36C25725Q0468 0003.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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

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

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

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)

(X)

CHECK

ONE

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) 08-29-2025 None 36C257 Department of Veterans Affairs VHA RPO West - NCO 17 Health Care Resources Branch 11495 Turner Road El Paso TX 79936-1372 Nesha S. Nelson, Contract Specialist nesha.nelson@va.gov 36C257 See Block #6

To all Offerors/Bidders

36C25725Q0468

X X X X The purpose of this amendment is to post vendor questions and answers.

a. See continuation page for questions and answers.

b. All other terms and conditions remain in full force and effect.

Carlos Jaquez Contracting Officer

CONTINUATION PAGE

57. What are the makes and models of VA-owned equipment (heart-lung machine, autotransfusion pump, intra-aortic balloon pump, centrifugal ventricular assist device, ECMO machine)?

58. I would like to bring to your attention a compliance issue related to the current requirements for conduit harvesting services. According to state licensing boards, only credentialed and licensed Cardiac and Vascular Surgeons are authorized to perform conduit harvesting procedures. Perfusionists and autotransfusion technicians are not licensed, credentialed, or trained to perform these services.

Perfusionists and autotransfusion technicians will not conduct harvesting services.

59. Does the VA practice AMSECT best standards such as N+1?

This PWS references American Board of Cardiovascular Perfusion (ABCP)

60. Does the VAMC do AngioVac cases?

Yes

61. What days of the week does the VA schedule Open-Heart cases?

Thursdays Usually

62. Are Open-Heart cases performed on the weekend?

Yes, on emergency basis

63. Does the VAMC do off-Pump with Perfusion stand by?

Yes

64. What is the make of the Heart Lung Machine (HLM)?

Terumo pump

65. How many HLM are available?

Two

66. Does the VA use an IStat, a HMS Plus, a Sat/Crit Monitor or a CDI 500?

ISat

67. How many total cases per year has the VAMC averaged over the past 4 years?

Average 73 cases a year

68. Does the VAMC do Heart, Liver, Lung transplants?

No

69. Does the VAMC do AngioVac cases?

Yes

70. Does the VAMC do TAVR cases, and do they have Perfusionists on standby? In the operating room or not?

No

71. Does the VAMC do any HIPEC Chemo cases for cancer treatments?

No

72. How many VADs does the VAMC do per year?

Not Applicable

73. What type of VADs does the VAMC use?

Not Applicable

74. Who is responsible for VAD monitoring?

Not Applicable

75. Can a Perfusion be submitted and be compliant if the board certified Perfusionist is licensed in another state and meets all qualifications, except for a Texas license which is pending approval?

No, they require a Texas license.

76. Pg. 10, 2.1.2., Board certification: May we request a modification to reflect- 2 years of Experience or 250 cases, Justification- To fulfill the contract requirements effectively, it’s crucial for EVT to engage all 10 key personnel designated for VA coverage. EVT is committed to providing key personnel who are competent, qualified, and adequately trained to perform assigned duties. Our new employees with a min. of 2 years of experience or 250 cases, offer the capability to ensure a long-term commitment, provide novel viewpoints, and demonstrate adaptability to emerging technologies.

No

77. pg. 11, 2.1.6., Training: What type of course is VHA-288? Online course?

HIPPA / privacy

78. pg. 14, 3.1.2., States ECMO support; however, the POP does not reflect a cost line for that service. Will it be added?

We do not do ECMO

79. pg. 21, 5.1., Missing Heater-Cooler from list. Can it be added?

See updated Section 5.1.1. on PWS

80. Is the verbiage professional liability insurance the same as medical professional liability insurance the same?

Yes

81. Is the Medical Professional Liability we currently carry of 200,000 / 800,000 meet the bid requirements?

No, the correct about is $1M per Occurrence and $3M aggregate

82. Do I insert 200,000/800,000 in the blank line below?

Contractor and its healthcare providers shall be liable for their liability-producing acts or omissions. The Contractor shall maintain or require all health-care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence: *__________________. However, if the Contractor is an entity or a subdivision of a State that either provides for self-insurance or limits the liability or the amount of insurance purchased by State entities, then the insurance requirement of this contract shall be fulfilled by incorporating the provisions of the applicable State law.

*Amounts are listed below:

1 Million per occurrence 3 Million aggregate

No, only the Contracting Officer can make changes to the FAR and VAAR clauses.

83. There is a conflict with the government’s requirement in B.2 Schedule of Services which states services shall be provided and meet the standard of care meeting or exceeding currently recognized national standards as established by the American Board of Cardiovascular Perfusion (ABCP).

In the context of an open heart surgery, the "n+1" staffing model for perfusionists signifies that for every "n" number of operating/procedure rooms requiring perfusion support at a single site, there should be an additional certified clinical perfusionist available. This is the standard set by the ABCP for a primary and secondary perfusionist and a solicitation requirement. The solicitation also states a Certified Clinical Perfusionist and a Autotransfusion Technician requirement, which does not meet the standard of care. Thus, creating a conflict.

See Section 3.1.2. on PWS

3.1.2. Certified Clinical Perfusionist and/or Autotransfusion Technician services will be on as needed basis, on-call Monday through Sunday, to support these procedures and patients that are in the Intensive Care Unit requiring balloon pump/Extracorporeal Membrane Oxygenation (ECMO) support. The requirement is for the contractor to provide one (1) Certified Cardiovascular Perfusionists (CCP) and one (1) Certified Autotransfusionist. One perfusionist FTEE will be used to support the emergency services as well as provide for coverage during vacation, illness, etc.

84. B.2 Schedule of Services continues to state, “the maximum contract amount, including the base year and any option years exercised, shall not exceed $1,000,000.00”. If the contractor is to follow ABCP standard of care, providing two Certified Clinical Perfusionist, at today’s perfusionist market rate, the maximum shall not exceed $1,000,000 is not feasible. At the current perfusionist market compensation, the maximum should be set to $3,100,000.

The maximum will be increased if the contract award is over $1,000,000.00.

B.3 PERFORMANCE WORK STATEMENT

Perfusion/Autotransfusion Physician Services

1. GENERAL:

1.1. Services Provided: The contractor shall provide Perfusion/Autotransfusion Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), South Texas VA Health Care System (STVHCS).

1.2. Place of Performance: Contractor shall furnish services at the Audie L Murphy Memorial Veterans Hospital, 7400 Merton Minter Street, San Antonio, TX 78229-4404.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority, FAR Part 12, Acquisition of Commercial Products and Commercial Services, and VAAR 873, Simplified Procedures for Health-Care Resources.

1.4. Policy/Directives/Handbooks: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications and VHA Publications.

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

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

1.4.14. Joint Commission: http://www.jointcommission.org/standards/

1.4.15. HHS OIG Website: http://oig.hhs.gov/exclusions/index.asp

1.4.16. American Journal for Infection Control - AJIC 1998; 26:289-354: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.5. Acronyms/Definitions: 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. ABCP: American Board of Cardiovascular Perfusion

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. BLS: Basic Life Support

1.5.5. Call Back: Occurs when the provider is contacted during on-call availability to report onsite to provide services.

1.5.6. CCP: Certified Clinical Perfusionist

1.5.7. CDC: Centers for Disease Control and Prevention

1.5.8. CEU: Certified Education Unit

1.5.9. Clinical Privileging: Clinical 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, and within available resources.

1.5.10. CME: Continuing Medical Education

1.5.11. CMP: Civil Monetary Penalty

1.5.12. CMS: Centers for Medicare and Medicaid Services

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

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

1.5.15. COS: Chief of Staff

1.5.16. CPARS: Contractor Performance Assessment Reporting System

1.5.17. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.5.18. DEA: Drug Enforcement Agency

1.5.19. ED: Emergency Department

1.5.20. ECMO: Extracorporeal Membrane Oxygenation

1.5.21. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.22. EMR: Electronic Medical Record

1.5.23. FAR: Federal Acquisition Regulation

1.5.24. FSMB: Federation of State Medical Boards

1.5.25. FTE: Full Time Employee VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.26. HHS: Department of Health and Human Services

1.5.27. HIPAA: Health Insurance Portability and Accountability Act

1.5.28. ISO: Information Security Officer

1.5.29. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.30. 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).

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

1.5.32. NP: Nurse Practitioner

1.5.33. NPPES: National Plan and Provider Enumeration System

1.5.34. On-Call: On call coverage is defined as on-call availability. The provider is available to the VA in case of urgent need and will respond to contact from the VA as required in the performance work statement; and, if clinically necessary, be available for being “called back” onsite to provide services OPPE: Ongoing Provider Practice Evaluation.

1.5.35. OR: Operating Room

1.5.36. OSHA: Occupational Safety and Health Administration

1.5.37. PA: Physician Assistant

1.5.38. PIV: Personal Identity Verification

1.5.39. POP: Period of Performance

1.5.40. PPD: Purified Protein Derivative

1.5.41. PWS: Performance Work Statement

1.5.42. QASP: Quality Assurance Surveillance Plan

1.5.43. VA: Department of Veterans Affairs

1.5.44. VAAR: VA Acquisition Regulation

1.5.45. VAMC: Veterans Affairs Medical Center, unless identified with the name of a different VA Medical Center, for the purpose of this contract, this term shall mean the South Texas Veterans Health Care System, Audie L. Murphy VA Medical Center.

1.5.46. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.47. VHA: Veterans Health Administration

1.5.48. VISN: Veterans Integrated Services Network

1.5.49. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility: Certified Clinical Perfusionist and/or Autotransfusion Technician services will be on as needed basis.

2.1.1. License: All licenses held by the key personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.1.2. Board Certification: The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Perfusionists and Autotransfusionist shall be certified with at least a minimum of five (5) years of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 500 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, autotransfusion, heart lung machine, membrane oxygenation, left/right heart bypass, intra-aortic balloon pumping and centrifugal ventricular assist device.

2.1.2.1. The Autotransfusionist shall have only a certification as an Autotransfusionist. All continuing education courses required for maintaining certification must always be kept up to date. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance. A folder with the stated qualifications will be maintained by the COR.

2.1.3. Credentialing and Privileging: Contract Perfusionist/Autotransfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each Perfusionist/Autotransfusionist shall be credentialed and privileged (if required) prior to providing services and must be found acceptable by the Facility Medical Executive Board and Medical Center Director (or designee). Credentialing and privileging is to be completed in accordance with VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The ability for an individual Perfusionist/Autotransfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis for all Perfusionists/Autotransfusionists and shall be reported as practitioner specific practice information, in compliance with an accreditation body with equal or better standards to The Joint Commission.

2.1.3.1. If a contract personnel(s) member is 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: Contract personnel(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. The 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. Contractors shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(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 required or requested by the facility. Contract personnel registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. The contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel(s).

2.1.6. Training (ACLS, BLS, EHR and 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. Other training may be required. VA will communicate any changes to the training requirement to the contractor.

2.1.7. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following 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 Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

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

2.1.7.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.7.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.7.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.7.7. The facility 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. Contractors shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.8. National Provider Identification (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. Conflict of Interest: The Contractor and all contract personnel(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 and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.10. Citizenship related Requirements:

2.1.10.1. 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.

2.1.10.2. 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.

2.1.10.3. 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.

2.1.10.4. 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.

2.1.10.5. 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.

2.1.11. 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.

2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract 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.

2.1.11.2. 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 Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility 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 contract personnel(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 Contract personnel(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 Contract personnel(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 to include:

2.7.3.1. Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test.

2.7.3.2. Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series.

2.7.3.3. Evidence of a Hepatitis C titer.

2.7.3.4. Varicella titer if contracted employee has not had chicken pox.

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 contract personnel(s). When Contractor or contract personnel 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 contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. Certified Clinical Perfusionist and/or Autotransfusion Technician services will be on as needed basis.

2.9.2. 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 provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.10. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.10.1. 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 15 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.

2.10.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays 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 above.

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

2.10.4. The CO and COR shall deal with issues raised concerning Contract personnel(s) conduct. The final arbiter on questions of acceptability is the CO.

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

2.10.6. Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: VA business hours/hours of operation are 24 hours a day, 365 days a year.

3.1.1. Work Schedule: Regular work hours are Monday through Friday for eight (8) hours a day from 8:00 a.m. to 4:30 p.m.

3.1.2. Certified Clinical Perfusionist and/or Autotransfusion Technician services will be on as needed basis, on-call Monday through Sunday, to support these procedures and patients that are in the Intensive Care Unit requiring balloon pump/Extracorporeal Membrane Oxygenation (ECMO) support. The requirement is for the contractor to provide one (1) Certified Cardiovascular Perfusionists (CCP) and one (1) Certified Autotransfusionist. One perfusionist FTEE will be used to support the emergency services as well as provide for coverage during vacation, illness, etc.

3.1.3. Off-hours Coverage: It is required by the contractor that one (1) of the full time Perfusionist be in an on-call status for 24 hours a day and seven (7) days a week including all Federal Holidays and be within 30 minutes of the facility to support these emergent cases. On-call service is considered part of the Perfusionist services and will not be paid separately. Any hours worked during an on-call status for an emergency procedure shall be paid the same rate as regular tour hours.

3.1.4. Parking: In order to ensure timely access to the facility, the Contractor will be authorized to park in the main hospital parking lot. Contractors should attempt to park in areas of the parking lot that will not cause undue strain on patients arriving for their appointments. It is preferred that the Contractor will park farthest from the main entrance when available and any open spot if the parking lot is full.

3.2. Federal Holidays: The following holidays are observed by the VA:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

In addition to the days designated as holidays, the Government observes the following days:

· Any other day designated by Federal Statute

· Any other day designated by Executive Order

· Any other day designated by the President’s Proclamation

It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor's personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

4. CONTRACTOR RESPONSIBILITIES:

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

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

4.2. Standards of Care: The contract personnel(s)’ care shall cover the range of Perfusionist/Autotransfusion 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 national standards as established by:

4.2.1. American Board of Cardiovascular Perfusion:

http://www.abcp.org

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

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

4.2.4. The requirements contained in this PWS.

4.3. Medical Records:

4.3.1. Authorities: Contract personnel(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (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 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. Health 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’ (24VA10A7). 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. The contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

4.3.3. Disclosure: Contract personnel(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, 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 Directive 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the Facility.

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. The contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility that were assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.3.7. Confidentiality: VA will provide the contract personnel(s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel(s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

4.3.8. Personal Identity Verification (PIV): Contract personnel(s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel(s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in computer security and documentation training.

4.3.9. Contract personnel(s) shall provide medical record documentation in accordance with the rules and regulations of the medical staff and medical staff by-laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records.

4.3.10. Records created by contract personnel(s) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel(s) shall maintain computer access and prepare for cases the following day by obtaining patient information and record within the current electronic health record system for review.

4.3.11. Contract personnel(s) shall participate in quality improvement projects, initiatives, and reporting as requested.

4.3.11.1. VA utilizes a fully automated electronic medical record. The EMR consists of two primary components. The first is the Veterans Health Information System and Technology Architecture (VISTA), which consists of commercial hardware and software developed by the VA. VISTA is a collection of over 100 applications that make up a comprehensive hospital information system. It includes both medical records and clinical applications or packages such as order entry, progress note, laboratory, radiology, and scheduling/admission-discharge-transfer and discharge summary. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EMR. Contract personnel(s) shall be responsible for viewing the patient record within the EHR and will not be utilizing the VISTA system.

4.3.11.2. Upon transfusion of components, the Perfusionists are responsible for completing the required information on the SF-518 form (Record of Transfusion on the Standard Form 518) to include pre-transfusion data and post-transfusion data. The completed original SF-518 shall be scanned into the patient's chart, and a copy of the SF-518 shall be placed in the designated location for return to the Blood Bank. Under no circumstances will the SF-518 be discarded.

4.3.11.3. The second component uses optical disk imaging technology to meet the remaining 20 percent of the EMR information needs such as advance directive/guardianship papers, medical record documentation from non-VA facilities and informed consents.

4.3.11.4. VA will provide the necessary training to contract personnel(s) on the proper use and operation of the current computerized medical records system (Electronic Health Record - EHR). Contractors agree and shall instruct their employees in signing computer security access agreements and is bound by confidentiality and release of information restrictions. For purposes of clarity, where the VA Forms reference “Contracted Employee Name” it shall mean “Contractor’s Employee Name.”

4.4. Direct Patient Care: Estimated 90% of the time involved in direct patient care. The Perfusionists and Autotransfusionist role will be 90% to patient care related.

4.4.1. Scope of Care: Contract personnel (as appropriate and within scope of practice/privileging) shall be responsible for providing Perfusion/Autotransfusion care, including, but not limited to:

4.4.1.1. All Perfusionists shall assist the Cardio-Thoracic service with by-pass surgical cases and valve replacement of various types. The contractor shall perform onsite Perfusion/Autotransfusion Services in the treatment of care for eligible veteran beneficiaries as referred and authorized by the South Texas Veterans Health Care System (STVHCS). The Perfusionists are responsible for preparation, and operation of the heart and lung machines/pumps in conjunction with maintaining a sterile environment for procedures maintaining blood volume in the patients preventing shock or air embolus.