VA263-16-R-0748-00001000.docx

5. PROJECT NUMBER (if applicable)

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2. AMENDMENT/MODIFICATION NUMBER

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8. NAME AND ADDRESS OF CONTRACTOR

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

BY

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

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Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

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13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 00001 N/A Department of Veterans Affairs Network 23 Contracting Office Attention: Toni Wasgatt 316 Robert Street N., Suite 506 St. Paul

MN

55101 Department of Veterans Affairs Network 23 Contracting Office Attention: Toni Wasgatt 316 Robert Street N., Suite 506 St. Paul

MN

55101 To all Offerors/Bidders

VA263-16-R-0748

11-17-2017

X X X X Solicitation VA263-16-R-0748 for Interventional Radiology Physician Services on-site at the Minneapolis VA Health Care System is hereby amended as follows:

1. Performance Work Statement (Sections 3.1.3., 4.3.6.1., 4.4.4.2. and 6.1.1.) is herein revised. Section A.1 of this Amendment hereby replaces Section B.5, pages 10 through 34 of original Solicitation.

2. Revised Attachment D.3 QASP is attached herein and replaces original Solicitation Attachment D.3.

3. Questions and Answers are provided herein as Attachment D.9. to Solicitation.

Toni W Wasgatt Contracting Officer

A.1 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The Contractor shall provide American Board of Radiology (ABR) Certified, fellowship-trained, Interventional Radiology and Vascular Ultrasound Physician Services on-site in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Minneapolis Veterans Affairs Health Care System (MVAHCS). These services will be coordinated with the VA’s 0.4 FTE IR Radiologist, whose schedule is Thursday and Friday every week. This includes covering 83.2 planned hours of leave. The VA Radiology Services follow the standards & guidelines set forth by American College of Radiology (ACR). A contractor providing on-site Interventional Radiologist services shall provide services that meet or exceed the ACR Guidelines http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Interventional as well as the guidelines of the Intersocietal Accreditation Committee: for Extracranial Cerebrovascular testing, Peripheral Venous testing, and Peripheral Arterial testing: http://www.intersocietal.org/vascular/standards/IACVascularTestingStandards2016.pdf.

1.2. Place of Performance - Contractor shall furnish services at the Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.

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

1.4. Policy/Handbooks - the contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

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

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

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

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

1.4.6. VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

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

1.5. 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. ACEP: American College of Emergency Physicians

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. AOD: Admitting Officer of the Day

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CDR: Contract Discrepancy Report

1.5.6. CEU: Certified Education Unit

1.5.7. CME: Continuing Medical Education

1.5.8. CMS: Centers for Medicare and Medicaid Services

1.5.9. 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.

1.5.10. 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.

1.5.11. COS: Chief of Staff

1.5.12. CPARS: Contractor Performance Assessment Reporting System

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

1.5.14. 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.

1.5.15. DEA: Drug Enforcement Agency

1.5.16. ePER: Electronic Patient Event report

1.5.17. FSMB: Federation of State Medical Boards

1.5.18. HHS: Department of Health and Human Services

1.5.19. HIPAA: Health Insurance Portability and Accountability Act

1.5.20. HR: Human Resources

1.5.21. IAC: Intersocietal Accreditation Committee

1.5.22. ISO: Information Security Officer

1.5.23. MOD: Medical Officer of the Day

1.5.24. MVAHCS: Unless identified with the name of a different VA Medical Center, for purposes of this contract, this term shall mean the Minneapolis VA Health Care System.

1.5.25. 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).

1.5.26. NPPES: National Plan and Provider Enumeration System

1.5.27. POP: Period of Performance

1.5.28. PPD: Purified Protein Derivative

1.5.29. PWS: Performance Work Statement

1.5.30. 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.

1.5.31. QA/QI: Quality Assurance/Quality Improvement

1.5.32. QM/PI: Quality Management/Performance Improvement

1.5.33. QASP: Quality Assurance Surveillance Plan

1.5.34. 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.

1.5.35. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers in The VA Midwest Healthcare Network (VISN 23).

1.5.36. 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.

1.5.37. VetPro: A federal web-based credentialing program for healthcare providers.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License – The Contractor’s physician(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 when services are performed onsite on VA property.

All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s physician(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. Board Certification - All contractor’s physician(s) shall be Board Certified by the American Board of Radiology (ABR) (http://www.theabr.org/). All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. Credentialing and Privileging – Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s physician(s) prior to obtaining approval by the MVAHCS Credential Committee, Executive Committee of the Medical Staff (ECMS) and Medical Center Director.

2.1.3.1. If contractor’s physician(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.

2.1.4. Technical Proficiency - All contractor’s physician(s) shall have a minimum of two (2) years (post fellowship) experience as a dedicated IR Physician. Contractor’s physician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write the English language 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 physician(s) and contractor’s physician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME) / Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as requested by the MVAHCS. Contractor’s physician(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 physician(s).

Contractor must meet CME requirements for the MVAHCS accredited vascular lab. http://www.intersocietal.org/vascular/standards/IACVascularTestingStandards2016.pdf

2.1.6. Training (ACLS, BLS, CPRS TMS and other VA MANDATORY: Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA.

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

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

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

2.1.7.3. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all contract physician(s); provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. The MVAHCS shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow-up documentation of clearance to return to the workplace prior to their return.

2.1.8. 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.9. DEA License - Contractor must have current DEA License and shall submit certificate upon request.

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

2.1.11. Citizenship-related Requirements:

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

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

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

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

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

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

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

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

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the MVAHCS Chief of Staff 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 physician(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 physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. Inherent Government Functions: Contractor and Contractor’s physician(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 physician(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 physician(s). When a Contractor or contractor’s physician(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 physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is 1.84 FTE or 3827 hours with 5595 hours of call. FTE is defined by VA as a minimum of eighty (80) hours every two (2) weeks and does not include holidays.

2.9.2. The number of ABR Certified physicians to staff Interventional Radiology located within the MVAHCS daily (be on site) is:

2.9.2.1. Staffing schedules must be provided to COR or designee five (5) weeks in advance.

2.9.2.2. Only VA business is to be conducted on site. Contractor focus on outside business can jeopardize patient care or interfere with the regular and ordinary operation of the facility.

2.9.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled physician is unable to complete an assigned shift; the contractor shall provide replacement physician coverage within two (2) hours and immediately notify the COR at the MVAHCS of the schedule change.

2.9.4. 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 and COR, in writing, within five (5) calendar days after the occurrence of any of these events and provide the information required below. After ninety (90) calendar days of performance, the Contractor shall submit the information required below to the CO at least five (5) calendar days prior to making any permanent substitutions.

2.9.4.1. 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 three (3) calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.9.4.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated in the paragraph above.

2.9.4.3. 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, sexual harassment, 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 Chief of Staff or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s physician(s), s/he may request, without cause, immediate replacement of said Contractor’s physician(s). The CO and COR shall deal with issues raised concerning Contractor’s physician(s) conduct. The final arbiter on questions of acceptability is the CO.

2.9.4.4. Contingency Plan: Because continuity of care is an essential part of MVAHCS’s medical services, the Contractor shall have a contingency plan in place to be utilized if the Contractor’s physician(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. VA Business (Patient) Hours: Monday through Friday from 8:00 AM to 4:30 PM.

Interventional Radiologists: Monday through Friday from 8:00 AM to 4:30 PM.

After a 3- to 8-minute daily huddle, Interventional Radiologists must be ready for first case by 8:00 AM.

3.1.1. Patient procedures must be performed by Contractor’s physician(s) on-site at MVAHCS in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR a month in advance about any obstacles to meeting this performance measure.

3.1.2. Contractor’s physician(s) shall be available and present in clinic during normal MVAHCS Interventional Radiology and Vascular Ultrasound clinic hours. These hours will be established, and may be revised, as deemed appropriate for patient care by the Chief of Imaging. Currently, normal clinic hours are between 8:00 AM and 4:30 PM Monday through Friday with two, half-day consultation clinics.

3.1.3. Contractor Physicians who meet volume and CME qualifications (documentation to be provided with proposal) required by Imaging’s IAC accredited vascular lab will interpret all vascular ultrasound exams on site in accordance with the specifications contained herein to beneficiaries of the VA and the MVAHCS. Vascular ultrasound exams include:

The only ultrasound exams not interpreted will be: Upper Extremity Vein for Deep Vein Thrombosis (UEV for DVT); Lower Extremity Vein for Deep Vein Thrombosis (LEV for DVT); Carotid and Carotid Stent; Aorta (F/U AAA and Screening studies).

The exam interpretation will be completed in a clinically-meaningful and appropriate time frame. In addition to exam interpretation, duties will include working with the ultrasound technologists for the purposes of maintaining image quality and patient care, and teaching of the Radiology resident assigned to the non-invasive vascular rotation. The contractor will also provide a radiologist to attend clinical conferences, such as the Vascular Interdisciplinary Conference, as directed by the Chief of Imaging.

3.1.4. Off-hours Coverage: On-call emergency services will be required by Interventional Radiologists during off-duty hours. Call coverage hours are as follows:

Weekday (Monday through Thursday) call coverage: 4:30 PM through 7:30 AM.

Weekend Call coverage is as follows:

Friday to Saturday: 4:30 PM to 7:30 AM (15 hours) Saturday to Sunday: 7:30 AM to 7:30 AM (24 hours) Sunday to Monday: 7:30 AM to 7:30 AM (24 hours)

A VA Interventional Radiologist will take call in rotation with contract Radiologists for a total of seven (7) weekends and thirty-seven (37) weeknights. Verbal response time to the emergency page is ten (10) Minutes. The Nurse Manager will use the call log to monitor compliance.

3.1.4.1. Contractor’s on-call physician(s) must be available at all times for phone consultations with MVAHCS residents and physicians.

3.1.4.2. Patients must be seen within one (1) hour of the page when medically indicated.

3.1.4.3. Call may not be taken concurrently with another site.

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

3.3. Cancellations: Contractor must contact the Interventional Radiology Nurse Manager in the event of an unavoidable circumstance that requires cancellation of scheduled procedures to avoid outsourcing critically ill patient needs. Unless a state of emergency has been declared or clinics are otherwise cancelled by the MVAHCS, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide contractor’s physician(s) who are competent and qualified per this performance work statement and adequately trained to perform assigned duties.

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

4.2. Standards of Care: The contract physician’s care shall provide all Interventional Radiology services including CTAs, vascular ultrasound exams and consultation clinics, comparable to what would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1. The American College of Radiology Guidelines for Interventional Radiology: http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Interventional, and guidelines of;

4.2.2. The Intersocietal Accreditation Committee Guidelines:

http://www.intersocietal.org/vascular/standards/IACVascularTestingStandards2016.pdf

4.2.3. 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

4.2.4. The professional standards of the Joint Commission (TJC) http://www.jointcommission.org/standards_information/hap_requirements.aspx, and,

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

4.3. Medical Records:

4.3.1. Authorities: Contractor’s physician(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).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA 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.

4.3.3. Disclosure: Contractor’s physician(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.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by 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 MVAHCS.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following number: Jon Power 612-467-2365.

4.3.6. Direct Patient Care: 95% of the time involved in direct patient care.

4.3.6.1. Scope of Care: Contractor’s physician(s) shall be responsible for providing Interventional Radiology procedures, including, but not limited to:

Y90 Ablation Diagnostic Cerebral and Extracranial Angiography

4.3.6.2. Clinic: Contractor physician(s) shall be present on time for any scheduled clinics as documented by physical presence in the clinic at the scheduled start time.

4.3.6.3. Consultation Responsibilities: Contractor physician(s) shall provide consultation with and instruction to referring physicians regarding appropriate indications for interventional radiologic procedures so that the most expeditious and clinically appropriate work-up can be done. Contractor physician(s) shall determine the appropriate course of treatment and communicate in person or by phone with the referring clinicians.

4.3.6.3.1. Contractor physician(s) shall provide review of all requested exams daily.

4.3.6.3.2. Contractor shall interpret vascular ultrasound exams in the timeframe as flagged by MVAHCS Technologist.

4.3.6.3.3. Contractor Physician(s) shall attend one, half-day consultation clinic on Wednesday afternoons. Contractor Physician(s) shall provide backup coverage for VA IR Physician half-day consultation clinic on Thursday afternoons as necessary.

4.3.6.3.4. Contractor physician(s) shall provide post-procedure evaluation and follow-up and clinical consultation regarding complications of interventional radiologic procedures.

4.3.6.3.5. Contractor physician(s) will case review with the affiliate resident assigned to the non-invasive vascular rotation.

4.3.6.3.6. Critical Value findings shall be reported per MVAHCS Policy #PE-08Q, “Critical Values and Abnormal Values.” See Attachment D.8, Policy #PE-08Q.

4.3.6.4. Medications: Contractor physician(s) shall follow all established medication policies and procedures. No sample medications shall be provided to patients.

4.3.6.5. Discharge Education: Provide discharge education and follow-up instructions that are coordinated with the next care setting for all emergency department patients.

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

4.3.7.1. Quality Improvement Meetings: The contractor’s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the MVAHCS Chief of Service, Chief of Staff, or designee.

4.4.7.1.1 Attendance at Morbidity and Mortality (M&M) quarterly conference (an estimated 4 hours per year) is required by Contractor IR Chief and Physicians onsite at time of conference. All other Key Personnel identified on this contract are encouraged to attend on their own time and at their own discretion. Contractor shall report any conflicts that may interfere with attendance to the COR.

4.3.7.2. Staff Meetings: The contractor’s physician(s) shall attend daily 3- to 8-minute daily huddles prior to first case and staff meetings as required by the MVAHCS Chief of Service, Chief of Staff, or designee.

4.3.7.3. Specialized Meetings: The contractor’s physician(s) shall prepare for, attend and complete all follow up activities resulting from the following specialized meetings:

4.3.7.4. QA/QI documentation: The contractor’s physician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

4.3.7.5. Patient Safety Compliance and Reporting: Contractor’s physician(s) shall follow all established patient safety and infection control standards of care. Contractor’s physician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches 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.

4.3.7.6. Documentation verifying volumes and CME as specified in 2.1.2 shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

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

4.4.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). 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.

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

4.4.3. 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.

4.4.4. Performance Standards:

4.4.4.1. Measure: Provider Quality Performance (Clinical).

Performance Requirement: All contractor’s Radiologists(s) shall perform in accordance with clinical standards.

Standard: OPPE documentation for all (100%) staff providing services under the contract. All staff (100%) meet standards.

Acceptable Quality Level: Meets standard as stated above.

Surveillance Method: Ongoing Provider Performance Evaluation (OPPE) data pertinent to care performed for each provider working under this contract. OPPE data will review the following elements:

Frequency: At award and as required.

4.4.4.2. Measure: Provider Quality Performance (Specific for Interventional Radiology).

Performance Requirement: All contractor’s Radiologists shall perform in accordance with VA administrative process.

Standard: Procedure complications: outside the waiting room

1. ≥ 2 cases per year that exhibit potentially significant quality of care concerns for cases that meet criteria for a major complication as defined by policy.

2. Appropriate follow-up for skin does:

a. 3 Gy dose and location recorded in CPRS; PT instructed in self-exam for erythema and report effects to the Physician.

b. 5 Gy Arrangements made to have patient examined by a provider 4-6 weeks following the procedure with subsequent exams as appropriate; RSO notified.

c. 15 Gy skin dose exceeded. ≥ 2 events in a rolling 12-month period.

1. Procedure complications

2. Skin dose exceeding 3 Gy, 5 Gy, 15 Gy Frequency: At award and as required.

4.4.4.3. Measure: Provider Quality Performance (VA administrative processes and policies) Performance Requirement: All contractor’s Radiologists shall perform in accordance with VA administrative process.

Standard: Contractor adheres to VA policies and processes described in this document. All staff (100%) providing services meet standards.

Acceptable Quality Level: Meets standard as stated above.

Surveillance Method: Ongoing Provider Performance Evaluation (OPPE) data pertinent to care performed for each provider working under this contract. OPPE data will review the following elements:

1. Case start time

2. Timely provision of staff schedules

3. Conducting Non-VA Business during scheduled hours.

4. Response time to call Frequency: At award and as required.

4.4.