RFQ_36C24525Q0652 .pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. 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

36C24525Q0652 07-17-2025

Paschal Dawson (410) 637-1508 07-28-2025

2:00 PM EDT

Department of Veterans Affairs

VISN 5 Contracting

Network Contracting Office 5

849 International Drive

Linthicum MD 21090

Paschal Dawson, Contracting Officer paschal.dawson@va.gov

X 100

X

621999

$20.5 Million

N/A

X

Department of Veterans Affairs

Baltimore VA Medical Center

Heidi Cushenette

10 N Greene Street

Baltimore MD 21201

Department of Veterans Affairs

Network Contracting Office 5

Darcy Gray, Contract Specialist

10 N Greene Street

Baltimore MD 21201

Department of Veterans Affairs

VA Financial Services Center

Attn East Team

PO BOX 149971

Austin TX 78714

See CONTINUATION Page

Contractor shall provide Autologous Blood Services as described in the Performance Work Statement (PWS).

Contractor shall be responsible for correct wages, titles, and compliance with all applicable wages and hours laws.

Period of Performance shall be from August 2, 2025 through

August 1, 2026 with four (4) 12-month Option Periods.

Offerors shall follow the submission instructions specified in Addendum to FAR provision 52.212-1 included in this solicitation. Failure to follow the instructions will result in an unfavorable evaluation and may not be considered for award.

All questions shall be submitted in writing by 1:00 PM EST on July 23, 2025.

See CONTINUATION Page

X X

Paschal Dawson

Contracting Officer

36C24525Q0652

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 PRICE/COST SCHEDULE

B.3 PERFORMANCE WORK STATEMENT (PWS)

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

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

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.9 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ...35

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D.2 CONTRACTOR CERTIFICATION: IMMIGRATION AND NATIONALITY ACT OF

1952, AS AMENDED

D.3 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020)

D.4 CONTRACTOR RULES OF BEHAVIOR

D.5 DEPARTMENT OF LABOR WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

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

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

(DEVIATION FEB 2025)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

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

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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:

BUSINESS NAME

ADDRESS

CITY/STATE/ZIP

CONTACT POC

PHONE NUMBER

EMAIL ADDRESS

UNIQUE ENTITY ID (UEI)

b. GOVERNMENT:

Paschal L. Dawson, Contracting Officer Darcy Gray, Contract Specialist Department of Veterans Affairs Department of Veterans Affairs NCO 5 Contracting Office (90C) NCO 5 Contracting Office (90C) 849 International Drive 10 N Greene Street Linthicum, MD 21090 Baltimore, MD 21201

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.

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

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

The Contractor shall provide Autologous Blood Services for the Surgical Care Clinical

Center at the VA Maryland Health Care System (VAMHCS), Baltimore campus.

The Government intends to enter into a Fixed Price, Indefinite Delivery Indefinite Quantity

(IDIQ) contract for the required services. The minimum guarantee on the contract shall be

$20,000.00. The ceiling for this contract will be set at the time of award. The Government is not obligated to purchase any specific quantity beyond the minimum guarantee but shall be obligated to provide payments for all services provided in accordance with this solicitation.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE AMOUNT

45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician

Contract Period: Base POP Begin: 08-02-2025 POP End: 08-01-2026 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

11.00 EA _______________ _______________

Cancellation of service request (less than 24-hours' notice)

Contract Period: Base POP Begin: 08-02-2025 POP End: 08-01-2026 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 1 POP Begin: 08-02-2026 POP End: 08-01-2027 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 1 POP Begin: 08-02-2026 POP End: 08-01-2027 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 2 POP Begin: 08-02-2027 POP End: 08-01-2028 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 2 POP Begin: 08-02-2027 POP End: 08-01-2028 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 3 POP Begin: 08-02-2028 POP End: 08-01-2029 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 3 POP Begin: 08-02-2028 POP End: 08-01-2029 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

Contract Period: Option 4 POP Begin: 08-02-2029 POP End: 08-01-2030 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

11.00

Contract Period: Option 4 POP Begin: 08-02-2029 POP End: 08-01-2030 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous

GRAND TOTAL __________________

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL

The Department of Veterans Affairs Maryland Health Care System (VAMHCS) Surgical Care Clinic Center, Baltimore Campus has a requirement for Autologous Blood Services.

Place of Performance: Baltimore VA Medical Center, 10 N Greene Street, Baltimore, MD 21201

Period of Performance: The anticipated period of performance is August 02, 2025 through August 01, 2026 with four (4) one (1) year option periods.

The North American Classification System (NAICS) code for this acquisition is 621999 (Blood and Organ Banks). The Small Business Size Standard for this acquisition is $20.5M.

Description of Services: The Contractor shall furnish all key personnel to provide services necessary to perform onsite Autotransfusion Services to eligible beneficiaries. The

Autotransfusionist is responsible for responding to calls and providing services as needed. They will also provide maintenance and servicing of contractor owned equipment and maintain a record of such. They will set up and operate Autotransfusion pump for surgical procedures other than open heart. Also, generates a record during each surgical case to include the surgical time of the procedure and the amount of autotransfused blood given to attending surgeon for delivery to the patient and handle breakdown of disposable within autotransfusion pump after completion of each procedure. The Autotransfusionist shall be available and be in location as needed to properly perform tasks as specified. Be onsite during all scheduled OR hours. The Autotransfusionist is responsible for coordinating scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain record as such.

2. BACKGROUND

Autologous Blood donation is the process of donating blood before surgery and receiving one’s own blood during and after surgery. It is considered better and safer than receiving someone else's blood. Autotransfusion should be considered when it is anticipated that blood will be shed from a clean wound from which it can be retrieved at a rate permitting aspiration without undue hemolysis (the destruction of red blood cells which leads to the release of hemoglobin from within the red blood cells into the blood plasma).

Autotransfusion procedures include open-heart surgery, vascular surgery, total joint replacements, spine surgery, and selected neurosurgical procedures. The VAMHCS does all of these procedures, except open-heart surgery.

Autotransfusion may be medically indicated if the anticipated blood loss is greater than 20% of the patients’ estimated blood volume, blood routinely cross-matched for the procedure, greater than 10% of patients undergoing the procedure require transfusion, and the mean transfusion volume for the procedure exceeds one unit.

3. SCOPE OF WORK

The contractor shall:

• Provide proof of Joint Commission certification and/or accreditation

• Provide appropriate and qualified staffing with required certification(s) for the Services to be provided under an Agreement through individuals who are either employees of Contractor or a Contractor-affiliated entity (“Staff”). Contractor will not use subcontractors.

• Perform autologous blood services when requested, to include Autotransfusion, Autologous Blood Component Therapy, Platelet Sequestration, and Platelet Gel.

• Be available for all scheduled cases during which autologous blood services are requested;

and make every reasonable effort to be available for emergency or non- scheduled cases.

• Be present prior to the induction of anesthesia and throughout the surgical procedure.

• Provide proof of qualified technicians to perform the services.

• Document the Services using its own form of clinical record, the original of which shall become part of Government’s permanent medical record, and to complete documentation related to medical records and patient variance reporting and management in a timely manner.

o The monthly report shall include at a minimum:

▪ The date of the procedure

▪ Patient’s name

▪ Name of autotransfusionist who performed the procedure

▪ The equipment used

▪ Cell Salvage procedure (if any)

▪ Volume sequestration/administration (as applicable)

▪ Platelet gel administered (as applicable)

▪ Autotransfusion Procedure checklist completed

• Contractor and its Staff shall not be responsible for providing any services or care directly to patients of Government, or in any way interact with patients, except as necessary to provide the Services pursuant to this Agreement

• Contractor reserves the right to make all decisions regarding its Staff, including, but not limited to, hiring, retention, and scheduling as mutually agreed. Notwithstanding Contractor agrees to remove from Government services any Staff /individual to whom the Government reasonably objects.

o In the event of the removal of a Staff individual, and for the purpose of facilitating Contractor’s prompt replacement of such individual, Government agrees to have in place a process by which Contractor can have such replacement individual granted Government privileges as soon as practicable. Any delay in granting privileges so that Contractor is unable to perform the Services shall not be deemed a breach of this Agreement by Contractor.

• Have qualified, on-site technician provides documentation of services provided per VAMHCS and American Association of Blood Banks (AABB) standards.

• Contractor to complete and return to the COR and/or Contracting Officer the Contractor Security Control Assessment (CSCA) within 30 days of the contract award date.

• Provide documentation of quality control, quality assurance, policy and procedure manual and individual case records

• Be responsible for all ordering and maintenance of equipment and shall provide all maintenance documentation to the VAMHCS Biomedical Engineering Service.

• Provide proof of such coverage, professional liability insurance in the amount not less than $1,500,000 per occurrence and $3,000,000 in the aggregate.

• Technicians assigned by the Contractor to provide these services at VAMHCS shall work with the Government’s Contracting Officer Representative to complete the government background check process and obtain a VA Personal Identification Verification (PIV) Card.

4. VHA PROVISIONS FOR CONTRACTOR

The VAMHCS shall:

• Notify contractor of any scheduled procedures at least one business day before the procedure is scheduled and as soon as reasonably feasible after scheduling the procedure for emergency procedures.

• Supply all cardiotomy reservoirs, bowl sets, aspiration/anticoagulation sets, blood transfer bags, 1000cc intravenous bags of 0.9% NaCI, appropriate anticoagulant drug, syringes, needles, and miscellaneous disposable products used in the salvage and return of autologous blood products.

• Contractor shall report Patient Safety incidents to the authorizing VA Medical Center employee and the COR within 24 hours of incident.

• Agree and acknowledge that it shall have full medical responsibility for its patients in general, and specifically, during the provision of the Services and agrees to supervise its patients accordingly.

• Provide or complete, or cause its approved physicians to complete, a written order for the Services, to be available at the time that the Services are scheduled. Government shall obtain proper patient consents for such Services and shall cause its approved physicians to sign any verbal order made by the physicians to Contractor during the course of treatment.

• Pursuant to the American Association of Blood Banks' "Standards for Perioperative Autologous Blood Collection and Administration," and as otherwise required by state or federal law or regulation, Government shall provide a Medical Director(s) for such perioperative blood Services.

• Government agrees that during the term of this Agreement, and for a period of one

(1) year after its termination of this Agreement, or completion, or for a period of one (1) year after the last day on which Contractor provides the Services, whichever is later, Government shall not: (i) hire or accept Services, directly or indirectly, from any person who was employed by Contractor and who performed any services for Government at any time during the term of this Agreement or any extension (whether written, verbal, or course of dealing) thereof; (ii) hire or accept services, directly or indirectly, from any person who was employed by Contractor in any location, including Government, at any time during the twelve (12) months preceding the termination or completion of this Agreement or the last day on which Contractor provides Services, whichever is later; or (iii) enter into any contract or other relationship with, or accept any Services from, any entity that provides Services to Government using any individual described in Subsections (i) or (ii) of this Article 4.3. Government acknowledges that this provision 2.5 is a significant part of this Agreement, and that its breach would cause Contractor irreparable harm. In the event of any breach or threatened breach of this provision, Contractor may have this provision specifically enforced by any court of appropriate jurisdiction, in addition to pursuing any other remedies that Contractor may have at law or in equity. This provision shall survive the completion or termination of this Agreement.

5. MEASUREMENT OF PERFORMANCE

VAMHCS shall document the following for the purpose of measuring performance:

• The number of times the contractor is unable to provide services for scheduled cases.

• The number of times the contractor is unable to provide a written report of services within ten (10) business days of the procedure.

• The number of times the contractor does not report a patient safety incident, that involved these services or the action or omission of action by the contractor.

• The number of times the contractor is unable to provide the monthly clinical quality report on/before the 15th of the following month.

6. INVOICING

The contractor shall submit all invoices for services rendered. Each invoice shall have at a minimum: the purchase order number, the name of the patient(s), patient number, the date of the service, the name of the surgical procedure, the name of the attending surgeon performing the surgical procedure, and the cost of the service(s) provided. All invoices will be sent electronically to:

Tungsten Support Phone:

1-877-489-6135

Website: https://www.tungstenautomation.com/

Department of Veterans Affairs Financial Service Center: https://www.fsc.va.gov/einvoice.asp

7. MEDICAL RECORDS

All records remain property of VA.

Clinical or other medical records of VA beneficiaries treated by the Contractor shall be completed at the time the patient is seen or directly after. VA Computerized Patient Record System (CPRS) and all other computerized methods of record input, update, retrieval, and storage available to the same extent as any other provider working at VA.

The Contractor, and contract Health Care Providers, shall prepare all documentation to meet or exceed established standards of the U.S. Government to include, but not limited to, timeliness, legibility, accuracy, content, and signature. Only the Joint Commission approved abbreviations shall be used in documentation of care in the patient’s health care record.

8. HEALTH REQUIREMENTS

For each individual contract Health Care Provider, upon request by the COR the Contractor shall provide the COR with all the information necessary to ensure that U.S. Government records are maintained correctly and in compliance with Join Commission, OSHA, and the Center for Disease Control (CDC) health records requirement.

1. As a condition of employment, OSHA requires that all personnel who will have occupational exposure to blood, other body fluids, or other potentially infectious materials, shall receive Hepatitis B vaccine, sign a voluntary declination or have documented proof of immunity to Hepatitis B infection. Contract Health Care Providers who signed declinations may later receive the vaccine without penalty.

2. Contract Health Care Providers shall be free of infectious disease that might reasonably be expected to place other workers, patients, or the public at risk, including active Tuberculosis (TB).

All contract Healthcare Providers must have documentation of a TB test within the last twelve months. If the test was positive, then a chest x-ray with completion of a questionnaire is required.

TB testing (or completion of a TB questionnaire with a positive TB test in the past) may be an https://www.tungstenautomation.com/ https://www.fsc.va.gov/einvoice.asp annual requirement. Staff may refuse HIV testing but must submit a signed statement of refusal to that effect.

3. When a Healthcare Provider has been found medically unfit for providing services required under this contract, they shall be required to discontinue work immediately. Contract Healthcare Providers will not return to work until given clearance by the appropriate physician.

4. The U.S. Government may take nose and throat cultures from contract Healthcare Providers when required by U.S. Government Infection Control Committees (ICC).

5. The U.S. Government will provide emergency health care for injuries sustained by contract Healthcare Provider sustained while performing work under this Contract.

9. DRUG SCREENING

Contract Health Care Providers are subject to drug testing when there is a reasonable suspicion that they have used or are impaired by drugs while on duty. Conditions leading to a reasonable suspicion of drug use or impairment include, but are not limited to, the following:

1. Observable phenomena, such as direct observation of drug use or possession and/or the physical symptoms of being under the influence of a drug;

2. A pattern of abnormal conduct or erratic behavior;

3. Arrest or conviction for a drug related offense, or the identification of a contract Healthcare Provider as the focus of a criminal investigation into illegal drug possession, use or trafficking;

4. Information provided either by reliable and credible sources or independently corroborated;

5. Newly discovered evidence that the contract Healthcare Provider has tampered with a previous drug test.

10. SMOKING POLICY

The VA Maryland Healthcare System is a smoke free institution.

11. IDENTIFICATION BADGE

An identification (ID) badge will be issued by the VA to contract technologists rendering services at the VA. The appropriate ID badge shall be worn at all times while on Government facility grounds, clearly displayed on the outermost garment (i.e. coat, jacket sweater, shirt, blouse, lab coat, and etc.).

12. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

The Office of Security and Law Enforcement provides Department wide policy on the assignment of appropriate position sensitivity designations associated with the Department of Veterans Affairs positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions. In addition to VA employees, the policy and investigative requirements are applicable to Contractor personnel who require access to VA computer systems designated as sensitive.

Contractor and subcontractor personnel who require access to VA computer systems shall be subject to all necessary background investigations and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under this contract.

Should the contract require Contractor personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, the Contractor personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

The cost for such investigations shall be borne by the Government, either in advance or as reimbursement to the Contractor. The level of sensitivity shall be determined by the Government on the basis of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:

LEVEL OF SENSITIVITY BACKGROUND INVESTIGATION LEVEL APPROX COST

Low Risk National Agency Check with Written Inquiries $125.00 Moderate Risk Minimum Background Investigation $752.00 High Risk Background Investigation $3189.00

The Contractor shall be required to furnish all applicable employee information required to conduct investigations, such as, but not limited to, the name, address, and social security number of Contractor personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required for Contractor personnel who will not be required to access VA computer systems nor gain access to sensitive materials.

13. INFORMATION SECURITY

The contractor, and contract Health Care Providers, shall be responsible for maintaining privacy of patient information in performance of this Contract. Patient information is protected under the Privacy Act.

Contractors and contractor 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.

In order to perform the services required in this PWS, the contractor will not be required to connect contractor-owned IT devices (e.g., laptops) to a VA internal trusted network. The C&A requirements do not apply; thus a Security Accreditation Package is not required.

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

The contractor 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 employ. The Contracting Officer must also be notified immediately by the contractor prior to an unfriendly termination.

Information Custody

Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor 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’s rights to use data as described in Rights in Data - General, FAR 52.227-14(d)(1).

The contractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement. Once the copies are no longer needed, the copies must be appropriately destroyed (placed inside a document shred box).

If VA determines 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.

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: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) 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 above-mentioned information, that contractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

Security Incident Investigation

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 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.

To the extent known by the contractor, the contractor’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 considers relevant.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. 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 situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. 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 and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract.

This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP.

Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States.

All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA

COR/CO.

4. TRAINING

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY:

711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues.

After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

(End of Clause) https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance.