36C26320Q0702 - Microwave and Cryoablation.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER

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

636-21-1-1048-0001

36C26320Q0702

6. SOLICITATION ISSUE DATE

9-17-2020

Laura Nabity, Contract Specialist 651-293-3048 10-07-2020

1159 ET

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Attn:Laura Nabity, Contract Specialist 316 Robert Street N. STE. 506 St. Paul MN 55101

X

621512

$16.5 Million

N/A

X

Department of Veterans Affairs Nebraska-Western Iowa Healthcare System 4101 Woolworth Avenue

Omaha NE 68105

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Attn:Laura Nabity, Contract Specialist 316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Microwave Ablation (MWA) and Cryoablation Procedures for the Nebraska - Western Iowa VA Healthcare System - Omaha

Period of Performance: November 1, 2020 - October 31, 2021, with 4 (four) one-year options.

See Schedule of Services - section B.2 (page 5) See Performance Work Statement - section B.4 (page 7)

Proposal Submittal Instructions - section E (Page 39)

See CONTINUATION Page

636-3610160-1048-822200-2560 010022243

X X

X -one-

Contracting Officer

X

36C26320Q0702

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/COST SCHEDULE

B.3 DELIVERY SCHEDULE

B.4 PERFORMANCE WORK STATEMENT (PWS)

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) 20

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 26

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 26

C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF

COMMERCIAL ITEMS (APR 2020)

C.10 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED

SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.11 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.12 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.13 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)

C.14 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.15 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

ATTACHMENT D.1a – Business Associate Questionnaire ATTACHMENT D.1b – Business Associate Agreement (BAA) ATTACHMENT D.2 – Organizational Conflict of Interest Statement ATTACHMENT D.3 – Contractor Rules of Behavior – 6500.6 Appendix D ATTACHMENT D.4 – Immigration and Nationality Act Form ATTACHMENT D.5 - Time & Attendance ATTACHMENT D.6 - Department of Labor (DoL) SCA Wage Determination ATTACHMENT D.7 - Quality Assurance Surveillance Plan (QASP) ATTACHMENT D.8 – Past Performance Questionnaire

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTUCTIONS TO OFFERORS – COMMERICAL ITEMS, SUBMITTAL

INSTRUCTIONS

E.2 ADDENDUM TO 52.212-1 NSTRUCTIONS TO OFFERORS (OCT 2014)

E.3 52.204-22 ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)43

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 45

E.9 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (JUN 2020)

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: Name:

Address:

City, State, ZIP:

DUNS:

Contact Person:

Telephone:

E-mail:

b. GOVERNMENT: Department of Veterans Affairs Network Contract Office 23 (NCO 23) 316 North Robert Street St. Paul, MN 55101-1495 Contracting Officer: Sandra McAnany 651-293-3032 Contract Specialist: Laura Nabity 651-293-3048 Contracting Officer Representative: Thomas vonAhlefeld 402-203-7868

*If Government contacts change, notification will be sent to the Contractor by e-mail. Contract modification(s) shall not be required.

2. TYPE and TERM OF CONTRACT: The contract type for this service procurement is a single award, Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) for a period of one base performance period from the effective date of award or November 1, 2020 through October 31, 2021, plus four (4) one-year options to be exercised at the Government’s discretion. Additionally, there is an option to extend services up to six

(6) months beyond the four option years.

3. AVAILABILITY OF FUNDS: The Contractor shall perform no service until funding is provided for the applicable performance period and the Contracting Officer authorizes such services in writing.

4. CONTRACT REMITTANCE ADDRESS: All payments by the Government to the Contractor will be made in accordance with FAR 52.232-33, Payment by Electronic Funds Transfer – System for Award Management, and VAAR 852.232-72, Electronic Submission of Payment Requests.

5. INVOICES: Invoices shall be submitted electronically monthly in arrears. The Contracting Officer’s Representative (COR) will review all invoices submitted. The COR is responsible for certifying invoices for payment for only those services received and deemed acceptable by VA. Once certified by the COR, payment can be made via the Tungsten Network. See Performance Work Statement (PWS) Section 17 for billing instructions.

6. SECURE FAX: VA Handbook 6500 requires the following statement on all fax cover sheets be included:

“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, distribute on, 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.”

7. ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of Amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO. DATE

B.2 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/ SERVICES

BASE YEAR QUANTITY UNIT UNIT PRICE AMOUNT

26 EA _____________ _____________ Cryoablation Procedures (All Inclusive) Contract Period: Base POP Begin: 11-01-2020 POP End: 10-31-2021

0002 4 EA _____________ _____________ MicroWave Ablation Procedures (All Inclusive) Contract Period: Base POP Begin: 11-01-2020 POP End: 10-31-2021

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

OPTION YEAR #1 QUANTITY UNIT UNIT PRICE AMOUNT

Contract Period: Option 1 POP Begin: 11-01-2021 POP End: 10-31-2022

1002 4 EA _____________ _____________ MicroWave Ablation Procedures (All Inclusive) Contract Period: Option 1 POP Begin: 11-01-2021 POP End: 10-31-2022

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

OPTION YEAR #2 QUANTITY UNIT UNIT PRICE AMOUNT

Contract Period: Option 2 POP Begin: 11-01-2022 POP End: 10-31-2023

2002 4 EA _____________ _____________ MicroWave Ablation Procedures (All Inclusive) Contract Period: Option 2 POP Begin: 11-01-2022 POP End: 10-31-2023

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

OPTION YEAR #3 QUANTITY UNIT UNIT PRICE AMOUNT

Contract Period: Option 3 POP Begin: 11-01-2023 POP End: 10-31-2024

3002 4 EA _____________ _____________ MicroWave Ablation Procedures (All Inclusive) Contract Period: Option 3 POP Begin: 11-01-2023 POP End: 10-31-2024

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

OPTION YEAR #4 QUANTITY UNIT UNIT PRICE AMOUNT

Contract Period: Option 4 POP Begin: 11-01-2024 POP End: 10-31-2025

4002 4 EA _____________ _____________ MicroWave Ablation Procedures (All Inclusive) Contract Period: Option 4 POP Begin: 11-01-2024 POP End: 10-31-2025

GRAND TOTAL _______________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

PLACE OF

PERFORMANCE

ALL

TO:

Department of Veterans Affairs

NWI Health Care System

OMAHA VA HCS

4101 Woolworth Avenue Omaha, NE 68105 1850 United States

ALL ON-SITE

***The guaranteed contract (includes base year and any/all option year(s) exercised) minimum quantity is 15 procedures. The maximum annual quantity is 75 procedures. The contract (includes base year and any/all option exercised) maximum quantity is 400 procedures.

B.4 PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL

1.1. Services: The Omaha VA Nebraska-Western Iowa Healthcare System (VA NWIHCS) has a requirement for on-site ablation equipment and technical assistance to support VA Interventional Radiologists when Microwave Ablation (MWA) and Cryoablation procedures are being performed to maximize patient safety.

1.1.1. The contractor’s certified technician will assist the VA Interventional Radiologist by providing all needed mobile MWA / Cryoablation (ablation) equipment and supplies and by providing technical expertise and guidance.

1.1.2. Quantities listed are estimated yearly requirements. The VA attempts to be as accurate as possible when providing estimated quantities. However, actual quantities required may vary from quantities listed.

1.1.3. The guaranteed contract (includes base year and any/all option year(s) exercised) minimum quantity is 15 procedures. The contract (includes base year and any/all option exercised) maximum quantity is 400 procedures.

1.2. Place of Performance: All services will be provided on-site at the Omaha VA NWIHCS with the primary place of performance being in the Imaging Department. The Omaha VA is located at 4101 Woolworth Avenue, Omaha, NE 68105.

1.3. Period of Performance: The base contract period is effective November 1, 2020 through October 31, 2021, plus 4 (four), one-year options that may be exercised at the government’s discretion.

1.4. Authorities: Title 38 USC § 8153, Health Care Resources (HCR) Sharing Authority, Federal Acquisition Regulation (FAR) Parts 12, 13 and 15, and Veterans Affairs Acquisition Regulation

(VAAR).

1.5. VA Policies/Directives/Handbooks: The Contractor is considered part of the VA activity for purposes of the following applicable federal and state statutes, VA regulations, VA directives, VA handbooks and policies implementing U.S. statutes. This contract incorporates the attachments by reference with the same force and effect as if they were given in full text. Copies of VA NWIHCS Policies will be provided to the contractor upon request. The Contractor shall be subject to the following policies, directives, and handbooks including any subsequent updates during the performance period of this contract. Any updated policies or new statutes will be communicated via email and not by a contract modification.

Electronic copies of statutes and VA directives may be obtained at the VA Publications, and Library of Congress websites. Most current VA and VHA publications can be located at https://www.va.gov/vhapublications/. U.S. Codes (statutes) can be located at https://uscode.house.gov/.

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

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

1.5.2. Health Insurance Portability and Accountability Act of 1996 (HIPAA)(Public Law 104-191)

1.5.3. VHA Directive 1605.01 Privacy and Release of Information

1.5.4. VA Nebraska-Western Iowa Health Care System Medical Center Policy:

• EC-14C – PIV Card

• EC-28A - Operating Room Security

• IC-01F - Infection Precautions

• IM-06D - Information Security Policy/Procedures

• POL-017 - Vendors (Contractors)

Note: As the VA routinely reviews and updates policies and procedures covering contractors, policies and security requirements may change during the term of this contract. New policies and procedures will be communicated via email to the contractor. If a contract modification is required due to statute, it shall be implemented unilaterally.

1.6. 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.

1.6.1. BAA: Business Associate Agreement

1.6.2. CDR/CR: Contract Discrepancy Report/Contract Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance.

1.6.3. CLIN: Contract Line Item Number. This is unit, description of work to be performed by the https://www.va.gov/vhapublications/ https://uscode.house.gov/ https://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm contractor as a payment item.

1.6.4. CO: Contracting Officer. A person executing this contract on behalf of the Government who has the authority to enter into and award, administer, modify, and/or terminate contracts and make related determinations and findings.

1.6.5. COR: Contracting Officer’s Representative. An individual appointed by the CO, designated and authorized in writing, to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall promptly report to the CO any indication of non-compliance in order that appropriate action can be taken. The COR does not have the authority to make changes to the contract.

1.6.6. CPAR: Contractor Performance Assessment Report

1.6.7. CPARS: Contractor Performance Assessment Reporting System

1.6.8. CS: Contract Specialist

1.6.9. FAR: Federal Acquisition Regulation. Principal set of rules governing all U.S. Federal

Government’s procurement processes.

1.6.10. HIPAA: Health Insurance Portability and Accountability Act of 1996. The act deals with the protection and standardization of healthcare related information systems. The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information.

1.6.11. IDIQ: Indefinite Delivery Indefinite Quantity

1.6.12. ISO: Information Security Officer. Individual within the VA responsible for ensuring information assets (i.e. VA sensitive information) are adequately protected.

1.6.13. NWIHCS: Nebraska – Western Iowa Healthcare System

1.6.14. PIV: Personal Identity Verification. Personal identity verification is required of federal employees and contractors and secures access to federal facilities and information systems.

1.6.15. PO: Privacy Officer. Individual within the VA who is responsible for managing the risks and impacts of privacy laws and policies.

1.6.16. POP: Period of Performance

1.6.17. PWS: Performance Work Statement. A statement of work in the contract that describes the required results in clear, specific and objective terms with measurable outcomes.

1.6.18. QA: Quality Assurance. Actions taken by the government to assure contracted services meet

PWS requirements

1.6.19. QASP: Quality Assurance Surveillance Plan. A written document specifying the method used for surveillance of contractor performance.

1.6.20. QC: Quality Control. Actions taken by the contractor to control the performance of contracted services to meet the PWS requirements.

1.6.21. VA: Veterans Affairs or Department of Veterans Affairs

1.6.22. VHA: Veterans Health Administration

1.6.23. VA NWIHCS: VA Nebraska - Western Iowa Health Care System

2. SERVICES AND EQUIPMENT

2.1. The contractor agrees to furnish all personnel, supplies, and equipment necessary to perform Microwave Ablation and Cryoablation procedures during normal business hours to eligible beneficiaries of the VA NWIHCS. The contractor’s certified technician will assist and support the VA Interventional Radiologist by providing technical expertise and guidance during procedures and by providing all needed mobile MWA / Cryoablation (ablation) equipment and supplies (MWA/Cryoablation unit).

2.1.1. Services and equipment required include, but are not limited to, management, training, labor, time, transportation, equipment, mobile ablation equipment, tools, supplies to include gases, maintenance and repair of all contractor furnished equipment, and a fully qualified technician.

The unit price shall be an all-inclusive per procedure price.

2.1.2. The experienced and qualified technician will assist and support VA Imaging Interventionist Physicians using the mobile ablation equipment. Services are required for complex Microwave Ablation (MWA) and Cryoablation (Cryo) procedures in order to optimize successful patient outcomes.

2.1.3. Contract provider’s standard of care shall cover the same range of services as would be provided in a civilian medical treatment facility and shall follow the standard of care required by the policies of the VA NWIHCS for patient safety and quality assurance.

2.1.4. Contractor shall comply with all appropriate and applicable policies, procedures and regulations of the VHA and VA NWIHCS, and ensure compliance with Joint Commission standards and guidelines.

2.1.5. Contractor will possess collaborative skills sufficient to work effectively with the imaging interventionist physicians and other medical center staff.

2.1.6. Contract personnel must maintain professional conduct and the highest standard of integrity during interactions with patients, nurses, physicians and other healthcare professionals.

Contractor will consistently communicate and treat others in a courteous, tactful and respectful manner.

2.1.7. All ablation equipment used during the performance of this contract must be FDA approved.

Contractor is responsible for maintaining and ensuring all ablation equipment is in good working order.

2.1.8. Contractor is responsible for the procurement, dispensing, administration and safekeeping of all supplies required in the performance of this contract. Safe keeping of gas cylinders may be arranged with Omaha VA Logistics.

3. VA HOURS of OPERATION / SCHEDULING:

3.1. Services will be scheduled through the VA NWIHCS Imaging Service. Generally, the VA will provide a minimum of 48 hours’ notice. However, there may be emergency situations that will require same day services.

3.1.1. Coordination of needed services (time and date) will be coordinated by VA Interventional Radiologist Nurses.

3.2. The MWA/Cryoablation unit is required to be on-site and in the Imaging Department / Computed Tomography (C.T.) Suite a minimum of 60 minutes prior to procedure’s scheduled start time and shall remain in the C.T. Suite until procedure is completed.

3.3. It is estimated that 30 procedures (26 Cryoablation and 4 Microwave Ablation) will be performed each year requiring the MWA/Cryoablation unit.

3.4. The following holidays are observed by the Department of Veterans Affairs:

• New Year’s Day

• President’s Day

• Martin Luther King’s Day

• Memorial Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared by the President of the United States to be a national holiday.

When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday.

When a holiday falls on a Saturday, the preceding Friday is observed by US Government agencies.

3.5. Emergency situations may require a procedure on a holiday or with a same day notice.

3.6. A procedure can be cancelled at any time due to medical/patient necessity without cost to the VA.

4. QUALIFICATION/EDUCATION/TRAINING

4.1. Contractor provided personnel must be a Technician/Equipment Specialist. All technicians provided must have certified training and expertise in using the ablation equipment. A minimum of one year of experience with this equipment is required.

4.2. Contractor personnel shall be proficient in written and spoken English (38 USC 7402).

5. VA REQUIRED TRAINING:

5.1. HIPAA/Privacy Training: Contractor and their sub-contractor employees assigned to work under the contract are required to receive annual training on patient privacy as established by HIPAA statutes.

Training must meet VHA’s and the Department of Health and Human Services (HHS) Standards for Privacy of individually identifiable health information. Contractor shall provide documented proof annually of training to the contracting officer for all employees that are assigned work and/or having access to protected health information.

5.2. Contractor personnel assigned to provide services at the VA NWIHCS must have completed VA privacy, security, ethics and fire prevention training before performing any services and must complete annual VA education training requirements.

NOTE: VA routinely reviews and updates policies and procedures covering contractors. All updated training requirements shall be communicated via e-mail to the contractor.

6. STANDARD PERSONNEL TESTING: The contractor shall assume full responsibility for health of personnel furnishing services under this contract and shall provide evidence of health examination records ensuring the health of contract personnel to include: a) annual PPD Tuberculosis skin test, b) recent, within the last year, chest x-ray if there is a history of positive TB skin test, c) record of Hepatitis B immunity, and (d) annual Influenza vaccination.

7. CITIZENSHIP RELATED REQUIREMENTS: 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 Department of Veterans Affairs patient referrals.

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 any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

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(s) where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

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

8. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT: In accordance with HHS/OIG regulations, to ensure that the individuals or entities providing services under contract to the Federal Government have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG) List of Excluded Individuals/Entities on the OIG website (www.hhs.gov/oig) for each person providing services under this contract. Further, the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG Excluded list and are NOT listed. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. The VA does not have the burden of defending the merits of the HHS/OIG decision established under §42 U.S.C. 1320a-7.

9. NON-PERSONAL SERVICES: Contractor employees are considered to be providing non-personal government services as defined in FAR 37.01, and as such are not considered employees of the U.S. Department of Veterans Affairs. Contractor employees shall not perform inherently governmental functions.

The Contractor shall be responsible for protecting the contractor’s staff furnishing services. To carry out this responsibility, the contractor shall provide certificates and certify that the following is provided for all contractor staff providing services under the resultant contract:

• Workers’ compensation

• Professional liability insurance

• Sick leave

• Vacation time

• Health examinations

• Income tax withholding and Social Security payment

10. TORT: The Federal Tort Claims Act does not cover contractors or contractor’s employees. When a contractor or a member of their staff has been identified as a provider in a tort claim, the contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a http://www.hhs.gov/oig contractor’s action or non-action is the responsibility of the contract and/or their insurance carrier.

11. MEDICAL LIABILITY: The Contractor shall furnish their own medical liability insurance and will hold certificate of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Prior to award of the contract and at renewal, the Contractor shall furnish to the VA a certificate of insurance evidencing that all required coverage has been obtained. The Contractor shall be responsible for maintaining this certificate/coverage for the duration of the contract. Under no circumstances will the contractor be considered a VA NWIHCS employee nor will contractor be covered by VA liability insurance

12. KEY PERSONNEL

12.1. Contractor will be responsible to ensure that the contractor personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period.

Contractor’s personnel provided under this contract must meet the qualifications as stated above in section 4.

12.2. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 business days after the occurrence of any of these events and provide the information required by paragraph below.

12.3. After the initial 90-day period of the contract, the Contractor shall submit the information required below to the CO and COR at least 15 business days prior to making any permanent substitutions.

12.4. List of Key Contractor Personnel. The Contract shall submit a listing of all key personnel who will be providing services in the following format:

Provider Name:_________________________

Certification/Title: ____________________________

A work resume for each key personnel shall be submitted with the proposal and for any new key personnel added to the contract.

12.5. Removing/Replacing/Adding Key Personnel: Contractor personnel performing in accordance with the contract are considered essential to the work being performed under this contract. Before removing, replacing, adding or diverting any of the listed personnel, the contractor shall (1) notify the Contracting Officer and the COR reasonably in advance; (2) submit justification including proposed substitutions in sufficient detail to permit evaluation of the impact on this contract; and (3) provide required documentation establishing proposed personnel qualifications. With consent of all parties, the list of key personnel may be modified by the VA Contracting Officer to add or delete persons authorized to provide services under this contract.

12.6. The Government reserves the right to refuse acceptance of contractor’s key personnel at any time after performance begins, if personal and 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 contract requirements, or other conduct resulting in formal complaints by patients or staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current Federal Personnel Regulations. The CO and COR shall deal with issues raised concerning contractor’s conduct and/or relations with Government employees or patients. The CO is the arbiter and final authority on validating questions of acceptability of contractor conduct and complaint issues.

14. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

14.1. Prior to starting at the NWIHCS, the contract employee must have a completed:

• Security background screening which requires fingerprinting for SAC clearance.

• Completion and submission of course certificate for VA privacy and security courses.

• Completion of eQIP process for a low risk (NACI) background investigation

In accordance with NWIHCS Policy POL-017, Identification Badges, Passes and PIV Card, Contractors/vendors requiring on-site access will be issued ID badges/PIV card during the effective term of their contract. Purchase & Contract staff or the Contracting Officer’s Representative (COR) will advise VA Police and Human Resources on the type of access required. Contractors must provide a list of representatives requiring VA access ID badges/PIV card.

The ID badges/PIV card is representative specific and must accompany the person to which it was issued. The badges must be returned at the expiration of the contract period, representative change, or at the request of the VA. Representatives displaying these badges are not required to sign in with the VA Police on entering the building but must comply with all other terms of the vendor/contractor ID policy and are limited to visits to departments serviced by the contract.

14.2. The Certification and Accreditation (C & A) requirements do not apply, and a Security Accreditation Package is not required.

14.3. A Business Associate Agreement (BAA) is required. See attachment in Section D of the solicitation document.

14.4. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY (VA Handbook 6500.6, Contract Security, Appendix C #1 and #4)

14.4.1. 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.

14.4.2. VA Information Custodial Language:

14.4.2.1. 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). (See contract’s clauses)

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

14.4.2.3. 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.

14.4.2.4. 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.

14.4.2.5. 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.

14.4.2.6. 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.

14.4.2.7. 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.

14.4.2.8. 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.

14.4.2.9. 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.

14.4.2.10. 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.

14.4.2.11. 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.

14.4.2.12. 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.

15. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT

REPORTING SYSTEM (CPARS): As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold (SAT) and shares 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, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (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 federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

Each contractor whose contract award is estimated to exceed the SAT 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: 684-1690 or COMM: 207-438-1690.

For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the Contracting Officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor’s representative will have sixty (60) days to submit any comments and re-assign the report to the VA Contracting Officer.

Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) 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.

16. OVERSIGHT OF SERVICE / PERFORMANCE MONITORING – CONTRACT

ADMINISTRATION:

16.1. Contracting Officer (CO): After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the Contracting Officer. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include, but not limited to, terms affecting price, quantity or quality of performance of this contract.

Contracting Officer: Sandra McAnany Phone: 651-293-3032 email: sandra.mcanany@va.gov Contract Specialist: Laura Nabity Phone: 651-293-3048 email: laura.nabity@va.gov Department of Veterans Affairs mailto:sandra.mcanany@va.gov mailto:laura.nabity@va.gov

Network 23 Contracting Office (NCO 23) 316 North Robert St, #506 Minneapolis, MN 55101-1495 Fax: 651-293-3060

16.2. Contracting Officer’s Representative (COR): The COR shall be the VA official who is responsible for verifying contractor’s contract compliance.

Contracting Officer’s Representative: Thomas vonAhlefeld Phone: 402-995-3411 email: thomas.vonAhlefeld@va.gov VA Nebraska-Western Iowa Healthcare System Manager, NWIHCS Imaging Service (114) 4101 Woolworth Avenue Omaha, NE 68105

**If Government contacts change, notification will be sent to the Contractor by e-mail. Contract modification(s) shall not be required.

16.3. COR Performance Monitoring: After contract award, the COR will be the VA official responsible for verifying contractor contract compliance. A record-keeping system of procedures will be maintained and reported monthly to the COR. These procedures used by the COR must be able to demonstrate through time and attendance logs or other appropriate records that services called for in the contract have been received.

Any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer or Contract Specialist.

The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: quality assurance incident reporting (including root cause and corrective action plan);

complaints from staff; complaints related to professionalism; and adherence to National Patient Safety Goals. This data is reported quarterly to the Medical Executive Board and Clinical Performance Committee.

The COR will review and certify monthly invoices for payment.

Any evidence of the Contractor’s or Contractor’s staff non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. If in the event the Contractor fails to provide the services as specified in this contract, payments may be adjusted to compensate the Government.

16.4. PERFORMANCE STANDARDS

16.4.1. Measure: Response Time to VA

Performance Requirement: The MWA/Cryoablation unit is required to be on-site and in the

C.T. Suite a minimum of 60 minutes prior to procedure’s scheduled start time

Standard: The vendor shall provide the staff and equipment to provide ablation services 60 minutes prior to the procedure’s schedule time

Acceptable Quality Level: 95% Method of Surveillance: Direct Observation by procedure nurse / Time and Attendance Sheet and validated complaints.

Frequency: Ongoing

16.4.2. Measure: Mandatory Training

Performance Requirement: Contractor staff shall complete all mandatory required VA training on time and remain current per VA NWIHCS policy.

mailto:thomas.vonAhlefeld@va.gov

Standard: Contractor’s staff who provide services at the VA must complete all VA required training to include, but not limited to; HIPAA/Privacy Training, Fire safety, Infection control, blood borne pathogens and remain current

Acceptable Quality Level: 100%; no deviations accepted.

Method of Surveillance: Direct Observation Frequency: Ongoing; COR review of training records.

17. BILLING: Contractor shall establish a recordkeeping system of contractor services provided. At the end of each month the contractor will submit an invoice for payment.

17.1. Invoice Requirements and Supporting Documentation: Supporting documentation and invoices must be submitted no later than the 20th workday of the month after services have been provided. 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:

• Name and address of Contractor

• Invoice Date and Invoice Number

• Contract Number, Task Order Number and Purchase Order (PO) Number

• Date of Service

• Technician(s) Name

• Description of Services provided

• Contract fee/price for each provided Service (CLIN number)

• Total Price

17.2. Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are NOT acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods as outlined on the VA Financial Services Center (VAFSC) website: http://www.fsc.va.gov/einvoice.asp.

Contact the VAFSC if you need assistance.

As part of compliance with the Prompt Payment Act of 1982, and the Improper Payment Elimination and Recovery Act of 2010, the VA uses a third-party electronic invoicing provider named Tungsten (previously OB10). Refer to the Tungsten Network https://www.tungsten-network.com/customer-campaigns/veterans-affairs/ for information on how to register and points of contact for questions and assistance. 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. 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 Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 E-mail: vafscched@va.gov

17.3. 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 http://www.fsc.va.gov/einvoice.asp https://www.tungsten-network.com/customer-campaigns/veterans-affairs/ https://www.tungsten-network.com/customer-campaigns/veterans-affairs/ mailto:vafscched@va.gov charged nor shall their insurance companies including Medicare be charged for services rendered by the contractor under this contract, even if VA does not pay for those services.