S02 - 36C24826Q0328_Final.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24826Q0328 03-06-2026

Peter Bedard 813-785-0881 03-27-2026

12:00 EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Tampa FL 33637

X 0

622110

$10 Million

N/A

X

Department of Veterans Affairs CW Bill Young VA Medical Center

10000 Bay Pines Blvd.

Bay Pines FL 33744

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Tampa FL 33637

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The Contractor shall provide Electro Shockwave Lithotripsy Services in support of the CW Bill Young VA Medical Center located 10000 Bay Pines Blvd, Bay Pines, FL 33744.

Indefinite Delivery Indefinite Quantity (IDIQ) is for one

(1) base year plus four (4) - one (1) year options.

Reference pages 6 - 7 for Schedule of Services.

Reference pages 8 - 41 for Performance Work Statement.

Please direct all questions concerning this Request for Quotation (RFQ) and related documents to Peter Bedard peter.bedard@va.gov, no later than 12:00pm EST 03/13/2026.

See CONTINUATION Page

X

X 1

Peter Bedard

VA-VHA-RPOE-2023-0123

36C24826Q0328

TABLE OF CONTENTS

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

SECTION C – CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (Deviation OCT 2025)

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

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 50

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.10 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.11 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)

C.12 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.13 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.14 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.16 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.17 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.18 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 67

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 Attachment 1 - Conflict of Interest D.2 Attachment 2 - Certification of Immigration and Nationality Act D.3 Attachment 3 - Contractor Rules of Behavior D.4 Attachment 4 - QASP D.5 Attachment 5 - Past Performance Questionnaire D.6 Attachment 6 - Wage Determination

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION OCT 2025)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (DEVIATION OCT 2025)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (DEVIATION

NOV 2025)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (DEVIATION NOV 2025)

E.6 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.7 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

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

1998)

E.9 52.252-5 AUTHORIZED DEVIATIONS IN PROVISION (NOV 2020)

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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:

Phone:

Email:

SAM UEI:

b. GOVERNMENT: Contracting Officer 36C248 Peter Bedard

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy

Tampa FL 33637

Peter.bedard@va.gov

813-785-0881

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

mailto:Peter.bedard@va.gov

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6. CONFORMITY TO REGULATIONS: The contractor and his/her operations shall conform to all regulations, Federal, State and Local governing the performance of contracted services.

7. CAUTION: Late submissions, modification, and withdrawals: See Provisions FAR 52.212-1.

8. POST AWARD ORIENTATION: The contracting officer will schedule a post award orientation conference for contract orientation purposes as required by FAR Overhaul 42.502 and any local policy established by their HCA.

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B.2 SCHEDULE OF SERVICES

The contractor shall furnish all personnel and equipment to provide services necessary to perform Electro Shockwave Lithotripsy Services to eligible beneficiaries of the Department of Veterans Affairs, Bay Pines VA Healthcare System. Location of services to be provided on-site at the Urology Services Departments within the BAVAHCS catchment area.

Contract Type: Indefinite Delivery Indefinite Quantity (IDIQ)

Minimum and Maximum Quantity: The guaranteed minimum amount to be ordered for this procurement is $2,500.00 – total – inclusive of the base period and all option periods. The contract maximum is $250,000.00 total – inclusive of the base period and all options. If the maximum aggregate amount of $250,000.00 is reached prior to the end date of the final period of performance, no further task order will be issued on the contract.

Task Order Procedures: A task order will be issued at the start of the performance period and orders will be placed by NCO 8 Contracting Officers. The Task Order will contain date of order, order number, line-item number, description, quantity, unit price, performance schedule, accounting and appropriation data and method of payment.

Estimated Quantities: The quantities or dollar threshold listed in the Price Schedule effective for the periods stated are estimated only and are not purchased by the resultant contract. Except as this contract otherwise provides if the VA’s requirement does not result in orders in the quantities or dollar amount described that fact shall not constitute the basis for an equitable price adjustment.

Pricing: Price schedule for Line-Item Number (LIN) for the base year and each option year includes the following: estimated quantity, unit, proposed unit price, proposed total annual price for each LIN, and the estimated grand total.

Pricing Instructions: The offeror is instructed to edit the Unit Cost and Total Annual Cost correspond with the cost for the line-item number (LIN).

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Base Year: 05/21/2026 – 05/20/2027

Item Number Description Unit Est. QTY Cost Est. Amount 0001 Electro

Shockwave Lithotripsy

EA 15 $ $

Option 1: 05/21/2027 – 05/20/2028

Item Number Description Unit Est. QTY Cost Est. Amount 1001 Electro

Shockwave

Option 2: 05/21/2028 – 05/20/2029

2001 Electro

Shockwave

Option 3: 05/21/2029 – 05/20/2030

3001 Electro

Shockwave

Option 4: 05/21/2030 – 05/20/2031

4001 Electro

Shockwave

Estimated Total Base and all Options $

Revision 04/01/2025 Page 8 of 84

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The contractor shall provide State licensed radiologic technician(s) (licensed in diagnostic radiography – X-ray) on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), C.W. Bill Young VA Medical Center and Facility locations. The contractor shall provide State licensed radiologic technician(s) (licensed in diagnostic radiography - X-ray) and all required equipment to perform Extracorporeal Shock Wave Lithotripsy (ESWL). A licensed radiologic technician(s) shall be present at CWYVAHCS and perform the required services for payment. The Contractor will be paid for actual performance on a by case basis, not for standing by or being on-call. Payment for any leave, including sick leave or vacation time, and holiday pay is the responsibility of the Contractor.

1.1. Place of Performance: On-site at the Urology Services Departments within the BPVAHCS catchment area.

1.2. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority Federal Acquisition Regulation (FAR) Overhaul 12 Acquisition of Commercial Products and Commercial Services.

1.3. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153.

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider

Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health

Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

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

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

1.4.14. Joint Commission: http://www.jointcommission.org/standards/

1.4.15. HHS OIG Website: http://oig.hhs.gov/exclusions/index.asp

1.4.16. American Journal for Infection Control - AJIC 1998; 26:289-354:

http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm https://www.va.gov/vhapublications/index.cfm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.jointcommission.org/standards/ http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

Revision 04/01/2025 Page 9 of 84

1.2. Acronyms/Definitions: 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.

1.2.1. ABCP: American Board of Cardiovascular Perfusion

1.2.2. ACGME: Accreditation Council for Graduate Medical Education

1.2.3. ACLS: Advanced Cardiac Life Support

1.2.4. BLS: Basic Life Support

1.2.5. CDC: Centers for Disease Control and Prevention

1.2.6. CEU: Certified Education Unit

1.2.7. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.2.8. CME: Continuing Medical Education

1.2.9. CMP: Civil Monetary Penalty

1.2.10. CMS: Centers for Medicare and Medicaid Services

1.2.11. CO: Contracting Officer: The person executing this contract on behalf of the

Government with the authority to enter into and administer contracts and make related determinations and findings.

1.2.12. COR: Contracting Officer’s Representative: A person appointed by the CO to take necessary action 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 report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.2.13. COS: Chief of Staff

1.2.14. CPARS: Contractor Performance Assessment Reporting System

1.2.15. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.2.16. DEA: Drug Enforcement Agency

1.2.17. ED: Emergency Department

1.2.18. ECMO: Extracorporeal Membrane Oxygenation

1.2.19. EHR: Electronic Health Record - electronic health record system used by the VA

1.2.20. EMR: Electronic Medical Record

1.2.21. FSMB: Federation of State Medical Boards

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1.2.22. FTE: Full Time Employee VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.2.23. HHS: Department of Health and Human Services

1.2.24. HIPAA: Health Insurance Portability and Accountability Act

1.2.25. ISO: Information Security Officer

1.2.26. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.2.27. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.2.28. Non-Contract Provider: any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors.

1.2.29. NP: Nurse Practitioner

1.2.30. NPPES: National Plan and Provider Enumeration System

1.2.31. OSHA: Occupational Safety and Health Administration

1.2.32. OPPE: Ongoing Provider Practice Evaluation

1.2.33. OR: Operating Room

1.2.34. PA: Physician Assistant

1.2.35. PIV: Personal Identity Verification

1.2.36. POP: Period of Performance

1.2.37. PPD: Purified Protein Derivative

1.2.38. PWS: Performance Work Statement

1.2.39. QASP: Quality Assurance Surveillance Plan

1.2.40. VHA: Veterans Health Administration

1.2.41. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.2.42. VISN: Veterans Integrated Services Network

1.2.43. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1 License: All licenses held by the key personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

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The licensed radiologic technician(s) shall have a state license as a licensed radiologic technician, with ESWL proficiency. A log of completed ESWL cases per licensed radiologic technician, is required at minimum to exemplify proficiency. All continuing education courses required for maintaining state licensure must be kept up to date at all times.

Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance. A folder with the stated qualifications will be maintained by the COR.

2.1.1. Credentialing and Privileging: Contract licensed radiologic technician(s) fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each licensed radiologic technician shall be credentialed and privileged (if required) prior to providing services and must be found acceptable by the Facility Medical Executive Board and Medical Center Director (or designee).

Credentialing and privileging is to be completed in accordance with VHA Directive

1100.20 and VHA Directive 1100.21 referenced above.

2.1.1.1. If contract personnel(s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.2. Technical Proficiency: Radiologic technician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

Familiar in dealing with hospital patient population, including working with elderly and difficult patients. Shall have tact and personality conducive to interacting with ill, disoriented, sometimes difficult, inpatient and outpatient population.

Contract personnel (s) / licensed radiologic technician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English language fluently.

Qualifications/eligibilities that are required for all licensed radiologic technician such as citizenship, English language proficiency, and physical requirements.

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

Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.3 Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CEUs as required or requested by the facility. Contract personnel(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CEU to remain current. Contractor shall report CEU hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel(s).

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2.1.4 Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA.

Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training (The following training is mandatory per VHACO for Contracted Physicians)

Frequency (once a year, etc.)

Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior

Once a year 1

VHA Privacy and HIPAA Focused Training Once a year 1

2.1.5 STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS,

ETC.): Contractor shall provide proof of the following for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.5.1 TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.1.5.2 MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.5.3 VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.5.4 ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

2.1.5.5 INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.5.6 OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers};

provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

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2.1.5.7 The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control.

Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.6 Conflict of Interest: The Contractor and all contract personnel(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, 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 and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.7 Citizenship related Requirements:

2.1.7.1 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 Department of Veterans Affairs patient referrals.

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

2.1.7.3 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 form the basis for termination of this contract for breach.

2.1.7.4 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.

http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

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2.1.7.5 The Contractor agrees to obtain a similar certification from its subcontractors.

The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.1.8 Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (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 Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.8.1 Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract physician (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service.

CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.8.2 By submitting their proposal, 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.

2.2 Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive

1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

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

2.4 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.

2.5 Prohibition Against Self-Referral: Contractor’s physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6 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.

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2.7 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:

2.7.3 Workers’ compensation

2.7.4 Professional liability insurance

2.7.5 Health examinations to include:

2.7.5.1 Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test.

2.7.5.2 Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

2.7.5.3 Evidence of a Hepatitis C titer

2.7.5.4 Varicella titer if contracted employee has not had chicken pox.

2.7.6 Income tax withholding, and

2.7.7 Social security payments

2.8 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 provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9 Key Personnel: Contractor shall provide the number of qualified staff as is necessary to perform the services under this contract, qt the staffing level determine to be professionally acceptable by the CWYVAMC Chief of Staff.

2.9.3 The number of State Licensed Radiologic Technologist required to be on site during each case is two (2) as defined in paragraph “Services Required” of the PWS listed herein.

2.9.4 The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.9.5 Contractor shall provide the names of the contracted employee(s) assigned to the performance:

Key Personnel: Official Title:

radiologic technologist

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Substitutes:

2.10 Personnel Substitutions: During the first ninety (90) calendar 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 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.10.1 The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.10.2 For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.10.3 The Government reserves the right to refuse acceptance of any Contractor personnel 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).

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

2.10.5 Contingency Plan: Because continuity of care is an essential part of the Facility’s medical services, The Contractor shall have a contingency plan in place to be

Revision 04/01/2025 Page 17 of 84 utilized if the contract personnel(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.10.6 Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3 VA HOURS OF OPERATION/SCHEDULING:

3.1 VA Business Hours: VA business hours/hours of operation are 7:00 a.m. – 4:30 p.m.

excluding federal holidays.

3.1.1 Emergency Operations: Twenty-Four (24) hours a day, seven (7) days a week.

3.2 Federal Holidays:

• New Year’s Day

• Martin Luther King’s Birthday

• President’s Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Any day specifically declared to be a national holiday.

4 CONTRACTOR RESPONSIBILITIES:

4.1 Clinical Personnel Required: The Contractor shall provide contract personnel(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1 Contract personnel(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

4.1.2 Contractor shall provide state licensed radiologic technologist who are licensed in diagnostic radiography/X-ray.

4.1.3 On the day of the procedure, the licensed radiologic technician shall transport the ESWL equipment to the operating room and shall provide ongoing technical support for its usage until all scheduled cases for the day are completed. The contractor’s licensed radiologic technologist shall be expected to arrive with all necessary equipment a minimum of one (1) hour before procedures are scheduled to commence. On the day of scheduled services, the contractor shall provide all

Revision 04/01/2025 Page 18 of 84 necessary equipment (including lithotripsy unit, treatment table, workstation/monitors, and X-ray C-arm) for use during the entire day. The contractor shall not be required, except in cases of emergency, to furnish services during off-duty hours.

4.1.4 Contractors transportable ESWL system shall include but not limited to a transportable lithotripter with treatment table for each ESWL procedure. The lithotripter provided by the contractor shall be able to achieve a minimum penetration depth of 165mm. The lithotripsy treatment table shall have a minimum weight limit of 460 lbs. The treatment table shall be able to move efficiently in three dimensions (x, y, z coordinate directions) and have the ability to easily accommodate a Trendelenburg position/reverse Trendelenburg/inclination. Shock Wave Lithotripsy shockhead shall be able to rotate to the anterior approach for lower ureteral/renal calculi (so as not to turn the patient in the prone position).

4.1.5 Contractors X-Ray C-Arm Fluoroscopy Unit shall be a transportable X-ray C-arm fluoroscopy unit to be used during each ESWL procedure. The fluoroscopy unit generator shall be able to provide a minimum power of 15kW, provide a proper degree of both, radiographic contrast and density, provide a peak kilovoltage (minimum requirement) of 120KVp, provide a kVp range of 40kVp to 120kVp, provide an electric current range of 0.2mA to 10mA during normal fluoroscopy function, and capable of continuous high level fluoroscopy at a current magnitude of up to 10mA.

4.1.6 Contractor shall provide the BPVAMC Operating Room (OR) staff/COR/ or OR Point of Contact with the cleaning and disinfecting requirements for all ESWL equipment. The cleaning and disinfecting requirements shall specify which chemical solutions shall be used to clean and disinfect each unique piece of equipment (including lithotripsy unit, treatment table, workstation/monitors, X-ray C-arm).

4.1.7 The contractors workstation shall enable OR personnel to easily use the ESWL system which includes the minimum of 1280x1024 High Resolution Monitors with the capability of being viewed from all sides.

4.1.8 The contractor shall maintain all the equipment (including lithotripsy unit, treatment table, workstation/monitors, X-ray C-arm), in safe, clean and operational condition at all times. The contractor is responsible to ensure that all components (including lithotripsy unit, treatment table, workstation/monitors, X-ray C-arm) will operate at optimum performance to provide the best possible treatment to the patients and minimize downtime. The Biomedical Engineering Department (Biomed) will be contacted by the Licensed Radiologic Technologist immediately upon arrival to the CWYVAHCS to check in the equipment. Current radiation compliance testing and calibration documentation shall be presented to the Biomed Department for each individual fluoroscopy/radiographic unit brought to the CWYVAHCS OR at this check-in, before procedures commence. Up to date preventive maintenance and corrective maintenance records for the ESWL equipment shall also be made available to the CWYVAHCS Biomed Department the day of any procedure(s) prior to procedure start times.

4.1.9 The contractor shall maintain a written record of procedure/study summaries for each procedure/study conducted at the CWYVAHCS. The written records for each procedure/study shall display air kerma and dose area product values. All written records for procedures/studies shall permanently reside at the CWYVAHCS with the assigned COR.

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4.2 Standards of Care: The contract personnel(s)’ care shall cover the range of Perfusionist/Autotransfusion services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1 The professional standards of The Joint Commission (TJC):

http://www.jointcommission.org/standards_information/standards.aspx

4.2.2 The standards of the American Hospital Association (AHA):

http://www.hpoe.org/resources?show=100&type=8

4.2.3 The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. 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 5 U.S.C.552a (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 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).

4.3.2. 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. Health 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’ (24VA10A7). 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 provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

4.3.3. Disclosure: Contract personnel(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the Facility.

4.3.5. 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. Contractor will not release or disclose copies http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

Revision 04/01/2025 Page 20 of 84 of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.4. Direct Patient Care: 90 % of the time involved in direct patient care. The Perfusionists and Autotransfusionist role will be 90% to patient care related.

4.5. ADMINISTRATIVE: estimated 10% of time not involved in direct patient care

4.5.1. QA/QI documentation: The Contractor’s physician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

4.5.2. Patient Safety Compliance and Reporting: Contractor’s radiologic technologist(s) shall follow all established patient safety and infection control standards of care.

Contractor’s radiologic technologist(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the Patient Safety Reporting System, following up with COR as required or requested.

4.6. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE PLAN

AND QUALITY IMPROVEMENT(QI)

4.6.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance:

Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP).