36C24624Q0137_2.docx

36C24624Q0137 Richmond VAMC Cardiac Event Monitoring Services

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

652-24-1-089-0006 36C24624Q0137 12-05-2023 Cleveland Wynne 757-728-3182 12-08-2023 11:00am

EST

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X 621511 $41.5 Million

NET 30

N/A X Department of Veterans Affairs 1201 Broad Rock Blvd Richmond

VA

23249 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page Richmond VAMC Cardiac Event Monitoring Services Vendor to provide cardiac monitors and cardiac event monitoring services IAW SOW in this solicitation.

Period of Performance: 12/15/2023 - 12/14/2024 See CONTINUATION Page X X Cleveland Wynne Contracting Officer 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 36C246 Cleveland Wynne

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Wireless Event Technical Service Code PRIMARY CPT CODE: 93271 Contract Period: Base POP Begin: 12-15-2023 POP End: 12-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q502 - Medical - Cardio-Vascular

Extended Holter 3-7 days Technical Service Code CPT CODE: 93243

POP Begin: 12-15-2023 POP End: 12-14-2024

Extended Holter 8-14 days Technical Service Code CPT CODE: 93247

POP Begin: 12-15-2023 POP End: 12-14-2024

MCT Technical Service Code CPT CODE: 93229

POP Begin: 12-15-2023 POP End: 12-14-2024 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers

B.3 PERFORMANCE WORK STATEMENT

Cardiac Event Monitoring Performance Work Statement

1. PURPOSE: The purpose of this contract is to furnish the Department of Veterans Affairs, Hunter Holmes McGuire VA Medical Center (Richmond VAMC) with the services required for cardiac monitoring to Veteran patients.

The Contractor shall provide all equipment needed for up to 30-day wireless, dual alert, and Mobile Cardiac Outpatient Telemetry (MCOT) monitoring by hospital delivery for patients. The contracted company will provide continuous 24-hour physical observation of rhythm strips and immediately inform a representative from the vascular lab, agent on duty, or on call physician/department to any significant changes as specified by a doctor.

2. SCOPE OF SERVICE:

In accordance with the terms and conditions stated herein, the contractor shall furnish the Richmond VAMC located at 1201 Broad Rock Boulevard, Richmond, Virginia 23249, Cardiac Event Monitoring service as specified and at the prices specified in the price/cost schedule.

The Richmond VAMC requires approximately twenty-five (25) MCOTs, 14-30-day event monitors in office at all times to be used by our veteran population. Monitors shall comply with industry standards for two-channel wireless and single three-channel MCOT event monitoring. They shall be of such weight and size as to be user-friendly for our predominantly geriatric population. The monitor shall use batteries that are readily available, easily changed, and supplied by the Contractor. They shall be capable of monitoring heart rates, between 0-500 BPM and recording at least 1.5 minutes, including both pre and post symptoms.

At the beginning of the contract, and any time there is a change in equipment, the Contractor shall provide on-site training for VA personnel.

Contractor shall provide the monitors, which shall be kept at the Richmond VAMC, and will be issued by the Cardiology Department. The Point of Contact (POC) for the Richmond VAMC is the Health Technicians (804-675-5413 or 804-675-5466). Patients will use the event monitor for approximately 14-30-days before returning them to the Contractor or Richmond VAMC using a postage-paid return container supplied by the Contractor.

Additional monitors may be needed during the contract period at times of high usage. In such situations, the Richmond VAMC will contact the contractor by phone, fax, or email to request additional monitors. The Contractor will provide the requested monitors to the Richmond VAMC within 2-3 business days.

Both the patients and Richmond VAMC shall have toll-free 24 hour/7 day per week telephone access to the Contractors support staff who will supply help in resolving any monitoring problems.

The patient will call the staffed toll-free 24 hour phone number to transmit recordings. Upon receipt of a recording, the Contractor shall review the ECG data and asses the patient’s status using patient assessment techniques appropriate for the phone to determine the urgency of the situation. If it is determined to be potentially life-threatening (e.g. sustained tachycardia, significant bradycardia or pauses), then the Contractor will call the Richmond VAMC Officer of the Day at 804-675-5529. In such situations, the ECG rhythm is to be faxed to the Richmond VAMC within ten (10) minutes (804-675-5467 and to 804-675-5907). In the event of life-threatening dysrhythmias (such as sustained ventricular tachycardia) the vendor is expected to follow their standard policies in terms of instructing patients to go to the nearest medical facility or immediately call 911.

All other transmissions determined to be routine (i.e. not potentially life-threatening) are to be faxed with 24 hours of receipt to the Richmond VAMC, Cardiology Department at 804-675-5413.

At the end of the 14-30-day monitoring period, the patent will return the monitor to the Contractor or the Richmond VAMC who in turn will return it to the Contractor. Upon receipt of the monitor or notification of termination of the study, the Contractor will then issue a replacement monitor within 2-3 business days. All patient supplies shall be included in the contract (e.g. monitor, holder, ECG electrodes, batteries, pre-postage paid shipping containers).

2.1 EQUIPMENT FEATURES and MINIMAL Requirements

The Cardiology Electrophysiology Lab is looking for the following features in a diagnostic kit.

· 1 or 2 Channel 2 or 3 lead-wires

· Event recordings up to 30 days

· Transmission over cell phone network

· Continuous monitoring & recording

· Patient activation and Auto-trigger activation

· A-fib, Brady, Tachycardia, and Pause detection

· Storage on device for analysis and review

· Asymptomatic patient, Periodic symptoms. Need for auto trigger feature. Ability to view all the data if necessary.

3. PERIOD OF REQUIRED SERVICES:

Services are required from 1 October 2023 through 30 September 2028 with four (1) year option periods. Any resultant contract will be subject to availability of VAMC appropriations.

4. SPECIFIC TASKS

4.1 PROCESS and POLICY MANAGEMENT CONTROL

4.1.1 Contract Management – Contractor will provide a bi-monthly status, or as requested, to assist with monitoring the quality assurance, progress/status reporting and program reviews applied to this contract to the COR (Contracting Officer’s Representative).

4.2 PATIENT ENROLLMENT

4.2.1. Online Enrollment – The Contractor shall provide means of online/fax patient enrollment for 14-30-day Event Monitor patient services for approximately 350 studies annually, with an approximate of 10% growth each year.

4.2.2 Online Access – Online access to database for Primary Care Providers, Richmond VAMC Cardiologists, and Non-Invasive Lab. Contractor will have 99% uptime of website.

4.2.3 Transmission Responsiveness/Timeliness – Contractor shall provide live customer service to download transmissions within one minute.

4.2.4 Patient Service – Contractor will have 24 hour continuous live patient service availability to answer questions or help with proper monitor usage.

4.3 EQUIPMENT

4.3.1 Patient Instructions – Complete and clear written instructions included with every monitor.

4.3.2 Equipment Distribution – Contractor will supply a minimum of Twenty-five (25) MCOTs, 14-30-day event monitors to be applied in inventory in the Richmond VAMC, Cardiology Department, ECHO Lab.

4.3.3 Equipment Supplies – All necessary supplies, cleaned, reset monitors, and accessories in monitor package including, but not limited to, instructions, electrodes, batteries and diaries.

4.3.4 Equipment Condition – Equipment shall be maintained in good working order. Equipment shall arrive in ECHO Lab that meets QA standards for cleanliness.

4.3.5 Equipment Inventory – Contractor will supply inventory of monitors and needed supplies at site listed for distribution.

4.3.6 EKG Tracings – All wireless tracings are acquired in two simultaneous leads.

4.3.7 Monitor Device Configuration – 14-30-day wireless and MCOT event recorders.

4.4 REPORT MANAGEMENT

4.4.1 Rhythm Monitoring – Contractor shall ensure that tracings are monitored by trained personnel and overseen by a Cardiologist specialized in rhythm monitoring.

4.4.2 Quality Transmission of Tracing – If indicated, Contractor will provide verbal education to patient producing the highest quality tracing possible, with little or no artifact.

4.4.3 Report Information – Contractor shall provide precise information, graphs, and analysis as agreed upon between Company and the Richmond VAMC, Cardiology Department, to fit need of studies.

4.4.4 Report Information Delivery – Prompt delivery of accurate reports either by fax, or on-line acquisition as prearranged criteria 24 hours a day, 7 days a week, 365 calendar days of the year.

4.4.5 Equipment Compliance Review – Contractor shall contact patients or Cardiology Department, ECHO Lab, if no events are transmitted in the first week to ensure compliance, understanding, and quality.

4.4.6 Online Access/Event Monitor – Contractor shall provide 24 hours online access to full event monitoring recording.

4.4.7 Urgent vs. Routine Notification – Contractor shall provide prompt and accurate notification for any urgent findings. Notification shall be by fax, email and/or phone call to the Administrative Officer of the Day (AOD) or the ECHO Lab.

4.5 BILLING/REIMBURSEMENT

4.5.1 The Contractor shall provide and itemized invoice within fifteen (15) days of the end of each month services were provided. Payments will only be made for services rendered. All invoices, including supporting documents, should be submitted electronically according to the Federal mandate.

4.5.2 Pricing and Reimbursement Rates – Company will provide and adhere to agree upon reimbursement rates.

4.6 Customer Service

4.6.1 Help Desk/Phone Line – Contractor shall provide live customer service phone lines that will be available for both patients and hospital employees 24 hours a day, 7 days a week, and 365 days of the year.

4.6.2 Urgent Notifications – In the event of any unexpected findings, key individuals will be alerted, ECHO Lab during business days M-F 0730-1630 EST or the AOD after hours at the Richmond VAMC by the Contractor.

5. PERFORMANCE MONITORING

The COR will monitor contractor performance and certify completion of work in accordance with Table 1 “Performance Measures” and the Contract.

5.1 Equipment Oversight

COR will randomly select one monitor every two weeks to audit for supplies, cleanliness and performance. Any deficiencies will be documented and immediately reported to Supervisor and Contracted Company. There will be no more than three (2) deficiency reports in a rating period of six months.

5.2 Notification Oversight

Notification failures will require written documentation from the Contracted Company stating reason for failure and an outline of the process implemented to eliminate issue of the failure.

5.3 Rhythm Strip Oversight

COR will randomly select three monitor reports per month to ensure proper process are being followed for rhythm interpretation. The results of these reports will be sent to the ECHO Lab Supervisor. Any deficiencies will be reported to the Contract Company for follow-up and documentation outlining the process adjusted to eliminate this issue.

5.4 Table 1: CARDIAC EVENT MONITORING SERVICES -

PERFORMANCE MEASURES – FY-23

Reference Performance Requirement

Method

Immediate removal from contract.

4.5.1 4.5.2 Submission of itemized invoice within fifteen (15) days of the end of each month services were provided. Payments will only be made for services rendered. All invoices, including supporting documents, should be submitted electronically according to the Federal mandate.

4.4.3 4.4.5

Reports

6. SECURITY REQUIREMENTS

6.1 Patient Information – Mail out material.

The Contractor shall develop and implement procedure to ensure that no sensitive patient identifying information is sent out in the mail. Any breaches will be immediately reported and remedied.

6.2 Patient Information – Secure online program.

The Contractor shall provide an online system that adheres to all standards and policies set by the Richmond VAMC Information Security Officer. Any breaches shall be immediately reported and remedied.

6.3 Patient Information – Online access of VA and Contract Company Employees

Only Richmond VAMC and Contract Company employees with a “need to know” shall have access to the online reporting system. All standards and policies set by VA Information Security Officer regarding online system usage shall be strictly adhered to. Any breaches shall be immediately reported and remedied.

6.4 Patient Information – Faxing and phone usage – patient information

Contractor shall establish strict standards and procedures for Contractor employees, which will be set and followed to ensure patient confidentially. Any breaches shall be immediately reported and remedied.

6.5 Patient Information – Patient reports

The Contactor shall establish strict standards and procedures in regards to patient reports to ensure patient confidentiality. Any breaches shall be immediately reported and remedied.

6.6 Secure Patient Information – Escorted access to Richmond VAMC facilities.

Strict standards to professionalism and patient confidentiality will be adhered to when visiting any Richmond VAMC facilities.

7. OTHER PERTINENT INFORMATION or SPECIAL CONSIDERATIONS

7.1 Packaging, Packing and Shipping Instructions.

The Contractor shall provide a consistent inventory, whether it is by personal drop off or mail. The Contractor shall provide a postage paid process to return monitors for cleaning and interpretation.

7.2 INSPECTION AND ACCEPTANCE CRITERIA

The COR will be responsible for periodically inspecting and certifying that the Contracted Company is performing to pre-arranged upon standards in regards to timeliness, quality and performance.

8. RISK CONTROL

The Contractor shall be responsible for the proper cleaning and disinfection of equipment prior to each patient use, or as mandated by RME (reusable medical equipment) standards.

9. PLACE of PERFORMANCE

The Contractor will only be providing equipment and off-site monitoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price.

10. PERSONNEL POLICY:

Contractor employees, agents and subcontractors shall not be considered VA employees for any purpose.

11. DESIGNATION OF CONTRACTING OFFICERS REPRESENTATIVE:

A VA Medical Center representative of the Contracting Officer shall be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice or information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested and is the sole responsibility of the Contracting Officer.

12. CONTRACT PERFORMANCE MONITORING:

The Contracting Officer’s Representative (COR) shall be the VA official responsible for verifying contract compliance. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. The Contractor is advised that only the Contracting Officer has the authority to make changes to the contract. After contract award, any incidents of noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

13. CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

(a) FAR 42.1502 direct all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CP ARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15

(b) The past performance evaluation process is a totally paperless process using CP ARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

(c) Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm's past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

(d) When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CP ARS, they will receive an automatically-generated email with detailed login instructions. Further details, system requirements, and training information for CP ARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.

(e) Within 60 days after the end of a performance period, the Contracting Officer will complete an interim or final past performance evaluation and the report will be accessible at www.cpars.gov Contractor Representatives may then provide comments in response to the evaluation, or return the evaluation without comment. Comments are limited to the space provided in Block 22. Your comments should focus on objective facts in the Assessing Official's narrative and should provide your views on the causes and ramifications of the assessed performance. In addition to the ratings and supporting narratives, blocks 1-17 should be reviewed for accuracy, as these include key fields that will be used by the Government to identify your firm in future source selection evaluations. If you elect not to provide comments, please acknowledge receipt of the evaluation by indicating, "No Comment" in Block 22, and then signing and dating Block 23 of the form. Without a statement in Block 22, you will be unable to sign and submit the evaluation back to the Government. If you do not sign and submit the CP AR within 30 days, it will automatically be returned to the Government and will be annotated: "The report was delivered/received by the contractor on (date). The contractor neither signed nor offered comment in response to this assessment." Your response is due within 30 · calendar days after receipt of the CPAR.

(f) The following guidelines apply concerning your use of the past performance evaluation:

(1) Protect the evaluation as "source selection information." After review, transit the evaluation by completing and submitting the form through CP ARS. If for some reason you are unable to view and/or submit the form through CP ARS, contact the Contracting Officer for instructions.

(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, pre-award surveys, responsibility determination, production readiness reviews, or other similar purposes.

(g) If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30- day review period.

(h) A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.

14. BILLING AND PAYMENT

A. INVOICES

The Contractor shall submit payment requests in electronic form via VA's Electronic Invoice Presentment and Payment System http://www.fsc.va.gov/fsc/einvoice.asp. Invoices shall be submitted monthly in arrears. The following information must be included on all submitted invoices. Invoices submitted without the following information may be rejected for payment. Invoices shall include at a minimum:

· Contract number

· Obligation/Purchase Order Number

· Invoice Number

· CLIN (Contract Line-Item Number)

· Date of Service

· All invoices submitted must be accompanied by copies of all route sheets for that billing period. Route sheets shall contain date and time of pick up and/or delivery. All route sheets must contain the signature of the person receiving the items delivered.

15. OTHER STATION RULES AND GUIDELINES:

A. The contractor will adhere to the following station rules:

1. This is a hospital environment. The contractor and his personnel are expected to be appropriately dressed (preferably uniformed) and to conduct themselves professionally.

2. This is a federal facility as well as a medical center. As such, there is NO tobacco usage allowed inside any federal building or on the grounds except in designated areas. The POC will brief the contractor as to designated smoking areas prior to commencement of the contract. Failure to follow these regulations can result in removal of the worker or contractor from the facility and/or a US Magistrate’s ticket and fine.

3. Parking will be in designated lots. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Service. The Richmond VAMC will not invalidate or make reimbursement for parking violations of Contract employees under any conditions.

4. Since the incidents of September 11, 2001, the Federal Government has begun to implement new security measures to help protect federal facilities. The contractor will provide to the POC a list of employees expected to work on this contract. This list will be on company letterhead and contain the employees’ name, driver’s license number, address and nationality. This list will be verified and signed by a corporate officer. These personnel are subject to a background check and fingerprinting to be eligible to receive a security badge.

5. The Contractor shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and comply with all standards.

6. Contractor employee(s) shall wear visible identification at all times while on the premises of the Richmond VAMC.

7. Possession of weapons is prohibited. Enclosed containers including tool kits shall be subject to search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court.

16. VAMC SMOKE FREE POLICY

In striving to provide a healthy and safe environment at our facilities, VHA is implementing a smoke-free policy for all VHA health care facilities and property assigned to VHA that is under the charge and control of VA.

Under VHA Directive 1085, all VHA health care facilities (including CBOCs and HCCs) will be smoke-free for patients, visitors, contractors, volunteers, and vendors effective October 1, 2019. The policy applies to cigarettes, cigars, pipes, or any other combustion of tobacco, including but not limited to electronic or e-cigarettes, vape pens or e-cigars.

Although VA has historically permitted smoking in designated areas, there is growing evidence that smoking and exposure to secondhand and thirdhand smoke creates significant medical risks, and risks to safety and direct patient care that are inconsistent with medical requirements and limitations.

17. CONTRACT ADMINISTRATION

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall 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 WITHOUT AUTHORITY, NO ADJUSTMENT SHALL BE MADE IN THE CONTRACT PRICE TO COVER AN INCREASE IN COSTS INCURRED AS A RESULT THEREOF.

Contracting Officer (CO) Cleveland Wynne Department of Veterans Affairs Network Contracting Office (NCO) 6 100 Emancipation Drive, Bldg 27 Hampton, VA 23667 757-728-3182 Cleveland.Wynne@va.gov

Richmond VA Medical Center ATTN: Clara Evans 1201 Broad Rock Boulevard Richmond, VA 23249 804-675-5111 clara.evans2@va.gov

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct 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 in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R.

Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the 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 firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

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

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

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

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

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

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

c. Outsourcing (contractor facility, contractor…