36C26319Q0031.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. DUNS: DUNS+4:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 94

636-18-3-1049-0008

36C26319Q0031 11-16-2018

Matthew Dale 651-293-3010 11-29-2018

5:00 PM

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Matthew Dale 316 Robert Street N.

St. Paul MN 55101

X 100

X

621999

$15 Million

N/A

NCO 23 - Sioux Falls 2501 W 22nd Street

Sioux Falls SD 57105

NETWORK 23 CONTRACTING OFFICE

Matthew Dale 316 Robert Street N.

St. Paul MN 55101

Y

Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This procurement is for Mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services for the Sioux Falls VA Medical Center (VA SFHCS).

Base + 4 option Years Base period of performance: 1 Jan 2019 – 31 Dec 2019

See CONTINUATION Page

X One

Chara L. Collins Contracting Officer

36C26319Q0031

Table of Contents

SECTION A SF 1449 SOLICITATION

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

B.4 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

B.5 VA HANDBOOK 6500.6 VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017) 46

C.2 52.212-2 EVALUATION – COMMERCIAL ITEMS (OCT 2014)

C.3 52.216-18 ORDERING (OCT 1995)

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……………………………………………….59

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

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN

2008)

C.13 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.14 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)57

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

C.16 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2016)

C.17 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (AUG 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (AUG 2018)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

E.2 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED

SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 78

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (AUG 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

SYSTEM FOR AWARD MANAGEMENT (SAM) REGISTRATION IS REQUIRED TO BE

ACCOMPLISHED BY THE CONTRACTOR BEFORE CONTRACT AWARD.

https://www.sam.gov/portal/public/SAM (SEE FAR PART 12)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1 “Instructions to Offerors – Commercial Items). All offers are subject to all terms and conditions of this solicitation.

1. CONTRACT ADMINISTRATION DATA

a. CONTRACT ADMINISTRATION: List below responsible party that may be contacted during the term of this contract for matters pertaining to the contract:

Contractor Name: __________________________________________

Title: __________________________________________

Address: __________________________________________

Telephone: __________________________________________

Facsimile: __________________________________________

E-mail: __________________________________________

Federal Taxpayer Identification ___________________________________________ Number Dun and Bradstreet Number ___________________________________________

b. Government: Matthew Dale, Contract Specialist Network Contracting Office 23 316 Robert Street N., Suite 506 St. Paul, MN 55101 Matthew.Dale3@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: 52.232-33, Payment by Electronic Funds Transfer - System for Award Management.

3. BILLING FOR SERVICES: See Performance Work Statement (PWS) section 15 for Billing Instructions.

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

AMENDMENT NUMBER DATE

https://www.sam.gov/portal/public/SAM

5. SAFETY REQUIREMENTS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee may determine to be reasonably necessary to protect the lives and health of the occupants of the buildings. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the forgoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purposes aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

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

7. TYPE OF CONTRACT: Resultant contract shall be an Indefinite Delivery / Indefinite Quantity (IDIQ) contract effective for the period stated in the Schedule of Services.

8 TERM OF CONTRACT: Resultant contract shall be effective for a base period of one year from 01/01/2019 (or date of award) through 12/31/2019 with four (4) twelve-month option periods.

9. AVAILABILITY OF FUNDS: The contract is subject to the availability of VA funds. The contractor shall perform no service after the end of the current exercised contract year until the Contracting Officer authorizes such services in writing.

10. POINT OF CONTACT: The Contractor shall provide a point of contact (POC) who shall be responsible for the performance of the work under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The POC may be a contract health care provider performing under this contract. An alternate may be designated, but the Contractor shall identify, in writing, those times when the alternate shall act as the POC. The Contractor shall identify the POC and alternate in writing to the Contracting Officer’s Representative (COR) and Contracting Officer (CO). The Contractor shall give written notification to the COR and CO of the time when the alternate will act as the POC. The POC shall be available by telephone Monday through Friday, 8:00 AM through 4:30 PM, excluding Federal holidays.

11. SECURE FAX: VA Handbook 6500 requires the following statement on all fax cover sheets be included: “This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribute on, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

12. POST AWARD ORIENTATION: The Contracting Officer will schedule a post-award orientation conference for contract orientation purposes as required by IL 003A3-12-04.

B.2 SCHEDULE OF SERVICES

The Contractor shall furnish all personnel and equipment to provide Turnkey Mobile Lithotripsy unit to perform Extracorporeal Shockwave Lithotripsy (ESWL) services to eligible beneficiaries of the Department of Veterans Affairs South Dakota – Sioux Falls Health Care System (hereinafter referred to as “VA SFHCS”), located at Sioux Falls VA at 2501 West 22nd Street, Sioux Falls, SD 57105. The contractor’s technicians’ care shall cover the range of Turnkey Mobile Lithotripsy 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.

Place of Performance: Services shall be provided on site at the Sioux Falls VA at 2501 West 22nd Street, Sioux Falls, SD 57105

Contract Minimum: $17,800.00 Contract Maximum: $285,000.00

BASE PERIOD: 01/01/2019 – 12/31/2019

LINE

ITEM

Description Est.

Qty.

Unit of Measure

Unit Cost Total Cost

CLIN

Turnkey Mobile Lithotripter Unit for ESWL's (all inclusive)

15 EA

CLIN

Emergency Services, Turnkey Mobile Lithotripter Unit for ESWL's

1 EA

TOTAL – BASE YEAR

OPTION YEAR 1: 01/01/2020 – 12/31/2020

ITEM

Description Est.

Qty.

Unit of Measure

Unit Cost Total Cost

CLIN

Turnkey Mobile Lithotripter Unit for ESWL's (all inclusive)

15 EA

CLIN

Emergency Services, Turnkey Mobile Lithotripter Unit for ESWL's

TOTAL – OPTION YEAR 1

OPTION YEAR 2: 01/01/2021 – 12/31/2021

LINE

ITEM

Description Est.

Qty.

Unit of Measure

Unit Cost

Total Cost

CLIN

Turnkey Mobile Lithotripter Unit for ESWL's (all inclusive)

15 EA

CLIN

Emergency Services, Turnkey Mobile Lithotripter Unit for ESWL's

TOTAL – OPTION YEAR 2

OPTION YEAR 3: 01/01/2022 – 12/31/2022

ITEM

Description Est.

Qty.

Unit of Measure

Unit Cost Total Cost

CLIN

Turnkey Mobile Lithotripter Unit for ESWL's (all inclusive)

15 EA

CLIN

Emergency Services, Turnkey Mobile Lithotripter Unit for ESWL's

TOTAL – OPTION YEAR 3

OPTION 4: 01/01/2023 – 12/31/2023

ITEM

Description Est.

Qty.

Unit of Measure

Unit Cost Total Cost

CLIN

Turnkey Mobile Lithotripter Unit for ESWL's (all inclusive)

15 EA

CLIN

Emergency Services, Turnkey Mobile Lithotripter Unit for ESWL's

TOTAL – OPTION YEAR 4

TOTAL BASE PERIOD AND ALL OPTION PERIODS:____________

B.3 PERFORMANCE WORK STATEMENT

ON-SITE MOBILE EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) SERVICE

1. GENERAL:

a. Services Provided. The Contractor shall provide Lithotripsy Technologist and Equipment to provide Mobile Extracorporeal Shock Wave Lithotripsy (ESWL) Services on-site in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Sioux Falls VA Health Care System (VASFHCS), 2501 W 22nd St Sioux Falls SD 57105.

(1) The Contractor’s Lithotripsy Technologist(s) shall be licensed, certified and trained in ESWL Lithotripsy Service and operation of the equipment unit(s). The Lithotripsy Technologist(s) shall administer procedure(s) under the direction and supervision of Sioux Falls VAHCS Physician(s).

(2) The contractor shall provide portable, state-of-the-art, digital units that can be moved into the operating room. The equipment shall meet or exceed the following:

i. Treat all stones anywhere in the urinary tract.

ii. Has a greater than 80% success rate based on FDA clinical study data.

iii. Is modular and can treat patients in the operating room.

iv. Can do endourological procedures before and after ESWL without moving the patient.

(3) The Sioux Falls VAHCS anticipates 15 cases annually. This is only an estimate and is dependent upon patient volume and actual need.

(4) Contractor personnel shall be required to attend a Sioux Falls VAHCS orientation prior to commencing work under this contract.

i. The orientation shall include a tour of the surgical facility.

ii. Review of applicable VA policies and procedures governing the medical care provided at the Sioux Falls VAHCS.

b. Authority. Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority.

c. Policy/Handbooks:

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

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

(3) VHA Handbook 1100.17: National Practitioner Data Bank Reports -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

(4) VHA Handbook 1100.18 Reporting and Responding To State Licensing Boards -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

(5) VHA Handbook 1100.19 Credentialing and Privileging -http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

(6) VHA Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

(7) Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

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

(1) ABU: American Board of Urology

(2) BLS: Basic Life Support

(3) CDR: Contract Discrepancy Report

(4) 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.

(5) 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.

(6) COS: Chief of Staff.

(7) CPARS: Contractor Performance Assessment Reporting System

(8) Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status

(9) HHS: Department of Health and Human Services

(10) HIPAA: Health Insurance Portability and Accountability Act

(11) HR: Human Resources

(12) ISO: Information Security Officer

(13) 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.

(14) POP: Period of Performance

(15) PWS: Performance Work Statement

(16) QASP: Quality Assurance Surveillance Plan

(17) QA/QI. Quality Assurance/Quality Improvement http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

(18) QM/PI: Quality Management/Performance Improvement

(19) TJC: The Joint Commission https://www.jointcommission.org/

(20) VETPRO: a federal web-based credentialing program for healthcare providers

(21) Veterans Health Administration (VHA): The central office for administration of the

VA medical centers throughout the United States. The VHA is located in Washington D.C.

(22) Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

(23) Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical center, for purposes of this contract, this term shall mean the Sioux Falls Medical Center.

(24) VA Health Care System (VAHCS): Unless identified with the name of a different VA Health Care System, for purposes of this contract, this term shall mean the Sioux Falls VA Health Care System.

2. QUALIFICATIONS:

a. License.

(1) The Contractor’s employee(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia.

(2) All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s employee(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

b. Board Certification. All contractor’s employee(s) shall be certified by an accrediting agency, and be currently certified in Basic Life Support (BLS). All continuing education courses required for maintaining certification 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.

c. Credentialing and Privileging.

(1) Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced above. The Contractor is responsible to ensure that proposed employee(s) possess the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s employee(s) prior to obtaining approval by the Sioux Falls VAHCS Professional Standards Board, Medical Executive Board and Medical Center Director.

https://www.jointcommission.org/

(2) If a contractor’s employee(s) is/are 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.

d. Technical Proficiency. The Contractor’s employee(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’s employee(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

e. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements.

Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contractor’s employee(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract employee(s).

f. 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 employee(s) as required by the VA.

Training Frequency Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior TMS 10176

Annually 1.0 Hour

SUX-AHA BLS (Basic Life Support for Healthcare Providers) TMS 1337195

Biennial 4.0 Hours

Privacy and HIPAA Training TMS 10203

Annually 1.0 Hour

Life-Sustaining Treatment Decisions Initiative: New Processes to Support Patient-Centered Care TMS 31722

Annually 1.0 Hour

Mandatory Training for Transient Clinical Staff (Non-Trainees) TMS 20152

Annually 1.5 Hours

Age Specific and Cultural Competencies TMS 3945965

Annually 0.5 Hour

g. Standard Personnel Testing (PPD, ETC). Contractor shall provide proof of the following tests for contract employee(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.

(1) TUBERCULOSIS TESTING: Contractor shall provide proof of a negative

Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s employee(s) (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. The TST or IGRA testing shall be repeated annually.

(2) MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor employee. This is applicable to all health care workers.

(3) VARICELLA: Contractors shall provide proof of immunity for all Contractor employee(s). This is applicable to all health care workers.

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

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

(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 employee(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.

(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.

h. Conflict of Interest. The Contractor and all contractor’s employee(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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf same information for any identified consultants or subcontractors who shall provide services.

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

i. Citizenship Related Requirements.

(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) 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.

(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.

(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.

(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.

j. 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.

(1) Therefore, Contractor shall review the HHS OIG List of Excluded

Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s employee(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) 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.

k. 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 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 Sioux Falls VAHCS Chief of Staff (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.

l. Non-Personal Healthcare Services: The parties agree that the Contractor and all contractor’s employee(s) shall not be considered VA employees for any purpose.

m. 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.

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

o. Inherent Government Functions: Contractor and Contractor’s employee(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 http://oig.hhs.gov/exclusions/index.asp employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

p. No Employee status: The Contractor shall be responsible for protecting Contractor’s employee(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:

(1) Workers’ compensation

(2) Professional liability insurance

(3) Health examinations

(4) Income tax withholding, and

(5) Social security payments.

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

r. Key Personnel.

(1) Procedures shall be scheduled in advance. The contractor shall be responsible to ensure contract employee(s) are available and in place to provide services.

(2) The Sioux Falls VAHCS anticipates between 15 to 18 procedures per year.

(3) The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s employee(s) due to sick leave, personal leave, vacations and additional coverage as required.

s. 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 30 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 30 calendar days prior to making any permanent substitutions.

(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 10 calendar days after receipt of all required information of the decision on the proposed substitutes.

t. For temporary substitutions where the key person shall not be reporting to work, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person.

u. 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 Contractor’s employee(s), she/he may request, without cause, immediate replacement of said Contractor’s employee(s). The CO and COR shall deal with issues raised concerning Contractor’s employee(s) conduct. The final arbiter on questions of acceptability is the CO.

v. Contingency Plan: Because continuity of care is an essential part of the Sioux Falls VAHCS’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s employee(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. HOURS OF OPERATION.

a. VA Business Hours: Monday-Friday, based on Surgery Department Schedule. Normal working hours are Monday – Friday, 7:00am – 7:00pm.

b. Procedures shall be scheduled in advance between the Sioux Falls VAHCS and the contractor.

(1) The Sioux Falls VAHCS will attempt to provide a minimum of five (5) calendar days’ notice prior to the scheduled procedure date. In the event the contractor is unable to confirm the scheduled procedure date, the Sioux Falls VAHCS and contractor shall determine an acceptable date.

(2) Short Notice/Urgent Requests. The contractor will attempt to fulfill short notice or urgent service requests when contacted by the Sioux Falls VAHCS. If unable to provide short notice or urgent services, the contractor and Sioux Falls VAHCS will negotiate the procedure date or abide by the five (5) calendar day notice.

(3) Cancellations. The contractor and/or the Government shall provide a minimum of 24-hour notice when cancelling a procedure.

c. Unless a state of emergency has been declared or clinics are otherwise cancelled by the Sioux

Falls VAHCS, the Contractor shall be responsible for providing services.

d. 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

• 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.

4. CANCELLATIONS AND RETREATMENTS.

a. Advance Cancellation will adhere to a 24-hour notice period.

(1) The contractor shall not invoice for procedures if the Sioux Falls VAHCS provides a 24-hour cancellation notice.

(2) The contractor may invoice for 50% of the contract procedure cost if the Sioux Falls VAHCS cancels the procedure with less than a 24-hour notice.

(3) The contractor shall provide 50% credit/discount of the contract procedure cost if the contractor cancels the procedure with less than 24-hour notice. The credit/discount will be applied to the rescheduled date. If not rescheduled, the credit/discount shall be applied to the next available procedure.

b. Same Day Cancellation Procedures for Single and Multiple Procedures.

(1) In the event, multiple procedures are scheduled consecutively on the same day, and the contractor is only making one trip to the Sioux Falls VAHCS, and a procedure is cancelled, the contractor shall be paid 25% of the contract procedure price for the cancelled procedure.

(2) In the event, multiple procedures are scheduled at various intervals (breaks greater than 1.5 hours) on the same day, and the contractor is making trips to the Sioux Falls VAHCS between the scheduled procedures, and a procedure is cancelled, the contractor shall be paid 50% of the contract procedure price for the cancelled procedure.

(3) In the event, one procedure is scheduled at the Sioux Falls VAHCS, and the procedure is cancelled, the contractor shall be paid 50% of the contract procedure price for the cancelled procedure.

c. Additional Treatment. If a patient must undergo an additional treatment within ninety (90) days from his/her initial procedure date due to continued problems with the stone(s), i.e., stone(s) was not broken down small enough to pass or fragments of the stones(s) remain, the contractor will provide the treatment at 50% of the contract procedure cost.

5. CONTRACTOR RESPONSIBILITIES

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

(1) Contractor’s employee(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm services provided against the contractor’s invoices.

b. Standards of Care. The contractor’s employee(s) care shall cover the range of Lithotripsy 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:

(1) American Urological Association Guidelines: https://www.auanet.org/education/aua-guidelines.cfm

(2) VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision)

(3) The professional standards of the Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx

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

(5) The requirements contained in this PWS

c. Contractor Equipment.

(1) Contractor shall provide a state-of-the art portable/modular, digital unit that can be easily moved into the procedure room at the Sioux Falls VAHCS. Contractor is responsible for obtaining all necessary licenses, and approvals and shall comply with all federal, state, and local laws and regulations applicable to the equipment and delivery of ESWL.

(2) Contractor is responsible for preventive and emergency maintenance of the contractor’s equipment.

https://www.auanet.org/education/aua-guidelines.cfm https://www.auanet.org/education/aua-guidelines.cfm https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8

(3) Maintenance of contractor equipment shall be in accordance with manufacturer’s recommendations.

(4) Contractor’s equipment shall be inspected annually. Proof of maintenance and inspection must be provided to the VA upon request.

i. The Government may, at its option and expense, request an unrelated third party to inspect the equipment provided by the contractor. The contractor shall repair, at the contractor’s cost, any defects discovered by the inspection of the third party within fifteen (15) days when notified by the COR.

ii. All equipment maintenance documentation is to be provided quarterly to Biomedical Services at the Sioux Falls VAHCS. All equipment is required to be safety checked by the local VA Biomed staff each time it arrives on site before any procedures begin. The VA Service Line shall arrange for the VA Biomedical staff to inspect the equipment with the contractor technician.

d. Contract employee(s) shall administer ESWL procedure(s) and must be present at all time while the equipment is used at the Sioux Falls VAHCS. The VA will not be held liable for any loss or damage to the Contractor’s property.

e. Contractor will supply additional materials and supplies including consumables as are necessary to conduct ESWL services, i.e., stirrups.

f. Contractor’s equipment must meet or exceed the following criteria:

(1) Has ability to treat all stones anywhere in the urinary tract.

(2) Has been approved by the Federal Drug Administration (FDA).

(3) Has a greater than 80% success rate based on FDA clinical study data.

(4) Has ability to do endourological procedures before and after ESWL without moving the Patient.

g. Contractor Lithotripsy Technologist Responsibilities.

(1) Operate the ESWL equipment under direction of the attending VA physician.

(2) Troubleshoot and resolve equipment issues.

(3) Educate Sioux Falls VAHCS employee(s) as it relates to the operation and parameters of the lithotripsy machine.

(4) Deliver all digital reports and files of all procedures performed with the equipment to the Surgery Nurse Manager.

(5) Clean and sterilize the ESWL machine.

6. GOVERNMENT RESPONSIBILITIES.

a. The VA shall provide the following:

(1) Suitable electric service to operate the unit(s). Contractor to notify the Sioux Falls

VAHCS in advance of power requirements for machines.

(2) Scheduling of patients for the procedure and coordinating the scheduling of any in-service, relating to the units for facility staff.

(3) Pre-operative preparation of patients for ESWL.

i. The Sioux Falls VAHCS shall obtain written patient consent forms and provide patients with the necessary services related to post procedure recovery. Facility shall be responsible for providing emergency service personnel, physicians, facilities and supplies necessary to provide patients with emergency medical care as may be required, as well as physicians, facilities and supplies necessary to provide patients with inpatient or outpatient post procedure care.

ii. Collect and dispose of infectious waste and sharps related to the ESWL procedures.

(4) Provide other necessary personnel for the operation of the services contracted for at the VA. These other necessary personnel shall be mutually agreed upon between the VA and the contractor who are compatible with the safety of the patient and are personnel with quality medical care programming.

i. Procedures will only be conducted when the attending VA physician is present. The VA physician shall provide direction and oversight.

7. MEDICAL RECORDS.

a. Authority: Contractor’s employee(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).

b. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www.rms.oit.va.gov/SOR_Records/24VA19.asp medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

c. Disclosure: Contractor’s employee(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information.

Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, 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.

d. Professional Standards for Documenting Care: The Sioux Falls VAHCS attending physician shall document care in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC

(1) The contractor’s employee(s) will NOT have direct access to patient records or information. The Sioux Falls VAHCS shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements.

e. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms.

Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form.

Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address:

Aaron Cork, Privacy Officer Aaron.cork@va.gov 605-336-3230 x9-6784 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf mailto:Aaron.cork@va.gov

8. PATIENT SAFETY COMPLIANCE AND REPORTING. Contractor’s employee(s) shall follow all established patient safety and infection control standards of care.