36C24925R0021.docx

36C24925R0021

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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

36C24925R0021 Samantha Shackelford, CS 02-24-2025 17:00

EST

90C Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129 X 621399 $10 Million N/A X Department of Veterans Affairs

VAMC

Lt. Col Luke Weathers Jr., VAMC 1030 Jefferson Avenue Memphis TN 38104 90C Department of Veterans Affairs Network Contracting Office - 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

90C FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page Contractor shall provide Urology Cryoablation Services in support of the Lt. Col Luke Weathers Jr. VA Medical Center.

See Instructions for the Preparation of Proposal on page __ __ for proposal guidance.

Schedule of Services is located on page _ Performance Work Statement is located on page _ See CONTINUATION Page X X X Angela Tucker Contracting Officer Table of Contents

E.9 VAAR 852.273-73 EVALUATION – HEALTH-CARE RESOURCES (NOV 2021)…80

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) 81

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

Contract Administration: All contract administration matters will be handled by the following individuals:

____________________________ (Address) ____________________________ (Address) ____________________________ (Phone Number) ____________________________ (Email)

____________________________ (UEI)

____________________________ (Tax ID Number)

U.S. Department of Veterans Affairs Network Contracting Office 9 Phone: (615) 225-5422 E-mail: samantha.shackelford@va.gov CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

GOVERNMENT INVOICE ADDRESS: All invoices from the Affiliate shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Invoicing shall be in accordance with the requirements of the Department of Veterans Affairs Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the period of performance of this acquisition. Current invoicing information is located at http://www.fsc.va.gov/einvoice.asp. Invoices shall be submitted monthly in arrears.

SECURE FAX: The following statement shall be included on all fax cover sheets: This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by FAR Part 42.

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

B.2 PRICE/COST SCHEDULE

SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform onsite Urology Cryoablation Services to eligible beneficiaries of the Lt. Col Luke Weathers Jr. Department of Veterans Affairs Medical Center (hereinafter referred to as VAMC), located in Memphis, TN.

Place of Performance: Services shall be provided on site at Lt. Col Luke Weathers Jr., VA Medical Center, 1030 Jefferson Avenue, Memphis TN 38104 Estimated Quantities: Estimated hours, and maximum quantities.

Contractual minimum and maximum: The guaranteed minimum contract amount, including the base period and any option periods exercised, is $10,000.00, and the maximum contract amount shall not exceed $500,000.00.

Orders: This is a Fixed Price (FP), Indefinite Delivery Indefinite Quantity (IDIQ) contract (see FAR 52.216-22). Task Orders shall be placed against this IDIQ contract at the time of contract award, and as needed during the term of the contract. The Task Orders shall specify the estimated quantities of services for each period of performance and shall comply with FAR 52.216-18 and 52.216-19.

PERIOD OF PERFORMANCE (POP): March 01, 2025 to February 28, 2030.

Base Ordering Period: March 1, 2025 – February 28, 2026

Total for Base Ordering Period:

Ordering Period 1: March 1, 2026 – February 28, 2027

Total for Ordering Period 1:

Ordering Period 2: March 1, 2027 – February 29, 2028

Total for Ordering Period 2:

Ordering Period 3: March 1, 2028 – February 28, 2029

Total for Ordering Period 3:

Ordering Period 4: March 1, 2029 – February 28, 2030

Total for Ordering Period 4:

Contract Total:

** Changes to the contract can only be made by a written modification which is formally executed by the contractor and the Contracting Officer.

Orders shall be issued only the Contracting Officer.

All unit prices shall be a fixed price.

This contract is a fixed price Indefinite Delivery -Indefinite Quantity contract. The guaranteed contract minimum is $10,000 and the contract maximum is $500,000.

ORDERS: This is a Fixed Price (FP) Indefinite Delivery/Indefinite Quantity (IDIQ) contract (see FAR 52.216-22). The Task Orders shall be issued “as needed” during the term of the contract.

Task Order Procedures

a. This contract type allows the Veteran Affairs Network Contracting Office (NCO 9) contracting officers to place orders with the contractor on an as needed basis. In accordance with the Federal Acquisition Regulation (FAR) Clauses 52.216-18, Ordering. NCO 9 will obligate the funding and order the services by issuing a Task Order.

b. A Task Order shall be issued to the contractor when cryoablation services are required. One task order may be issued for all line items if necessary or the Government may issue a task order for only one line item depending on the Government’s need.

c. The contractor shall initiate work when, so directed by a Task Order issued by the contracting officer. No work under any Task Order shall be performed unless specifically authorized by the contracting officer. Approval of a Task Order shall not constitute approval to exceed any item listed in the contract or general provisions of the contract. The contractor shall not exceed the estimated task order amount or change the task order without prior written approval of the Contracting Officer.

d. In event the contractor is unable to fulfill the task order requirements; the government reserves the right to fulfill its need outside of this contract. A written confirmation from the contractor indicating the inability to fulfill the task order is immediately required. The estimated dollar amount on the unfilled task order will be applied to the minimum quantity. The government’s right to fulfill its need outside this contract does not waive its right to the issuance of a cure notice nor does it waive its right to terminate for cause.

Task Order Issuance Procedure. The terms that apply to the issuance of Task Orders under this contract are set forth below:

a. The estimated quantities for performance of each task shall be set forth in each Task Order. Each Task Order shall not exceed the quantities specified and total amount obligated for each Task Order.

Task Order Pricing

a. Task Order prices shall be Fixed-Price (FP) as agreed to in the contractor’s schedule and individually funded. The Unit Price is an all-inclusive cost. Task Order Performance Period. When cryoablation services are needed and a Task Order is issued, each Task Order shall have an established period of performance or delivery date. Individual Task Orders shall not exceed a 12-month period.

36C24925R0021

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B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1 Services Provided: The contractor shall provide cryosurgical equipment and all related cryosurgical disposable probes required to perform cryosurgical procedures, ultrasound equipment, and a technician trained in the services and operation of the CryoCare CS or Cryo 20 unit as required to perform targeted cryoablation of the prostate (TCAP) procedures for the treatment of localized adenocarcinoma of the prostate in accordance with the specifications contained herein to the Lt. Col Luke Weathers Jr. VA Medical Center.

1.2 Place of Performance: Contractor shall furnish services at the Lt. Col Luke Weathers Jr., VA Medical Center, 1030 Jefferson Avenue, Memphis TN 38104

1.3 Authority: Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority and FAR parts 12 in combination with VAAR 873.

1.4 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 VHA Directive 2009-004, Use and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities

1.4.15 VHA Directive 2009-031, Improving Safety in the Use of Reusable Medical Equipment Through Standardization of Organizational Structure and Reprocessing Requirements

1.5 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.

1.5.1 ABU: American Board of Urology

1.5.2 ACGME: Accreditation Council for Graduate Medical Education

1.5.3 ACLS: Advanced Cardiac Life Support

1.5.4 BLS: Basic Life Support

1.5.5 CDC: Centers for Disease Control and Prevention

1.5.6 CEU: Certified Education Unit

1.5.7 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.

1.5.8 CME: Continuing Medical Education

1.5.9 CMS: Centers for Medicare and Medicaid Services

1.5.10 Contracting Officer (CO): 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.

1.5.11 Contracting Officer’s Representative (COR): 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.

1.5.12 COS: Chief of Staff

1.5.13 CPARS: Contractor Performance Assessment Reporting System

1.5.14 DEA: Drug Enforcement Agency

1.5.15 ED: Emergency Department

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

1.5.17 FSMB: Federation of State Medical Boards

1.5.18 FTE: Full Time Equivalent 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.

1.5.19 HHS: Department of Health and Human Services

1.5.20 HIPAA: Health Insurance Portability and Accountability Act

1.5.21 HR: Human Resources

1.5.22 ISO: Information Security Officer

1.5.23 Medical Emergency: a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.5.24 NPI: National Provider Identifier. 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).

1.5.25 POP: Period of Performance

1.5.26 PPD: Purified Protein Derivative

1.5.27 PWS: Performance Work Statement

1.5.28 QA/QI: Quality Assurance/Quality Improvement

1.5.29 QM/PI: Quality Management/Performance Improvement QASP: Quality Assurance Surveillance Plan

1.5.30 VETPro: 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.

1.5.31 VHA: Veterans Health Administration

1.5.32 VISN: Veterans Integrated Services Network

1.5.33 VistA: Veterans Information Systems Technology Architecture

1.5.34 Reusable Medical Equipment (RME): Any medical equipment designed by the manufacturer to be reused for multiple patients. All RME must be accompanied by reprocessing instructions provided by the manufacturer

1.5.35 Standard Procedure: A document detailing all steps and activities of process or procedure that is dates and signed by the appropriate company official

1.5.36 Reprocessing: the cleaning, disinfection, sterilization, and preparation of equipment to full readiness for its subsequent use

1.5.37 Set-up: the process of assembling the RME in preparation for a procedure in accordance with the manufacturer’s instructions

1.5.38 Competency: the assurance that an individual has received the appropriate training and has demonstrated an achieved skill level required to independently and appropriately perform an assigned task or responsibility

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License/Certification – The Contractor will ensure that the contractor technician(s) possess all licenses, certifications, competencies required to perform the services covered by this contract.

2.1.2. Technical Proficiency - Contractor’s technicians(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 Contractor’s technician(s). Contractor’s technician(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. Training (ACLS, BLS, CPRS 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 technician(s) as required by the VA

Training

Contract technician(s) must complete the "VA Privacy and Information Security Awareness and Rules of Behavior," (10176) and “VHA HIPAA Focused Training.” (10203) This training is a web-based course that may be accessed on the Talent Management System (TMS) https://www.tms.va.gov/SecureAuth35/. A copy of the training certificate must be forwarded to the Surgical Service COR who will in turn forward to VA Information Security Officers and Privacy Officer. This is an annual mandatory requirement. The Contractor shall provide to the contracting officer a copy of the training certificates for each applicable technician within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete this mandatory training within the timeframe required will be grounds for suspension or termination of all physical and/or electronic access privileges and removal from work on the contract until such time as the training is completed.

2.1.4. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for technician(s) 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.

2.1.4.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all Contractor’s technician(s). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2.1.4.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor technician(s). {This is applicable to all health care workers}.

2.1.4.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor technician(s). {This is applicable to all health care workers}.

2.1.4.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor technician(s) {This is applicable to all health care workers}

2.1.4.5. INFLUENZA: Contractors shall provide proof that all Contractor technician(s) have received the annual Influenza vaccine unless it is contraindicated.

2.1.4.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contractor’s technician(s); provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. The VAMC 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.

2.1.4.7. The VAMC 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.

2.1.5. 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.6. DEA - Contractor shall provide copy of current DEA certificate.

2.1.7. Conflict of Interest: The Contractor and all Contractor’s technician(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.

2.1.8. Citizenship related Requirements:

2.1.8.1. The Contractor certifies that the Contractor’s technician(s) shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN patient referrals;

2.1.8.2. While performing services for the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN, 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.

2.1.8.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN 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 Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN; and shall form the basis for termination of this contract for breach.

2.1.8.4. 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.

2.1.8.5. 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.

2.1.9. 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.

2.1.9.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG website at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s technician(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.

2.1.9.2. 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’s technician(s) 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 Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC 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 Contractor’s technician(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 technician(s) are prohibited from referring VA patients to contractor’s or their own practice(s).

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

2.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s technician(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:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s technician(s). When a Contractor or Contractor’s technician(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 Contractor’s technician(s) action, or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Personnel:

2.9.1. No FTE is required for this service.

2.9.2. 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.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Operating Room Hours shall be scheduled during normal VA operating hours which are Monday through Friday, 8:00 AM to 4:30 PM.

3.1.1. The VA will schedule patients as services are needed. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Juneteenth

· 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.

3.3. Cancellations:

3.3.1. Unless a state of emergency has been declared, the Contractor technician(s) shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. General: The contractor shall make the CryoCare CS or Cryo 20 unit and technician available to the VAMC Surgical Service Urology Department in accordance with a schedule mutually agreed upon between the parties. The VA Nurse Liaison will contact the contractor with a schedule and provide approximately 3-4 weeks advance notice. In the event the facility requires the use of the Unit at an unforeseen time other than those scheduled, contractor will make every effort to provide the Unit to the facility upon 48 hours advance notice from facility personnel. A standby fee of 50% of the total cost of the procedure will be paid for any case not cancelled within 24 hours of advanced notice. Exception shall apply when two cases are scheduled for the same day and one case requires cancelling, no standby charges will be assessed.

4.1.1. The contractor and it’s representatives shall be responsible to ensure that RME systematic processes are fully implemented and executed at contractor locations providing services under this contract. Contractor shall ensure that appropriate training is provided and completed for all users of RME prior to initial use.

4.1.2. All contractor personnel that are in any way involved in the set-up, use and reprocessing of RME shall have documented training on the setup, use, reprocessing, and maintenance of the specific equipment leading to initial competency and validation of that competency on an annual basis.

4.1.3. All contractor personnel charged with reprocessing duties shall be appropriately training and competent in performing the assigned task, and when procedures are changed all designated staff are retrained and competency is again established. Personnel reprocessing RMF must be continually evaluated to ensure that they are demonstrating proficiency in all reprocessing activities. Appropriate training must be done whenever new or different equipment is used. Contractor shall provide evidence of training and competencies to the VA COR.

4.1.4. Contractor shall have established, or establish for this contract, specific standard processes and procedures for all RME. This includes, but is not limited to following specific guidance regarding the use and reprocessing of RME:

4.1.4.1 All clinical and technical personnel involved in RME set-up, use and reprocessing are to be trained in standard infection control methods, including those to protect both patients and themselves.

4.1.4.2 Standard Procedures must reflect current manufacturers’ instructions and must be available in each area where reprocessing occurs for each type of RME used. Personnel assigned to reprocess RME must be trained according to device-specific procedures in order to ensure proper cleaning and high-level disinfection and sterilization.

4.1.4.3 All standard procedures must be kept up to date according to the manufacture’s instructions, and methods in place to sequester outdated versions and to disseminate revised procedures, as well as to ensure compliance and competence in the execution of any revised procedure.

4.1.4.4 Current manufacturer’s instruction for RME are available and on file.

4.1.4.5 A method shall be in place to identify that a given RME has been reprocesses; if not clearly identifies as having been done, it must be reprocessed before use. A system or log shall be in place to record, for each instance of use, the:

· Serial number, or other unique identifier, of the endoscopic equipment used for each patient procedure.

· Specific procedure, operator(s), date and time, and patient identifier.

4.1.4.6 A quality management program must be in place to ensure appropriate and safe reprocessing is being performed.

4.1.5. The contracting technician, also known as a clinical applications specialist, shall be responsible for setting up the equipment, and will be responsible for the following criteria:

· Setting up of the Urethral Warming System

· Proper sterilization and decontamination of the cryosurgical Cryo probes and temperature probes, the holders, and the ultrasound probe.

· Connect ultrasound probe to the cryosurgical system

· Proper gas setup and power on sequence

· Connect cryosurgical probe and temperature probe to the cryosurgical system

· Enter patient information into the proper fields

· Run pre-test for the cryosurgical probe

· Adjust ultrasound imaging (sagittal and transverse) for the best quality

· Has knowledge of ultrasound functions

· Properly will run mapping portions of the procedure unless dictated otherwise by the physician

· Demonstrate the ability to ad or delete probes when needed

· Engage auto freeze or manual mode as needed

· Store case information

· Load printer paper

· Print case information

· Shut down and bleed the cryosurgical systems at termination of the case

4.1.2. The technician is also responsible for:

· Identification cryosurgical machine and use of console components

· Have knowledge of the parameters of Auto freeze treatment modes (targe temperature and safety stopes, etc.)

· Acknowledge adequate time for the urethral warmer to warm fluid

· Turning the power on and off on the cryosurgical machine

· Attaching the Argon regulators

· Attaching the Helium gauge

· Being able to connect the Argon supply line to the cryosurgical system

· Connecting the Helium supply line to the cryosurgical system

· Being able to connect the Cryoprobes to the back of the Cryocare system

· Being able to attach the temperature probes and label according to the anatomy

· Accomplishing the breakdown of equipment, bleed and shutdown the cryosurgical system

· Operating the Cryocare keypad

· Identifying disposable supplies necessary for cryosurgery

· Making sure the Cryoprobe holder is affixed to a sterile drape fixture

· Ensuring the Cryoprobe is tested prior to patient use

· Knowing that one Argon tank should be regulated at 3000 psi and the other at 3200 psi, another Argon tank is considered empty once it reaches less than 3000 psi

· Having a Helium tank ready to be used which will be supplied by the hospital

· Hooking up the helium tank and know that once it falls below 900 psi for 2500 psi tanks and below 3000 psi for 6000 psi tanks, it should be considered empty

4.1.3. The technician supplied by the contractor must demonstrate the ability to:

· Turn the fluid warmer and circulating pump power on and off.

· Insert the heat exchanger cassette in the fluid warmer

· Connect urethral warming tubing to 1-liter bag of room temperature NACL or water

· Apply IV pressure cuff to fluid and maintain fluid between 100 mm Hg and 200 mm Hg

· Install tubing into circulating pump with proper placement of tubing between “A” and “B” indicators

· Prime tubing after opening all clamps and turn pump speed at “2”, ensuring that all air bubbles are removed for proper priming

· Increase circulating pump speed to “3” and confirm with physician.

· Set temperature to 37.5° C and verify temperature of fluid warmer with physician.

· Increase and decrease temperature on fluid warmer.

· Monitor the urethral warming system during cryosurgical procedure by:

a. Observation of paddle wheel spinning.

b. Ensuring consistent fluid level in IV bag.

c. Consistent temperature of fluid warmer.

· Knowing that if a leak does occur, notify physician immediately and replace the urethral warming catheter, or any or all components of tubing set as necessary.

· After removal, the urethral catheter, tubing, warming cassette, and fluid bag should be discarded in designated hospital container.

· Instructions provided to scrub nurse for handling urethral catheter and tubing

· Handing off two distal ends of catheter tubing and separate spike tubing

· Securing tubing to OR field

· The remainder of the case and the actual performance of the targeted cryoablation of the prostate cancer will be performed by a VA licensed Urologic Physician.

4.1.4. The Contractor shall provide the following supplies:

· Cryoablation System

· Transrectal Ultrasound probe

· Argon & Helium regulator set

· Stepper (check bed for compatibility)

· Urethral warmer

· Grid

· Probe Holder

· Ultrasound Machine (renal)

· Laparoscopic or intra-operative US probe (renal)

· Cryosurgery Technician

· Disposables:

a. Prostate: CRYO-270V Prostate Kit and CRYO-77 Warming Cartridge

b. Renal: CVA2400 Cryoprobes and CRYO-55 Temperature Probes

4.1.5. Memphis VAMC shall provide the following supplies:

· Gas requirements for the Cryocare system

· ARGON: 99.998 pure or better 6000 PSI (grade 4.8 or better) Fitting: CGA677

· HELIUM: 99.995 pure or better 6000 PSI (industrial grade or better) Fitting: CGA677

· Gas: per prostate procedure – Hospital should order all gases and have on-site 5 days prior to cases

· 1 Tank Argon (Grade 4.8 – 99.998% Pure - 6000 PSI)

· 1 Tank Helium (6000 PSI)

· A back up of 1 Argon and 1 Helium should be on hand for each prostate procedure

4.1.5.1. Instrumentation (Prostate)

· 1 ea. Hyperthermia Unit with upper body pad (Bair Hugger)

· 1 ea. Bowl set (1 large, 1 med., 1 small)

· 1 pair Allen Stirrups, Yellow Fins, Candy cane w/ padding

· 1 ea. Pressure bag for urethral warming system fluid

· 1 ea. Flexible Cystoscopy set

· 1 ea. Light source

· 1 ea. Video Set Up

4.1.5.2. Minor Tray

· 6 ea. Hemostats

· ea. Kelly

· ea. Allis

· 2 ea. Std. Mayo (scissors)

· 1 ea. Short Needle Holder

· 2 ea. Tissue Forceps with teeth Suture

· 1 ea. Blade holder

· ea. Towel clamps

4.1.5.3. Drugs / Irrigation:

· 1 ea. 1-liter saline or H2O bag (double port at base) for warmer

· ea. 1-liter saline bottles (Heated) on table

· 1 ea. 1-liter water bottles for probe testing

· 1 ea. Saline bag for Cysto

4.1.5.4. Drapes:

· 1 ea. Cysto pack

· 1 ea. Mayo stand cover

· 1 ea. 3/4 sheet (under Buttocks)

· 1 ea. Back table cover

4.1.5.5. Disposables:

· 1 pair Ted Hose, SCD’s

· Tubes KY jelly

· ea. 10cc syringe

· 1 ea. 6Occ syringe (luer lock)

· 1 ea. 6Occ syringe (toomey)

· 1 ea. 18fr or 20fr Foley with balloon

· 1 ea. Amplatz Super Stiff Guidewire, .035 or .038.

· 1 pk. 4 X 4

· 1 pk. Towels

· 1 ea. Perineal prep. Kit

· 1 ea. Cysto tubing

· 1 ea. Microtek Sterile endocavity transducer cover PC3688 (prostate)

4.1.5.6. Instrumentation Renal

· Set up as partial laparoscopic nephrectomy unless Surgery is specified as “open”

4.1.5.7. Disposables:

· ea. FloSeal or comparable hemostasis product (do not open)

· 1 ea. Civco Sterile laparoscopic transducer cover 610-941 (renal)

4.1.6. Maintenance of Unit: Contractor shall provide service and preventive maintenance of the Unit. Preventive maintenance shall include the performance of reasonable tests to ensure that the Unit is in the highest – level working condition. Vendor must supply Preventive maintenance documentation to Biomedical Engineering prior to first use.

4.1.7. Quality Assurance: Contractor shall ensure that contract technician(s) contribute to the ongoing quality improvement programs in the organization as described in Medical Center Memorandum No. 00-12, Quality Management System may be accessed at the following URL: http://vaww.memphis.va.gov/docs/memo.aspx

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

4.2.1. Contractor’s technician(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.

4.3. STANDARDS OF CARE: the contractor’s technician(s) shall perform urology cryoablation 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 TJC, VA and national standards as established by:

4.3.1. American Urological Association Guidelines:

https://www.auanet.org/education/aua-guidelines.cfm

4.3.2. The professional standards of The Joint Commission (TJC):

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

4.3.3. The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8

4.3.4. The requirements contained in this PWS.

4.4. MEDICAL RECORDS

4.4.1. Authorities: Contractor’s technician (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of 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). Its employees, agents, and subcontractors will not be considered employees of the VA. Notwithstanding any other provision of this agreement, contractor and/or its employees may not disclose information contained in general files and patient records and any or other individually identified patient information, including information and records generated by the contractor in performance of this agreement, except pursuant to explicit instructions from the VA. For the purposes of this paragraph, instruction to disclose may be provided by these officials only: Contracting Officer, Contracting Officer Technical Advisor, the Privacy Officer, or VA attorneys. In responding to enrolled patient’s, release of information requests the contractor shall supply a blank VA Form 10-4553 or 10-4553a to the enrolled patient and inform them to complete the form and mail it to VAMC Memphis. Release of Information consent is not required to transfer medical information between the contractor and the VAMC, Memphis, TN.

4.4.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19).