36C26119Q0273-010.docx

36C26119Q0273

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

36C26119Q0273 03-08-2019 Latasha Winston 916-923-4973 03-22-2019

12:00 PM PST

612MCP

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd., Bldg. 209 McClellan

CA

95652-2609 X 532490 $32.5 Million X N/A X Department of Veteran Affairs VA Palo Alto Healthcare System 3801 Miranda Ave Palo Alto CA 94304

612MCP

Department of Veterans Affairs Department of Veterans Affairs VA Northern California HealthCare System 3230 Peacekeeper Way, Bldg. 209 McClellan

CA

95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page The Contractor shall provide Technologist(s) and Equipment to provide Extracorporeal Shock Wave Lithotripsy (ESWL) and Laser Services on-site at VA Palo Alto Healthcare System All services shall be in accordance with the attached Performance Work Statement (PWS) contained herein.

See CONTINUATION Page X x X X Durell Salaz Contracting Officer Table of Contents

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: TBD

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Monthly - in Arrears

4. GOVERNMENT INVOICE ADDRESS: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact: 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.

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/us/en/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C26119Q0273

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B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided. The Contractor shall provide Technologist(s) and Equipment to provide Extracorporeal Shock Wave Lithotripsy (ESWL) and Laser Services on-site at VA in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the VA Palo Alto Health Care System (VAPAHCS), located at: 3801 Miranda Avenue, Palo Alto, California 94304.

1.1.1. The Contractor’s Technologist(s) shall be licensed, certified, and trained in ESWL Lithotripsy, Greenlight Laser, and Holmium Laser Services and operation of the equipment unit(s). The Technologist(s) shall administer procedure(s) under the direction and supervision of VAPAHCS Physician(s).

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

1.1.2.1. Treat all stones anywhere in the urinary tract.

1.1.2.2. Greenlight laser that can perform prostate ablation.

1.1.2.3. Holmium laser that can perform lithotripsy to treat all stones anywhere in the urinary tract.

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

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

1.1.2.6. Can do endourological procedures before and after the procedure without moving the patient.

1.1.3. VAPAHCS anticipates an estimated 15 ESWL cases, 10 Greenlight laser, and 20 emergency Holmium laser cases annually. This is only an estimate and is dependent upon patient volume and actual need.

1.1.4. Contractor personnel shall be required to attend a VAPAHCS orientation and prior to commencing work under this contract. Contractor personnel will also be required to check-in and check-out when on-site.

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

1.1.4.2. Review of applicable VA policies and procedures governing the medical care provided at VAPAHCS.

1.1.4.3. The contractor will be contacted to schedule work to perform including what procedure will be performed. The technologist will arrive with equipment and check in at the reception desk where the technologist will be logged in. Afterwards, the technologist will be escorted to the operating room and then escorted back to the reception desk to check out after the procedure is performed.

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

1.3. Policy/Handbooks:

1.3.1. VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

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

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

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

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

1.3.6. VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.3.7. 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. DEFINITIONS/ACRONYMS Terms used in this contract shall be interpreted as below unless the context expressly requires a different construction and/or interpretation. If there is a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.4.1. ABU: American Board of Urology.

1.4.2. BLS: Basic Life Support.

1.4.3. CDR: Contract Discrepancy Report.

1.4.4. CO: Contracting Officer: The person executing this contract on behalf of the Government with the authority to enter-into, and administer contracts and make related determinations and findings.

1.4.5. COR: Contracting Officer’s Representative. A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.4.6. COS: Chief of Staff.

1.4.7. CPARS: Contractor Performance Assessment Reporting System.

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

1.4.9. HHS: Department of Health and Human Services.

1.4.10. HIPAA: Health Insurance Portability and Accountability Act.

1.4.11. HR: Human Resources.

1.4.12. ISO: Information Security Officer.

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

1.4.14. POP: Period of Performance.

1.4.15. PWS: Performance Work Statement.

1.4.16. QASP: Quality Assurance Surveillance Plan.

1.4.17. QA/QI. Quality Assurance/Quality Improvement.

1.4.18. QM/PI: Quality Management/Performance Improvement.

1.4.19. TJC: The Joint Commission https://www.jointcommission.org/

1.4.20. VETPRO: a federal web-based credentialing program for healthcare providers.

1.4.21. Veterans Health Administration (VHA): The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington D.C.

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

1.4.23. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical center, for purposes of this contract, this term shall mean the VA Palo Alto Health Care System

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

1.4.25. VA Palo Alto Health Care System (VAPAHCS): Unless identified with the name of a different location, for purposes of this contract, this term shall mean the VA Palo Alto Health Care System, Palo Alto Division, located at 3801 Miranda Avenue, Palo Alto, California 94304.

2. QUALIFICATIONS:

2.1. License.

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

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

2.2. Board Certification. All contractor’s employee(s) shall be certified by an accrediting agency and be currently certified in Basic Life Support (BLS). All continuing education courses required for maintaining certification must be kept up to date. Documentation verifying current certification shall be provided by the Contractor to the VA COR for each year of contract performance.

2.3. Credentialing and Privileging.

2.3.1. Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced at section 1(c)(5) utilizing VHA Handbook 1100.19, Credentialing and privileging. The Contractor is responsible to ensure that proposed employee(s) possess the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s employee(s) prior to obtaining approval by the VAPAHCS Professional Standards Board, Medical Executive Board and Medical Center Director.

2.3.2. If a contractor’s employee(s) is/are not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the Government.

2.4. Technical Proficiency. The Contractor’s employee(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor’s employee(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

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

2.6. Training (ACLS, BLS, CPRS and VA MANDATORY): Contractor shall meet all of the VA educational requirements and mandatory course requirements listed below; all training must be completed by the contractor’s employee(s) as required by the VA.

2.7. Standard Personnel Testing (PPD, ETC). Contractor shall provide proof of the following tests for contract employee(s) within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s employee(s) (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

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

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

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

2.7.5. INFLUENZA: Contractors shall provide proof that all Contractor employee(s) have received the annual Influenza vaccine unless it is contraindicated. If the Contractor employee(s) has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season. This is applicable to all health care workers.

2.7.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s employee(s). This is applicable to all health care workers}; provide their own hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.8. Conflict of Interest. The Contractor and all contractor’s employee(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.9. Citizenship Related Requirements.

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

2.9.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

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

2.9.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.9.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.10. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.10.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s employee(s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to triple damages. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.10.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.11. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAPAHCS Chief of Staff (COS) and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

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

2.13. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

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

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

2.16. No Employee status: The Contractor shall be responsible for protecting Contractor’s employee(s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.16.1. Workers’ compensation

2.16.2. Professional liability insurance

2.16.3. Health examinations

2.16.4. Income tax withholding, and

2.16.5. Social security payments.

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

2.18. Key Personnel.

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

2.18.2. VAPAHCS anticipates between 15 to 25 procedures per year.

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

2.19. Personnel Substitutions. During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 30 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 30 calendar days prior to making any permanent substitutions.

2.19.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 10 calendar days after receipt of all required information of the decision on the proposed substitutes.

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

2.21. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s employee(s), she/he may request, without cause, immediate replacement of said Contractor’s employee(s). The CO and COR shall deal with issues raised concerning Contractor’s employee(s) conduct. The final arbiter on questions of acceptability is the CO.

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

3. HOURS OF OPERATION.

3.1. Procedures shall be scheduled in advance between VAPAHCS and the contractor.

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

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

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

3.2. Unless a state of emergency has been declared or clinics are otherwise cancelled by VAPAHCS, the Contractor shall be responsible for providing services.

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

3.3.1. New Year’s Day

3.3.2. President’s Day

3.3.3. Martin Luther King’s Birthday

3.3.4. Memorial Day

3.3.5. Independence Day

3.3.6. Labor Day

3.3.7. Columbus Day

3.3.8. Veterans Day

3.3.9. Thanksgiving

3.3.10. Christmas

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

4. CANCELLATIONS AND RETREATMENTS.

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

4.1.1. The contractor shall not invoice for procedures if VAPAHCS provides a 24-hour cancellation notice.

4.1.2. The contractor may invoice for 50% of the contract procedure cost if the VAPAHCS cancels the procedure with less than a 24-hour notice.

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

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

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

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

4.2.3. In the event, one procedure is scheduled at VAPAHCS, and the procedure is cancelled, the contractor shall be paid 50% of the contract procedure price for the cancelled procedure.

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

5. CONTRACTOR RESPONSIBILITIES.

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

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

5.2. Standards of Care. The contractor’s employee(s) care shall cover the range of Lithotripsy, Greenlight, and/or Holmium Laser services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding and the following national standards as established by:

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

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

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

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

5.2.5. The requirements contained in this PWS.

5.3. Contractor Equipment.

5.3.1. Contractor shall provide a state-of-the art portable/modular, digital unit that can be easily moved into the procedure room at the VAPAHCS. Contractor is responsible for obtaining all necessary licenses and approvals and shall comply with all Federal, state, and local laws and regulations applicable to the equipment and delivery of ESWL and/or Laser Services.

5.3.2. Contractor is responsible for preventive and emergency maintenance of the contractor’s equipment.

5.3.3. Maintenance of contractor equipment shall be in accordance with manufacturer’s recommendations.

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

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

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

5.4. Contract employee(s) shall provide support in ESWL and/or laser procedure(s) and must be present at all time while the equipment is used at VAPAHCS. The VA will not be held liable for any loss or damage to the Contractor’s property.

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

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

5.6.1. Has ability to treat all stones anywhere in the urinary tract.

5.6.2. Greenlight laser that can perform prostate ablation.

5.6.3. Holmium laser that can perform lithotripsy to treat all stones anywhere in the urinary tract.

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

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

5.6.6. Has ability to do endourological procedures before and after the operation without moving the patient.

5.7. Contractor Technologist Responsibilities.

5.7.1. Operate the ESWL and/or laser equipment under direction of the attending VA physician.

5.7.2. Troubleshoot and resolve equipment issues.

5.7.3. Educate VAPAHCS employee(s) as it relates to the operation and parameters of the lithotripsy and/or laser machines.

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

5.7.5. Clean and sterilize the ESWL and/or laser machines.

6. GOVERNMENT RESPONSIBILITIES.

6.1. The VA shall provide the following:

6.1.1. Suitable electric service to operate the unit(s). Contractor to notify VAPAHCS in advance of power requirements for machines.

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

6.1.3. Pre-operative preparation of patients for ESWL and/or laser procedures.

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

6.1.3.2. Collect and dispose of infectious waste and sharps related to the ESWL and/or laser procedures.

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

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

7. MEDICAL RECORDS.

7.1. Authority: Contractor’s employee(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

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

7.3. Disclosure: Contractor’s employee(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information Management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

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

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

7.5. 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 at the following address:

Aaron Cork, Privacy Officer Aaron.cork@va.gov 605-336-3230 x9-6784

8. PATIENT SAFETY COMPLIANCE AND REPORTING. Contractor’s employee(s) shall follow all established patient safety and infection control standards of care. Contractor’s employee(s) shall make every effort to prevent any injury(s) caused by acts of commission or omission in the delivery of care. All events related to patient injury, errors, and other breaches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

9. SPECIAL CONTRACT REQUIREMENTS.

9.1. The services specified herein may be changed by written modification to this contract. The modification will be prepared by the VA Contracting Officer.

9.2. Other necessary personnel for the operation of the services contracted for at VA will be provided by VA that is compatible with the safety of the patient and personnel and with quality medical care programming.

9.3. The service to be performed by the Contractor will be performed within the ethical, professional, and technical standards of the healthcare industry and that are consistent with VA policies and procedures and the regulations of the medical staff bylaws of this VA facility.

9.4. The contractor is required to maintain medical liability insurance for the duration of this contract. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

10. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA), AND QUALITY IMPROVEMENT (QI).

10.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of services, and Peer Reviews. Methods of Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

10.2. Patient Complaints: The CO will 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 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.

10.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

10.4. Performance Standards

10.4.1. Measure: Employee Quality Performance

Performance Requirement: Follows procedures and operates equipment without difficulty or issues.

Standard: 100% Acceptable Quality Level: 100% No deviations accepted Surveillance Method: Direct Observation Frequency: Quarterly

10.4.2. Measure: Qualifications of Key Personnel

Performance Requirement: All contractor employee(s) shall be certified and trained to operate equipment.

Standard: 100% Acceptable Quality Level: 100% No deviations accepted Surveillance Method: Direct Observation Frequency: Annually

10.4.3. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Acceptable Quality Level: All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident. No acceptable deviation.

Surveillance Method: Direct Observation Frequency: Quarterly

10.4.4. Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per VA…