36C26125Q0198.docx

36C26125Q0198

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

36C261-25-AP-0632

36C26125Q0198 02-05-2025 Mohammed Hussain 916-923-4534 02-21-2025 15:00

PST

Department of Veterans Affairs Network Contracting Office (NCO 21)

X 325412 1300 Employees N/A

"See Delivery Schedule"

FMS-VA-2(101) Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page Radiopharmaceutical Delivery for VASNHCS The Government anticipates a single award IDIQ Period of Performance: 04/01/2025 - 03/31/2030 Ordering Period 1: 04/01/2025- 03/31/2026 Ordering Period 2: 04/01/2026 - 03/31/2027 Ordering Period 3: 04/01/2027 - 03/31/2028 Ordering Period 4: 04/01/2028 - 03/31/2029 Ordering Period 5: 04/01/2029 - 03/31/2030 Please pay particular attention to Addendum to FAR 52.212-1 and 52.212-2 for submission instructions and requirements.

See CONTINUATION Page X X Mohammed F Hussain

VA-VHA-RPOW-2024-0038

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

STATEMENT OF WORK (SOW)

Background The Imaging Service at the VA Southern Nevada Healthcare System (VASNHCS), 6900 North Pecos Road, North Las Vegas Nevada 89086 has a requirement for radiopharmaceuticals. The radiopharmaceuticals will be used for patients’ nuclear medicine studies and testing. Due to the population served within the VASNHCS, it is imperative to possess the ability to provide the Veterans with the means to receive expensive nuclear medicine exams within the VASNHCS. Radiopharmaceuticals are used as a diagnostic tool in the evaluation of organ function and certain disease processes. They are also used in the treatment of certain conditions including but not limited to Hyperthyroidism (Grave’s disease), Thyroid cancer, and palliation of bone pain due to metastatic prostate cancer.

Scope

The contractor shall provide Non-High Enriched Uranium (non-HEU) Derived Medical Isotopes when it is commercially available. When non-HEU Derived Medical Isotopes are not available in the commercial marketplace, then High Enriched Uranium (HEU) is acceptable and may be substituted for the non-HEU Derived Medical Isotopes. HEU is uranium enriched to twenty (20) percent or greater in the isotope U-235. The contractor shall provide all labor, supervision, and transportation for all deliveries.

Qualifications

The contractor must be licensed by the United States Nuclear Regulatory Commission (USNRC) and be regularly established in the business of providing radiopharmaceuticals. A current copy of the license shall be provided to the contracting officer (CO) within fifteen (15) days of the CO’s request for a copy of the license.

The contractor shall perform all quality control procedures as required by federal and state regulatory agencies and the Joint Commission.

The contractor shall meet all USNRC, US Department of Transportation (USDOT), US Food and Drug Administration (USFDA), Occupational Safety and Health Administration (OSHA), and federal and state laws, rules, and regulations.

The contractor shall have a current Radioactive Material License. A current copy of the license shall be provided to the CO within fifteen (15) days of the CO’s request for a copy of the license. A copy of all licenses and credentials will be given to the VA facility as required by the Nuclear Regulatory Commission (NRC).

Specifications

The contractor shall provide prepared single unit doses or multi dose vials at the discretion of the VA facility. Multi dose vials must be prepared and shipped in the manner described by Med Rad and in the lead and glass containers that are compatible with the Med Rad Intego Administration systems or similar administration system.

The contractor shall have an adequate supply of the items listed in the Price Cost Schedule of Supplies and Services to meet the requirements of the VA facility.

Non-HEU radioisotopes must be medical grade radioisotopes. Any HEU radioisotopes that are substituted in due to non-availability of non-HEU radioisotopes must be medical grade.

The contractor shall have an adequate supply of the items listed in the Price Cost Schedule of Supplies and Services available at its distribution points to fulfill the orders of the VA facility.

Radiopharmaceuticals shall be non-highly enriched uranium (non-HEU) whenever possible. Otherwise, HEU is acceptable.

The quantity of radioactivity of the radiopharmaceuticals will not deviate more than +/- 10 percent for therapeutic doses and +/- 20 percent for imaging doses at the time of calibration from the quantities specified.

The contractor shall perform all quality control (QC) procedures on each radiopharmaceutical in accordance with all applicable licensing authorities and regulating bodies. A copy of the results of all QC procedures conducted must be provided to the VA facility upon request.

In the event that a defect is suspected and/or detected by the COR or alternate COR, the contractor shall provide any consultation requested and deemed necessary by the VA facility to alleviate any suspicion and/or defect by doing the following:

· Provide technical expertise in calibration.

· Provide a professional examination of the radiopharmaceutical(s) and submit results and recommendations to the COR or alternate COR.

· Products suspected of being deficient must be replaced expediently and delivered to the VA facility within ninety (90) minutes or within a timeframe agreed upon by the contractor and COR or alternate COR.

· The contractor shall make QC records available to the VA facility upon written request from the COR or alternate COR.

· The contractor must provide waste disposal of used radioactive dose syringes, vials, and other related items at no additional charge unless otherwise stipulated or prohibited by licensure or regulations.

· The contractor shall provide technical support for the technical staff, physicians, and patient education.

· Any dose(s) recalled for any reason shall be credited to the U.S. Government (Government) for the full amount.

· Any dose deemed below standard by the VA facility shall be credited to the Government. This shall be determined by COR or alternate COR.

· Substitutions or generic radiopharmaceuticals may only be used with the express permission of the VA facility.

· The contactor shall perform all functions of this contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The contractor shall self-report any violations to the COR within twenty-four (24) hours.

ORDERS, DELIVERIES, AND PACKING & MARKING

Orders

Emergency Orders

Emergency orders shall be delivered to the VASNHCS Imaging Service, Nuclear Medicine, Building 1, Room 1D143, 1st Floor when delivered during normal business hours. Normal business hours are Monday through Friday, except Federal holidays, from 7 a.m. to 5:30 p.m. Pacific Standard Time (PST). Isotopes arriving outside of normal working hours, on weekends, or on holidays shall be delivered to the VASNHCS Imaging Service, Nuclear Medicine, building 1, room 1D1433, 1st floor.

Emergency orders shall be delivered within 1.5 – 2.5 hours from the time the order is placed. Emergency orders may be placed at any time or on any day and the contractor shall be available to fulfill orders twenty-four (24) hours per day, seven (7) days per week, and three-hundred and sixty-five (365) days per year.

Doses must be delivered at least thirty (30) minutes before calibration times when possible.

Urgent Same Day Orders

Urgent same day orders shall be delivered to the VASNHCS Imaging Service, Nuclear Medicine, Building 1, Room 1D143, 1st Floor.

Urgent same day orders shall be placed during normal business hours and delivered on the same day that the order is placed and shall be delivered within two (2) hours of the order. Normal business hours are Monday through Friday, except Federal holidays, from 7 a.m. to 5:30 p.m. PST.

Doses must be delivered at thirty (30) minutes before calibration times when possible.

Routine Orders

Routine orders shall be delivered to the VASNHCS Imaging Service, Nuclear Medicine, Building 1, Room 1D143, 1st Floor.

Orders will be placed each day for delivery on the next business day by 5:00 p.m. PST or five (5) business days in advance of the delivery date of order(s). Normal business hours are Monday through Friday, except Federal holidays, from 7 a.m. to 5:30 p.m. Pacific Standard Time (PST).

Doses must be delivered at least thirty (30) minutes before calibration times when possible.

The contractor shall provide routine deliveries and pick-ups as many times as ordered by the VA at no additional charge.

The CO, COR(s), alternate COR(s), or other authorized VA employee(s) are the only individuals authorized to place orders.

Orders shall be delivered by the applicable time stated in the SOW except as otherwise authorized by the CO, COR(s), alternate COR(s), or other authorized VA employee(s).

Orders may be placed via e-mail, electronic data interchange (EDI), FAX, telephone, in hardcopy format, or in any other manner consistent with accepted commercial business practices. Each individual order will describe the tasks, services, and/or deliverables required. The contractor shall have the ability to receive orders via email, telephone, and facsimile transmission, and shall provide the applicable email address and fax number below. The contractor shall also provide a telephone number and name/title as a point of contact for orders.

Name/Title

Email Address Phone Number Fax Number

Deliveries

· Another source, other than the contractor, shall be utilized if the contractor is unable to fulfill an order and make the delivery. If this occurs, the contractor shall be responsible for paying the difference in price.

· The contractor shall have sole responsibility for the proper care and handling of all products until delivery and acceptance has taken place at the designated room at the VA facility.

· All shipments under the contract shall be accompanied by delivery tickets or sales slips that shall contain the following minimum information: name of supplier/contractor, contract number, date of purchase, purchase order number, itemized list of supplies or services furnished, quantity, unit price, extended price of each item, less applicable discounts, and the date of delivery or shipment.

· All deliveries under the contract shall include the shipping documents for dangerous goods, and a packing list with a barcode.

· Shipping documents must be readable by Nuclear Medicine Information System (NMIS) barcode readers.

· If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to notify the VA facility’s nuclear medicine department by phone or in writing as soon as is feasible.

· The contractor shall meet all requirements of regulatory agencies for deliveries of radioactive isotopes between facilities and shall strictly adhere to these requirements. Deliveries not properly handled according to regulations will not be accepted at the VA facility.

PACKING & MARKING:

· Items shall be bar-coded and compatible with existing network system called the Nuclear Medical Information System (NMIS).

· [For PET] Bulk Fluorodeoxyglucose (FDG) in the approved Intego (Medrad) vial shielding system, doses shall be delivered as unit doses or intego (Medrad) vial system at the VA facility’s discretion.

· Unit-dose items shall be pre-drawn into a syringe, calibrated, and delivered. The word "Dose" means the maximum size potency per unit price. However, an order or a portion of an order may be for an amount that is less than a full “dose.”

· The contractor shall package, mark, and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

· Items must be adequately packaged to prevent damage during shipping, handling, and storage.

· All outer packages must contain the complete order number, obligation number, contract number, and shipping address. The order number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

· Packaging List: A packing list/slip shall be enclosed with each shipment and have printed on it the complete order number, obligation number, contract number, items/quantity ordered, and items/quantity shipped.

· All deliveries under the contract shall include the shipping documents for dangerous goods, and a packing list with a barcode

RETURNS

The contractor shall provide a credit under the following conditions:

· When product(s) is/are damaged in shipment,

· When there are concealed shipping damages, and

· When product(s) is/are recalled.

PERFORMANCE

· In the event of a manufacturer or pharmacy recall or quality assurance failure, the Contractor shall notify the VASNHCS Nuclear Medicine Services immediately.

· A radio-pharmacist that is employed by the contractor must be available to:

· Set up the quality assurance program on radiopharmaceutical preparations required by Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), and the Joint Commission.

· Act as a reference source concerning questions on regulation of radiopharmaceuticals.

· Provide reference services for research drugs and radionuclides under research protocols.

· Provide continuing education direct link where technologists can learn about new changes in radiopharmaceutical products and availability.

RECALLED AND DEFECTIVE PRODUCTS

· The contractor shall immediately notify the COR or alternate COR of any recalls of product or other important product safety issues. The contractor shall replace or reimburse recalled or defective products at no cost to the Government. The contractor shall not add the cost of overages to the invoice. The contractor may be liable for costs of processing recalls (e.g. administrative or clinical services to replace recalled/defective products).

· The contractor shall provide Material Safety Data Sheets (MSDS) and updates as necessary on all delivered products to the medical center.

Federal Holidays Observed by The Government

The President of the United States of America may declare additional days as a federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday the following Monday shall be observed as a Federal holiday. a holiday falls on & Saturday. the preceding Friday shall be observed as a Federal Holiday.

BADGES

All Contractor personnel are required to wear identification (I.D.) badges during the entire time they are at the VA facility. I.D. badges must include a name, picture, and name of contractor on it.

POST AWARD PERFORMANCE CONFERENCE

A post award conference shall be scheduled with the contractor if deemed necessary for orientation purposes.

SMOKING POLICY

Smoking, vaping, e-cigarettes, chew, and dip products are not permitted within or around VA facility grounds. VASNHCS is a smoke free facility.

PARKING

It is important that the contractor’s delivery personnel take the most direct route to the drop off point reducing exposure risk to the public. Parking in patient or employee parking is allowed if it provides the most direct and safest route. This does not apply to handicap parking unless the driver is authorized handicap parking per the Department of Motor Vehicles. The VA facility will not provide reimbursement for or invalidate parking violations of the contractor’s delivery personnel outside of these circumstance(s).

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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.

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.

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.

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

VA INFORMATION CUSTODIAL LANGUAGE

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).

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 within 30 days to the VA or destroyed in accordance with VA’s sanitization requirements as noted below. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

Prior to termination or completion of this contract, contractor/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.

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.

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.

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.

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.

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.

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.

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, or Release of Information (ROI) Unit for response. 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 or ROI for response.

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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

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.

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

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

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

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

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

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

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

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

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

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

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/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

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

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

(1) Notification;

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

(3) Data breach analysis;

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

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

SECURITY CONTROLS COMPLIANCE TESTING

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

PRIVACY TRAINING

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VHA HIPAA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

The contractor shall conduct training using the Talent Management System (TMS) for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.

RECORDS MANAGEMENT LANGUAGE

Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, the contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

The VA Southern Nevada Healthcare System (VASNHCS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VASNHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The contractor shall immediately notify the appropriate Contracting Officer (CO) upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract documents. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VASNHCS control or the contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract documents. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The contractor (and any sub-contractor) is required to abide by Government and VASNHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHCS policy.

The contractor shall not create or maintain any records containing any non-public VASNHCS information that are not specifically tied to or authorized by the contract.

The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the FOIA.

VASNHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VASNHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Flow down of requirements to Subcontractors:

The contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the contractor.

VHA Directives: Medical Center Memorandum IT-13-04

· No ESMD’s will be removed from VA property by a vendor or any other individual without following the instructions contained in this policy. Facilities Management Services/Biomedical Engineering will be responsible for sanitizing any Electronic Storage and Memory Devices (ESMD) attached to medical equipment which requires replacement, upgrade, repair, or turn-in. Information Technology Service (ITS) is responsible for sanitizing all IT-related ESMD’s. Sanitizing processes outlined in VHA Handbook 6500 will be used. All devices containing an ESMD will be prominently flagged with a bright red sticker containing the proper instructions to follow if the ESMD needs servicing in any way.

This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Accordingly, all quantities in the price schedule are estimates and are not a guarantee. Funds are obligated via delivery orders issued against this IDIQ. Orders may be placed against this IDIQ during its 5-year period.

The guaranteed minimum award amount for this contract is $1,000. The maximum aggregate value of orders that can be placed under this contract is $6,500,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

This is not an option year contract. The period of performance for this IDIQ is 04/01/2025 to 03/31/2030.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

104644 - Xenon Mask Case of 20 - CARD2380 Contract Period: Base POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

MANUFACTURER PART NUMBER (MPN): ____________________

101881 - Aerovent

POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

104853/198001 - After Hours Call Out

POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

198002 - After Hours Delivery Charge

POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

105608 - Canceled After Hours Call Out

POP Begin: 04-01-2025 POP…