36C25618Q9727-013.docx

36C25618Q9727

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

580-19-1-047-0003 36C25618Q9727 11-13-2018 Corey Labbe corey.labbe@va.gov 713-794-7792 12-03-2018 4:00pm Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston

TX

77030 4298 X 621999 $15 Million X N/A X 36C580 Department of Veterans Affairs Michael E. DeBakey VA Medical Center 2002 Holcombe Boulvard Houston

TX

77030-4298 36C256 Department of Veterans Affairs Nework Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe Boulvard Houston

TX

77030 4298

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin

TX

78714-9971 1-877-353-9791 512-460-5429 See CONTINUATION Page This solicitation is a request for quote (RFQ) for Lithotripsy Services. The government intends to award a firm fixed price Indefinite Delivery Indefinite Quantity (IDIQ) contract. Contractor shall provide all neccassary personnel, supervision, labor, equipment and materials to provide Lithotripsy Services to the Michael E DeBakey VA Medical Center, Houston TX in accordance with the Performance Work Statement (PWS).

*note to contractor:

Reference Addendum to FAR 52.212-1 for offerer instructions.

The following wage determination applies:

Wage Determination No. 2015-5233 Rev 9 Dated 01/10/2018 This acquisition is in accordance with Federal Acquisition Regulation (FAR) 12, FAR 13 and FAR 13.5.

See CONTINUATION Page X X Corey Labbe

NCO116L2-2708

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

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

a. CONTRACTOR:

Phone: ____________________________________

Email: ____________________________________

DUNS Number: ____________________________

TAX ID: __________________________________

b. GOVERNMENT:

Corey Labbe, Contracting Officer Department of Veterans Affairs Network Contracting Office 16 2002 Holcombe Boulevard Houston, TX 77030

Phone: 713-794-7721 Email: corey.labbe@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor shall be electronically reimbursed:

[X} 52.232-33, Payment by Electronic Funds Transfer- System For Award Management

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

c. Other

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

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

B.2 PRICE/COST SCHEDULE

An initial Task Order for Services will be issued by the VA Contracting Officer at the beginning of the contract’s period of performance. The Task Order will be emailed to the Contractor and will include estimated quantities. The VA anticipates funding one Task Order per 12-months. If the value of a particular Task Order needs to be increased or decreased, a Modification will be done to the Task Order by a VA Contracting Officer. Task Orders will be bulk funded so that funds are already available when the VA requires services. Do not exceed the amount bulk funded without first receiving a Modification.

ORDERING PERIOD ONE: Date of Award for one (1) Year

QUANTITY

ESWL Services

Additional ESWL Services(90 days)

Cancelled Procedures (see PWS,4.1)

ORDERING PERIOD TWO: 1 Year

QUANTITY

ESWL Services

(see PWS,4.1)

ORDERING PERIOD THREE: 1 Year

QUANTITY

ESWL Services

(see PWS,4.1)

ORDERING PERIOD FOUR: 1 Year

QUANTITY

ESWL Services

(see PWS,4.1)

ORDERING PERIOD FIVE: 1 Year

QUANTITY

ESWL Services

(see PWS,4.1)

TOTAL ESTIMATED VALUE TO INCLUDE ALL ORDERING PERIODS: __________________

Minimum Quantity (all CLINS): 54 Procedures.

Maximum Quantity (all CLINS): 380 Procedures.

Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT (PWS)

LITHOTRIPSY SERVICES

1. GENERAL:

1.1. SERVICES REQUIRED: The purpose of this PWS is for the contractor to provide Michael E. DeBakey VAMC (MEDVAMC), 2002 Holcombe Blvd., Houston, TX 77030 with lithotripsy services for the duration of the new contract, which will be for a ordering period of fie (5) years.

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 Representative (COR). These medical records shall be the property of the MEDVAMC.

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

2002 Holcombe Boulevard Houston, Texas 77030

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

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

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

1.3.3. VHA Handbook 1100.19 Credentialing and Privileging - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

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

1.3.5. Patient Self Determination Act of 1991: http://www.gpo.gov/fdsys/search/pagedetails.action?st=citation%3A42+USC+1395dd&granuleId=USCODE-2010-title42-chap7-subchapXVIII-partE-sec1395cc&packageId=USCODE-2010-title42&bread=true

1.4. DEFINITIONS/ACRONYMS:

1.4.1. ACLS: Advanced Cardiac Life Support

1.4.2. ACGME: Accreditation Council for Graduate Medical Education

1.4.3. ACO: Administrative Contracting Officer

1.4.4. AOA: American Osteopathic Association

1.4.5. BAA : Business Associate Agreement

1.4.6. BLS: Basic Life Support

1.4.7. CARF: Commission on Accreditation of Rehabilitation Facilities

1.4.8. CDC: Centers for Disease Control and Prevention

1.4.9. CEU: Certified Education Unit

1.4.10. CME: Continuing Medical Education

1.4.11. CMS: Center for Medicare and Medicaid Services

1.4.12. CO: Contracting Officer

1.4.13. COR: Contracting Officer’s Representative

1.4.14. COS: Chief of Staff

1.4.15. CPARS: Contractor Performance Assessment Reporting System

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

1.4.17. FSMB: Federation of State Medical Boards

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

1.4.19. HHS: Department of Health and Human Services

1.4.20. 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.

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

1.4.22. ISO: Information Security Officer

1.4.23. JC: Joint Commission

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

1.4.25. 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.

1.4.26. PWS: Performance Work Statement

1.4.27. QAPI: Quality Assessment and Performance Improvement

1.4.28. QASP: Quality Assurance Surveillance Plan

1.4.29. SPE: Senior Procurement Executive

1.4.30. VA: Veterans Affairs

1.4.31. VAMC: Veterans Affairs Medical Center(also identified as MEDVAMC and are interchangeable).

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

1.4.33. VHA: Veterans Health Administration

1.4.34. "All needed supply items" are defined as those items needed in order 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.

1.4.35. “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. 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.

2.1.3. 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.

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

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

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

2.1.7. 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.

2.1.8. 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. Mandatory courses are as follows:

VA Cyber Security Awareness and Rules of Behavior Training (completed annually) (TMS course # 10176)

VA Privacy training (completed annually) (TMS course # 10203)

2.1.9. STANDARD PERSONNEL TESTING/INFECTION CONTROL

2.1.9.1. 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.

2.1.9.2. 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.

2.1.9.3. 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.

2.1.9.4. 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.

2.1.9.5. 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.

2.1.10. 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.

2.1.11. 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.

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

2.1.12.1. 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.

2.1.12.2. 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.

2.1.12.3. 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/RESCHEDULING POLICY: Unless a state of emergency has been declared or clinics are otherwise cancelled by th

3.4. e VAMC, the Contractor shall be responsible for providing services.

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

1. New Year’s Day

2. Washington’s Birthday

3. Martin Luther King’s Birthday

4. Memorial Day

5. Independence Day

6. Labor Day

7. Columbus Day

8. Veterans Day

9. Thanksgiving

10. Christmas

11. 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: Contractors 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. Performance shall be according to the requirements contained in this PWS and equal to that of the professional standards of the TJC.

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:

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.

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 Contracting Officer and the COR.

· Contracting Officer: Corey Labbe: Corey.Labbe@va.gov

· Contracting Officer Representative: Hayley.Raymer@va.gov

4.6.3. 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.

4.6.4. 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.

4.6.5. 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.

4.6.6. 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 Contractors conduct. The final arbiter on questions of acceptability is the CO.

4.6.7. The CO shall resolve complaints concerning Contractor and/or Contractors 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.

4.6.8. 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.

4.6.9. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

4.6.10. 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 the Simplified Acquisition Threshold (SAT), 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. AR 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

4.6.11. 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.

4.6.12. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold (SAT), is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the Contractors registered representative.

4.6.13. For contracts with a period of once year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractors performance annually. Interim reports will be foiled each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will haver thirty days to submit any comments and re-assign the report to the CO.

4.6.14. Failure to have a current registration with the CPARS database, or to re-assign the report to the CO within those thirty days, will result in the Governments evaluation being placed on file in the database with a statement that the Contractor failed to respond.

4.6.15. 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.

4.6.15.1. Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

4.6.15.2. Prohibit the use of or reference to evaluation data for advertising, promotional material, pre-award surveys, responsibility determination, production readiness reviews, or other similar purposes.

4.6.15.3. If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30-day review period.

4.6.15.4. A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.

4.7 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI) The government may evaluate the quality of services provided in accordance with the standards (ACR standards and others) as outlined in this document, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgements, diagnosis for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR 37.401(b). The following measures represent the performance standards required to be met and will be included on the governments Quality Assurance Surveillance Plan”

4.7.1 Measure: Availability of Lithotripsy Services

Performance Requirement: Lithotripsy Services shall be available at the scheduled date and time.

Standard: All (100%) of Lithotripsy Services shall be completed on the scheduled date and time.

Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.2 Measure: Creation of Treatment Plan

Performance Requirement: ESWL Technologist formulates an accurate plan of treatment for each patient based on collaborative advice of Uroligist.

Standard: All (100%).

Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.3 Measure: Patient Safety

Performance Requirement: ESWL Technologist ensures a secure and safe patient and work environment by maintaining a continued awareness of the safety hazards and providing for routine safety checks of the equipment.

Standard: All (100%). Ensuring patient safety and a safe environment shall be maintained at all times.

Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff

4.7.4 Measure: Availability of Supplies

Performance Requirement: EWSL Technologist maintains supplies needed to ensure adequate levels as required by sites with an emphasis on cost control.

Standard: All (100%) supplies needed to perform Lithotripsy Services shall be available at all times.

Acceptable Quality Level: No deviations from the standard. (100% Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.5 Measure: Quality Improvement

Performance Requirement: ESWL Technologist demonstrates commitment to the Center and organization by supporting and contributing to the Centers continuous quality improving efforts.

Standard: All (100%) Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.6 Measure: Visualization of Fluoroscopy equipment.

Performance Requirement: The fluoroscopy equipment allows for proper visualization during lithotripsy procedures.

Standard: All (100%).

Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.7 Measure: Performance of Lithotripsy Equipment

Performance Requirement: Lithotripsy equipment delivers energy across the entire range to produce stone fragmentation.

Standard: All (100%) Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.7.8 Measure: Availability of Ancillary Equipment

Performance Requirement: Adequate ancillary equipment is available to perform any necessary Lithotripsy procedure.

Standard: All (100%) Acceptable Quality Level: No deviations from the standard. (100%) Surveillance Method: Direct Observation by attending physician and nursing staff.

4.8 The Governed reserves the right to refuse acceptance of any Contractor personnel at any 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. Standard 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.

4.9 The CO shall resolve complaints concerning 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 names in a validated 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.

5. GOVERNMENT RESPONSIBILITIES:

5. OVERSIGHT OF SERVICE/PERFORMANCE MONITORING: Contract Administration: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

Corey Labbe, Contracting Officer (CO) 2002 Holcombe Boulevard, Houston, Texas 77030 E-mail: Corey.Labbe@va.gov Phone: 713-791-7792

Hayley Raymer, Contracting Officer's Representative (COR) 2002 Holcombe Boulevard, Houston, Texas 77030 E-mail: Hayley.Raymer@va.gov Phone: 713-791-1414 x24145

5. CO RESPONSIBILITIES: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

1. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

1. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for the contract staff to be provided by the VA or the contract agency as indicated; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract.

5. COR…