36C26318R0245-002.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 73

636-18-3-1049-0008

36C26318R0245 01-18-2018

Scott Hendrix 651-293-3024 02-21-2018 1:00 pm CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Scott Hendrix 316 Robert Street N.

St. Paul MN 55101

X 100

X

621999

$15 Million

X

N/A

X

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

Omaha NE 68105-1850

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Scott Hendrix 316 Robert Street N.

St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Provide Turn-Key Mobile Lithotripsy services on-site at the Nebraska - Western Iowa VA Medical Center.

See Performance Work Statement Section B.5.

See Schedule of Services Section B.4.

See Proposal Submittal Instructions Section E.2.

See CONTINUATION Page

X One

Scott E. Hendrix Contracting Officer

X

36C26318R0245

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

(Continuation from Standard Form 1449, block 18A.)

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN

2011)

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN

2011)

B.4 SCHEDULE OF SERVICES

B.5 PERFORMANCE WORK STATEMENT

B.6 CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

2017)

C.2 52.216-18 ORDERING (OCT 1995)

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

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

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

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

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 40

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

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

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.11 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(JAN 2008)

C.12 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2017)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017)

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

E.2 PROPOSAL SUBMITTAL INSTRUCTIONS

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(JAN 2008)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)

E.8 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (NOV 2017)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

(Continuation from Standard Form 1449, block 18A.)

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: Contracting Officer - Scott E. Hendrix Network Contracting Office 23 316 Robert Street N., Suite 506 St. Paul, MN 55101 Phone (651) 293-3024 Scott.hendrix@va.gov

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

[X] 52.232-33, Payment by Electronic Funds Transfer - System for Award Management, or https://www.sam.gov/portal/public/SAM mailto:Scott.hendrix@va.gov

[ ] 52.232-36, Payment by Third Party

3. BILLING FOR SERVICES: See Performance Work Statement (PWS) section 7.2 for Billing Instructions.

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

AMENDMENT NUMBER DATE

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 10/01/2018 (or date of award) through 09/30/2019 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 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments.

Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

B.4 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 Nebraska – Western Iowa Health Care System (hereinafter referred to as “VA NWIHCS”), located at 4101 Woolworth Avenue, Omaha, NE 68105. 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 VA NWIHCS, 4101 Woolworth Avenue, Omaha, NE 68105.

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

BASE PERIOD: 10/01/2018 – 09/30/2019

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: 10/01/2019 – 09/30/2020

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: 10/01/2020 – 09/30/2021

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: 10/01/2021 – 09/30/2022

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: 10/01/2022 – 09/30/2023

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.5 PERFORMANCE WORK STATEMENT

1. General:

1.1. Services Provided: The contractor shall provide specialized medical resources for an FDA approved turnkey Mobile Lithotripter Unit to perform Extracorporeal Shockwave Lithotripsy (ESWL) services on a scheduled or an emergency per procedure cost basis.

1.2. Standard of Care: The standard of care should be equal to that provided by the VA NWIHCS if the VA NWIHCS can provide the services required at their location. The contractor shall provide competent, quality Lithotripsy services to all patients of the VA NWIHCS, in the performance of contract requirements. Contractor shall provide all services specified in this contract for any VA beneficiary, regardless of the race, color, religion, sex, or national origin of the person for whom such services are ordered. The Contractor further warrants that he/she shall not resort to subcontracting as a means of circumventing this provision.

1.3. Place of Performance – Contractor is to provide services at the VA NWIHCS, Omaha Division, located at 4101 Woolworth Avenue, Omaha, NE.

1.4. Policy/Handbooks:

1.4.1. VHA Handbook 1605.1 Privacy and Release of Information http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1423

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

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

1.4.3. VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (corrected version) http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.4.4. VHA Directive 2010-017: Prevention of Retained Surgical Items http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2186

1.4.5. VA Forms

https://www.va.gov/vaforms/search_action.asp

1.4.6. VA NWIHCS Blood and Body Fluid Exposure Management Procedure Policy (See Attachment 5)

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

1.5.1. AORN: Association of Perioperative Registered Nurses

1.5.2. BLS: Basic Life Support

1.5.3. Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1423 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2186 https://www.va.gov/vaforms/search_action.asp

1.5.4. 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.

1.5.5. COS: Chief of Staff

1.5.6. CPARS: Contractor Performance Assessment Reporting System

1.5.7. HIPAA: Health Insurance Portability and Accountability Act

1.5.8. NWIHCS: Nebraska-Western Iowa Health Care System

1.5.9. PWS: Performance Work Statement

1.5.10. POP: Period of Performance

1.5.11. QASP: Quality Assurance Surveillance Plan

1.5.12. VA: Department of Veterans Affairs

1.5.13. VAMC: Veterans Affairs Medical Center

2. QUALIFICATIONS – MOBILE LITHOTRISY TECHNICIAN:

2.1. Staff:

2.1.1. License/certifications: The Contractor’s technician(s) assigned by the Contractor to perform the services covered by this contract shall have a current certification to preform Lithotripsy services in any State, Territory, or Commonwealth of the United States or the District of Columbia) when services are performed onsite on VA property.

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

2.1.1.2. The qualifications of such personnel shall also be subject to review by the VA facility Director, Chief of Staff, Chief of Surgery or Credentialing Coordinator if appropriate.

2.1.2. Certifications: Radiologic certification by American Registry of Radiology Technologist or equal.

2.1.2.1. Each person assigned to work under this contract shall be certified and trained in ESWL service and operation of the unit(s).

2.1.3. Experience: Minimum of one year of documented experience in (ESWL) services.

Experience must have been in the last year. Documented competency in (ESWL) (see listing below in Knowledge, Skills and Abilities section) as well as evidence of having performed at least 20 cases per year.

2.1.4. Knowledge, Skills and Abilities - Knowledge required by the Mobile Lithotripsy Technician:

2.1.4.1. Knowledge of Lithotripters

2.1.4.2. General Knowledge with medical terminology as it pertains to anatomy and surgical procedures for an operating room

2.1.4.3. Ability to setup and calibrate ESWL equipment.

2.1.4.4. Ability to setup and position patient for the patient to receive the treatment as directed by the physician

2.1.4.5. Ability to work with and comply with all physician directives and facility requirements.

2.1.5. Technical Proficiency: Contractor’s technician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contractor’s technician(s).

2.1.6. Training (BLS, and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein in time to maintain patient care; all training must be completed by the contractor’s technician(s) as required by the VA (referenced below):

2.1.6.1. BLS: For contractors that will not utilize moderate sedation, the following identifies the training requirements:

2.1.6.1.1. Evidence of current American Heart Association BLS training. Must remain current.

Notes:

1. Contractors are ultimately responsible for their own cost of BLS training.

2. For radiologic technologist working on contract at VA NWIHCS: There are three options for completing the BLS requirement through the American Heart Association:

a. Contractor can purchase at their own expense a BLS course in the community.

b. Take the American Heart Association blended learning offered by VA NWIHCS Talent Management System (TMS). There will be no cost to the contractor to complete course by contacting the NWI BLS VA program director.

c. If there is space available in a face-to-face class, there will be no cost to the contractor. Contractors will register for Basic Life Support for Healthcare Providers (BLS) via the VA’s TMS.

3. A copy of the front and back of an American Heart Association BLS course card must be provided to the clinical service’s point of contact.

2.1.7. Other Mandatory VA training as required:

2.1.7.1. VA Privacy / HIPPA

2.1.7.2. High Risk invasive fires.

2.1.8. All contracted staff shall complete a formal VA NWIHCS orientation.

2.1.9. 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.

2.1.9.1. MANTOUX/PURIFIED PROTEIN DERIVATIVE (PPD) TESTING:

2.1.9.1.1. Contractor shall provide proof of a negative reaction to PPD testing for all contractor’s technician(s) within fourteen (14) calendar days prior to beginning service. If an earlier PPD test was given over twelve (12) months previously, the current test shall be a 2-step Mantoux test.

2.1.9.1.2. Medical evidence that personnel are disease free for those having a positive PPD. A negative chest radiographic report for active tuberculosis (TB) shall be provided in cases of positive PPD results.

2.1.9.1.3. An annual TB test is completed for all contract personnel listed on this contract. Contractor shall provide evidence of re-tests to the COR within ten

(10) calendar days of the re-test.

2.1.9.2. RUBELLA TESTING: Contractor shall provide proof of immunization for all contractor’s technician(s) for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.

2.1.9.3. 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.

2.1.9.4. VA NWIHCS shall notify the contractor and vice versa of any significant communicable disease exposures as appropriate. Contractors 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. Contractors shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.9.5. Surgical Masks: Mask should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the surgical attire top.

(Reference Association of Perioperative Registered Nurses (AORN), 2013 Standards http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf and Recommend Practices, Practice V1. b.1 http://www.faultlesslinen.com/images/2013%20AORN%20RP's%20for%20Surgical%2 0Attire.pdf ).

2.1.10. Conflict of Interest: The Contractor and all Contractor’s physician (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 (Jan 2008) and fully outlined in response to the subject attachment (Attachment 3) in Section D of the solicitation document.

2.1.11. Citizenship related Requirements:

2.1.11.1. The Contractor certifies that the Contractor shall comply with all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.1.11.2. 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, because 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.

2.1.11.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.11.4. 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.

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2.1.11.5. 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 (Attachment 4) in Section D of the solicitation document.

2.1.12. 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.

2.1.12.1. 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.

2.1.12.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of

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

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA 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 employee(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 employees are prohibited from referring VA patients to contractor’s or their own practice(s)

2.6. 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 employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

http://oig.hhs.gov/exclusions/index.asp

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.

2.7.6. Vehicle insurance

2.8. 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.

2.9. Key Personnel:

2.9.1. Qualified personnel shall have PIV / NON-PIV card (as applicable) and be on location as needed to properly perform tasks as specified.

2.9.2. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar day(s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

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

2.9.2.2. 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), s/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.

2.9.2.3. Contingency Plan: Because continuity of care is an essential part of VAMC’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. A copy of this contingency plan shall be submitted with the proposal and updated throughout the period of performance (POP).

3. VA HOURS OF OPERATION/SCHEDULING: The services covered by this contract shall be furnished by the contractor as defined herein.

3.1. VA Business Hours: Monday-Friday, based on Surgery Department Schedule. Normal working hours are Monday – Friday, 7:00am – 7:00pm. - The services covered by this contract shall be furnished by the contractor as defined herein.

3.2. On-Call Coverage:

3.2.1. It is VA NWIHCS Medical Service policy that a technician will be “on call” at home, or where available by phone or pager during the same tour of duty as the assigned house officers.

Thus, the technician is to be available for both ward and officer of the Day (OD) support, and is expected to visit the medical center for evaluation of care of patients as needed.

Arrangements should be made for transfer of on call responsibility if the assigned technician will be unavailable.

3.2.2. Contractor will provide a master call list with an assigned point of contact and will provide a new roster when changes occur. Personnel on call along with pager/cell phone numbers must be provided.

3.2.3. On-call technician should respond within 15 minutes (by phone) and 2 hours (in person) of being notified. Failure to meet this requirement could result in review of contract compliance.

3.2.4. 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. CONTRACTOR RESPONSIBILITIES

4.1. Contractor shall provide all supplies, equipment, clinical software and competent and qualified personnel to be used in performing the services below:

4.1.1. Provide Turnkey Lithotripsy system to include, at a minimum, all equipment, table, supplies and personnel as necessary to conduct ESWL procedures within the operating room.

4.1.2. Provide Contractor radiologic technologist(s) as necessary, to be available for surgical procedures as determined by the attending physician. Surgeries are typically scheduled during the hours of 7:00 a.m. – 7:00 p.m., Monday through Friday. VA NWIHCS will pay only for actual services performed at the VA NWIHCS facility and will not pay for “on-call” or standby time.

4.1.3. Supply a FDA approved Fluoroscopy with image intensifier equipment ready to use (the firing of the shockwave should be controlled to coordinate with the patient’s cardiac cycle).

4.1.4. Operate the mobile unit inside VA NWIHCS’s Operating Room or Cystoscopy Suite as directed by VA NWIHCS. Perform all standard Lithotripsy procedures including distal ureteral stones.

4.1.5. Maintain and service equipment routinely to ensure that the device is in the highest level of functioning condition without breakdowns, causing no delay to VA NWIHCS patient procedures. Maintain service records to document performance reports.

4.1.6. Contractor shall take immediate action to notify the Contracting Officer (CO) whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe to remove such products, equipment or items from use. This notification process also applies to safety alerts. The contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment or items can be made in as expedient and efficient manner as possible. The contractor shall provide to the CO their plan for this safety notification process and maintain a record system to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the CO.

4.1.7. Services are to be conducted in the operating room and associated areas of the Omaha VA NWIHCS on a per case basis as determined by the Chief of Surgical Service.

4.1.8. Be sufficiently knowledgeable to test equipment prior to use and to make any adjustments in the equipment settings that are required.

4.1.9. Surgeon will notify the OR/Case Manager in Surgical Service when Lithotripsy services are needed for a patient. The OR/Case Manager or appropriate designee will contact the Contractor with the request for Lithotripsy services. All changes to the proposed Lithotripsy services, to include date/time, type of monitoring, etc., will be conveyed by the OR/Case Manager or appropriate designee to the Contractor.

4.1.10. Maintain and service equipment routinely to ensure that the device is in the highest level of functioning condition without breakdowns, causing no delay to VA NWIHCS patient procedures. Service records are to be maintained to document performance reports and will be furnished the Contracting Officer prior to the start of the contract and each option year thereafter.

4.1.11. Deliver and remove equipment on a scheduled or emergent basis, with these costs included in the “per case” cost.

4.1.12. Participate in establishing before surgery, communication protocols with the surgical team to report Lithotripsy services.

4.1.13. Responsible for setting up all necessary OR equipment and supplies for lithotripsy services.

4.1.14. Technician must maintain up-to-date knowledge of developments in the field of lithotripsy.

4.1.15. Effective member of patient care team, e.g., participates in patient care activities, telephone usage, communicates effectively with surgical staff.

4.1.16. Promotes quality patient care by coordinating and evaluating the care of selected patients in collaboration with multidisciplinary and interdepartmental personnel.

4.1.17. Follow all VA infection control policies and procedures to include, but not limited to:

4.1.17.1. Dress Code

4.1.17.2. Surgical Conscience

4.1.17.3. Complies and sets up equipment and supplies utilizing recommended practices and aseptic technique.

4.1.17.4. Maintains integrity of all sterile areas.

4.1.17.5. Arrives in a timely manner so as not to delay the surgical process.

4.2. Scheduling of Mobile Lithotripsy services. Contractor will provide Mobile Lithotripsy services to

VA Nebraska Western Iowa Health Care System as requested by the appropriate designee in the Surgical Services when Mobile Lithotripsy services are needed for a patient. The OR Manager/Case Manager or appropriate designee will contact contractor with the request for Mobile Lithotripsy services. All changes to the proposed monitoring, to include date/time, type of Mobile Lithotripsy services, etc., will be conveyed by the OR Manager/Case Manager or appropriate designee to the Contractor.

4.3. The provision of Mobile Lithotripsy services does not include training or supervision of VA Nebraska Western Iowa Health Care System’s personnel or the provision of services which are not described in this agreement.

5. SPECIAL CONTRACT REQUIREMENTS

5.1. Under no circumstances will Contractor bill any patient or patient’s insurance company for any procedure. All costs will be charged only to Omaha VA NWIHCS at the designated rate(s) as listed by the Contractor in the Schedule of Items.

5.2. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT

(QI): Monitoring of contractor’s performance shall be done by the Contracting Officer’s Representative (COR). Incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. Contractor shall comply with the required standards as outlined in the Quality Assurance Surveillance Plan (QASP) (or 1 in Section D of the solicitation document). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. The QASP will be signed by the Contractor Program Manager and COR, outlining the evaluation criteria to ensure the contractor is aware of the management and quality criteria required to meet the terms of the contract.

5.2.1. Frequency of Performance Measure Assessment: The COR shall visit/correspond with the contractor either as needed or, at a minimum, on a quarterly basis. In addition, the following performance measure reports will occur:

5.2.2. Quarterly Reports are prepared and completed by the COR within 45 days of the end of the reporting period. Contractor will review quarterly performance measure reports and acknowledge receipt of report by returning a signed copy, along with any comments, to the Contracting Officer within 30 days of receipt of the report.

5.2.3. Contractor’s Performance Report: At the end of each contract period, the COR will assess the summary of the contractor’s performance and shall provide a written assessment.

This written assessment will be forwarded to the Contracting Officer as documentation of contractor’s performance and/or for a request to exercise option period, renewal of a contract or termination of a contract. This information will be loaded into the Contractor Performance Assessment Reporting System (CPARS) (see 5.5.5.3.).

5.3. Performance Standards:

5.3.1. Measure: Measure: Maintains Licensing, Registration and Certifications

Performance Requirement: Updated licensing, registration and certifications will be provided as they are renewed.

Standard: Licensing and registration information kept current.

Acceptable Quality Level: 100% Surveillance Method: Periodic Sampling Frequency: Quarterly

5.3.2. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Standard: Zero breaches of privacy or confidentiality Acceptable Quality Level: 100% Surveillance Method: Contractor to provide evidence of training required by VA NWIHCS, reports violations per policy Frequency: Quarterly

5.3.3. Measure: Mandatory Training

Performance Requirement: Contractor completes all mandatory required training.

Standard: Contractor will complete all required training per VA NWIHCS policy Acceptable Quality Level: 100% Surveillance Method: Contractor to provide evidence of training required by VA NWIHCS, reports violations per policy Frequency: Quarterly

5.3.4. Registration with Contractor Performance Assessment Reporting System

5.3.4.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

5.3.4.2. Each Contractor whose contract award is estimated to exceed $150,000 requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations).