36C25025Q0031.docx

36C25025Q0031

A.1 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more SDVOSBs or VOSBs for subcontract work of the same or similar value.

(b) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

A.2 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

It is the policy of the Department of Veterans Affairs that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of VA programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental). By acceptance of this contract, the Contractor agrees to comply with this policy in supporting the program and in performing the services called for under this contract. The Contractor shall include this clause in all subcontracts awarded under this contract for supporting or performing the specified program and services. Accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with this policy.

(End of Clause) A.3 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY (FEB 2023)

(a) All information and communication technology (ICT) (formerly referred to as electronic and information technology (EIT)) supplies, information, documentation and services support developed, acquired, maintained or delivered under this contract or order must comply with the ‘‘Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards’’ (see 36 CFR part 1194). Information about Section 508 is available at http://www.section508.va.gov/.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are: Revised 508 Standards and 255 Guidelines - https://www.access-board.gov/ict/

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the Contractor submit a completed VA Section 508 Checklist and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed VA Section 508 Checklist and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of Clause)

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

539-25-1-556-0002 36C25025Q0031 10-08-2024 Teri Miller - Teri.Miller@VA.gov 317-988-1543 10-17-2024 13:30

EDT

Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis

IN

46240 X 541380 $19 Million N/A X Department of Veteran Affairs VA Medical Center (90 CSC) 1481 West Tenth Street Indianapolis

IN

46202 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis

IN

46240

Department of Veterans Affairs Financial Management System P O Box 149971 Austin

TX

78714-9971 512-242-7300 N/A See CONTINUATION Page Contractor shall be an Independent Diagnostic Testing Facility (IDTF) and shall facilitate PST services with each VA location identified, including patient education and support services, testing supplies and materials, reporting services, quality control, and customer service for warfarin management.

Period of Performance: 11/23/24 - 11/22/25 with four (4) option years, exercisable at the Government's discretion.

This acquisition will be conducted using FAR 12 and FAR 13 procedures, under the authority of FAR 13.5.

The award shall be based on the best overall value to the Government using comparative evaluation and factors as specified in Section E of this solicitation.

Questions are due no later than 1:30 PM EST on 10/14/2024.

All responses shall be emailed to Teri.Miller@va.gov no later than 1:30 PM EST on 10/17/2024. Any quote not compliant with RFQ requirements will not be considered.

See CONTINUATION Page X X 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 36C250 Josh Kovar Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis IN 46240

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/ ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

Veterans Integrated Service Network Serving Indiana, Michigan, and Ohio (VISN 10) International Normalized Ratio (INR) Patient Self Testing Service (PST) Updated 10/9/2024.

· Introduction:

· VISN 10 has identified the continued need to have an International Normalized Ratio (INR) Patient Self Testing (PST) option available for Veterans Affairs (VA) beneficiaries (referred to as “patient” and/or “Veteran” from hereafter) seen at VA facilities and Community Based Outpatient Clinics (CBOCs) who are receiving the anticoagulant warfarin (Coumadin).

· Warfarin requires frequent monitoring to maintain patients within a narrow therapeutic range, patients outside this range can experience severe and potentially fatal bleeding or thromboembolic events. Use of PST has been shown to be equivalent to the safety and efficacy of high-quality anticoagulation care without the traditional limitations of disability, geographic distance, or other factors. VA facilities can additionally use PST to add additional efficiency to resource utilization.

· In May 2022, a 2-year contract (36C25022P1056) was awarded to allow 4 VISN 10 facilities to pilot an INR PST program. This statement of work and associated documents for a new 5-year (base plus 4 option years) contract reflects the updated requirements identified during the pilot. The new contract will be expanded to additional VISN 10 facilities. During the transition, to potentially a new vendor, there shall be no disruption in care and services to those Veterans currently enrolled in the program.

· Scope of Services/Descriptions: The VISN will contract with an Independent Diagnostic Testing Facility (IDTF) to facilitate PST services with each VA location identified below including patient education and support services, testing supplies and materials, reporting services, quality control, and customer service. Each individual VA will utilize IDTF services in the provision of warfarin management.

· Currently, only a portion of VA VISN 10 Medical Centers and/or facilities take part in this program. All potential VISN 10 Medical Centers are listed below. Medical Centers and/or facilities that are not included in the schedule may be added through a bilateral contract modification. Any Wage Determination for the added Medical Centers will be identified and added at the time of contract modification.

***NOTE: The Government reserves the right to add or remove any additional Medical Centers, CBOC’s, other facilities, or patients to the contract as they become available. Furthermore, the Government reserves the right to add, increase, or decrease quantities to allow for fluctuations of client demand that are otherwise unknown at time of solicitation. The total contract value may increase up to 20% of the base award.

Period of Performance:

Base Year: 11/23/24 – 11/22/25

· Meters:

· Patients who are approved by the VA facility point of contact (POC), or their designee, will be provided a validated meter directly from the vendor. The meter may be shipped or provided during the educational session. If not provided during the educational session, the device shall be received by the patient prior to the session. The device must be FDA-approved for CLIA-waived testing and have documented research on its utilization in the role of patient self-testing. Documentation that the meter has been tested and certified ready to use shall be provided to the VA within 14 days of being provided to the patient. This information should also be available in the online portal system.

· The meters currently being used by VHA VISN 10 are the CoaguChek XS system manufactured by Roche. The vendor shall provide the same or similarly functioning meter that meets all of the requirements set forth herein.

· The device should include all accessories required for long-term use including, but not limited to, rechargeable battery, charging cord, and any potential devices required to report INRs.

· If a meter fails validation at any time, a replacement meter will be provided to the patient at no additional charge within 48 hours or 2 business days. If the vendor wishes return of the affected meter they shall coordinate return of the meter directly with the patient, at no cost, after a replacement meter has been provided.

· Testing Supplies: Supplies include test strips, lancets, ancillary supplies, and quality control materials.

· A vendor will establish a recurring shipment schedule to ensure the patient has appropriate supplies to test based on the VA recommended treatment regimen.

· The facility POC will communicate the need for additional testing supplies directly to the vendor which are to be provided to the patient.

· Ancillary supplies required for sterility and disposal prior to and after lancing for blood samples will be provided by the vendor, such as alcohol swabs, gauze or bandage, and sharps container.

· Supplies required for quality control of the meter will be supplied by the vendor to the patient for:

· Regularly scheduled maintenance in intervals required for meter upkeep

· VAMC required quality control testing, if regularly scheduled maintenance intervals are deemed too infrequent

· Ad hoc quality control as required for erroneous results or troubleshooting

· Patient Education: Initial education is to be provided to the patient by the vendor. The session shall take place face-to-face to allow the patient to view the demonstration. Certificate of completion of training should be emailed to the facility POC in addition to being uploaded to a portal system within 14 days. Education is to include, but not limited to:

· Care and maintenance of the meter

· Utilization of test strips

· Testing technique

· Frequency of testing

· How to notify vendor of results

· Communication with provider

· Patient resources available

· Coding and meter configurations/set up

· Troubleshooting errors

· Review of contacts available for troubleshooting or ordering more supplies

· Importance of not self-adjusting warfarin

· Result Communication:

· INR results shall be transmitted from the device to the vendor via Bluetooth or some type of automatic downloading capabilities. This is the preferred method, however, patient may self-report via an online portal system or phone call to the vendor is acceptable if downloading/Bluetooth is not available.

· Test results should be sent via encrypted email, fax, and/or phone to the VA facility POC or group (all members of identified group if group email is not possible) as designated by the POC by close of business the same day as the result is received by the vendor.

· All test results must be available via an online portal that specified VA facility users can access 24/7. VA users shall be able to copy information from the portal into the patient’s VA medical record. The availability of the online portal is in addition to the other communication methods. Access to the portal will be available to the VISN 10 points of contact at no additional charge. SaaS approval is required for portal once vendor is selected – please see security language at bottom of this document.

· All test results outside of specified parameters will be communicated to the facility via a phone call to the facility POC in addition to the email and fax.

· Access or ability to view results in the future should be available, for a minimum of 2 years, even if the patient is off warfarin or no longer utilizing PST services.

· Reporting: The vendor shall provide a report to the facility and VISN POCs on a monthly basis on the following:

· New patient information broken down by facility

· Breakdown of cost

· Time in Therapeutic Range (TTR) of each individual patient

· Billing:

· The vendor shall bill a flat fee monthly per patient per facility. Billing shall not be based on the number of tests performed.

· The billing invoices that are submitted through the VA electronic billing system shall also be sent via email to the VISN POCs. The invoice must list each individual patient and clearly define the time period covered.

· A patient participating in the VA/VISN 10 program shall not receive any type of bill or invoice at any time or be contacted regarding the status of payment.

· Payment shall be made monthly in arrears upon receipt of a properly prepared detailed invoice and validated by the SITE POC. Invoices must be sent electronically through VA Tungsten Network Portal. https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

· A properly prepared invoice shall contain:

· Invoice Number and Date services were provided

· Contract Number

· Contractor’s Name and Address

· Accurate Purchase Order Number

· CLIN & Date of service/period of supply – number of patients per facility

· Description of Supply or Service provided

· Quality Control:

· The vendor shall have a system in place to notify both the patient and facility in the case of a recall to anything related to self-testing (quality control solution, test strips, etc.) within 1-2 business days.

· Prior to distribution and initial testing by patient, quality control testing will be performed on all testing supplies by the vendor to ensure accuracy.

· Quality control of the meters will be administered by the vendor at intervals required for regular machine maintenance or intervals required by VAMC for quality control reporting, whichever is more frequent.

· The vendor shall have a system in place to provide summary reports or information in an organized fashion of any quality control completed should it be needed for audits, governing body reviews, VA lab requirements, etc.

· The vendor shall have a system in place to provide appropriate communication related to system downtime or issues arising that may affect patient follow up.

· The vendor shall accept orders from the pharmacist POC.

· Customer Service:

· Customer service options shall be provided to both the patient and the healthcare provider (HCP) should further assistance be needed. These options may include a toll-free/1-800 number and/or online portal to assist with answering questions and addressing issues.

· Training on the meter and services shall also be provided to members of the Anticoagulation Program Management team as requested. This may include, but is not limited to, pharmacists, pharmacy technicians, and nurses.

· If unable to reach a resolution, a higher responsible POC should be assigned to ensure the health care provider or patient is able to speak with someone.

· Customer service should be available to address a myriad of needs such as, but not limited to:

· Meter troubleshooting

· Patient request for additional test strip supplies or replacements

· INR result errors

· Patient education assistance as needed/requested per the “Veteran Education Section” list.

· HCP assistance in obtaining necessary reports.

· Communicating vendor system issues

· Patient Selection:

· Ideal candidates for enrollment in the VISN 10 INR PST program would be those with health, safety, logistical, and/or other concerns that would make in person or frequent testing at a Veterans Affairs (VA) facility difficult.

· The VISN has developed a written policy defining the parameters and clinical eligibility criteria.

· The VA provider will determine the testing frequency, not the vendor.

· Specific clinical eligibility criteria for PST for INR monitoring will include at a minimum.

· Requirement of chronic warfarin; patients have been on warfarin therapy for a minimum of 1 month (clinical judgement will be used on patients on warfarin therapy less than 3 months),

· Patients are committed to testing as directed and follow the policies and standards of care for INR patient self-testing of the VA medical facility,

· Patients/caregivers have received education regarding warfarin therapy and this education is documented in the patient’s medical record,

· Patients/caregivers have documented competency in all necessary functions required for normal meter operations after vendor training,

· Patients and or their caregivers have the necessary vision, hearing, dexterity, language, and cognitive skills to perform PST,

· Patients must have regular access to a telephone and maintain good communication with their anticoagulation provider,

· Patients with known or suspected lupus anticoagulant or antiphospholipid antibody syndrome will not be eligible to participate in PST, and

· Patients who require testing more frequently than once a week will not be eligible to participate in PST.

· Qualifying patients selected by a VAMC facility will be enrolled in the PST program following local standard operating procedure and IDTF protocol.

· PST for INR testing will be discontinued for patients who fail to continue to meet the eligibility criteria. Other criteria for discharge can include the need for repeated calls to review basic PST instructions, excessive use of testing supplies, refusal to test according to each facility policy, refusal to return phone calls or respond to letters by providers.

· If a new patient is to be added a secure email will be sent to the vendor with the necessary information in order to initiate service. The vendor shall not perform any additional items without the necessary approval and subsequent contract modification (if the maximum quantity will be eclipsed as a result of the addition) sent by contracting.

· In the event of discharge from the PST program, the patients will be reverted to management of warfarin via traditional methods at the VAMC facility.

Facility Information: Patients who receive care at the following VA locations are eligible to receive meter, supplies, and services under this contract when approved by the facility POC. These patients may also receive care at one of the associated outpatient clinics. The locations that are underlined are currently participating in the contract and will continue in the new contract during the base year.

Address

Lieutenant Colonel Charles S. Kettles VA Medical Center (Ann Arbor) POC will be provided at time of award

2215 Fuller Road Ann Arbor, MI 8105

5500 Armstrong Rd Battle Creek, MI 49037

17273 State Route 104 Chillicothe, OH 45601

3200 Vine Street Cincinnati, OH 45220

10701 East Boulevard Cleveland, OH 44106

Chalmers P. Wyle VA Outpatient Clinic (Columbus)

POC will be provided at time of award

420 North James Rd Columbus, OH 43219

4100 West Third St Dayton, OH 45428

John D. Dingell VA Medical Center (Detroit)

POC will be provided at time of award

4646 John R St Detroit, MI 48201

1481 West Tenth Street Indianapolis, IN 46202

VA Northern Indiana Healthcare System

POC will be provided at time of award

Marion VA Medical Center 1700 East 38th Street Marion, IN 46953

Fort Wayne VA Medical Center 2121 Lake Avenue Fort Wayne, IN 46805

1500 Weiss Street Saginaw, MI 48602

VISN 10 Points of Contact/Project Managers

Not a care site participating in this contract POC will be provided at time of award

Ms. Seng serves as the Contracting Officer’s Representative (COR) on this contract.

VISN 10

Pharmacy Benefits Management (119) 3200 Vine Street Cincinnati, OH 45220

· Quality Control/Assurance: The contractor shall be responsible for the effective implementation of a Quality Control Program and shall be responsive to the requirements of the Government’s Quality Assurance Plan conducted by the facility and/or VISN POC.

· The contractor shall have a Quality Control program to assure that the requirements of the contract are provided as specified. One copy of the Contractor’s basic Quality Control Program shall be submitted for approval by the SITE POC. Subsequent changes to the approved Quality Control Program must also be reviewed and approved by the SITE POC with final approval by the Contracting officer. The program shall include, but not be limited to the following.

· An inspection system covering the performance indicators given in the Quality Assurance/Performance Requirements table below.

· A method for identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable.

· A file of all quality control inspections inspection results, and any corrective action required shall be maintained by the Contractor throughout the duration of this contract. This file shall be the property of the Government and shall be available to the SITE POC during normal working hours. The file shall be turned over to the Government within 14 days of completion of termination of the contract.

QASP: A (Quality Assurance Surveillance Plan (QASP) has been developed for in-house operations or to implement a service contract. It is designed to aid the Government in providing effective and systematic surveillance of all aspects of document and media destruction. This plan provides for monitoring all contract requirements through a combination of methods. These are:

1. Random observation

2. Client/Customer Complaints

3. Surveillance Activity Checklist The QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

The objective of this surveillance plan is to evaluate how the Government or contractor is performing in key areas. We are primarily interested in the final product or service being provided and not the details of the accomplishment.

QUALITY ASSURANCE / PERFORMANCE REQUIREMENTS STANDARDS

Monthly

Incentive: favorable performance review and exercise option years Disincentive: A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service and lead to possible termination of contract

Monthly Reports Incentive: favorable performance review and use option years; Disincentive: A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service and lead to possible termination of contract

Monthly

Incentive: favorable performance review and use option years; Disincentive: A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service and lead to possible termination of contract

Disincentive: A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service and lead to possible termination of contract. In addition, a referral will be sent to the Department of Labor that indicates any discrepancies for further remediation.

14.4 PERFORMANCE MONITORING:

ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the SITE POC shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the SITE POC shall document the discussion and place it in the SITE POC file.

a. When the SITE POC determines formal written communication is required, the SITE POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

b. The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the SITE POC. The Government shall review the contractor's corrective action plan to determine acceptability.

c. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

d. Custom software development and outsourced operations must be in the U.S.

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

- General, FAR 52.227-14(d) (1).

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

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

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

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT (Not Applicable)

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. For purposes of the Act when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

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

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

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

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