36C25624Q0993_RFQrev1.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25624Q0993 08-14-2024

Michaela S. Brown, michaela.brown@va.gov 713-791-1414 Ext 149006 08-28-2024

14:00 PM CDT

36C256 Department of Veterans Affairs Veterans Health Administration Network Contracting Office (NOC)16 5075 Westheimer Rd, Suite 750 Houston TX 77056-5643

X

621999

$20.5 Million

N/A

36C580

Department of Veterans Affairs

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd.

Houston TX 77030

36C256

Department of Veterans Affairs Network Contract Office (NCO) 16

5075 Westheimer Rd, Suite 750 Houston TX 77056

36C256

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

1-877-489-6135

See CONTINUATION Page

Non-personal Services: Contractor shall provide patient Extracorporeal Shock Wave Lithotripsy (ESWL) services on an as needed basis in accordance with the Performance Work Statement and per the terms and conditions stated herein.

All questions must be submitted to michaela.brown@va.gov no later than 08/19/2024 14:00PM (CST). Answers to questions will be provided via solicitation amendment. No telephone requests will be accepted or returned.

Contract type is Fixed Price, Indefinite-Delivery, Indefinite-Quantity type (IDIQ), 5-Year contract.

The solicitation is conducted under Federal Acquisition Regulation (FAR) Part 12 in combination with FAR Part 13.

Please pay close attention to Addendum FAR 52.212-1 Instructions to Offerors.

Estimated See CONTINUATION Page

Melanie Hawley

VA-VHA-2020-AC34AE75

36C25624Q0993

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE- Pricing Instructions:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.2 PRICE/COST SCHEDULE – Ordering Procedures:

B.3 PERFORMANCE WORK STATEMENT (PWS)

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

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

C.3 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (JAN 2011)

C.4 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

C.5 52.216-18 ORDERING (AUG 2020)

C.6 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

C.9 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.11 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.12 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 48

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 ADDENDUM to FAR 52.212-2

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR (Name): ____________________________________

POINT OF CONTACT: ____________________________________

TELEPHONE: ____________________________________

E-MAIL: ____________________________________

Tax ID Number: ____________________________________

SAM UEI Number: ___________________________________

b. GOVERNMENT:

Contract Specialist (NCO) 16‐ Michela S. Brown Department of Veterans Affairs Network Contracting Office(NCO) 16 5075 Westheimer Rd, Ste 750 Houston, TX 77056 Email: michaela.brown@va.gov 713‐791‐1414 x49006

Contracting Officer (NCO) 16‐ Melanie Hawley Department of Veterans Affairs Network Contracting Office (NCO) 16 400 Veterans Ave Biloxi, MS 39531 Email: melanie.hawley@va.gov 601‐688‐4109

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly, in Arrears

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

Post Award Orientation: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual 842.502-70.

Secure Fax - Please review VA Handbook 6500 that 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, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

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

AMENDMENT NO DATE

The resultant contract is a nonpersonal services contract in accordance with FAR 37.401.

B.2 PRICE/COST SCHEDULE- Pricing Instructions:

SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide technical personnel that are certified and trained in Extracorporeal Shock Wave Lithotripsy (ESWL) services and operation of the equipment units in the Michael E. DeBakey VAMC (herein after referred to as MEDVAMC). The Contractor’s care shall cover the services include providing technical personnel that are certified and trained in Extracorporeal Shock Wave Lithotripsy (ESWL) services and operation of the equipment units. The technician shall assist the attending Urologist and other physicians in the operating room and/or cysto suite in the MEDVAMC.

Place of Performance: Services shall be provided on site, MEDVAMC. Contractor shall furnish services as follows as per PWS, Section B3, Paragraph 1.2:

Pricing Instructions:

The offeror is instructed to include all other than price and cost information supporting the proposed price as directed in Instructions to Offerors addendum to 52.212-1 and/or Section D- Contract Documents, Exhibits, or attachments, Other Than Cost and Pricing Information.

The Government will order the below specified minimum contract value of services and may order up to and including the below specified maximum contract value of services through task orders under this basis five (5)-year, Indefinite Delivery Indefinite Quantity (IDIQ) contract during the duration of the contract. The maximum amount under this contract is not guaranteed. The task orders shall be issued by each period of performance and will cover the funding/payments for services performed during that period.

Contract Minimum: $10,000.00

Contract Maximum: $2,000,000.00

All unit prices shall be a fixed price and all inclusive.

The Contractor shall provide Extracorporeal Shock Wave Lithotripsy (ESWL) services in accordance with Section B3 of Performance Work Statement (PWS) and the terms and conditions stated herein. Contractor to furnish services to eligible Veteran beneficiaries enrolled with the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX at the prices specified herein.

Period of Performance: 1ST Ordering Period: 01 September 2024 to 31 August 2025 2ND Ordering Period: 01 September 2025 to 31 August 2026 3rd Ordering Period: 01 September 2026 to 31 August 2027 4th Ordering Period: 01 September 2027 to 31 August 2028 5th Ordering Period: 01 September 2028 to 31 August 2029

This award will be a Fixed-Priced, Indefinite Delivery, Indefinite Quantity (IDIQ) contract type with five (5) twelve-month ordering periods. Initial/Base and Ordering Periods of Performance are estimated subject to the effective date of award.

Note: if start date is delayed the quantity of hours will be adjusted accordingly before award.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

QUANTITY

(Estimated Monthly)

UNIT

(Procedures) UNIT PRICE

AMOUNT

(Estimated Yearly Total Price)

79.00 EA ________________ __________________

Mobile Lithotripsy Laser (Technician and equipment) Services in accordance with the Performance Work Statement at the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX.

Contract Period: Ordering Period One POP Begin: 09-01-2024 POP End: 08-31-2025 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health Care Services PRODUCT/SERVICE CODE: Q525 - Medical - Urology

79.00 EA __________________ __________________

the Performance Work Statement at the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX.

Contract Period: Ordering Period Two POP Begin: 09-01-2025 POP End: 08-31-2026 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health the Performance Work Statement at the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX.

Contract Period: Ordering Period Three POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health the Performance Work Statement at the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX.

Contract Period: Ordering Period Four POP Begin: 09-01-2027 POP End: 08-31-2028 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health the Performance Work Statement at the Michael E. DeBakey VAMC (MEDVAMC), Houston, TX.

Contract Period: Ordering Period Five POP Begin: 09-01-2028 POP End: 08-31-2029 PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous Ambulatory Health

GRAND ESTIMATED

TOTAL

B.2 PRICE/COST SCHEDULE – Ordering Procedures:

a. This contract type allows the Department of Veteran Affairs Network Contracting Office (NCO) 16 Contracting Officers (CO) to place orders with the contractor on an as needed basis, in accordance with the FAR Clauses 52.216‐18, Ordering. NCO 16 will obligate the funding and order the services by issuing a task order.

b. The contractor shall initiate work when, so directed by a Task Order. No work under any Task Order shall be performed unless specifically authorized by the CO.

Approval of a Task Order shall not constitute approval to exceed any item listed in the contract or general provisions of the contract. The contractor shall not exceed the task order amount or change the task order without prior written approval of the CO.

c. Task orders within scope of the IDIQ contract will be issued unilaterally in accordance with the IDIQ Contract terms and conditions and bilaterally when change in terms and conditions is negotiated in accordance with contract clauses FAR 52.212‐4 (c), FAR 52.216‐18, FAR 52.216‐19 and FAR 52.216‐22.

d. Task order pricing for services will be based on IDIQ prices based on negotiated priced contract line items as outlined in B.2 Schedule of Services section of awarded IDIQ contract.

e. Contractor is required to deliver services in accordance with the task order terms and conditions during the task order specified period of performance.

f. The NCO 16 Contracting Officer is the only authorized official to issue task orders under this IDIQ Contract.

g. Task order prices shall be Fixed‐Price (FP) as agreed to in the contractor’s schedule and individually funded.

h. Each task order shall have an established period of performance or delivery date. Individual Task order shall not exceed a 12‐month period.

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL:

1.1. SERVICES REQUIRED: To provide the Michael E. DeBakey VAMC (MEDVAMC) with lithotripsy services necessary to support the urology section.

1.1.1. These services include providing technical personnel that are certified and trained in Extracorporeal Shock Wave Lithotripsy (ESWL) services and operation of the equipment units. The technician shall assist the attending Urologist and other physicians in the operating room and/or cysto suite in the MEDVAMC.

1.1.2. The equipment must meet or exceed the following criteria treats all stones anywhere in the urinary tract; has a greater than 80% success rate based on FDA clinical study data; is modular and can treat patients in the operating room/cysto suite; has the ability to do endourological procedures before and after ESWL without moving the patient.

1.1.3. Such additional materials and supplies, including consumables, as are necessary to conduct ESWL.

1.1.4. Maintenance of the devices to include service and preventative maintenance to ensure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer’s manual requirements.

1.1.5. Assist in the education of each facility’s personnel as it relates to ESWL.

1.1.6. Be responsible for obtaining all necessary licenses, approvals, permits and be in compliance with all federal state and local laws and regulations applicable to the devices and delivery of ESWL.

1.1.7. Delivery of all reports, digital, film and file records of all procedures performed with the devices to the Contracting Officer’s Technical Representative (COTR).

These medical records shall be the property of the MEDVAMC.

1.2. PLACE OF PERFORMANCE: Michael E DeBakey VAMC (MEDVAMC) 2002

Holcombe Blvd, Houston, Texas 77030.

1.3. AUTHORITY: Health Care Resources in accordance with Title 38 United States Code (USC) 8153, FAR 12, Acquisition of Commercial Products and FAR 13, Simplified Acquisition Procedures to be furnished by the contractor on behalf of Michael E DeBakey VAMC.

1.4. POLICY AND REGULATIONS: Contractor shall comply with all applicable policy and regulations, including, but not limited to the following:

1.4.1. 42 Code of Federal Regulations (CFR) Part 482 Conditions of Participation

Hospitals, including Sub-part E Requirements for Specialty Hospitals.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=aceca18b9fbe0110ffa37c08075c2b0e;rgn=div5;view=text;node=42% 3A5.0.1.1.1;idno=42;cc=ecfr

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

1.4.3. VHA Handbook 1100.17: National Practitioner Data Bank Reports -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

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

1.4.5. VHA Handbook 1100.19 Credentialing and Privileging -

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

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

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

1.4.7. Patient Self Determination Act of 1991:

http://www.gpo.gov/fdsys/search/pagedetails.action?st=citation%3A42+USC+139 5dd&granuleId=USCODE-2010-title42-chap7-subchapXVIII-partE-sec1395cc&packageId=USCODE-2010-title42&bread=true

1.4.8. Public Law 95-201 95th Congress An Act

www.gpo.gov/fdsys/pkg/STATUTE-91/pdf/STATUTE-91-Pg1433.pdf

1.4.9. 29 CFR Part 1910.1030 Toxic and Hazardous Substances https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDA RDS&p_id=1005

1.4.10. Public Law 104-191 Health Insurance Portability and Accountability Act of 1996 http://aspe.hhs.gov/admnsimp/p1104191.htm

1.4.11. Bylaws of the Medical Staff, VAMC, Houston, TX

1.4.12. HHS OIG Exclusions List

http://exclusions.oig.hhs.gov/Default.aspx

1.4.13. VHA Directive 2012-030 Credentialing of Health Care Professionals http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID-=2815

1.4.14. Title 42 CFR 415.170 Centersfor Medicare & Medicaid Services, HHS http://www.gpo.gov/fdsys/pkg/CFR-2013-title42-vol3/pdf/CFR-2013-title42-vol3-sec415-170.pdf

1.4.15. FAR 52.227-14(d)(1) Rights in Data

https://acquisition.gov/far/current/html/52_227.html

1.4.16. VA Directive 6300 Records and Information Management

http://vaww1.va.gov/vapubs/viewPublication.asp?Pub_ID=429&FType=2

1.4.17. VA Handbook 6300.1 Records Management Procedures

1.4.18. VA Handbook 6500.1 Records Management Procedures

1.4.19. FAR Part 12 Acquisition of Commercial Items

http://www.acquisition.gov/far.html/FARTOCP12.html

1.4.20. VA Handbook 1605.05 Business Associate Agreements

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3027

1.4.21. Title 5 U.S.C. 552a Records Maintained on Individuals http://www.gpo.gov/fdsys/granule/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

1.4.22. Title 38 U.S.C. 5701 Confidential Nature of Claims

http://www/.gpo/fdsys.pkg/USCODE-2011-title38/pdf/USCODE-2011-title38-partIV-chap57-subchapI-sec5701.pdf

1.4.23. Title 38 U.S.C. 5705 Confidentiality of Medical Quality-Assurance Records http://www.gpo.gov/fsdsys/granule/USCODE-2010-title38/USCODE-2010-title38-partIV-chap57-subchapI-sec5705/content-detail.html

1.4.24. Title 38 U.S.C. 7362 Purpose of Corporations

http://www.gpo.gov/fdyd/pkg/USCODE-2011-title38/pdf/USCODE-2011-title38-partV-chap73-subchapIV-sec7363.pdf

1.4.25. 5 U.S.C. 552 Public information; agency rules, opinions, orders, records, and proceedings http://www.gpo.gov/fdsys/pkg/USCODE-2011-title5/pdf/USCODE-2011-title5-partI-chap5.pdf

1.4.26. 38 U.S.C. 7332 Confidentiality of Certain Medical Records http://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html

1.4.27. VA Handbook 0710 PERSONNEL SUITABILITY AND SECURITY PROGRAM http://www1.va/gov/vapubs/viewPublication.asp?Pub_ID=86

1.4.28. VA Directive 0710 PERSONNEL SECURITY AND SUITABILITY PROGRAM http://www1.va/gov/vapubs/viewPublication.asp?Pub_ID=1568

1.5. DEFINITIONS/ACRONYMS:

1.5.1. ACLS: Advanced Cardiac Life Support

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACO: Administrative Contracting Officer

1.5.4. AOA: American Osteopathic Association

1.5.5. BAA: Business Associate Agreement

1.5.6. BLS: Basic Life Support

1.5.7. CARF: Commission on Accreditation of Rehabilitation Facilities

1.5.8. CDC: Centers for Disease Control and Prevention

1.5.9. CEU: Certified Education Unit

1.5.10. CME: Continuing Medical Education

1.5.11. CMS: Center for Medicare and Medicaid Services

1.5.12. CO: Contracting Officer

1.5.13. COR: Contracting Officer’s Representative

1.5.14. COS: Chief of Staff

1.5.15. CPARS: Contractor Performance Assessment Reporting System

1.5.16. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.17. FSMB: Federation of State Medical Boards

1.5.18. Follow-Up Outpatient – The patient has been discharged back to primary VAMC.

1.5.19. HHS: Department of Health and Human Services

1.5.20. HICPAC: Healthcare Infection Control Practices Advisory Committee- a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.

1.5.21. ICAVL: Intersocietal Commission for the Accreditation of Vascular Laboratories

1.5.22. ISO: Information Security Officer

1.5.23. JC: Joint Commission

1.5.24. NSQIP/CICSP: National Surgical Quality Improvement Program/Continuing Improvement in Cardiac Surgical Program

1.5.25. OUTPATIENT – The patient’s status during the transplant episode when the patient is no longer an inpatient but has not yet been discharged back to primary VAMC. Patient is followed by the MEDVAMC.

1.5.26. PWS: Performance Work Statement

1.5.27. QAPI: Quality Assessment and Performance Improvement

1.5.28. QASP: Quality Assurance Surveillance Plan

1.5.29. SPE: Senior Procurement Executive

1.5.30. VA: Veterans Affairs

1.5.31. VAMC: Veterans Affairs Medical Center

1.5.32. VetPro: a federal web-based credentialing program for healthcare providers.

1.5.33. VHA: Veterans Health Administration

1.5.34. "All needed supply items" are defined as those items needed to furnish the lithotripsy services to the patient. These items will be budgeted for and purchased by the VAMC. No supply item required to perform any of the perfusion services shall be purchased nor provided by the contractor.

1.5.35. “Stand by emergencies" at the VAMC as listed on Option Form (OF) 336 is strictly for standby at the VAMC. Time begins after being called in while on-call or standby; VA will pay only for actual services performed at the VA facility. On-site response time shall not exceed thirty (30) minutes.

2. QUALIFICATIONS:

2.1. THE CONTRACTOR SHALL:

2.1.1. LICENSE: All licenses held by the Contractor staff working on this contract shall be full and unrestricted licenses. Contractor staff must submit evidence of at least one full, active, current and unrestricted licensure, registration, certification, and/or other relevant credentials, for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the VA COR apprised of anything that would adversely affect or otherwise limit their clinical privileges. Note: Failure to keep VA fully informed on these matters may result in administrative or disciplinary action.

2.1.2. Board Certification/Eligibility. N/A

2.1.3. Credentialing and Privileging. N/A

2.1.4. TECHNICAL PROFICIENCY: Contractors 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 and be certified and trained in ESWL lithotripsy services and operation of the equipment units. Contractor shall provide documents as needed to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed.

2.1.5. The equipment must meet or exceed the following criteria treats all stones anywhere in the urinary tract; has a greater than 80% success rate based on FDA clinical study data; is modular and can treat patients in the operating room/cysto suite; has the ability to do endourological procedures before and after ESWL without moving the patient.

2.1.6. Such additional materials and supplies, including consumables, as are necessary to conduct ESWL.

2.1.7. Maintenance of the devices to include service and preventative maintenance to ensure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer’s manual requirements.

2.1.8. Assist in the education of each facility’s personnel as it relates to ESWL.

2.1.9. Be responsible for obtaining all necessary licenses, approvals, permits and be in compliance with all federal state and local laws and regulations applicable to the devices and delivery of ESWL.

2.1.10. TRAINING (VA MANDATORY): Contractors shall meet all VA educational requirements. All mandatory courses must be completed by the Contractor staff as required by the VA.

2.1.11. STANDARD PERSONNEL TESTING/INFECTION CONTROL

2.1.11.1. Contractor shall provide proof of the following tests for their staff 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.

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

2.1.11.3. RUBELLA TESTING: Contractor shall provide proof of immunization for all Contractor staff 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.

2.1.11.4. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractors shall provide generic self-study training for all Contractor staff; 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.

2.1.11.5. The VAMC shall notify the Contractor 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.

2.1.12. CONFLICT OF INTEREST: the Contractor and all Contractor staff 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 sub-Contractors 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.

2.1.13. Citizenship related Requirements: While performing services for the VA, 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. The Contractor must return a signed certification at the time of proposal 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 the VA. 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 and is applicable to the entire POP.

2.1.14. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT:

2.1.14.1. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA 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.

2.1.14.2. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed Contractors and/or firm(s) are not listed. Contractors 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 or entity 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 Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

2.1.14.3. By submitting their proposal, the Contractor certifies that the 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. TECHNICAL DIRECTION: 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. Technical direction of all clinical personnel covered by this contract shall 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 during the administration of the resultant contract.

2.3. NON-PERSONAL SERVICES: The parties agree that The Contractor, all Contractor staff, agents and sub-Contractors shall not be considered VA employees for any purpose.

2.3.1. Government Inherent Functions: Contractor and Contractor staff 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, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.3.2. No Employee status: The Contractor shall be responsible for protecting the Contractor’s staff 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:

Workers’ compensation Professional liability insurance Health examinations Income tax withholding, and Social security payments.

2.3.3. TORT: The Federal Tort Claims Act does not cover Contractors or Contractor’s staff. When a Contractor or a member of their staff has been identified as a provider in a tort claim, The Contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s staff) action or non-action is the responsibility of The Contractor and/or insurance carrier.

3. HOURS OF OPERATION:

3.1. BUSINESS HOURS: The services covered by this contract shall be furnished by the contractor as defined herein. The contractor will not be required, except in case of any emergency, to furnish such services on a national holiday or during nonworking hours as described below.

3.2. WORK SCHEDULE: WORK HOURS: 8:00 a.m. to 4:30 p.m. Monday through Friday

3.3. CANCELLATION POLICY: Unless a state of emergency has been declared or clinics are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

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

1. New Year’s Day

2. Martin Luther King’s Birthday

3. President’s Day

4. Memorial Day

5. Juneteenth

6. Independence Day

7. Labor Day

8. Columbus Day

9. Veteran’s Day

10. Thanksgiving

11. Christmas

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

4. CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED: If a veteran must undergo an additional treatment within ninety

(90) days from his/her initial procedure due to continued problems with the stone(s), i.e., stone(s) was not broken down small enough to pass or fragments of the stone(s) remain, the contractor will provide the treatment at 50% of the contract price.

4.1.1. RETREATMENT AND CANCELLATIONS: On occasion (perhaps 1 to 3 times per year per facility) the scheduled procedure is needed to be cancelled. This may occur (1) when a stone passes between the time the patient was initially seen and scheduled and the actual procedure date or (2) when there is a medical emergency such as when anesthesia is administered or another medical emergency with the patient.

4.1.2. When a cancellation is known to the VA personnel and the contractor is notified by phone, fax or email twenty-four (24) hours prior to the contractor technician’s scheduled arrival time at the MEDVAMC, there shall be no charge for the procedure.

If notification is given to the contractor in less than twenty-four (24) hours, the contractor shall be paid 50% of the contracted price for the procedure.

4.1.3. When there is a medical emergency which prevents the patient from receiving the procedure, if only one patient was scheduled with the contractor to receive the procedure on that day, the contractor shall be paid 50% of the contracted price for the procedure. When there is a medical emergency which prevents a patient from receiving the procedure, and more than one patient was scheduled with the contractor to receive a procedure on that day, the contractor shall not be paid for the cancelled procedure.

4.2. STANDARDS OF PRACTICE: Contractor’s care shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care must be equal or exceed VA Standards.

4.2.1. Vendor must be available at all times during the hours of operation as outlined within PWS Section 3. Vendor must be available to perform Lithotripsy Services within 3 business days of receiving VA notification or request for services.

Performance shall be according to the requirements contained in this PWS and equal to that of the professional standards of the TJC. QASP Indicator 1.

4.2.2. Preventative maintenance documents shall be available to the VA Biomedical Engineering upon request. All equipment is required to be safety checked by the local VA Biomed staff each time it arrives on site before any procedures begin.

4.2.2.1. The Urology Staff shall arrange for the biomedical staff inspection with the contractor technician.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contractor 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 (Health Insurance Portability and Accountability Act).

4.3.2. The resultant 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 Contractor 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 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’s provider 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.

4.3.3. Disclosure: Contractor and Contractor may have access to patient medical records: however, Contractor and Contractors must 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, Contractor and/or sub- Contractors.

4.3.4. Professional standards for documenting care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by the MEDVAMC.

4.3.4.1. Medical record entries shall be legible and maintained in detail consistent with good medical and professional practices so as to facilitate internal and external peer reviews, medical audits and follow-up treatments. Copies of received medical information shall be authenticated (signed) copies.

4.3.4.2. The quality of medical practice shall meet or exceed reasonable standards of professional practice for the required services in health care as determined by the same authority that governs MEDVAMC medical professionals and will be audited by the Medical Center, Service Line or other processes established for that purpose.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. 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/Information Security Officers at the following address:

Mary Lou Reid/Michael Plummer MEDVAMC Privacy Officer/Information Security Officer 2002 Holcombe Blvd, Houston, Texas 77030

4.4. DIRECT PATIENT CARE: 95% of the time involved in direct patient care.

4.4.1. Services include selection of equipment and supplies ESWL with equipment with sufficient power, configuration, and interface to achieve nationally acceptable stone fragmentation and clearance efficacy standards based on stone size and location.

ESWL devices must meet efficacy standards to avoid excess retreatment procedures or ancillary urological procedures to manage the urinary calculus. QASP Indicator 2 and 3.

4.5. ADMINISTRATIVE: 5% of time not involved in direct patient care

4.5.1. Personnel will generate ESWL related records and documentation.

4.5.2. The assigned ESWL contractor employees must assist VA staff in ensuring all of their equipment has required preventative maintenance performed and has been cleared by Biomedical Engineering.

4.6. MANDATORY TRAINING AND ADP SECURITY

4.6.1. PATIENT INFORMATION: In performance of official duties, Contractor’s provider(s) have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. Contractor’s provider(s) are responsible for (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion and

(2) following all applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in a computer access agreement which contract provider(s) signs.

4.6.2. Contractor staff shall complete required security training and sign a VA Computer Access Agreement prior to having access to the VA computer system. Security Training will be accomplished annually. Contractor staff shall select training modules for Privacy Training and Information Security Training. Upon completion of the training, please email training certificates to the Contract Specialist and the

COR.

4.6.3. In addition, if providing medical services, Contractor staff shall attend CPRS training prior to providing any patient care services. Contractor staff shall document patient care in CPRS to comply with all VA and equivalent Joint Commission standards.

4.6.4. RULES OF BEHAVIOR FOR AUTOMATED INFORMATION SYSTEMS:

Contractor staff having access to VA Information Systems is required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility ISO, the Rules of Behavior to The Contractor for the respective facility.

4.6.5. VA Compliance Business and Integrity (CBI) Training: Contractor shall provide documented proof to the contracting officer or COR that all Contractor’s staff and sub-Contractor Contractors assigned revenue cycle-related work have received their annual CBI Training. The COR will arrange for training from the respective facility compliance officer.

4.6.6. Other Mandatory VA training as required. Contractors will be briefed on all required training by the COR upon reporting to the VAMC medical center.

Contractor may invoice for time required to complete mandatory VA training.

4.6.7. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY

IMPROVEMENT: The Government reserves the right to refuse acceptance of Contractors 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. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.6.8. The CO shall resolve complaints concerning Contractor and/or Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that The Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.6.9. Quality Improvement: Contractors shall participate in Quality Improvement, and Performance Improvement activities with staff as required by Joint Commission (or equivalent) and directed by Chief of Service or Chief of Staff or designee. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR) 37.401(b). Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews.

4.6.10. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE

ASSESSMENT REPORTING SYSTEM (CPARS)

4.6.11. FAR 42.1502 direct all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15

4.6.12. The past performance evaluation process is a totally paperless process using CPARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

4.6.13. Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm’s past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

4.6.14. When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically generated email with detailed login instructions. Further details, system requirements, and training information for CPARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.

4.6.15. Within 60 days after the end of a performance period, the Contracting Officer will complete an interim or final past performance evaluation and the report will be accessible at www.cpars.gov Contractor Representatives may then provide comments in response to the evaluation, or return the evaluation without comment.

Comments are limited to the space provided in Block 22. Your comments should focus on objective facts in the Assessing Official’s narrative and should provide your views on the causes and…