36C24525Q0762.pdf

PAGE 1 OF1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24525Q0762 08-11-2025

Paschal Dawson (410) 637-1508 08-25-2025

5:00 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

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.

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 3:00 PM EDT on August 19, 2025.

See CONTINUATION Page

X X

Paschal Dawson Contracting Officer

36C24525Q0762

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)

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 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 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:

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

[X] 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

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 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

0001 45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician Contract Period: Base POP Begin: 09-01-2025 POP End: 08-31-2026 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

0002 11.00 EA _______________ _______________

Cancellation of service request (less than 24-hours' notice) Contract Period: Base POP Begin: 09-01-2025 POP End: 08-31-2026 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

1001 45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician Contract Period: Option 1 POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

1002 11.00 EA _______________ _______________

Cancellation of service request (less than 24-hours' notice) Contract Period: Option 1 POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

2001 45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician Contract Period: Option 2 POP Begin: 09-01-2027 POP End: 08-31-2028 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services

PRODUCT/SERVICE CODE: Q999 - Medical - Other

2002 11.00 EA _______________ _______________

Cancellation of service request (less than 24-hours' notice) Contract Period: Option 2 POP Begin: 09-01-2027 POP End: 08-31-2028 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

3001 45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician Contract Period: Option 3 POP Begin: 09-01-2028 POP End: 08-31-2029 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

3002 11.00 EA _______________ _______________

Cancellation of service request (less than 24-hours' notice) Contract Period: Option 3 POP Begin: 09-01-2028 POP End: 08-31-2029 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

4001 45.00 EA _______________ _______________

Cell Salvage Equipment and Certified Technician Contract Period: Option 4 POP Begin: 09-01-2029 POP End: 08-31-2030 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

4002 11.00 _______________ _______________ Cancellation of service request (less than 24-hours' notice) Contract Period: Option 4 POP Begin: 09-01-2029 POP End: 08-31-2030 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q999 - Medical - Other

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 September 01, 2025 through August 31, 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 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 shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

SOR.

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 3 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 3 days.

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

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

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

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

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

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

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed…