facility COR by the 10th day into the next quarter.

1. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods:

1. Facility account number

1. Test names listed alphabetically

1. Test names listed in order of year-to-date test frequency (highest to lowest)

1. Test names listed in order of year-to-date total test cost (highest to lowest)

VIII. Data Management System

A. Contractor(s) shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor’s database. Required test parameters include:

1. Ordering code

1. LOINC code

1. CPT code

1. Interface code

1. Test cost

1. Reference ranges

1. Units of measurement

1. Test result interpretation or interpretive remarks, if appropriate

1. Testing site (if not performed at the vendor’s main laboratory facility

1. Test methodology

1. Specimen types

1. Specimen collection and handling requirements

1. Indication whether test is a panel/profile test, list of tests included

B. The parameters for all tests in the Contractor’s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor(s) shall provide telephone access to a Contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

The Contractor(s) shall provide a data management system that meets the following requirements:

1. Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test.

1. Test definition, test information and test requirements must be complete, available, and easily accessible.

3) Shipping manifest must be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

4) The status and the results of testing must be available within published timeframes and easily retrievable using varying options. At a minimum the options must include sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes.

5) Reports of test results must be immediately available upon verification of the test result. Contractor’s computer located at the Government site must be able to print test results upon request and reprint retrospective test results.

IX. TELECOMMUNICATIONS AND COMPUTER SERVICES

1. For contract performance to begin within the shortest time possible after contract award, Contractor(s) must already possess a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor(s) shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor’s host computer system and the Government’s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.)

1. Contractor(s) shall provide, install, and if necessary, remove, all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all sites. This may include, but is not limited to:

1) Shipping list printers

1. Form printer

1. Any required communication lines

1. Software to receive and send orders, display status of and/or test results

1. Consumable supplies to maintain the operation of the equipment listed above, e.g., toner, etc.

1. The Contractor(s) shall conduct preventive maintenance and repair of Contractor(s) furnished hardware, software, and associated communication lines. In addition, throughout the performance period of the contract, the Contractor(s) shall repair or replace any malfunctioning hardware or software.

1. VistA Laboratory Electronic Data Interchange (LEDI) identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

LEDI also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format during the implementation period. This information is also available in electronic HL7 format if required.

(LEDI) software will provide a HL7 acknowledgement for the receipt of tests results from the Contractor(s). If electronic communication is disrupted, the Contractor(s) shall provide hard copy of specimen results upon demand. The hard copy must contain Government’s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest.

1. The Contractor(s) shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government’s assigned specimen identification shall be returned to the requesting medical center.

1. Contractor(s) shall address, within two hours of initial inquiry, interface connection questions where information is required to update, maintain, and support the services of the host-to-host linkage between the Government and the Contractor(s).

1. Contractor(s) shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff is capable of performing routine servicing of hardware.

1. Meeting the below specified deadlines are of utmost importance to the Government. As such, Contractor(s) shall have an operational interface connection with the facilities listed in B.2 within 45 days of contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor(s) notifies the Government of an operational interface connection. The validation of the test transmissions through the interface connection will be the joint responsibility of the Government and Contractor(s).

1. The Contractor(s) shall certify in writing successful test validation before live testing commences.

X. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

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.

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

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

VA INFORMATION CUSTODIAL LANGUAGE

1. 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 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).

2. VA information should not be co-mingled, if possible, with any other data on the Contractors/Subcontractor’s information systems or media storage systems 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 VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of Contractor and Subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow VA directive requirements.

3. Prior to termination or completion of this contract, Contractor/Subcontractor must not destroy information received from VA, or gathered/created by the Contractor while performing this contract without prior written approval by 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.

4. 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.

5. 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.

6. 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.

7. If a VHA contract is terminated for cause, the associated Business Associate Agreement (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.

8. 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.

9. 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.

10. 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.

11. 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.

12. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or a Memorandum of Understanding-Interconnection Service Agreement (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.

INFORMATION SYSTEM DESIGN AND DEVELOPMENT

1. 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 6508, VA Privacy Impact Assessment.

2. 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 VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

3. 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.

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

5. 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.

6. 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.

7. The Contractor/Subcontractor agrees to:

a. 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:

i. The Systems of Records (SOR); and

ii. The design, development, or operation work that the Contractor/Subcontractor is to perform.

b. 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

c. 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.

8. 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.

a. “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.

b. “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…