SF1449 _ 36C24821Q1774.pdf

PAGE 1 OF 77 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

36C24821Q1774 11-04-2021

Mechelle Reaser 813-972-2000 Ext. 7541 11-15-2021

3:00 PM EDT

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525

Tampa FL 33637

X 100

X

621512

$16.5 Million

N/A

North Florida / South Georgia VHS

Malcom Randall VA Medical Center

1601 SW Archer Road

Gainesville FL 32608

36C248

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy

Tampa FL 33637

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971

The contractor shall provide off-site 3D Image Reconstruction

And Case Planning services to eligible beneficiaries of the

North Florida/South Georgia Veterans Healthcare System located

At Malcom Randall VA Medical Center.

The Period of Performance is 12/01/2021 – 11/30/2022

Ultimate Expiration Date: 11/30/2026

Reference pages five (5)-seven (7) for the Price Schedule.

Reference pages eight (8)- twenty-eight (28) for the

573-3620160-131-820200-2625 010020251

Mechelle D. Reaser, Contracting Officer

36C24821Q1774

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 PRICE SCHEDULE

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.5 52.223-99 ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR

FEDERAL CONTRACT0RS (OCT 2021) (DEVIATION)

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.9 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN

D.2 ORGANIZATIONAL CONFLICT OF INTEREST

D.3 IMMIGRATION CERTIFICATION

D.4 CONTRACTOR RULES OF BEHAVIOR

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUL 2021) . 51

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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: ______________________________________________

Title: ......................... ______________________________________________

Address: ................... ______________________________________________

Telephone: ................ ______________________________________________

Facsimile: ................. ______________________________________________

E-mail ....................... ______________________________________________

Federal Taxpayer ID Number ________________________________________

Dun and Bradstreet Number ________________________________________

b. GOVERNMENT: Contracting Officer (90C)

Mechelle D. Reaser

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525

Tampa FL 33637

Phone: 813-972-2000 Ext. 7541

Email: Mechelle.Reaser@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address:

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.

mailto:Mechelle.Reaser@va.gov

Department of Veterans Affairs

Financial Services Center

P.O. 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

END OF CONTRACT ADMINISTRATION DATA

B.2 PRICE SCHEDULE

The Government intends to award a firm-fixed price contract for 3-dimensional (3D) Image

Reconstruction and Case Planning Services. The specific services to be performed include the acquisition, upload and assessment of quality of digital CT Scan images, multiplanar reformatting of digital data and production of a 3D reconstruction tool for use in case planning for endovascular procedures. Contractor shall furnish all personnel to provide services necessary to perform off-site 3D Image Reconstruction and Case Planning

Services to eligible beneficiaries of the North Florida/South Georgia Veterans Healthcare

System, Malcom Randall VA Medical Center (hereinafter referred to as VAMC). The contractor shall provide 3D Image Reconstruction and Case Planning services in accordance with the Performance Work Statement (PWS). The contractor will be reimbursed at the rates specified in the schedule of services.

1. CONTRACT TYPE: Firm Fixed Price Contract.

2. AUTHORITY: Title 38 United States Code (U.S.C) 8153 Health Care Resources (HCR)

Sharing Authority, VA Directive 1663, FAR Part 12 Acquisition of Commercial Items in conjunction with FAR Part 13.5 Simplified Acquisition Procedures for Certain Commercial Items.

3. PLACE OF PERFORMANCE: All services shall be performed off-site at the contractor’s facility.

4. PERIOD OF PERFORMACE: One (1) Year Base Period and four (4), Twelve (12)

Month Option Periods.

5. PRICING: Price Schedule for Line-Item Number (LIN): LIN, Description of Services, Quantity, Unit, Unit Price, LIN Total Amount and Grand Total Amount.

BASE YEAR: DECEMBER 01, 2021 – NOVEMBER 30, 2022

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

0001 3D Image Reconstruction and Case Planning Services

100 CS

0002 Estimated Rush/Emergency Procedures

10 CS

0003 Extra Disc Usage 7 EA

TOTAL FOR BASE YEAR

OPTION YEAR ONE (1): DECEMBER 01, 2022 – NOVEMBER 30, 2023

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

1001 3D Image Reconstruction and Case Planning Services

117 CS

1002 Estimated Rush/Emergency Procedures

12 CS

1003 Extra Disc Usage 7 EA

TOTAL FOR OPTION YEAR ONE (1)

OPTION YEAR TWO (2): DECEMBER 01, 2023 – NOVEMBER 30, 2024

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

2001 3D Image Reconstruction and Case Planning Services

133 CS

2002 Estimated Rush/Emergency Procedures

19 CS

2003 Extra Disc Usage 12 EA

TOTAL FOR OPTION YEAR TWO (2)

OPTION YEAR THREE (3): DECEMBER 01, 2024 – NOVEMBER 30, 2025

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

3001 3D Image Reconstruction and Case Planning Services

150 CS

3002 Estimated Rush/Emergency Procedures

21 CS

3003 Extra Disc Usage 12 EA

TOTAL FOR OPTION YEAR THREE (3)

OPTION YEAR FOUR (4): DECEMBER 01, 2025 – NOVEMBER 30, 2026

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

3001 3D Image Reconstruction and Case Planning Services

167 CS

3002 Estimated Rush/Emergency Procedures

23 CS

3003 Extra Disc Usage 12 EA

TOTAL FOR OPTION YEAR FOUR (4)

TOTAL FOR BASE AND FOUR (4) ONE (1) YEAR OPTIONS:

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL

1.1. SERVICES REQUIRED: Contractor shall provide 3D Image Reconstruction and Case

Planning Services to perform multi-planar reformatting and 3D reconstruction of CT angiography cases for vascular surgical procedures for eligible Veteran’s beneficiaries for care at the VAMC. The specific services to be performed include the acquisition, upload, and assessment of quality of digital CT Scan images, multiplanar reformatting of digital data and production of a 3D reconstruction tool for use in case planning for endovascular procedures as related to:

1.1.1. Computerized Tomography (CT) Based Image Reconstruction – includes acquisition and assessment of digital data quality, transferring and reformatting the data to create a 3D reconstruction image suite for endovascular case planning.

1.1.2. Provision of Hard-Copy – return by next day services a CD containing all of the original image data, the reformatted image data, the 3D reconstruction images, and software self-contained for viewing, analysis and case planning.

1.1.3. Provision of Secure Electronic Access – electronic access via secure, password – protected account to the original images data, reformatted image data, the 3D reconstructed images and software for remote or urgent access privacyfor viewing, analysis, and case planning.

1.1.4. Software updates and technical support – regular announcement/delivery of software updates either contained within CS packaging or via online services, availability of technical support during regular business hours either online or via telephone.

1.2. PLACE OF PERFORMANCE: All services shall be performed off-site at the contractor’s facility.

1.3. AUTHORITY: Title 38 U.S.C. 8153 HCR Sharing Authority, VA Directive 1663, FAR

Part 12 Acquisition of Commercial Items in conjunction with FAR Part 13.5 Simplified

Acquisition Procedures for Certain Commercial Items.

1.4. POLICY AND REGULATIONS. Contractor shall comply with all applicable policy and regulations, including but not limited to the following:

1.4.1. VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

1.4.2. Privacy Act of 1974 (5 U.S.C. 552a) as amended

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.3. VHA Directive 2006-041: “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.4.4. Privacy Act of 1974 (5 U.S.C. 552a) as amended

1.5. DEFINITIONS/ACRONYMS: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. CD: Compact Disc

1.5.2. CO: Contracting Officer

1.5.3. COR: Contracting Officer’s Representative

1.5.4. COS: Chief of Staff

1.5.5. CT: Cardio Thoracic

1.5.6. EFT: Electronic Funds Transfer

1.5.7. EVAR: Endovascular Aneurysm Repair

1.5.8. FAR: Federal Acquisition Regulations

1.5.9. Health Care Resources

1.5.10. HIPAA: Health Insurance Portability Accountability Act

1.5.11. JC: Joint Commission

1.5.12. OPM: Office of Personnel Management

1.5.13. PO: Privacy Officer

http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.5.14. POP: Period of Performance

1.5.15. PWS: Performance Work Statement

1.5.16. 3D: 3-Dimensional

1.5.17. TJC: The Joint Commission

1.5.18. USC: United Stated Code

1.5.19. VA: Veterans Affairs

1.5.20. VAAR: Veterans Affairs Acquisition Regulations

1.5.21. VAMC: Veterans Affairs Medical Center

1.5.22. VHA: Veterans Healthcare Administration

2. QUALIFICATIONS

2.1. STAFF/FACILITY

2.1.1. License: Contractor’s employee (s) assigned by the contractor to perform the services covered by this contract shall have a full and unrestricted license in a

State, Territory, or Commonwealth of the United States or the District of Columbia, if applicable. If required by the State of Licensure current registration must also be maintained.

2.1.2. Technical Proficiency: Contractor and Contractor’s employee (s) shall be technically proficient in the skills necessary to fulfill the governments requirements including the ability to speak, understand, read and write English fluently.

Contractor shall provide documents upon request of the COR/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed.

2.1.3. Conflict of Interest. The contractor and all contract employee (s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of quote and during the entirety of contract performance. At the time of quote, the contractor shall provide a statement which describes in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The

Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The

Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.4. Citizenship Related Requirements:

2.1.4.1. The contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As

Amended; its related laws and regulations that are enforced by Homeland

Security, Immigration and Customs Enforcement and the U.S Department of

Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the

Department of Veterans Affairs patient referrals;

2.1.4.2. While performing services for the Department of Veterans Affairs, the

Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order

12989” and related pertinent Amendments, as well as applicable Federal

Acquisition Regulations.

2.1.4.3. If the contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans

Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the

Department of Veterans Affairs; and shall from the basis for termination of this contract for breach.

2.1.4.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C.

1001.

2.1.4.5. The contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFQ using the subject attachment in Section D of the solicitation document.

2.1.5. Annual Office of Inspector General Statement: In accordance with HIPPA and the BBA of 1977, the Department HHS OIG has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Healthcare program payments due to fraud and/or abuse if the Medicare and Medicaid programs.

2.1.5.1. By submitting their proposals, the contractor certifies that the HHS OIG

List of Excluded Individuals/Entities has been reviewed and that the contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.1.5.2. Exclusions and Sanction Certification: Contractor shall provide annual written certification to the CO which certifies that all employees, subcontractors and their employees have been checked to ensure that all agents providing services under this contract have been found not to be listed on the List of Parties Excluded from Federal Programs and the HHS/OIG

Cumulative Sanction Report. The annual certification shall be provided within three (3) weeks after award and within three (3) weeks after the exercise of any option periods.

2.1.6. Non-Personal Healthcare Services: The parties agree that the contractor and all contract personnel (s) shall not be considered VA employees for any purposes.

2.1.7. Indemnification: The contractor shall be liable for and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the contractor, its agents, or employees.

2.1.8. Inherent Government Functions: Contractor and contract personnel (s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance and strategy.

2.1.9. No Employee Status: The contractor shall be responsible for protecting contract personnel (s) furnishing services. To carry out this responsibility, the

Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.1.9.1. Workers’ compensation

2.1.9.2. Professional liability insurance

2.1.9.3. Health examinations

2.1.9.4. Income tax withholding, and

2.1.9.5. Social security payments

2.1.10. Tort Liability: The Federal Tort Claims Act does not cover contractor or contract personnel (s). When Contractor or contract personnel (s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract personnel (s)) action or non-action shall be the responsibility of the contractor and/or insurance carrier.

3. HOURS OF OPERATION:

3.1. VA Business Hours: The Malcom Randall VAMC business hours are 24 hours a day, seven (7) days per week.

3.1.1. Federal Holidays: The following are observed by the Department of Veterans

Affairs:

3.1.1.1. New Year’s Day

3.1.1.2. Martin Luther King’s Birthday

3.1.1.3. President’s Day

3.1.1.4. Memorial Day

3.1.1.5. Juneteenth Day

3.1.1.6. Independence Day

3.1.1.7. Labor Day

3.1.1.8. Columbus Day

3.1.1.9. Veterans Day

3.1.1.10. Thanksgiving Day

3.1.1.11. Christmas Day

3.1.1.12. Any day (s) specifically declared to be a national holiday

3.1.2. Continuity of services under contract: Unless a state of emergency has been declared or services are otherwise cancelled by the VAMC, the contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED: Contractor shall provide 3D image reconstruction and case planning services for endovascular procedures.

4.2. Contractor shall provide a patient-specific self-contained CD that contains the preview analysis software and all the original axial CT data as well as several reformatted multiplanar surface-rendered datasets that represents the data to allow for detailed precise measurement of vessel diameter, length, angle and aneurysm volume. The CD is portable allowing for use in the outpatient clinic, office and importantly in the OR assisting during EVAR surgery.

4.3. In addition to the multiplanar reformatting, contractor shall provide an interactive 3D reconstructed model of the patient’s aneurysm. Thus allows for complete 60 degree manipulation of the model for exact analysis of the morphology of the aneurysm, its relation to adjacent arteries, and vessel angle or tortuosity, all of which critically impact the technical aspect of EVAR procedure.

4.4. STANDARD OF PRACTICE: Contractor shall be responsible for meeting or exceeding

VA and Joint Commission (or equivalent) standards.

4.5. MEDICAL RECORDS

4.5.1. Authorities: Contract personnel (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical

Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of Medical Quality

Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R parts

160, 162, and 164 (HIPAA).

4.5.2. HIPAA: This contract and its requirements meet exception in 45 CFR

164.502(e), and do not require a BAA in order for Covered Entity to disclose

Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’

(24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense.

Contractor shall deliver all final patient records, correspondence, and notes to the

VA within twenty-one (21) calendar days after the contract expiration date.

4.5.3. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the

Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and

Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of

Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and

Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address:

Patrick Cheek 1601 SW Archer Road GVT-10, room 103 Gainesville, FL 32608 Telephone: (352) 548-7174 Fax: GV (352) 271-4579 E-mail: Patrick.Cheek@va.gov Mail Code: 001A-GV

4.6. DIRECT PATIENT CARE: 95% of the time will be devoted to patient care activities.

4.6.1. Contractor shall be responsible for the acquisition and assessment of digital data sent from NFSG/Vascular Service and then transferring and reformatting the data to create a 3D reconstruction image for endovascular case planning.

4.6.2. Returning the data sent from NFDG/Vascular Services the next day with a CD containing all of the original data, the reformatted data, the 3D reconstruction images, and software self-contained for viewing, analysis, and case planning.

4.6.3. Provided the returned data sent from NFSG/Vascular Services with an electric access via a secure, password-protected account.

4.6.4. Provision of software updates and technical support.

4.7. ADMINISTRATIVE: 5% of time not involved in direct patient care.

4.7.1. Contractor shall communicate with the COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.7.2. Contractor shall complete any required training within established guidelines.

5. PERFORMANCE STANDARDS, QUALITY ASSURANCE SURVEILLANCE PLAN AND

QUALITY IMPROVEMENT

5.1. Quality Management/Quality Assurance Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this PWS and methods of surveillance detailed in the QASP. The QASP shall be attached to the resultant contract and shall define the methods and surveillance conducted.

5.2. Quality Assurance - Contract monitoring will be accomplished through a record keeping system (attendance log) maintained by the Chief of Surgical Service and COR in order to reconcile payments. Contractor’s employees shall sign in and sign out of the attendance log indicating the dates and times worked. Procedure documentation shall be maintained by the contractor and shall be signed by the contractor’s employee(s). The Chief of

Surgical Service and COR shall certify the actual number of procedures completed.

Copies of the procedure documentation sheets shall be forwarded to the Chief of Surgical

Service and COR for review and concurrence. The Chief of Surgical Service and COR are responsible for monitoring the professional components of the contract. All adverse actions shall be reported to the CO immediately.

5.3. The CO and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with TJC standards and the policies and procedures of the Malcom Randall VAMC.

5.4. The Government reserves the right to refuse acceptance of any Contract personnel (s) at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract personnel (s), s/he may request, without cause, immediate replacement of said contract personnel (s).

The CO and COR shall deal with issues raised concerning Contract personnel (s) conduct. The final arbiter on questions or acceptability is the CO.

5.5. METHODS OF SURVEILLANCE: Various methods exist to monitor performance. The

COR will use the surveillance methods listed below in the administration of the QASP

5.5.1. Direct Observation. 100% surveillance: The COR and Vascular Service members will ensure that accuracy, quality and timeliness are not compromised.

This will be performed upon receipt and review of each CD images. Performance evaluation will be performed semi-annually.

5.5.2. Periodic Inspection. Inspections will be scheduled and reported quarterly per

COR Delegation or as needed a minimum of ten (10) samples will be selected randomly and reviewed for accuracy, quality and timeliness of submission. All inspections and reports will be conducted in compliance with VA Privacy and

Information security standards.

5.5.3. PERFORMANCE STANDARDS: Performance measures define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Performance Requirements

Summary Matrix in attachment D, QASP includes performance standards. The

Government will use these standards to determine contractor performance and will compare contractor performance to the Acceptable Quality Level (AQL).

5.6. Registration with Contractor Performance Assessment Reporting System

5.6.1. As prescribed in FAR 42.15, the Department of Veterans Affairs evaluates contractor past performance on al contracts that exceed $150,000.00 and share those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the PPIRS database, which is available to all Federal agencies.

PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the FAPIIS. FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

5.6.2. Each Contractor whose contract award is estimated to exceed $150,000 requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @DSN

@DSN: 684-1690 or COMM; 207-438-1690.

5.6.3. Failure for the Contractor’s representative to respond to the evaluation within those sixty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the

Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

6. GOVERNMENT RESPONSIBILITIES

6.1. VA Support Personnel, Services, or Equipment

6.1.1. Contractor shall be jointly responsible along with the Chief of Staff of the respective VAMCs in developing criteria for monitoring quality assurance, quality control, utilization review, procedures relevant to Engineering Support Services in order to assure compliance with the current Joint Commission on accreditation of

Healthcare Organizations standards. Contractor will be required to furnish peer review results at time of credentialing and as required in deliverables.

6.2. Contract Administration / Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to

Mechelle D. Reaser, CO

Department of Veterans Affairs – VHA

Regional Procurement Office (RPO) East – 8

Network Contracting Office 8

Tampa, FL 33637

Phone: 813-972-2000 Ext. 7541

Mechelle.Reaser@va.gov http://www.cpars.gov/ mailto:Mechelle.Reaser@va.gov

Matthew B. Hewes, COR, Program Analyst 1601 SW Archer Rd.

Gainesville, FL 32608 352-376-1611 ext. 5665 Matthew.Hewes@va.gov

6.2.1. CO RESPONSIBILITIES:

6.2.1.1. The CO is the only person authorized to approve changes or modify any of the requirements of the contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity, or quality of performance of this contract.

6.2.1.2. The CO will complaints concerning Contractor relations with the

Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

6.2.1.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contract personnel (s) to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

6.2.2. COR RESPONSIBILITIES

6.2.2.1. All work coordination shall be made through the COR. The Contractor will be provided a copy of the letter of delegation, authorizing the COR at the commencement of the term of this contract. No other person shall be authorized to act in such capacity unless appointed in writing by the CO. The

COR will be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the CO.

6.2.2.2. All contract administration functions will be retained by the VA.

7. SPECIAL CONTRACT REQUIREMENTS

7.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements mailto:Matthew.Hewes@va.gov regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

7.1.1. The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc.

identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

What Submit as noted Submit To

Quality Control Plan: Description and reporting reflecting the contractor’s plan for meeting of contract requirements and performance standards

Upon proposal and as frequently as indicated in the performance standards.

CO

Proof of Indemnification and Medical

Liability Insurance

Upon proposal and renewals. CO

VA Cyber Security Awareness and Rules of Behavior training

Privacy, Confidentiality and HIPAA training; and any other training required by the Malcom Randall VAMC

Before receiving an account on VA Network and annual training and new hires.

CO

Credentialing and Qualification information related to staff

Upon proposal and as updated

CO

Contractor Certification: Immigration and

Nationality Act of 1952, As Amended

Upon proposal CO

Contingency plan Upon proposal and as updated

COR

7.2. Billing:

7.2.1. Payment shall be denied by VA for services performed OUTSIDE

PERFORMANCE OF WORK OF THIS CONTRACT.

7.2.1.1. Payment will be paid monthly in arrears upon receipt of a proper invoice for the services furnished. The invoice shall identify the description of services, period of performance for services billed, dollar amount, and remit to address. Payment will be authorized upon written certification from the COR that the services have been performed.

7.2.1.2. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a

“proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

7.2.1.3. Name and Address of Contractor

7.2.1.4. Invoice Date and Invoice number

7.2.1.5. Contract Number and Purchase / Task Order Number

7.2.1.6. Date of Service

7.2.1.7. Service Rate

7.2.1.8. Quantity of procedures

7.2.1.9. Total Price

7.3. Electronic Invoicing: The U.S. Department of Veterans Affairs initiated an important change in the accounts payable process, which is mandatory and will ensure contractors are paid promptly. All invoices shall be submitted electronically through the

OB10 portal. The OB10 portal will pick up any flat text invoice format, any invoice data layout and can be sent through any electronic communication method of the contractor’s choice. What this means is that the contractor can now send electronic invoices from an existing billing system. To obtain access to the OB10 system, contact:

OB10 Client Services

Phone: 1-877-752-0900, Option 2

Email: VA.Registratrion@OB10.com

OB10 Support

Phone: 1-877-489-6135

Website: http://www.Ob10.com/Country/US/Support

Electronic Payment: While making the invoice submission process completely electronic, the VAFSC is expanding their electronic payments. To this end, an ACH enrollment form can be found at http://www.fms.treas.gov/index.html. Follow the link and search for “3881” within the FAQ guide. ACH offers significant advantages, including reduced delivery time for payment, eliminating postal system delays, automated payment generation through the VA accounting system and reducing the likelihood of errors. Contact the VAFSC if assistance is required.

mailto:VA.Registratrion@OB10.com http://www.ob10.com/Country/US/Support http://www.fms.treas.gov/index.html

VA Financial Service Center PO Box 149971 Austin, TX 78714-8971 Phone: 1-877-353-9791

7.4. Payment Adjustments:

7.4.1. Payment in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

7.4.2. To the extent that the Veterans desires services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

7.4.3. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.

Note: Contract personnel (s) are prohibited from referring VA patients to their own practices (s).

8. CONTRACTOR SECURITY REQUIREMENTS (HANDBOOK 6500.6) –

8.1. BACKGROUND INVESTIGATION

8.1.1. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

A. The cost of background investigations shall be borne by the contractor. All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and shall receive a favorable adjudication from the

VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all personnel requiring the same access. If the investigation is not completed prior to the start date of the contract, the contractor shall be responsible for the actions of those individuals they provide to perform work for VA.

B. Contractor shall insure the confidentiality of all patient and employee information and shall be held liable in the event of breach of confidentiality. Any person, who knowingly or willingly discloses confidential information from the VA Medical Center, may be subject to fines of up to

$20,000.00 as referenced in the VHA Handbook 1605.1 revised May 16, 2006, Privacy and

Release of Information.

C. All contractor employees are subject to the same level of investigation as VA employees who have access to VA Sensitive Information. The level of background investigation commensurate with the level of access needed to perform the performance work statement is:

i.. Position Sensitivity – The position sensitivity has been designated as Low risk.

ii. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquires (NACI).

D. Contractor Responsibilities

1. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse VA within 30 days of receipt of bill. If timely payment is not made within 30 days from date of bill for collection, then VA will deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

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

English language referenced in 38 USC 7402(d) and 7407(d).

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

i. Standard Form 85P, Questionnaire for Public Trust Positions

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

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

iv. VA Form 0710, Authority for Release of Information Form

v. Optional Form 306, Declaration for Federal Employment

vi. Optional Form 612, Optional Application for Federal Employment

3. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from working under the contract, and at the request of the VA, submit another employee for consideration.

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

5. Contractor shall be billed per OPM/Security Investigations Center guidelines and should anticipate annual increases. The fees associated with the different level of background investigations are subject to annual price changes as established by the OPM in the Federal

Investigation Notices.

E. Government Responsibilities

a. The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor or to the contractor's employees after receiving a list of names and addresses.

b. Upon receipt, the VA Office of Security and Law Enforcement will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

c. The VA facility will pay for investigations conducted by the OPM in advance. In these instances, the contractor will reimburse the VA facility within 30 days.

d. The VA Office of Security and Law Enforcement will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM.

e. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested.

9. VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY

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.

10. VA INFORMATION CUSTODIAL

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) 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…