36C25920Q0156-0001001.pdf

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. DUNS: DUNS+4:

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. 2/2012)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 135

36C25920Q0156 04-09-2020

Lance Davis 918-577-3838 04-16-2020

1600 (CST)

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74410

X 100

X

621610

$16.5 Million

N/A

X

Department of Veterans Affairs Oklahoma City VA Health Care System

921 NE 13th St Oklahoma City OK 73104

36C259

Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Solicitation for Ambulatory Cardiac Event Monitors

Respond to Solicitation:

Submit through E-Mail to Lance.Davis2@va.gov Ensure e-mail sizes don't exceed 7MB per e-mail. If Multiple e-mails, indicate "___of___" to ensure all are received and suggest Vendors send e-mail to request confirmation of receipt of ?? number of attachment(s) and # of emails.

Location of performnace:

Oklahoma City VA Health Care System 921 N.E. 13thg Street Oklahoma City OK 73104

Must provide: Price, Technical CapabilityStatement, and Past Performance Statement (see 52.212-2 Evaluation Commercial Items)

See CONTINUATION Page

X X

Judy Chambers

36C25920Q0156

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 Performance Work Statement B.3 Information System Security B.4 Quality Assurance Surveillance Plan (QASP)

B.5 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 40

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.7 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND

COMPLIANCE (JUL 2018)

C.8 IT CONTRACT SECURITY

C.9 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.10 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.11 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.13 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.14 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.15 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

C.16 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.17 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 Business Associate Agreement D.2 Wage Determination

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN

2008)

E.10 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.11 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES

INCORPORATED BY REFERENCE (JAN 2008)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (DEC 2019)

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 36C259

Network Contracting Office

NCO 19

1011 Honor Heights Drive

Muskogee OK 74410

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

Financial Service Center

PO Box 149971

Austin TX 78714-9971

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

AMENDMENT NO DATE

B.2 Performance Work Statement

PERFORMANCE WORK STATEMENT

Ambulatory Cardiac Event Monitoring Services

Oklahoma City Veterans Affairs Health Care System and Associated Community Based Outpatient Care Facilities.

General:

The Contractor shall provide Ambulatory Cardiac Event Monitoring Services to the Oklahoma City Veterans Affairs Health Care System (OKC VAHCS) and any current of future Community Bases Outpatient Care (CBOC) facilities. All services shall be performed in accordance with the terms and conditions listed in the following performance work statement (PWS).

Background:

It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. We strive to continuously look for technology that increases the efficacy of medical and diagnostic management of our patients. Cardiac symptoms are often transient in nature such that it is difficult to obtain an ECG the exact time they occur. Oftentimes, clinically relevant abnormalities and life-threatening rhythms have no cardiac symptoms. Ambulatory Cardiac Event Monitoring on a continuous basis is the solution to this problem. Ambulatory Cardiac Event Monitoring is used for patients experiencing intermittent symptoms, such as palpitations, syncope, dizziness, and shortness of breath.

Patients are provided with state-of-the-art technology in the form of a portable device which records the patient’s cardiac data, automatically or patient initiated, in real time while symptoms are occurring.

Definitions:

CBOC: Community Based Outpatient Care

CO: Contracting Officer

COR: Contracting Officer’s Representative

ECG: Electrocardiogram

FAR: Federal Acquisition Regulations

OK: Oklahoma

OKC VAHCS: Oklahoma City Veterans Affairs Health Care System

Oklahoma City VA Health Care System consist of the following locations:

Main Facility:

VA Medical Center

921 NE 13th St.

Oklahoma City OK 73101

405-456-1000

CBOC’s (Community Based Outpatient Clinics):

14th Street VA Clinic, Veterans Resource Center

1301 Northeast Fourteenth Street

Oklahoma City, OK 73117-2018

Phone: 405-456-1000

Ada VA Clinic

717 Better Now Plaza

Ada, OK 74820-2279

Phone: 580-436-2262

Altus VA Clinic

1604 North Main

Altus, OK 73521-2145

Phone: 580-482-0721

Ardmore VA Clinic

1235 12th Avenue Northwest

Ardmore, OK 73401-1850

Phone: 580-222-0400

Blackwell VA Clinic

1009 West Ferguson Avenue

Blackwell, OK 74631-5602

Phone: 580-363-0052

Enid VA Clinic

401 South 3rd Street

Enid, OK 73701-5737

Phone: 580-977-1855

Lawton/Ft. Sill, OK CBOC (on military installation)

4303 Pitman Street

Building 4303

Fort Sill, OK 73503-4473

Phone: 580-585-5600

North May VA Clinic, Oklahoma City

2915 Pine Ridge Road

Oklahoma City, OK 73120-6111

Phone: 405-456-1000

View on Facility Locator

South Oklahoma City VA Clinic

7919 Mid-America Boulevard

Third Floor

Oklahoma City, OK 73135-6610

Phone: 405-855-6000

Stillwater VA Clinic

320 North Perkins Road

Stillwater, OK 74075-5513

Phone: 405-707-8100

Wichita Falls VA Clinic (on military installation)

149 Hart Street

2nd Floor, Building 1200

Sheppard AFB, TX 76311-4204

Phone: 940-257-0001

Scope:

Contractor must be capable, meet, have, and/or has done the following:

All Cardiac Event Monitoring equipment used within this contract must be FDA approved Proof of Quality Control standards must be equal or greater than ISO Minimum of 2 years of previous VA contract experience 365/24/7 monitoring of devices/data Emergency situations, such as instances of critical or STAT events the contractor is to call the patient. If the patient is having an emergency have them call 911 then contact the VA Cardiology Clinic immediately. If the patient is not reachable the contractor is to contact the VA Cardiology Clinic immediately as extended time of no response could result in harm or death to the patient.

Provide reports upon request even if the monitor event has not concluded Contractor will be required to ship requested Cardiac Event Monitoring equipment to all locations within the OKC VAHCS coverage area (which includes central and western Oklahoma and a small portion of North Texas).

All technical communication between the Contractor and the VA must be secure, to include data transfer, storage, and submission, in order to protect patient information.

Contractor shall meet all Federal HIPAA Laws with regards to handling patient information.

Provide data on more than one lead or channel Stock devices at main Oklahoma City VA Medical Center hospital and/or our Community

Based Outpatient Clinics (CBOCs) within the “Oklahoma City VA Health Care System”.

Currently we only have the vendor stock needed equipment at the main hospital and needed equipment sent to the CBOCs as requested. CBOC’s names and addresses are:

Ship devices from the company to patients within the United States.

Provide free return shipping for patients to return devices to the manufacture All equipment used for this Cardiac Event Monitoring Service will be owned by the contractor.

Provide on-site training for staff

Provide 24/7/365 assistance for patients with devices via 1-800 phone number. Phone staff must be able to inform the veteran what is in the box (equipment mailed out to the patient), how to use the device, and where the electrodes are to be placed on the skin, along with any additional needed information.

Bill on monthly basis Easy method for patient to manually record events on devices Minimum experience of 1 VA Contract in similar size and complexity but no less than

10% of the complete value of this contract Electronic data base, available to VA staff, to track enrollment, verified patient information, and review the progress of tests Provide STAT results immediately to providers Transfer monitor data in real-time to monitoring station(s) using cellular data, WiFi, and/or Internet Ensure equipment allows patients are able to shower wearing the device Devices or leads can be moved around to prevent sores or irritation Provide comprehensive initial training with on-site demonstrations for VA staff along with demonstrations for any new technology or changes in equipment.

Provide up to 1100 wireless event monitors per year or up to 90 a month during peak times Provide up to 400 Holter monitors per year or up to 30 a month during peak times Provide reports within 48 hours of test being completed

Needed Characteristics

Contractor can transmit patient report directly to CPRS (Computerized Patient Record System)

Contractor can transmit patient report directly to Cerner (Electronic Health record System)

Equipment must have or provide Auto-Trigger technology which offers ECG monitoring that is programmed to recognize rhythms such as atrial fibrillation, tachycardia, bradycardia, ventricular tachycardia, and asystole. When the device recognizes these rhythms, it automatically records the patient's ECG, independent of the patient physically activating the device. This technology captures dysrhythmias when they would otherwise go undiagnosed. The ECG is automatically transferred to a cardiac monitoring center, where it is immediately reviewed, and the cardiologist is informed according to pre-selected notification criteria.

Device Service: Event monitor: Non-Looping, Looping including Auto Trigger, and Wireless

While patient is wearing the device, transmission report, urgent report, weekly report (wireless Event only), and End of Service report options will be made available as requested via fax or online. For wireless Event patients, wireless Event reports will be made available by the contractor.

The VA would like to have access to patient reporting 24 hours a day at the physician’s or authorized representative’s convenience through password protection.

The device is given to patients to use up to 1 month depending on the indication for continuous monitoring.

There are two different scenarios for device delivery to the patients.

The first is EKG technicians will instruct and explain to the patients about what the device is, how to use it, how to hook it up, and how to place leads. They will then hook up the device, and let the patient go home with specific instructions in order to continue to have the device on for the duration of evaluation.

The second is a monitor will be sent directly to the patient, and the patient will be hooked up at home with instructions from the vendor. In either of these cases a baseline is always submitted to the monitoring center where trained personnel record and interpret the strip.

Equipment must provide non-looping, looping, manually recording, and ambulatory cardiac 30-day event monitoring/monitors and applicable accessories. Devices shall be single or dual channel event monitor devices that operate in a looping mode or event mode and that are attached to the patient through removable electrodes. Monitors must be able to save the selected pre-symptom portion of the ECG rhythm, while continuing to record a post-symptom portion of the ECG. Patient must be able to transmit data by phone to vendor’s patient monitoring service.

Vendor shall also provide multi-channel ambulatory cardiac telemetry device that can be worn to provide up to 14 days of cardiac telemetry data and all applicable accessories.

Devices shall attach to the patient through removable electrodes. The device must automatically record and transmit an arrhythmia without patient intervention to vendor’s patient monitoring service.

Equipment must provide remote retrieval of 48-hour full disclosure of 3-channel ECG with option of transition to telemetry without interruption to patient.

The contractor shall be available to receive telephonic transmission of data from device seven days per week, twenty-four hours per day. Patient data must be reviewed by experienced cardiac technicians who prepare thorough diagnostic reports in hard copy or online format. The contractor shall also provide notification of cardiac abnormalities within one hour of discovery of abnormality. If pre-determined criteria are met, the patient's physician is notified immediately. Reports shall be faxed to the OKC VAMC and available on secure website for viewing within twenty-four hours of receipt of device.

Patient shall be able to send the event monitor directly back to the vendor at the end of the monitoring period at no cost. The contractor shall supply enrollment forms and a trackable self-addressed postage (ground or equivalent delivery) paid protective container for patients to return devices to the vendor’s facility. If the patient never sends the equipment back the Contractor, the VA is not responsible for the cost of that equipment.

All Monitors & Devices delivered shall come with a minimum of a 30 (thirty) day supply of all accessories required for operation including but not limited to batteries, electrodes, and patient instructions.

The Contractor shall provide monthly billing of all services performed, listing the type of procedure, the service date, the patient’s name and date of birth. Invoices will be provided no later than 20 days after the last day of the billing period. The Contractor shall be paid, in arrears, upon receipt of a proper invoice for the services furnished.

Included on the invoice should be Company name, tax ID number, contract number, funding obligation number (purchase order number), and remit to address.

Payment shall be made upon written certification from the COR the services have been performed. Invoices for payment may be rejected if all information required by the applicable clause in Contractor’s contract pertaining to payment is not included on the invoice.

DESIGNATION OF CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE:

An OKC VAMC representative will be designated as the COR 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 and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The COR does not have the authority to adjust anything within the contract that may or may not involve increased cost or adjustment of contract line items.

CONTRACT ADMINSTRATION DATA

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 COR on all matters pertaining to day to day contract operation. 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.

Training for VA Employees:

Within first 30 days from contract award, provide 2 days of on-site training for up to 5 VA staff members (3 technicians and 2 physician).

Performance Monitoring:

Performance will be monitored by a COR in Medicine Service and the Section Chief of Cardiology Service. The cardiac event monitor usage will be monitored and will be charted in CPRS under the patient’s medical chart. Each patient chart with recorded cardiac event monitoring data will be used for validating invoices.

TRAINING

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

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

Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

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

The contractor shall provide to the COR (the COR will forward to the Contracting Officer) a copy of all training certificates and certification of signing the Contractor Rules of

Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, and as required for new employees.

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.

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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

VA INFORMATION CUSTODIAL LANGUAGE

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.

VA information shall 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.

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

The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.

If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

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

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

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

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

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

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

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

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.

The A&A requirements do not apply, and the Security Accreditation Package is not required:

Training certificates are in place, which ensures the contractor and employee(s) will protect VA sensitive information.

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.

Line Items of Contract:

0001 Real-time Outpatient Cardiac Telemetry Device – 11 to 30 days. 2 Each

0002 Holter Monitoring 24-48 hours (with Real-time Outpatient Cardiac Telemetry). 300 Each

0003 Cardiac Event Monitoring with Telemetry: 1-30 Days Cardiac Event Monitoring with Telemetry Transmitting and Analyzing (real time event monitoring only) 1200 Each

MUST INCLUDE:

1. Real-time transmitting of 100% of ECG data to telemetry receiving center with 100% of the ECG and alarms being monitored by CCT technicians.

2. All patient events reported, posted and called in if meets physician criteria 24/7 in real-time /upon receipt.

3. All events meeting physician criteria reported, posted and call in 24/7 in real time/ upon receipt.

4. End of Study CE report

5. Minimum heart rate over monitoring period.

6. Maximum heart rate over monitoring period.

7. Average heart rate over monitoring period.

8. Additional ECG strips w/ correlating Full Disclosure providing overall ECG data (VE/SVE / Pauses, blocks, etc.) Showing overall view of patient ECG, as much does not meet criteria.

9. Additional requested customizable strips including 50 speed, color coded full disclosure, 2/3/or 6 Lead view of any ECG strip, onsets and offsets of any ectopy event, strips ranging from 8 seconds to hours, depending on physician’s needs and requests.

10. Atrial Fibrillation Burdens

B.3 Information System Security

IV. From VA Handbook 6500.6 Appendix C

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.

If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

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

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

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

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

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

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

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

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

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

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 COR and approved by VA Privacy Service prior to operational approval.

b. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA.

These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

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

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

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

i. Vendor must accept the system without the drive;

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

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

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

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

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

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

6. 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.