36C25719Q0693-002.docx

Performance Work Statement for Mobile Extracorporeal Shockwave Lithotripsy Services

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1. GENERAL:

1.1. Services Provided: The Contractor shall provide Certified Extracorporeal Shockwave Lithotripsy (ESWL) Technician Services and mobile equipment in accordance with the specifications contained herein to beneficiaries of the Department of Veteran Affairs (VA and the South Texas Veteran Health Care System. A contractor providing personnel and equipment services shall provide services consistent with TJC and that meet or exceed VA and the American Urological Association Guidelines as defined in this document.

1.2. Place of Performance - Contractor shall furnish services to STVHCS at the Christus Santa Rosa Physicians Ambulatory Surgery Center, 423 Treeline Park, Suite 202; and South Texas Veterans Health Care System, Audie L. Murphy VAMC, 7400 Merton Minter Blvd, San Antonio, Texas .

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority

1.4. Policy/Handbooks:

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

1.4.2. 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

1.4.3. VHA Directive 2010-018 “Facility Infrastructure”

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227

1.4.4. VHA Directive 1192 “Seasonal Influenza Prevention Program” https://www.publichealth.va.gov/docs/flu/VHA_Directive_1192_Sep

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

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

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

1.4.10. American Urological Association

https://www.auanet.org/guidelines

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

1.5.1. ACGME: Accreditation Council for Graduate Medical Education

1.5.2. ACLS: Advanced Cardiac Life Support

1.5.3. AOD: Admitting Officer of the Day

1.5.4. AUA: American Urological Association

1.5.5. ARRT: The American Registry of Radiologic Technologists

1.5.6. BLS: Basic Life Support

1.5.7. CDC: Centers for Disease Control and Prevention

1.5.8. CDR: Contract Discrepancy Report

1.5.9. CEU: Certified Education Unit

1.5.10. CME: Continuing Medical Education

1.5.11. CMS: Centers for Medicare and Medicaid Services

1.5.12. Contracting Officer (CO) – 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.

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

1.5.14. COS: Chief of Staff

1.5.15. CPARS: Contractor Performance Assessment Reporting System

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

1.5.17. 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.

1.5.18. DEA: Drug Enforcement Agency

1.5.19. ED: Emergency Department

1.5.20. FSMB: Federation of State Medical Boards

1.5.21. HHS: Department of Health and Human Services

1.5.22. HIPAA: Health Insurance Portability and Accountability Act

1.5.23. ISO: Information Security Officer

1.5.24. 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.

1.5.25. MOD: Medical Officer of the Day

1.5.26. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.27. Non-Contract Provider - any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

1.5.28. NPPES: National Plan and Provider Enumeration System

1.5.29. POP: Period of Performance

1.5.30. PPD: Purified Protein Derivative

1.5.31. PWS: Performance Work Statement

1.5.32. Privileging (Clinical Privileging): Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific.

1.5.33. QA/QI: Quality Assurance/Quality Improvement

1.5.34. QM/PI: Quality Management/Performance Improvement

1.5.35. QASP: Quality Assurance Surveillance Plan

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

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

1.5.38. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

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

1.5.40. 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 South Texas Veterans Health Care System, Audie L. Murphy Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. Licensing and Certification – Contractor technician(s) assigned by the Contractor to perform the services covered by this contract shall have a current certification and must be certified with the American Register of Radiologic Technologists (AART) to practice in Texas where services are being performed.

All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Information on state licensing by the American Registry of Radiologic Technologists may be found at this site: https://www.arrt.org/registration/verify-credentials. Contract technologist(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

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

2.1.3. 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 technician(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 Contractor’s technician(s).

2.1.4. Standard Personnel Testing/Infection Control: Contractor shall provide statement that all required infection control testing is current and that the contractor is compliant with OSHA regulations concerning occupational exposure to blood borne pathogens. The Contractor shall also notify the VA of any significant communicable disease exposures and the VA will also notify the contractor of the same, 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. Tests shall be current within the past year.

2.1.5. Conflict of Interest: The Contractor and all Contractor’s technician(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.

2.1.6. Citizenship related Requirements:

2.1.6.1. 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;

2.1.6.2. 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.

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

2.1.6.4. 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.

2.1.6.5. 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.

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

2.1.7.1. 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 technician(s)are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

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

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

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

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

2.6. Inherent Government Functions: Contractor and Contractor’s technician(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.

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

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

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

2.9. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s technician(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/SCHEDULING:

3.1. Business Hours: Work hours are described as Monday through Friday; 7:00 a.m. – 5:00 p.m. Urology Operating Room Days for each facility are:

Christus Santa Rosa PASC operating days are Thursdays Audie L. Murphy operating room days are Wednesday and Fridays

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

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

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

3.3. Patient Access/Timeliness of Scheduling:

Requests for mobile ESWL services shall be forwarded by the VA to the contractor at a minimum 5 days in advance once patient eligibility is determined. Subsequent emergent cases may be added and all appropriate documents required for ESWL services shall be provided the day of surgery or previous day. Contractor has one (1) business day to review and take action on the request.

3.3.1. Contractor technician(s) must be on time to deliver the equipment to the facility and set up the mobile ESWL equipment in the OR prior to the procedure.

3.4. Cancellations:

3.4.1. Unless a state of emergency has been declared, the Contractor shall be responsible for providing services

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide mobile ESWL equipment and contract technician (s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Management and Supervision:

4.1.2. The Contractor shall be responsible for supervising the services provided under this contract by the Contractor’s staff.

4.1.3. The Contractor shall have written policies and procedures regarding staff credentials and privileging.

4.1.4. The VAMC will provide to the Contractor policies, procedures and processes necessary to allow cooperative functioning between the agency and VAMC. Updates and refreshers will be provided to the Contractor upon request and when policy procedures or process changes.

4.1.5. The Contractor shall complete background investigations to insure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

5. Standards of Care: The contract technician(s)’ care shall cover the range of ESWL services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized TJC, VA and national standards as established by:

5.1.1. The American Urological Association Guidelines:

https://www.auanet.org/education/guidelines/shock-wave-lithotripsy.cfm

5.1.2. 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

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

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

5.1.5. The requirements contained in this PWS

5.2. MEDICAL RECORDS

5.2.1. Authorities: Contractor’s technician(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).

5.2.2. 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.

5.2.3. Disclosure: Contractor’s technician(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.

5.2.4. Professional Standards for Documenting Care: Care shall be appropriately documented 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.

4.2.1. Release of Information: The VA shall maintain control of releasing any VA patient medical information. Contractor will refer veterans to South Texas Veterans Health Care System Release of Information section to request copies of records.

4.2.1.1. . Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

4.2.1.2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

4.2.1.3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4.2.1.4. STVHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of STVHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to STVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

4.2.1.5. . The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to STVHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

4.2.1.6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and STVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

4.2.1.7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

4.2.1.8. The Contractor shall not create or maintain any records containing any non-public STVHCS information that are not specifically tied to or authorized by the contract.

4.2.1.9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

4.2.1.10. The STVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which STVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

5.2.5. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item # 10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

5.3. Direct Patient Care: 97% of the time involved in direct patient care. Contractor shall be responsible for transporting, setting up, and operating mobile ESWL equipment during the procedure. VA Urology Attending Physician will be monitoring the procedure and present in the operating room while ESWL services are performed.

5.3.1. Per the qualification section of this PWS, the Contractor shall provide the following staff: Contractor shall provide certified ESWL technicians to perform mobile ESWL services

5.3.1.1. Scope of Care: Contractor’s technician(s) shall be responsible for providing: including, but not limited to:

5.3.1.1.1. Technician(s) provided in satisfaction of this contract shall be required to perform their assigned duties with regards to all Urology patients requiring ESWL procedures.

5.3.2. ADMINISTRATIVE: estimated_3% of time not involved in direct patient care. Transporting mobile ESWL equipment from truck to the OR. setting up and operating the equipment.

5.3.3. SYSTEM REQUIREMENTS:

5.3.3.1. The contractor must maintain contractors mobile EWSL equipment to insure that it is reliable and functional to prevent any disruption in the delivery of services.

5.3.3.2. The contractor will not have access to patients health information. For scheduling and billing purposes, the contractor will be provided facility location where services are to be provided, either CSR PASC or STVHCS, the patient name, date, and time the procedure is scheduled in the OR and name of the physician performing the ESWL. VA will act as primary custodian of the patient information for all purposes related to VA and Government records retention requirements.

5.3.3.3. Contractor shall maintain its mobile ESWL equipment in good working order and in accordance with the specifications of the manufacturer. Equipment quality control shall be performed in accordance with manufacturer's specifications. Records of equipment quality control activities shall be made available to VA for review upon request.

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

5.4.1. 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.

5.4.2. Performance Standards:

5.4.2.1. Measure: Timeliness

Performance Requirement: Technician must be on time. Deliver equipment and set up equipment in the OR prior to the procedure Standard: Delivery 100% of the procedures Acceptable Quality Level: 99% meet Standards Surveillance Method: Direct observation by Attending Physician and OR staff Frequency: Monthly

5.4.2.2. Measure: Qualifications of Key Personnel

Performance Requirement: All Contractor’s technician(s)shall be Certified accordance with ACR Standards.

Standard: All (100%) contract technicians are Certified.

Acceptable Quality Level: _100% No deviations accepted.

Surveillance Method: Random Inspection of qualification documents Frequency: Annually

5.4.2.3. Measure: Patient Access

Performance Requirement: The Contractor shall be available and in location as needed to properly perform tasks as specified.

Standard: All (100%) Contractor’s technician(s)are on time and available to perform services.

Acceptable Quality Level: Contractor’s technician(s)is on-time and available to perform services 97% of the time Surveillance Method: Direct observation by Attending Physician and OR staff Frequency: Monthly

5.4.2.4. Measure: Maintains licensing and certification

Performance Requirement: Updated Licensing and certification shall be provided as they are renewed. Licensing and certification information kept current.

Standard: All (100%) licensing and certification(s) for Contractor’s technician(s)shall be provided as they are renewed. Licensing and certification information kept current.

Acceptable Quality Level: _100% licensing and certification(s) for Contractor’s technician(s)shall be provided as they are renewed. Licensing and certification information kept current. No acceptable deviation.

Surveillance Method: Periodic Sampling and Random Sampling Frequency: Annually

5.4.2.5. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality Standard: All (100%) contractor technician(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Acceptable Quality Level: _100% compliance; no deviations Surveillance Method: Direct observation by Attending VA Physician and OR staff Frequency: Monthly

5.4.3. Registration with Contractor Performance Assessment Reporting System

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

5.4.3.2. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

5.4.3.3. For contracts with a period of one 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 Contractor’s performance annually. Interim reports will be filed 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 have sixty (60) days to submit any comments and re-assign the report to the CO.

5.4.3.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

6. GOVERNMENT RESPONSIBILITIES

6.1. VA Support Personnel, Services or Equipment: Contractor will provide mobile ESWL equipment and certified technician to transport the equipment from contractor’s location to: offsite at Affiliate Christus Santa Rosa Physicians Ambulatory Surgery Center, 403 Treeline Park, Suite 202, San Antonio, Texas 78209 or onsite at South Texas Veterans Health Care System, 7400 Merton Minter Blvd., San Antonio, TX 78229. The technician is required to unload the equipment, set up and operate the equipment during the procedure. All services will be performed at either offsite at CSR PASC – Alamo Heights or onsite at STVHCS. The STVHCS will provide Attending Physicians to perform the procedure, ancillary OR staff needed to perform patient care and operating room equipment will be provided by CSR PASC – Alamo Heights if procedures are performed offsite. If procedures are performed onsite at STVHCS all ancillary OR staff needed to perform patient care and operating room equipment will be provided by STVHCS, other than the mobile ESWL equipment provided by the contractor.

6.1.1. The contractor will use qualified personnel (i.e. registered radiologic technologists) to operate equipment.

6.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: (enter contract administration if not already listed in another area- list the title (not name) and contact information for COR, Clinical point of contact, and any other relevant personnel involved).

6.2.1. CO RESPONSIBILITIES:

CO – Yomika Brock Contracting Officer Network Contracting Office 124 East Hwy 67 Suite 100 Duncanville, TX 75137 Yomika.Brock@va.gov

6.2.1.1. 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.

6.2.1.2. 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.

6.2.1.3. 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 Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

6.2.2. COR Responsibilities:

The COR for this contract is:

Ms. Rosemary Moore Contract Officer Representative South Texas Veterans Health Care System, Surgical Service 7400 Merton Minter Blvd.

San Antonio, TX 78229 Rosemary.Moore2@va.gov

6.2.2.1. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

6.2.2.2. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

6.2.2.3. The COR will maintain a record-keeping system of services by reviewing invoices against Urology Surgical schedule to verify – VA patients were seen and patient received the procedure. The COR will review this data monthly when invoices are received and certify all invoices against the Urology surgical schedule. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

6.2.2.4. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

6.2.2.5. All contract administration functions will be retained by the VA.

7. SPECIAL CONTRACT REQUIREMENTS

7.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

7.1.1. The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

7.2. Billing:

Invoice requirements and supporting documentation: Payment to the Contractor shall be made monthly, in arrears, upon receipt of a properly prepared invoice. Payment for services will be at the rates specified in the Schedule of Supplies/Services. The Contractor shall submit invoices using CMS Uniform Billing (UB-04) forms covering the services performed under this contract. The invoices shall contain the following information:

7.2.1. Name and Address of Contractor

7.2.2. Invoice Date and Invoice Number

7.2.3. Contract Number and Purchase Order Number (if applicable)

7.2.4. Date of Service

7.2.5. Name of Beneficiary and last four digits of the Social Security Number

7.2.6. Total Price

7.2.7. Vendor Electronic Invoice Submission Methods

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

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:

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

7.3. Payment Adjustments:

7.3.1. The contractor shall be paid only for actual work performed.

7.4. Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

7.4.1. To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

7.4.2. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.

7.5. Contractor Security Requirements (Handbook 6500.6) –

1. GENERAL: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’ National Institute of Standards and Technology (NIST)’ Web site at http://checklists.nist.gov.

1. To ensure that appropriate security controls are in place, contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts: located at the following Web site http://www.iprm.oit.va.gov.

1. On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day’s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

7.6. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and