RFQ 36C25723Q1429.pdf

PDF 1 MB Posted Sep 20, 2023

Attached to: Q301--NEW - CTX STAT/Expedited Reference Lab Federal contract opportunity
Solicitation number: 36C25723Q1429
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

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Written by GovTribe AI · Dec 20, 2023

This solicitation requests proposals for a five-year indefinite delivery indefinite quantity contract to provide laboratory testing services on an emergency and expedited basis for the Central Texas Veterans Healthcare System. Key details include a minimum award value of $5,000 and maximum value of $450,000 over five one-year ordering periods from January 2024 to January 2029. Testing will be provided for over 100 types of laboratory analyses across various medical disciplines including microbiology, hematology, clinical chemistry, and serology. Turnaround times range from two hours to six weeks depending on the specific test. Pricing is fixed for the contract period. The primary NAICS code is 621511 for medical laboratories.

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PAGE 1 OF 1. REQUISITION NO.

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

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

36C25723Q1429

6. SOLICITATION ISSUE DATE

9-20-2023

Delphia Schoenfeld 210-694-6310 10-20-2023

15:00 EDT

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

621511

$41.5 Million

N/A

Department of Veterans Affairs

Central Texas Veterans Healthcare System

Laboratory

1901 Veterans Memorial Dr.

Temple TX 76504

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for STAT and expedited testing for the

Central Texas Veterans Healthcare System (CTVHCS).

Any questions should be directed to the POC, Delphia

Schoenfeld, in writing, at delphia.schoenfeld@va.gov, no later than 10/6/2023, 11:00AM Eastern.

See Continuation Pages for more information.

See CONTINUATION Page

X X

X 1

36C25723Q1429

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

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

C.3 52.216-18 ORDERING (AUG 2020)

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

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

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

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

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

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 VAAR 852.273-70 LATE OFFERS (NOV 2021)

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 36C257

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

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

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.

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

B.2 STATEMENT OF WORK

STAT/Expedited Reference Laboratory Testing

I. GENERAL

The purpose of the requested requirement will be to provide an indefinite delivery indefinite quantity (IDIQ) contract for Laboratory Testing for Emergency (STAT) and Expedited lab testing for the Central Texas Veterans Health Care System (CTVHCS), at 1901 Veterans Memorial Blvd, Temple, Texas 76504. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153.

I I . P E RI OD OF P E RF ORMANCE

This contract shall be for a five (5) year IDIQ , with five (1) year ordering periods.

• Ordering Period 1: 01/03/2024 – 01/02/2025

• Ordering Period 2: 01/03/2025 – 01/02/2026

• Ordering Period 3: 01/03/2026 – 01/02/2027

• Ordering Period 4: 01/03/2027 – 01/02/2028

• Ordering Period 5: 01/03/2028 – 01/02/2029

I I I . SCOP E OF WORK

1. Contractor shall perform STAT and expedited (non-STAT) laboratory testing on specimens that cannot be sent out for routine testing in the event the test is unable to be performed in-house, or it has been determined the tests results require a faster turnaround time due to patient’s care/ treatment plan. Other, non-STAT testing would be used as confirmatory testing of testing done in-house or is required due to the short specimen stability requirements (e.g., 2–6-hour specimen stability time for a test).

2. Contractor shall provide a turnaround time (TAT) of 2 hours maximum for STAT tests; this includes specimen testing and test resulting from the time the specimen arrives at the reference laboratory for STAT ordered tests.

3. Contractor shall provide same day testing for STAT orders, if same day testing is not available contractor must notify CTVHCS laboratory staff immediately.

4. Contractor shall meet the TAT for all other tests as detailed for each test in the Cost/Price Schedule

5. Specimen Testing

a. The Contractor shall provide clinical diagnostic testing for all tests as annotated in the List of Tests. Contractor shall make available the following test information:

i. Alphabetized test name list

ii. Test order code

iii. Specimen collection and preservation requirements

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

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

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

vii. Result code

viii. Test critical values if any

ix. Policy for critical value notification

x. CPT coding

b. 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.

I V . ORDE RS:

1. The contractor shall receive requests for lab services in writing or electronically. The requisition form shall include the following information:

a. Patient's full name

b. Social Security number

c. Patient’s Date of Birth

d. Requesting facility

e. Attending physician name

f. Laboratory Test requested

g. Type of specimen

h. Date test ordered

i. Government laboratory accession number

j. Date and time specimen collected

V . RE P ORTI NG OF RE SUL TS:

1. All lab reports shall be clear, accurate, and informative and contain at a minimum the following information:

a. Patient's full name

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

c. Physician’s name

d. Government laboratory accession number

e. Submitting facility name

f. Submitting facility account number

g. Patient's location (clinic/ward)

h. Test(s) ordered

i. Date/time of specimen collection

j. Date/time test completed

k. Test result

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

m. Toxic and therapeutic ranges, if applicable

n. Flagged abnormal results

o. Reference laboratory accession number

p. Name and address of testing laboratory

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

2. The results of testing shall be reported within 1 hour of test completion.

3. A report of laboratory testing results must be issued 4Medica. Delivery by electronic mail i.e., MS Outlook, etc. is prohibited.

4. The following point of contact shall be notified when immediate inquiry regarding a pending test(s)is required:

a. CTVHCS P&LMS Supervisor Cell Phone: 254-493-6383

5. Test results determined by the contractor 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.

6. Contractor shall not, under any circumstances, furnish reports directly to patients.

V I . L I CE NSING AND ACCRE DI T AT I ON:

1. Offeror must have at least three years of experience in providing laboratory testing services.

2. Offerors, including subcontractor(s), must continuously hold a Clinical Laboratory Improvement

Amendments of 1988 certification as well as additional accreditation such as the College of American Pathologists, Joint Commission or another accrediting agency. The reference laboratory must maintain valid certifications during the entire performance period of this contract.

3. Contractor must notify immediately the Contracting Officer’s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation, or licensure.

4. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

5. The Contractor shall have an online electronic account or portal for ordering tests and providing results via a secure electronic pathway.

6. Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

7. Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

8. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

9. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes.

10. Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor’s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge.

V I I . Q UAL I TY CONT ROL S:

1. The VA shall have access to inspect the contractor's facilities, equipment and records. The results of these inspections shall be published and given to the contractor.

2. The Government may evaluate the quality of the professional and administrative services provided but retain no control over the medical professional aspects of services rendered (e.g., Professional judgments, diagnosis for specific medical treatment).

V I I I . I NV OI CI NG:

1. Invoices must contain at a minimum the following information and submitted electronically via

Tungsten on a monthly basis. Contractor shall provide this information on one original invoice:

a. Contract number

b. Purchase Order number

c. Patient Name

d. Date of birth

e. Date of Service

f. Test Number and Name

g. VA accession number

h. Proper CPT Code

i. Unit Cost

j. Total Cost

I X . GOV E RNI NG L AW:

This contract shall be governed, construed, and enforced in accordance with Federal Law.

X . MARKE T I NG:

Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the CTVHCS without the consent from CTVHCS.

XI . SE CURI T Y :

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.

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.

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

Prior to termination or completion of this contract, contractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor just 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.

The contractor 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.

The contractor 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 electronic storage media for restoration in case any electronic equipment or data used by the contractor 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. If the 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.

The contractor 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.

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

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two other situations:

1. in response to a qualifying order of a court of competent jurisdiction, or

2. with VA's prior written approval.

The contractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

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

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 vulnerability 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 COTR 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.

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.

This contractor requires no access to CTVHCS or any VA information system.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

XI I . ACCE SS T O V A I NF ORMAT I ON AND V A I NF ORMAT I ON SYST E MS:

1. 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.

2. 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.

3. 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.

XI I I . V A I NF ORMAT I ON CUST ODI AL L ANGUAGE

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 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).

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 the VA or destroyed in accordance with VA's sanitization requirements.

VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3. 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.

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 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 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.

XI V . SE CURI T Y INCI DE NT I NV E STI GAT ION

1. 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.

2. 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.

3. 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.

4. 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 Enforcement. The contractor, its ·employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

XV . L I Q UI DAT ED DAMAGE S F OR DAT A B RE ACH

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

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

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

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

i. Description of the event, including:

1. Date of occurrence.

2. Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

3. Number of individuals affected or potentially affected.

4. Names of individuals or groups affected or potentially affected.

5. Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text.

6. Amount of time the data has been out of VA control.

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

(made accessible to and usable by unauthorized persons.

8. Known misuses of data containing sensitive personal information, if any.

9. Assessment of the potential harm to the affected individuals.

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

Privacy Incidents, as appropriate.

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

a. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

1. Notification

2. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports

3. Data breach analysis

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

5. One year of identity theft insurance with $20,000.00 coverage at $0 deductible

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

XV I . SE CURI T Y CONT ROL S COMP L I ANCE T E STI NG

1. On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

B.3 PRICE/COST SCHEDULE

This is Single Award, Firm Fixed-Price, Indefinite Delivery Indefinite Quantity (IDIQ) Contract.

The guaranteed minimum award amount for this contract is $5,000.00. The maximum aggregate value of orders that can be placed under this contract is $450,000.00. The Government does not guarantee that it will place any orders in excess of the guaranteed minimum award amount.

Ordering Period 1: 1/3/2024 – 1/2/2025 Ordering Period 2: 1/3/2025 – 1/2/2026 Ordering Period 3: 1/3/2026 – 1/2/2027 Ordering Period 4: 1/3/2027 – 1/2/2028 Ordering Period 5: 1/3/2028 – 1/2/2029

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

700.00 EA __________________ __________________

DIALYSIS WATER

Ordering Period 1 POP Begin: 01-03-2024 POP End: 01-02-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing Max TAT: 48 Hrs

200.00 EA __________________ __________________

FLOW ADDL MARKERS