36C24825Q0682_3.docx

SUBJECT*

i-STAT CPT Bedside Handheld Analyzers Reagents

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525 Tampa FL 33637

POINT OF CONTACT*

Contract Specialist Carlos Notyce Carlos.notyce@va.gov 813-492-0566

PLACE OF PERFORMANCE

13000 Bruce B Downs Blvd

Tampa FL

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a Sources Sought (SS) for a requirement to continue using i-STAT CPT Bedside Handheld Analyzers Reagents supply purchase with equipment lease required laboratory instrument(s) system(s) and reagents to include cartridges, calibrator, controls, consumables, and any other necessary hardware to operate the contractor’s equipment and fulfill the test requirements. For all Pathology & Laboratory Medicine Service (P&LMS) locations in Veterans Integrated Service Network (VISN) 08 to provide the best patient care to our Veteran population:

Troponin-I Activated Clotting Time (Kaolin) Creatinine Arterial Blood Gas Panel* CG8+ Chem 8 Panel* Arterial Blood Gas Panel* CG4+ Glucose

PT

B-HCG

VISN 08 Sites include: Tampa James A. Haley Veterans Hospital, Bay Pines C.W. Bill Young VA Medical Center.

Single-use i-STAT test cartridges offer a broad menu of tests on a single, portable platform. Each test cartridge has a unique combination of biosensors to suit a wide range of clinical needs. Additional testing and testing sites may be added based on Veteran care needs and availability. Equipment should meet or exceed the below specifications for brand name or equivalent i-STAT CPT Bedside Handheld Analyzers Reagents.

A Draft Statement of Work is provided to assist with this SS.

The Government may use the responses to this SS for Market Research, information and planning purposes. The Government also intends to make this action a sole source award, if potential vendors cannot be identified.

The anticipated period of performance of: 1 May 2025 thru 30 April 2030 with possible four one-year option periods.

This SS will obtain information regarding the availability and capability of qualified businesses: Large Business, Service-Disabled Veteran-Owned, Small Business, Veteran-Owned Small Business, small business sources; HUB Zone 8(a), Women-Owned, or small disadvantaged business concerns; and their size classification relative to the North American Industry Classification System (NAICS) code 334516.

The responses to this announcement will assist in determining the availability of small businesses in consideration of a socio-economic set-aside.

Interested parties submitting a response to this inquiry must include the following information:

1. Name and address of company

2. Primary point of contact, including phone number and e-mail address

3. Federal Supply Schedule (FSS), if available

3. Applicable socioeconomic categories and any pertinent information, which demonstrates firm’s ability to meet the requirement

4. Experience. Brief descriptions of recent and relevant projects for tasks similar to those identified in paragraph one of this document. (1 page maximum)

5. Business size (the applicable NAICS code for this requirement is 334516)

6. Product and Service Code: 6640

Responses are due no later than 18 April 2025 @ 3:00 PM Eastern Time. Point of contact: Carlos Notyce carlos.notyce@va.gov.

NOTE: This is a SS for planning purposes. Issuance of this notice does not constitute any obligation on the part of the Government to procure these items or to issue a solicitation. In addition, the Government is under no obligation to pay for information submitted in response to this SS, and responses to this notice cannot be accepted as offers. Any information that the vendor considers proprietary should be clearly marked as such.

Sources Sought Notice Sources Sought Notice

Sources Sought Notice

STATEMENT OF WORK

Project Name & ID: Point of Care Blood Analyzers and Test Kits.

1. Introduction

1.1 Currently, The James A. Haley VA Medical Center (JAH VAMC-Station 673) Pathology & Laboratory Medicine Service (P&LMS) has a short-term, 6-month contract, reference number V797P-7322A 36C24825F0033 for procurement in place to enable the hospital to continue to lease and order the required FDA-cleared or approved point of care blood analyzers and test kits. The reference contract will expire on 04/30/2025, the JAHVH needs to pursue a base option period contract with four (4) option years covering the period of performance from 5/01/2025-04/30/2030. The C.W. Bill Young Healthcare System (Station 516) Pathology and Laboratory Medicine Service (P&LMS) will join the JAH VAMC to procure units and reagents kits needed by their facility and clinics.

2. Objectives

2.1 A key function of P&LMS is the ability to perform point of care (POC) testing using FDA-cleared or approved hand-held analyzers, reagents, supplies, and consumables to provide care for our patient population.

2.2 To ensure agency objectives are met and care can be provided to our veteran population effectively, P&LMS will require a long-term sole source contract covering the period of performance of 05/01/2025 through 04/30/2030.

2.3 The objective of this statement of work is to obtain a Cost per Test (CPT) contract that will include FDA-cleared or approved vendor-provided analyzers, reagents, supplies, and consumables for point of care (POC) testing for our patient population.

3. Scope

3.1 The JAH VAMC and the CWBY HCS requires a Cost Per Test (Reagent Usage) contract for use of the point of care analyzers, accessory supplies, training, shipping, handling, and upgrades, when applicable, and replacement of equipment if/when needed for the life of agreement as identified above.

4. Requirements

5. Equipment

5.1 The purpose of this solicitation is to identify the salient characteristics of the point of care blood analyzers systems and specify functionality and performance-based requirements of this system.

5.2 Salient Characteristics for Point of Care Analyzer

a. Point of Care analyzer must offer a comprehensive menu of tests using a single test system.

b. Point of Care Analyzer must be lightweight, portable, and ergonomically designed.

c. Point of Care Analyzer must measure and/or perform satisfactorily at any laboratory temperature between 61-86 degrees Fahrenheit (16-30 degrees Celsius), at any laboratory relative humidity of 10 to 90% (non-condensing), and at any barometric pressure of 300-850 mmHg.

d. Point of Care analyzer must guide operator through the testing process using standardized operating procedures.

e. Point of Care analyzer must require minimal or no maintenance.

f. Point of Care analyzer must be interfaceable with VA approved middleware software.

g. Point of Care system must meet all VHA, FDA, CLIA, CAP, and The Joint Commission (TJC) requirements for point-of-care testing.

5.3 Functionality and Performance Specifications

a. The system must be capable of performing Chemistry Panel to include measured glucose, sodium, potassium, chloride, urea nitrogen, creatinine, TCO2, ionized calcium hematocrit, and calculated anion gap and hemoglobin; Troponin-I, Activated Clotting Time (ACTk), Blood Gas Analysis Panels to include measured sodium, potassium, ionized calcium, glucose, hematocrit, pH, PCO2, PO2, lactate and calculated TCO2, HCO3, Base Excess (BE), O2Sat, and hemoglobin, Glucose, and Creatinine.

b. The system must be barcode driven for operator and patient identification.

c. The system must lock out unauthorized users.

d. The system must block testing unless quality control is acceptable.

e. The system must be capable of detecting test and operator errors.

f. The system must allow user generated customized test profiles for various areas of testing.

g. Test results must upload automatically through a docking station or downloader to the hospital information system.

6. Estimated Cost-Per-Test

6.1 The contractor is required to furnish the JAH VAMC and the CWBY HCS locations with the laboratory instrument(s) system(s) and reagents to include cartridges, calibrator, controls, consumables, and any other necessary hardware to operate the contractor’s equipment and fulfill the test requirements. The JAH VAMC and the CWBY HCS will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor’s equipment (payment rate is at an established average “cost-per test” figure). All quantities are estimated per annum. This requirement is for products and services required in Network Contracting Office 8 (NCO8). The initial requirement may only include the stations stated here. HOWEVER, the government reserves the right to increase the requirement area to include one (1) or more stations in the NCO8 or VISN 8 Area. The Government reserves the right to include products and services later at additional locations.

6.2 The Cost Per Test award will include pricing for our current minimum yearly estimated testing:

* Panel Description:

*Arterial Blood Gas Panel (4/8) to include measured sodium (Na), potassium (K), ionized calcium (iCa), glucose (Glu), hematocrit (Hct), pH, pCO2, pO2, lactate and calculated TCO2, HCO3, Base Excess (BE), O2Sat and hemoglobin (Hgb).

*Chem 8 Panel to include measured sodium (Na), potassium (K), chloride (Cl), TCO2, urea nitrogen (BUN), creatinine (Crea), glucose (Glu), ionized calcium (iCa), hematocrit (Hct) and calculated anion gap and hemoglobin (Hgb).

6.3 Cost per test includes (a) equipment use, (b) all necessary services/ replacements to keep the equipment in good operating condition, (c) user training for government personnel (d) all reagent cartridges, controls, calibrators, consumables, and includes shipping and handling charges for such items. Contractor is required to provide delivery/return of equipment’s, when necessary, at no additional charge.

7. Deliverables

7.1 The JAH VAMC and the CWBY HCS shall require the contractor to deliver the equipment ordered under this contract not later than THIRTY (30) calendar days after receipt of notice of award. The JAH VAMC and the CWBY HCS reserve the right to thoroughly inspect and investigate the contractor and manufacturer's business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. If the test and evaluation is not successful as determined by the Contracting Officer and Contracting Officer Representative for that VA, those individual VA’s will not be required to continue placing a delivery order under this contract, and no default or penalty will accrue.

7.2 Reagents Delivery Terms – The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, within 10 days from call, email and/or online orders.

7.3 Quality of Reagents, Supplies and Disposables- The contractor will ensure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. If any reagent, control, calibrator, supplies, and/or consumables, are found to be defective and unsuitable for use with the contractor’s equipment a written claim will be submitted for investigation. After completion of the investigation confirming the issue, the contractor will replace the faulty supplies at no cost to the government, within an estimated 60 to 90-day turnaround time. If the product requires replacement due to a shipping issues like damaged product, temperature inconsistency and/or incorrect product shipped a written claim will be submitted for investigation. After completion of the investigation confirming the shipping issue, credit will be provided within a 45 days turnround time.

7.4 Returned goods- The VA is responsible for inspecting all products shipped hereunder and give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. No returns will be authorized after 120 days following shipment to VA.

7.5 Installation procedures- The contractor shall be responsible for installation, which consists of in-house delivery of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated regarding installation which will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed. Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation.

8. Functional and Performance Characteristics

8.1 Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system:

a) Preventive Maintenance shall be performed per manufacturer’s guidelines.

b) Contractor will provide technical service troubleshooting or repair guidelines via telephone. If the equipment cannot be repaired a replacement will be sent out, within a 48-hour period, included on the CPT contract agreement.

8.2 The Cost per test includes costs covering (a) FDA-cleared or approved analyzer system (lease), (b) equipment use, downloaders, simulators and accessories including (c) reagents offered by the vendor, (d) all necessary supplies and consumables (e) instrument replacement at no additional charge when/if necessary to fulfill the test requirements and produce high-quality patient results. Upon termination of the agreement the contractor will provide shipping labels for equipment to returned at no additional charge.

8.3 All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA, and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

8.4 With all equipment, Ownership of Equipment shall remain with the contractor for the life of the contract. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor.

8.5 This base option period plus four (4) option years involves utilizing current/ new vendor analyzers describe below under a lease-CPT agreement, 72 unit’s total.

8.6 With all equipment, the standard and acceptance of performance shall begin on the contract awarded date. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the delivery/installation (when applicable) date, the user may, at his/her option, request a replacement or terminate the order.

9. Government’s Responsibility

9.1 The user will perform routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance user manual-instructions. No deviation from the manufacturer’s guidelines can occur to guarantee optimal function of the analyzer-equipment-system and to safeguard the terms of this contract. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

10. Maintenance

10.1 The government shall provide the contractor access to the equipment to perform maintenance services if/when needed.

11. Service

11.1 The contractor will troubleshoot or repair via telephone. If the analyzer cannot be repair over the phone, a replacement will be sent, within a 48-hour period.

11.2 The contractor guarantees the availability of analyzer replacement, when faulty for the term of this contract.

12. Warranty of Equipment

12.1 The Contractor provides equipment coverage with service included through the Cost Per Test.

13. Delivery Schedule

13.1 Delivery performance shall start on 05/01/2025-04/30/2030.

Period of performance

14. Place of Delivery

14.1 Station 673, Tampa FL

a- Department of Veterans Affairs, James A. Haley VAMC (Station: 673), 13000 Bruce B. Downs, Blvd. Tampa, FL. 33612. PLMS-Main Laboratory (Mail Code:113). Including current and future wards and clinics.

b- James A. Haley Veteran’s Hospital Primary Care Annex (PCA) 13515 Lake Terrace Lane Tampa, FL 33637 c- Brooksville CBOC (BR)14540 Cortez Blvd., Suite 108 Brooksville, FL 34613 d- Lecanto CBOC (LE) 2804 West Marc Knighton Court, Suite A Lecanto, FL 34461 e- Zephyrhills CBOC (ZE) 6937 Medical View Ln Zephyrhills, FL 33541 f- South Hillsborough VA Clinic (SOHI) 12920 Summerfield Crossing Blvd. Riverview, FL 33579 g- Sabal Park VA Clinic 9208 King Palm Drive Tampa, FL 33619 h- New Port Richey OPC (Station:673BZ)-Clinical Laboratory,7900 Little Road New Port Richey, FL 34654.

i- Lakeland CBOC (Station: 673GB)-Clinical Laboratory 2080 Meadowland Park Blvd. Lakeland, FL 33803.

j- Temple Terrace VA Clinic 8451 Temple Terrace Highway, Temple Terrace, FL 33637.

14.2 Station 516, Bay Pines FL

1. Department of Veterans Affairs Medical Center, C. W. Bill Young (Station: 516), 10000 Bay Pines Boulevard Bay Pines, FL 33744-8200. PLMS-Main Laboratory (Mail Code:113). Including current and future wards and clinics.

1. Bradenton CBOC 5520 S.R. 64 Suite 101 Bradenton, FL 34208

1. Lee County VA Healthcare Center 2489 Diplomat Parkway East Cape Coral, FL 33909

1. Naples CBOC 800 Goodlette-Frank Rd. N. Naples, FL 34102

1. Palm Harbor CBOC 35209 US Highway 19 North Palm Harbor, FL 34684

1. Port Charlotte CBOC 4161 Tamiami Trail Suite 401 & Suite 602 (Annex Bldg.) Port Charlotte, FL 33952

1. Sarasota CBOC 5682 Bee Ridge Road, Suite 100 Sarasota, FL 34233

1. Sebring CBOC 5901 U.S. Highway 27 South Sebring, FL 33870

1. St. Petersburg CBOC 840 Dr. MLK Jr. Street N St. Petersburg, FL 33705

1. North Pinellas VA Clinic 26286 US Highway 19 North Clearwater, FL 33761-4506

15. Regulatory Requirements If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall follow the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

16. Technical Industry Standards The contractor certifies that all applicable equipment offered under this contract shall conform to all applicable industry standards.

17. Manufactured Products Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least Sixty (60) days from shipping date unless FDA requires different expiration date.

18. Reference Specifications and Publications Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

19. Recalls If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

20. Security The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required for this SOW.

21. Contract Administration Data The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contract Specialist/Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

----------------------------------------------End of SOW------------------------------------------------------ Records Management Contract Language The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. 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 by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 10.Contractor is required to obtain the Contracting Officer'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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

With Sensitive Data and Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

a. 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.

b. 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.

c. 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.

d. 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.

Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as ( low ) risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The web site which provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

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 1600.1, 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.

SECURITY INCIDENT INVESTIGATION:

a. 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.

b. 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.

c. 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.

d. 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:

a. 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. However, it is the policy of the VA to forego collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. 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.

c. 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.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 for 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.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training and Privacy and HIPAA Training and HIPAA Training 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 Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. 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.

The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required for this SOW.

*** IF APPLICABLE***

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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR 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.

(2) 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

(3) 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.