36C25725Q0468 0001.docx

RFQ 36C25725Q0468

Questions and Answers – RFQ 36C25725Q0468

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

To all Offerors/Bidders

36C25725Q0468

X X X **HOUR & DATE for Receipt of Offers is EXTENDED to : 1 PM MT, 09-01-2025 See CONTINUATION Page X The purpose of this amendment is to extend the due date of RFQ 36C25725Q0468 and answer vendor questions.

a. The due date has been changed from 08-18-2025 to 09-01-2025 at 1:00 PM M T.

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

Carlos Jaquez Contracting Officer

CONTINUATION PAGE

1. What is the 2024 annual volume of procedures (not hours) required for perfusion? What about 2025 YTD volume?

2024 - 86, 2025 – 60

1. What is the 2024 annual volume of procedures (not hours) required for autotransfusion performed separately from perfusion? What about 2025 YTD volume?

2024 – five (5), 2025 – three (3) for CT surgery only. I do not know total numbers for other services.

1. What is the 2024 annual volume of procedures (not hours) required for conduit harvesting? What about 2025 YTD volume?

None

1. How many surgeons use perfusionist services?

Two (2)

1. How many surgeons use autotransfusion performed separately from perfusion?

Any surgeon from any service can request/use this.

1. How many surgeons use services for conduit harvesting?

None

1. Please clarify expectations regarding ECMO. How many insertions annually? Does the perfusionist monitor the ECMO? How many hours annually for ECMO monitoring? Are ECMO cases transported to an ECMO center or kept at the VA? Does the VA expect that the perfusionist will travel with ECMO transport?

Any patient requiring ECMO is transferred to the accepting ECMO center. The perfusionist is only involved if the patient is in the OR. The perfusionist would continue managing bypass and/or autotransfusion in line with normal duties and then transfer to the ECMO team in the OR.

1. How far in advance are conduit harvesting procedures scheduled?

N/A

1. What are the required qualifications for performing conduit harvesting?

N/A

1. How often do cases start outside of regular work hours (M-F, 8AM-4:30PM)?

Rarely for bypass/perfusion.

1. How many times in 2024 were perfusionist and/or autotransfusionist called for off-hours coverage? Year to date in 2025?

Unknown but 1-2/yr for CTS.

1. What is the maximum concurrency of perfusion/autotransfusion procedures? What is the typical concurrency?

Every perfusion case will have autotransfusion concurrently. Any autotransfusion need outside of CTS would require calling another person in.

1. Will the VA agree to increase response time for off-hours coverage from 30 minutes to 60 minutes?

No. 30 minutes is the required response time for OR staff during off-hours.

1. Who is the incumbent? What is the current contract number?

EVT, INC, Contract Number 36C25721D0002

1. Page 5 states, “maximum contract amount, including the base year and any option years exercised, shall not exceed $1,000,000.” This is far lower than the Indefinite Delivery Contract (IDC) originally valued at $2,215,500, awarded in October 2020. Will the maximum contract amount be increased to $3 million or $5 million to account for higher costs since 2020?

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

1. Section 2.1.2 requires 5 years of experience for perfusionists and autotransfusionists. It also requires perfusionists to have performed a minimum of 500 cases. Will the VA agree to remove these requirements in light of the increasing rarity of these clinical personnel?

No

1. Section 2.10 requires no substitutions for the first 90 days. This impedes contractors that might use travelers to start the services. Will the VA agree to remove this requirement?

No

1. Please clarify the expected start date. Will the VA agree to a minimum of 60 days from contract award to start of services? This would allow new contractor to credential staff and ramp services in conjunction with surgeon expectations.

No, the start date must be the day after the prior contract is no longer valid. This is a critical service. There cannot be any lapse in services.

1. Will VA provide disposable supplies or will contractor? If contractor, please provide details of the perfusion pack, autotransfusion pack. What are the spec sheets of the supplies? What non-pack specialty supplies are used?

All equipment and supplies will be provided by the VA.

1. If contractor provides supplies, will the supplies be invoiced separately from the line items listed in S02+D.3+Fillable+Schedule+of+Services.xlsx?

All equipment and supplies will be provided by the VA.

1. Does it require for the perfusionist and autotransfusion technician to be on call at the same time?

In theory yes, there must be at least 2 people (primary and a backup).

1. The requirements are for 750 hours annually for services; however, the SOW requires the 2 FTEEs to be on duty daily during regular business hours. What are the actual requirements and number of hours per year? With this there needs to always be someone on call. The current system is when the on call is called in, another perfusionist takes their place on call.

Section 2.9. of the Performance Work Statement (PWS) will be updated to the following:

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.

1. How many concurrent cases for the last 36 months Our best estimate is between 10 to 20 times but cannot account for all the times other services requested autotransfusion.

1. How many cases have there been where both the perfusionist and autotransfusion technician were on duty concurrently for the last 36 months?

Our best estimate is between 10 to 20 times but cannot account for all the times other services requested autotransfusion.

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

Yes

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

Terumo pump

25. How many HLM are available?

Two (2)

1. What is the make of the Cell Saver and Balloon Pump?

CatSmart/Maquet

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

ISat

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

No

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

No

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

No

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

No

1. What type of VADs does the VAMC use?

N/A

1. Who is responsible for VAD monitoring?

N/A

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

Surgeries are usually scheduled for Thursdays but that does not include urgent or emergency cases.

1. Per Section E, Sub-section F. Formal Communications, it states “questions regarding this solicitation must be submitted via email to Nesha Nelson, Contract Specialist at Nesha.Nelson@va.gov by 5:00 PM EST August 18, 2025, which is the date the solicitation is due. What is the date/time questions are due by?

Section E, Sub-section F. Formal Communications will be amended to the following:

Questions are due by 4:00 PM EST August 27, 2025. The Solicitation is due by 1:00 PM MDT, September 1, 2025.

1. The evaluation process will include Past Performance. Is there a form or format the government would like contractors to submit Past Performance with?

There is no form or format just as long as you submit the information requested on evaluation Factor 2: Past Performance:

ii. Quoters shall identify three (3) current or recently completed (within the past three years) contracts that are similar in scope and dollar value to the contract being offered herein, to include contract name, dates of performance, point of contact, telephone number and e-mail address. Contracts listed may include those entered with the Federal Government, State or local agencies, or commercial customers.

1. How many Cardiac Surgeons does the Audie L Murphy VA Medical Center (VAMC) have?

Two (2)

1. Are the Cardiac Surgeons Government employees or contractors?

Government employees

1. How many Perfusionists are on staff?

0 on staff

1. Are you Perfusionist Government employees or contractors?

Contractors

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

No

1. How many cell saver cases are performed per year?

Cell saver average three (3) per month

42. Are Perfusionists responsible for these?

1. How many ECMO’s does the VAMC do per year?

Any patient requiring ECMO is transferred to the accepting ECMO center. The perfusionist is only involved if the patient is in the OR. The perfusionist would continue managing bypass and/or autotransfusion in line with normal duties and then transfer to the ECMO team in the OR.

1. Section E, Part B. Format – states Attachment D.3 Fillable Schedule of Services to be included in Part 1. Attachment D.3 is a Microsoft Excel spreadsheet. Does the Government want this spreadsheet submitted as a separate file and referenced in Part 1, embedded within the Part 1 document as a file or content copy/pasted into Part 1 subsection v.?

D.3 Fillable Schedule of Services should be filled within the Microsoft Excel document and submitted as an attachment along with the other attachments and labeled as such. This is used for the contractor to verify the calculations inputted in Part 1, embedded within the Part 1 document.

1. Upon review of attachment D.4 Experience Worksheet (Technical Capabilities), the questionnaire appears to pigeonhole capabilities and is only considering direct Perfusionist services. Why? I am inquiring because our team has a history of providing exceptional medical support services to the federal government in the state of Texas and we have identified Perfusionists who meet the criteria set forth in the PWS for this opportunity. We are seeking a fair opportunity to offer the government our value added services and strongly feel that the experience criteria should be broadened to include various types of medical support services.

The attachment, D.4 Experience Worksheet (Technical Capabilities), is there to offer guidance as to what information is needed, use of a separate document is acceptable as long as all requested information is provided.

1. How many FTEs are required? On page 13, under Section 2.9.Key Personnel: 2.9.1 it states the VA Full Time Equivalency (FTE) for the services required is two (2); however on page 5 under section B.2 SCHEDULE OF SERVICES under Price Instructions it states the Contractor shall propose a minimum of four (4) key personnel to be credentialed and be available for scheduling. Please advise?

We suggest four (4) key personnel to cover on-site and on-call requirements.

1. Do we have to submit the listed CLAUSE AND PROVISIONS, if our SAM.gov registration is inclusive of each?

Yes

1. Will the Parking modification be added to PWS?

Yes, see updated section 3.1.4. of the PWS.

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.

1. 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

1. pg. 17, 4.4.1.1., Malcom Randall VAMC. Is this another location that needs coverage?

No

1. pg. 23, 6.1.1., The quality control plan was not required in the previous contract; therefore, I am unsure of the specific requirements.

This is a new contract and now it’s required. Quality Control Plan: Description and reporting reflecting the Quoter’s plan for meeting of contract requirements and performance standards

1. pg 24, 6.4. Statement concern: In no event will the VA pay for hours that exceed the total number of hours specified in the contract for the POP. Can we request an increase in hours in the event we exceed 750 hrs?

This statement will be deleted from the PWS.

1. pg. 35 C7 Does this refer to our Workers Comp limits?

Yes

1. pg 36 C10 The wording mentions a $1,000,000 limit per person. Could you please clarify if this means they want you to carry individual limits of $1,000,000/$3,000,000 for each provider, or if it refers to $1,000,000 per claim with a $3,000,000 aggregate?

$3,000,000.00 Aggregate

1. Due to these 3 concerns and no Q&A has been published; Posterity requests the government extend the solicitation due date until these concerns are addressed.

The Offer Due Date has been extended to September 1, 2025 at 1PM MDT.

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. CDC: Centers for Disease Control and Prevention

1.5.7. CEU: Certified Education Unit

1.5.8. 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.

1.5.9. CME: Continuing Medical Education

1.5.10. CMP: Civil Monetary Penalty

1.5.11. CMS: Centers for Medicare and Medicaid Services

1.5.12. 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.

1.5.13. 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.

1.5.14. COS: Chief of Staff

1.5.15. CPARS: Contractor Performance Assessment Reporting System

1.5.16. 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.

1.5.17. DEA: Drug Enforcement Agency

1.5.18. ED: Emergency Department

1.5.19. ECMO: Extracorporeal Membrane Oxygenation

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

1.5.21. EMR: Electronic Medical Record

1.5.22. FAR: Federal Acquisition Regulation

1.5.23. FSMB: Federation of State Medical Boards

1.5.24. 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.

1.5.25. HHS: Department of Health and Human Services

1.5.26. HIPAA: Health Insurance Portability and Accountability Act

1.5.27. ISO: Information Security Officer

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

1.5.29. 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).

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

1.5.31. NP: Nurse Practitioner

1.5.32. NPPES: National Plan and Provider Enumeration System

1.5.33. 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.

1.5.34. OR: Operating Room

1.5.35. OSHA: Occupational Safety and Health Administration

1.5.36. PA: Physician Assistant

1.5.37. PIV: Personal Identity Verification

1.5.38. POP: Period of Performance

1.5.39. PPD: Purified Protein Derivative

1.5.40. PWS: Performance Work Statement

1.5.41. QASP: Quality Assurance Surveillance Plan

1.5.42. VA: Department of Veterans Affairs

1.5.43. VAAR: VA Acquisition Regulation

1.5.44. 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.

1.5.45. 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.

1.5.46. VHA: Veterans Health Administration

1.5.47. VISN: Veterans Integrated Services Network

1.5.48. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility: The contractor shall provide two (2) Full Time Equivalency Employees (FTEEs), consisting of one (1) Board Certified Perfusionists and one (1) Certified Autotransfusionist located at the VAMC.

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) Board Certified Perfusionists 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).