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36C24518Q0108
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
36C24518Q0108 02-23-2018 Bradley.Davis3@va.gov
304-263-0811 X4971 03-08-2018 2:00 pm 90C Department of Veterans Affairs
VAMC (581)
VISN 5 Contract Satellite Office 1540 Spring Valley Drive Huntington WV 25704 X X 621999 $15 Million N/A X 90C Department of Veterans Affairs
VAMC (581)
VISN 5 Contract Satellite Office 1540 Spring Valley Drive Huntington WV 25704 90C Department of Veterans Affairs
VAMC (613)
VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405
Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/
See CONTINUATION Page The VA Medical Center in Huntington, WV is need of a contractor who will furnish all equipment, materials, maintenance, and training necessary to perform Transtelephonic Arrhythmia Monitoring services.
Period of Performance Base Year April 1, 2018 to March 31, 2019 Option Year 1 April 1, 2019 to March 31, 2020 Option Year 2 April 1, 2020 to March 31, 2021 Option Year 3 April 1, 2021 to March 31, 2022 Option Year 4 April 1, 2022 to March 31, 2023 Use Price / Cost Schdule on page 6 Submit offers to Bradley.Davis3@va.gov
Deliver "Demo" equipment to 1540 Spring Vally Dr. Huntington WV 25704 C/O Cora Hosey.
Provide tracking information if mailed.
See CONTINUATION Page x X x Bradley Davis Contracting Officer Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011) | 5 |
| B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011) | 5 |
| B.4 PRICE / COST SCHEDULE | 6 |
| B.5 STATE OF WORK | 7 |
| B.6 IT CONTRACT SECURITY | 13 |
| SECTION C - CONTRACT CLAUSES | 23 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017) | 23 |
| C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 29 |
| C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 29 |
| C.4 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) | 30 |
| C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 30 |
| C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) | 30 |
| C.7 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION) | 31 |
| C.8 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION) | 32 |
| C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) | 32 |
| C.10 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) | 34 |
| C.11 VAAR 852.246-70 GUARANTEE (JAN 2008) | 34 |
| C.12 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008) | 34 |
| C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018) | 34 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 42 |
| D.1 CONTRACTOR RULES OF BEHAVIOR | 42 |
| D.2 CONTRACTOR CERTIFICATION: IMMIGRATION AND NATIONALITY ACT OF 1952, AS AMENDED | 47 |
| D.3 BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION | 48 |
| SECTION E - SOLICITATION PROVISIONS | 53 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017) | 53 |
| Important Notes: | 57 |
| E.2 52.216-1 TYPE OF CONTRACT (APR 1984) | 58 |
| E.3 52.233-2 SERVICE OF PROTEST (SEP 2006) | 58 |
| E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 59 |
| E.5 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008) | 59 |
| E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (JAN 2008) | 60 |
| E.7 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) | 60 |
| E.8 VAAR 852.273-73 EVALUATION - HEALTH-CARE RESOURCES (JAN 2003) | 61 |
| E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2017) | 62 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
(continuation from Standard Form 1449, block 18A.)
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C245 Bradley Davis Department of Veterans Affairs
VAMC (581)
VISN 5 Contract Satellite Office 1540 Spring Valley Drive Huntington WV 25704
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] in the arrears 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.
Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)
This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran-Owned Small Business Set-Aside. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.
B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)
This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.
B.4 PRICE / COST SCHEDULE
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| Transtelephonic Arrhythmia Unit Monitoring Services. |
Contract Period: Base POP Begin: 04-01-2018 POP End: 03-31-2019
| 110.00 |
| EA |
| __________________ |
| __________________ |
| 0002 |
| ACT Monitors with cell phone to transmit. |
Contract Period: Base POP Begin: 04-01-2018 POP End: 03-31-2019
| 12.00 |
| MO |
| __________________ |
| __________________ |
| 1001 |
| Transtelephonic Arrhythmia Unit Monitoring Services. |
Contract Period: Option 1 POP Begin: 04-01-2019 POP End: 03-31-2020
| 110.00 |
| EA |
| __________________ |
| __________________ |
| 1002 |
| ACT Monitors with cell phone to transmit. |
Contract Period: Option 1 POP Begin: 04-01-2019 POP End: 03-31-2020
| 12.00 |
| MO |
| __________________ |
| __________________ |
| 2001 |
| Transtelephonic Arrhythmia Unit Monitoring Services. |
Contract Period: Option 2 POP Begin: 04-01-2020 POP End: 03-31-2021
| 110.00 |
| EA |
| __________________ |
| __________________ |
| 2002 |
| ACT Monitors with cell phone to transmit. |
Contract Period: Option 2 POP Begin: 04-01-2020 POP End: 03-31-2021
| 12.00 |
| MO |
| __________________ |
| __________________ |
| 3001 |
| Transtelephonic Arrhythmia Unit Monitoring Services. |
Contract Period: Option 3 POP Begin: 04-01-2021 POP End: 03-31-2022
| 110.00 |
| EA |
| __________________ |
| __________________ |
| 3002 |
| ACT Monitors with cell phone to transmit. |
Contract Period: Option 3 POP Begin: 04-01-2021 POP End: 03-31-2022
| 12.00 |
| MO |
| __________________ |
| __________________ |
| 4001 |
| Transtelephonic Arrhythmia Unit Monitoring Services. |
Contract Period: Option 4 POP Begin: 04-01-2022 POP End: 03-31-2023
| 110.00 |
| EA |
| __________________ |
| __________________ |
| 4002 |
| ACT Monitors with cell phone to transmit. |
Contract Period: Option 4 POP Begin: 04-01-2022 POP End: 03-31-2023
| 12.00 |
| MO |
| __________________ |
| __________________ |
| GRAND TOTAL |
| __________________ |
36C24518Q0108
B.5 STATE OF WORK
Contractor will furnish all equipment, materials, maintenance, and training necessary to perform transtelephonic arrhythmia monitoring services. Contractor will receive process and analyze any and all transmissions from said equipment and provide a report to the VA Medical Center within 24-hours of receipt of reading. In the event of abnormal and symptomatic strips are read for a patient, vendor will fax immediately to the VA Cardiology Department @ 304-429-7584 during normal business hours of Monday through Friday 8am till 4:30pm. After normal business hours, the vendor will fax strips to the VA MOD @ 304-429-7559, call VA MOD @ 1-800-827-8244 ext 2125 and call the on-call Cardiology Fellow @ 304-690-8183.
SERVICES
The services specified in this contract may be changed in written modifications to this contract. The modifications shall be prepared by the VA Contracting Officer and, prior to becoming effective, shall be approved by the VA Undersecretary for Health or his/her designee.
The services specified in this contract to be furnished to the VA by the Contractor shall be under the direction of the VA Medical Center Director for his/her designee(s).
TERM OF CONTRACT
The term of this contract will be for a base period of 4-1-2018 through 3-31-2019 with four optional renewal period of one year to be exercised at the discretion of the Government. This contract is issued subject to the availability of funds.
QUALIFICATIONS
1. Cardiac Technicians assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.
2. Personnel providing services under this contract must speak and write English proficiently.
3. The Contractor shall identify their contact person(s), who shall serve as liaison between the contractor and the VA Medical Center, and who shall ensure that services are performed in accordance with contract specifications. The contractor’s contact person(s) shall be available during the VA’s administrative tour of duty from 8:00 a.m. to 4:30 p.m., Monday through Friday.
5. Any subcontractor used by the Contractor for the provision of services required under this contract must meet the same qualifications herein for the Contractor. The Contractor must obtain approval from the VA Contracting Officer for any subcontractors to be utilized for the provision of services required under this contract.
PERSONNEL POLICY
1. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel:
Workers Compensation Professional Liability Insurance Health Examinations Income Tax Withholding and Social Security Payments
The parties agree that such personnel shall not be considered VA employees for any purpose and shall be considered employees of the Contractor (except as described in the paragraph below entitled “Privacy Act/VA Confidentiality Statutes”).
PAYMENT
Contractor shall accept payment for services rendered under this contract as payment in full and will not bill the veteran or his/her third party insurer for any services covered under this contract or for additional services for which the VA pays the contractor outside the contract.
Vendor Electronic Invoice Submission Methods: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:
Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/
Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov
RECORD KEEPING SYSTEM
VA shall have a record keeping system that documents the performance.
CONTRACTOR FURNISHED ITEMS
Contractor shall furnish all equipment and materials necessary to perform the tasks specified in the contract. The Contractor shall secure all materials. Vendor shall supply all Event Loop Monitoring recording equipment. The VA requires a minimum of four units to be delivered at beginning of the contract period and maintained throughout the contract period. The VA reserves the right to increase the number of units in order to meet patient demand. In the event the level of units of maintained at the VA exceeds ten the pricing may be amended.
Equipment to be provided to the patient for a minimum of 30 days or as needed. All maintenance, repair or placement of faulty equipment will be the sole responsibility of the vendor. The contractor shall also maintain their building space, equipment and supplies to the same standards as required by JCAHO and OSHA standards. The contractor warrants that any property furnished to the patients of the VA pursuant to the terms of this contract shall be free from defects in workmanship and will conform to the requirements of this contract as to cleanliness, safety, and suitability. Accordingly, the contractor shall procure and maintain bodily injury and property damage liability insurance. Such insurance shall ensure and protect the patient and members of the public from bodily injury or property damages arising out of the use of rental property furnished by the contractor. The bodily injury liability and property damage liability insurance shall be the minimum limits of $200,000 per person and $500,000 per accident or claim for bodily injury liability and $20,000 for property damage or other wise in accordance with state requirements for insurance coverage. The contractor is responsible for their equipment and therefore will be liable if equipment is lost/ damaged or stolen. The VA will assist the contractor in an attempt to recover arrhythmia units not returned by the Veteran. In no case should the Veteran or a third party be charged for the unit.
REPORTS AND DATA
VA will provide vendor with proper enrollment information on patients EKG Order Forms and initial strip must be phoned into the vendor.
At completion of all arrhythmia studies, vendor will send full report including a Summary Report on all transmissions received during monitoring period to VA. Reports must be thorough, complete and accurate.
Point of contact for critical information can be reached Monday through Friday, 8:00 a.m. to 4:30 p.m. at 1-800-827-8244, extension 2580 and fax 304-429-7584. All other hours point of contact can be reached at the emergency room MOD @ 1-800-827-8244 ext 2125 and fax 304-429-7559 and call the on-call Cardiology Fellow @ 304-690-8183.
TRAINING
Vendor to provide instructional information to VA staff regarding the use and application of all equipment to be used by the VA. Vendor will provide ongoing clinical support to VA and respond to any and all technical or billing questions through its toll free “800” telephone number which will be available 24 hours per day, 7 days per week.
VA will in-service appropriate patients or family members on proper utilization of arrhythmia monitoring equipment. Patient is responsible for returning equipment after monitoring period. Vendor must provide return postage and all necessary packing supplies.
PRIVACY ACT/SECURITY REQUIREMENTS FOR CONTRACTORS HAVING ACCESS TO VETERAN INFORMATION
Our nation's veterans entrust the VA with extensive medical, financial, and other personal data, and rely on the integrity of our staff and of our security procedures to protect that information, and to ensure that the VA properly protects their personal information. Any contractor, who may have access to this sensitive data, is also required to follow the same code of behavior when dealing with such information. In accordance with the VISN (Veterans Integrated Service Network) 9 Directive 10N9-31-06, dated May 26, 2006, contractor shall ensure that all contractor personnel with access to patient records comply with the Privacy Act of 1974, (38 USC 7332 & 5701) and the requirements of the Health Insurance Portability and Accountability Act (HIPAA). Each contractor employee that will have access to any sensitive data will be required to abide by the conditions and security requirements noted herein. Violations may be cause for termination of the contract. Contractor must provide adequate on-site security of your facilities, equipment, and software where patient information is stored, utilized, or accessed, to ensure protection from hazard, theft, and unauthorized access.
A. SECURING SENSITIVE DOCUMENTS: Forms and other types of printed output produced by any computer system will be evaluated by the responsible staff member for data sensitivity. Printed output containing sensitive data should be labeled as such, stored in locked cabinets or desks, and disposed of properly by shredding or placement in specially marked containers. All employees are responsible for retrieving all printed outputs they request from printers or facsimile machines. Data files, documentation, and other back-up materials will be stored in areas controlled by locks or personnel to prevent unauthorized access.
1. Contractor(s) shall insure the confidentiality of all patient and employee information and shall be held liable in the event of breech of confidentiality according to federal regulations contained in HIPAA. Any person, who knowingly or willingly discloses confidential information from the VA Medical Center, may be subject to fines of up to $50,000.00 and may be subjected to civil litigation from the patient.
2. Records: Contractor(s) personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under 38 U.S.C. §4132 or §3305, as defined by the Department of Veterans Affairs, shall not have access to the records unless absolutely necessary to perform their contractual duties. Any individual who has access to these data will disclose them to no one, including other employees of the Contractor(s) not involved in the performance of the particular contractual duty for which access was obtained. Violation of these statutory provisions, as stated in department regulations by the Contractor(s)’s employees may involve imposition of criminal penalties. The C&A requirements do not apply, and that a Security Accreditation Package is not required:
B. COMMUNICATIONS AND TRANSMISSIONS SECURITY (HIPAA 164.312e; FISMA 8.2):
1. Facsimile (Fax) Machines (if utilized for submission of reports): Individuals who FAX sensitive or confidential information must ensure the FAX is sent to the appropriate individual and they are aware the information is to be protected from unauthorized use.
a. Fax transmissions will contain a cover sheet with the following statement: "This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above." HIPAA regulations apply to all faxes transmitted to or from electronic devices.
b. Contractor staff shall ensure the correct recipient’s fax number is entered prior to transmittal. Delivery must be confirmed by telephoning the recipient, E-mail confirmation of FAX receipt, or review of fax transmittal confirmation sheet.
c. Fax machines should be placed in areas secured by physical access controls that require security keys, badges, or similar mechanisms in order to gain access.
d. Fax machines should have pre-programmed and tested destination numbers entered to minimize the potential for human error.
2. E-mail (if utilized for submission of reports): The transmission of e-mail messages containing sensitive information or ePHI via Outlook must be done in a secure manner, i.e., encryption. PKI is the only approved method of encryption for the VA. A PKI certificate can be obtained by contacting the facility ISO.
C. RESTRICTIONS ON TRANSMISSION, TRANSPORTATION AND USE OF, AND ACCESS TO, VA DATA OUTSIDE VA FACILITIES
1. VA information may not reside on non-VA systems or devices unless specifically designated and approved in advance by the appropriate VA official (supervisor), and only where the non-VA systems or devices conform to, or exceed, applicable VA security policies or are specifically authorized by VA guidance.
2. VA Protected Information (VAPI) must not be transmitted by remote access unless VA-approved protection mechanisms are used. All encryption modules used to protect VA data must be validated by NIST to meet the currently applicable version of Federal Information Processing Standards (FIPS) 140 (See http://csrc.nist.gov/crypval/140-1/1401val.htm for a complete list of validated cryptographic modules). Only approved encryption solutions using validated modules may be used when protecting data during transmission.
3. Passwords or other authentication information must not be stored on remote systems unless encrypted. VA-PKI certificates must be stored in encrypted form only and must be accessible only by using a personal identification number (PIN) or password.
4. Data Stored – Encryption. Additional security controls are required to guard VAPI stored on computers outside VA facilities. All VAPI stored on the computer, file or electronic storage media must be encrypted using VA-approved protection mechanisms (see bullet two, above).
5. Equipment must be housed and protected to reduce the risks from environmental threats and hazards, and the opportunities for unauthorized access, use, or removal.
6. Portable computers that have VAPI on their storage device(s) or have software that provides access to VA private networks must be secured under lock and key when not in immediate vicinity of responsible individual. This includes external hard drives and other storage devices.
7. Data and system backups that include VA information have the same confidentiality classification as the originals. Therefore, these materials must be protected with the same or equally effective physical security as that provided to the source computer, its media, and information contained therein.
8. All individually identifiable health records/information shall be treated with the strictest confidentiality. Access to records shall be limited to essential personnel only. Records shall be secured when not in use.
PHYSICIAN NOTIFICATION CRITERIA AND CALL BACK PHONE LIST
The above referenced contract is hereby modified to incorporate the Physician Notification Criteria shown on page 2 and the Call-Back Phone List provided. The contractor is required to make notification to the VA in accordance with this criteria. The “Call-Back” list must be utilized when calls are placed to the VA concerning results of the arrhythmia recordings.
VAMC HUNTINGTON NOTIFICATION CRITERIA
TWENTY -FOUR HOUR NOTIFICATION
Contractor will notify the VAMC Huntington Cardiology Office or the on-call MOD and Cardiology Fellow when a patient transmits a recording that meets one or more of the following criteria:
Pause 3 seconds or greater Wide Complex Tachycardia 120 BPM or greater with duration of 4 beats or greater Second or Third Degree AV Block All reported syncope Pacemaker Failure Any documented or reported defibrillator discharges
OFFICE HOUR NOTIFICATION
Recordings that meet the following criteria will be notified upon that same day, between the hours of 8 am to 4:30 pm, or the next business day when the recording is received by Contractor after 4:30 pm. If however, the follow-up recording demonstrates the notification rhythm, the VAMC Huntington Cardiology Office or the on-call MOD and Cardiology Fellow will be notified immediately:
Supraventricular Tachycardia 150 BPM or greater with duration of longer than 30 seconds.
Bradycardia less than 40 BPM with duration of longer than 30 seconds
Atrial flutter and/or Atrial Fibrillation New onset (as documented by contractor) with duration of greater than 30 seconds Ventricular response 150 BPM or greater with duration of greater than 30 seconds
EMERGENCY CRITERIA
If the patient presents with the following ECG criteria and the VAMC Huntington Cardiology Office or the on-call MOD and Cardiology Fellow cannot be reached, contractor will activate Emergency Medical Services (EMS).
Sustained Supraventricular Tachycardia or Atrial Fibrillation 150 BPM (adults) or greater Sustained Wide Complex Tachycardia 120 BPM or greater Sustained Bradycardia 35 BPM or less
B.6 IT CONTRACT SECURITY
NOTE: APPLICABLE SECTIONS: 2, 6, 7, 8, and 9.
VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY
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 [APPLICABLE]
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 [N/A]
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 COR.
4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT [N/A]
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 COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.
b. The contractor/subcontractor shall certify to the COR 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;
(1) 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
(2) 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 [N/A]
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. 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 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.
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