36C25221Q0060.docx

36C25221Q0060

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25221Q0060 11-04-2020 Mary Beth Wendt, Contract Specialist 414-844-4800 ext. 43220 11-18-2020 13:00

CST

36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X X 561320 Million N/A X 36C578 Department of Veterans Affairs Edward Hines, Jr. VA Hospital 5000 South 5th Avenue Hines IL 60141-5000 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 Perfusionist Services for the Hines VA Hospital (Hines, IL) in accordance with the terms and conditions contained herein.

This solicitation is a 100% Small Business Set-aside. https://web.sba.gov/pro-net/search/dsp_dsbs.cfm X X

ONE

PATRICE R. BOND

Contracting Officer

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACT ADMINISTRATION MATTERS WILL BE HANDLED BY:

1. CONTRACTOR’S NAME/ADDRESS/CITY-STATE-ZIP (please print or type):

Point of Contact/Title: ____________________________________________ Telephone Number: ______________________________________________ Fax Number: ___________________________________________________ Email: ________________________________________________________ Dun & Bradstreet Number: ____________________ Federal Taxpayer Identification Number: _____________________________

b. Contractor’s Past Performance Point of Contact:

Name & Title: ____________________________________________________ Telephone Number: ________________________________________________ Email: ___________________________________________________________

c. Government:

Department of Veterans Affairs Great Lakes Acquisition Center 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476 Fax: (414) 844-4888

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (31 U.S.C. 3332).

3. INVOICES:

Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.tungsten-network.com/Login.aspx. For questions regarding the submission of VA electronic invoices, Tungsten Corporation customer service may be contacted at 1-877-489-6135.

All invoices shall reference the vendor name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, provider name, number of hours worked, unit price (hourly rate) and the total cost. Invoices shall also include any payment discount terms.

For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791.

4. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by Procurement Policy Memorandum (PPM) 2019- 01.

5. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

[End of Contract Administration Data]

B.2 SCHEDULE OF SUPPLIES/SERVICES AND PRICE

The Contractor shall furnish all personnel to provide services necessary to perform on-site Perfusion/Autotransfusion Services to eligible beneficiaries of the Department of Veterans Affairs Hospital, Edward Hines, Jr. Veterans Hospital, 5000 S. 5th Avenue, Hines IL 60141 (hereinafter referred to as VAH). The Contractor’s perfusionist care shall cover the range of Perfusion 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 the American Board of Cardiovascular Perfusion http://www.abcp.org.

Place of Performance: Services shall be provided on-site, Edward Hines, Jr. VA Hospital, Hines IL 60141.

The Contractor shall propose a minimum of three (3) key personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

Period of Performance: FIVE YEAR ORDERING PERIOD In accordance with FAR Part 13.5 Simplified Procedures for Certain Commercial Items, the Great Lakes Acquisition Center is seeking a Veteran Owned Small Business contractor to provide contract services for Perfusionist Services. As such, the Government will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

Ordering Year 1

On-Call Monday thru Thursday 3:30 p.m. – 7:00 a.m.

On-Call Weekends Friday 3:30 p.m. – Monday 7:00 a.m.

Back-up coverage (10 days a year) Monday thru Friday, 7:00 a.m. – 3:30 p.m.

Call-back coverage, 7:00 a.m. – 3:30 p.m.

Ordering Year 2

On-Call Monday thru Thursday 3:30 p.m. – 7:00 a.m.

On-Call Weekends Friday 3:30 p.m. – Monday 7:00 a.m.

Back-up coverage (10 days a year) Monday thru Friday, 7:00 a.m. – 3:30 p.m.

Call-back coverage, 7:00 a.m. – 3:30 p.m.

Ordering Year 3

On-Call Monday thru Thursday 3:30 p.m. – 7:00 a.m.

On-Call Weekends Friday 3:30 p.m. – Monday 7:00 a.m.

Back-up coverage (10 days a year) Monday thru Friday, 7:00 a.m. – 3:30 p.m.

Call-back coverage, 7:00 a.m. – 3:30 p.m.

Ordering Year 4

On-Call Monday thru Thursday 3:30 p.m. – 7:00 a.m.

On-Call Weekends Friday 3:30 p.m. – Monday 7:00 a.m.

Back-up coverage (10 days a year) Monday thru Friday, 7:00 a.m. – 3:30 p.m.

Call-back coverage, 7:00 a.m. – 3:30 p.m.

Ordering Year 5

On-Call Monday thru Thursday 3:30 p.m. – 7:00 a.m.

On-Call Weekends Friday 3:30 p.m. – Monday 7:00 a.m.

Back-up coverage (10 days a year) Monday thru Friday, 7:00 a.m. – 3:30 p.m.

Call-back coverage, 7:00 a.m. – 3:30 p.m.

Total for Ordering Years (1-5): $ ______________

B.3 STATEMENT OF WORK

1. GENERAL:

0. SERVICES REQUIRED: The purpose of this contract is for a Veteran Owned Small Business (VOSB) contractor to provide the Edward Hines, Jr. Veterans Hospital, 5000 S. 5th Ave, Hines, IL 60141 (hereinafter called VA) with on-call, back-up and call-back services of cardiovascular perfusionists necessary to support Hines VAH’s Heart Surgery Program for 2 weeks during each ordering period of the five-year contract. Contractor shall provide the services of Board Certified Perfusionists to provide on-call Perfusionist services Monday thru Thursday from 3:30 p.m. – 7:00 a.m. and weekend coverage beginning Fridays at 3:30 p.m. through Monday 7:00a.m., coverage for 10 days during the hours of 7:30 a.m. – 3:30 p.m.to cover VA perfusionist’s absences, and Call-back coverage from 7:00 a.m. – 3:30 p.m. Services are required on Federal holidays.

0. The on-call Board Certified perfusionist shall respond, via telephone, to on-call required situations within fifteen (15) minutes of notification and shall report on site to the VA Attending Operating Room Surgeon within thirty (30) minutes of initial call for call back perfusion services.

1. These services shall include:

0. The position is based in the Surgical Services Line, but due to the nature of the work, provides clinical service throughout the hospital on a wide range of patients. Perfusionist shall work with other members of VA staff as part of the team that is providing care to patients. The perfusionist’s role most closely mimics that of the anesthesiologist. The individual also works closely with the surgeons, anesthesiologist and nursing staff in order to tailor the services to the needs of each patient.

0. Perfusionist shall document to the electronic patient record immediately following each procedure.

0. All Perfusionists must be currently providing clinical perfusion services.

0. The perfusionist shall provide advice on system management of the ventricular assist devices and ECMO circuits to ensure optimal performance.

0. The perfusionist shall be a contributor in the Quality Assurance/Management of the hospital. Perfusion related data is collected, examined and discussed amongst the cardio-thoracic team members for the purpose of identifying areas for improvement.

0. The perfusionist shall set technical and professional direction of all perfusionists performing work at Hines VA and shall participate in case conferences and coordinate with the VA to ensure appropriate clinical protocols are put into place.

0. The perfusionists must possess a high degree of innovation and organizational skills. He/she requires a high level of accountability for independent and interdependent decision making under minimal oversight.

6. The perfusionist shall remain alert, attentive and respond appropriately to changes and problems.

6. The perfusionist shall be fully prepared to evaluate and interpret any patient or mechanical response, as he/she has the awareness, knowledge, and expertise to rectify any situations that can be life threatening.

6. The standard perfusion practice shall conform to established protocols.

1.2.1.8 All Perfusionists are required to possess the knowledge and experience in-order to be thoroughly familiar with the operation and programming in all of the following:

1.2.1.8.1 balloon pumps

1.2.1.8.2 heart-lung machines

1.2.1.8.3 Auto transfusion/cell savers

1.2.1.8.4 VADS (ventricular assist devices)

1.2.1.8.5 CPB Certified Heart, Deep Hypothalamic Circulatory Arrest (DHCA)

1.2.1.8.6 Extra Corporeal Membrane Oxygenation (ECMO) machines

1.2.1.8.7 HEPCON heparin management system (HMS)

1.2.1.8.7.1 Quality control and preventative maintenance of aforementioned equipment.

1.2.1.8.8 Independently responsible for a wide range of mechanical life support systems

1.2.1.8.9 Monitors and maintains many patient parameters during cardio-pulmonary bypass (CPB)

1.2.1.8.10 Regulation of blood pressure, heart rate, urinary output, arterial and venous blood gases, acid/base status, blood coagulation, temperature and myocardial protection.

1.2.1.8.11 Constantly assess mechanical parameters of circuits

1.2.1.8.12 Complete understanding of cardiac, congenital, pulmonary, vascular and orthotopic transplantation procedures.

1.2.1.9 The perfusionist is responsible for equipment setup, operation and monitoring of the patient during the Hemofiltration cardiac procedures.

1.2.1.10 The perfusionist shall administer the cardioplegia with an understanding of delivery rates, antegrade, and retrograde routes during myocardial protection procedures.

1.2.1.11 Perfusionists shall independently operate an autotransfusion device during Intraoperative autotransfusion procedures, ensuring a safe blood product.

1.2.1.12 Perfusionists shall independently monitor and adjust timing for proper inflation and deflation of intra-aortic balloon pump devices during implantation procedures and trouble-shoot the device when not working properly.

1.2.1.13 Perfusionist shall inform Hines VA Logistics of all disposables, consumables, and equipment which need purchasing and stocking. VA may request the contractor’s input in decisions on capital equipment and disposable supply purchases.

1.2.1.14 All VA owned equipment used by contractor staff (i.e., cell savers, Sorin heater-coolers, balloon pumps, and VAD devices) shall be maintained by contractor staff according to manufacturer specifications and schedules. Documentation of all maintenance activities will be provided to VA annually and/or upon request.

1.2.1.15 The VA Attending Perfusionist, along with the Operating Room (OR) designees, will be responsible for OR scheduling. Schedules will be based upon the OR schedule, patient preference, and availability. However, as a matter of necessity perfusionists must also be flexible enough to accommodate emergencies as they arise without prior notification as operations may be scheduled the same day.

0. PLACE OF PERFORMANCE: Edward Hines Jr. VA Hospital 5000 South Fifth Ave Hines, IL 60141

0. AUTHORITY: Health Care Resources in accordance with Title 38 United States Code (USC) 8153, services are to be furnished by the Contractor on behalf of VA.

0. POLICY AND REGULATIONS: Contractor shall comply with all applicable policy and regulations, including, but not limited to the following:

4. 42 Code of Federal Regulations (CFR) Part 482 Conditions of Participation Hospitals, including Sub-part E Requirements for Specialty Hospitals. http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title42/42cfr482_main_02.tpl

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

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

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

4. VHA Handbook 1100.19 Credentialing and Privileging - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

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

4. Patient Self Determination Act of 1991: http://www.gpo.gov/fdsys/search/pagedetails.action?st=citation%3A42+USC+1395dd&granuleId=USCODE-2010-title42-chap7-subchapXVIII-partE-sec1395cc&packageId=USCODE-2010-title42&bread=true

0. DEFINITIONS/ACRONYMS:

5. COS: Chief of Staff

5. CPARS: Contractor Performance Assessment Reporting System

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

5. FSMB: Federation of State Medical Boards

5. HHS: Department of Health and Human Services

5. HIPAA: Health Insurance Portability and Accountability Act

5. ICAVL: Inter-societal Commission for the Accreditation of Vascular Laboratories

5. ISO: Information Security Officer

5. JC: Joint Commission

5. NSQIP/CICSP: National Surgical Quality Improvement Program/Continuing Improvement in Cardiac Surgical Program

5. OPPE: Ongoing Provider Practice Evaluation

5. QAPI: Quality Assessment and Performance Improvement

5. SPE: Senior Procurement Executive

5. VA: Veterans Affairs

5. VAH: Veterans Affairs Hospital

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

5. VHA: Veterans Health Administration

5. "All needed supply items" are defined as those items needed in order to furnish the perfusion services to the patient. These items will be budgeted for and purchased by the VAH. No supply item required to perform any of the perfusion services shall be purchased nor provided by the contractor.

5. "Complete pump case" includes the Contract Perfusionist's operation of the heart-lung bypass machine and all the life support equipment needed during all open-heart surgeries. It includes operation of the heart-lung bypass machine, operation of the autologous autotransfusion machine, blood gases monitoring and evaluation, anticoagulation management, myocardial preservation cardioplegia delivery, and thermo-regulation or temperature control management. It also includes a period of observation, approximately one to two hours, in the hospital after the patient is transferred to the Surgical Intensive Care Unit to assure emergency reinstitution of bypass or other procedures by the technicians will not be necessary.

5. “Stand by emergencies" at the VAH as listed on Optional Form (OF) 336 is strictly for standby at the VAH. Time begins after being called in while on-call or standby; VA will pay only for actual services performed at the VA facility. On-site response time shall not exceed thirty (30) minutes.

1. QUALIFICATIONS:

1. THE CONTRACTOR SHALL:

0. The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. Contract perfusionists shall be board certified as a perfusionist as recognized by the American Board of Cardiovascular Perfusion. The Contractor is responsible for keeping the VA COR apprised of anything that would adversely affect or otherwise limit their clinical privileges. Note: Failure to keep VA fully informed on these matters may result in contract termination.

0. Credentialing and privileging will be done in accordance with the provisions of VHA Handbook 1100.19. This VHA Handbook provides updated VHA procedures regarding credentialing and privileging. All perfusionist shall be credentialed and privileged prior to providing services and must be found acceptable by the Medical Executive committee and Governing body.

0. All contract perfusionist who will provide services under this contract must be appropriately credentialed and privileged according to the Bylaws and Rules of the contractor’s facility. http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910. If a contractor’s employee 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 within a reasonable period of time.

0. Contractors shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents as needed to verify current and ongoing competency, skills, certification and/or licensing related to the provision of care, treatment and/or services performed.

3. Each Contract Perfusionist providing services under this contract must have no less than three (3) years’ experience providing the types of services required by this contract, should remain updated in the latest techniques, and possess required board certification by the American Board of Cardiovascular Perfusion and State of Wisconsin licensure. Prior to coming to the VA, the contract perfusionists should have done no less than 150 cases in any one-year period. Their case mix should have included complex aortic arch and thoraco-abdominal surgeries.

0. Training (BLS and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by Contractor personnel as required by the VA.

0. STANDARD PERSONNEL TESTING/INFECTION CONTROL

5. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative TB Blood Test (also called interferon-gamma release assays (IGRA)) for all Contractor employees as a baseline. Two TB blood tests are approved by the FDA: the QuantiFERON – TB Gold In-Tube test (QFT-GIT) and the T-SPOT TB test (T-Spot). Subsequent testing is not required, unless the contractor employee has been exposed to someone with TB.

5. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor employees, i.e. at least 2 doses of vaccine are required or serologic evidence of immunity.

5. VARICELLA: Contractors shall provide proof of immunity for all Contractor employees, i.e. at least 2 doses of vaccine are required or serologic evidence of immunity.

5. TDAP (TETNUS/DIPTHERIA/PERTUSSIS): Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor employees. Boosters are required every 10 years.

5. INFLUENZA: Contractors shall provide proof that all Contractor employees have received the annual Influenza vaccine unless it is contraindicated. If the Contractor employees has a medical contraindication to the vaccine, they shall be required to wear a mask throughout the Influenza season in any VHA location, including both clinical and non-clinical areas. In additional the mask shall be worn during performance of their assigned duties and responsibilities. Contract employees in violation of this requirement may be removed from the providing services under the contract/task order.

MASKING FOR UNVACCINATED CONTRACT EMPLOYEE:

a. Contract employees may remove the face mask only under the following circumstances:

b. When eating or drinking (excluding elevators, hallways or common areas).

c. When working in an enclosed office alone.

d. When there are physical barriers or at least six feet of distance between the unvaccinated contract employee and any other contract employee, VA health care provider, patient; or other person; for example, when working in a cubicle with its open side at least six feet from anyone else.

5. After existing the VHA facilities provided that at least six feet of distance between the unvaccinated contract employee and any other contract employee, VA health care provider, patient, or other person can be maintained.

5. HEPATITIS B: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor employees; provide their own Hepatitis B vaccination series (3 doses required) plus a serologic titer (1-2 months after final dose) to document immunity 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.

5. SPECIAL NOTICE: COVID-19

Due to the current pandemic, Contractor employees who enter VHA facilities shall wear a mask (either personal or facility issued). Masks must be worn in all public and patient care areas throughout the VHA facilities.

Contractor employees will be screened for COVID-19, which, at a minimum, should include:

· Fever (100.4 F or 38C)

· New or worsening cough or difficulty breathing

· New symptoms of COVID-19 are available at: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Contractor’s employees screening positive shall not be allowed to enter VHA facilities.

5. The VAH shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractors 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.

0. CONFLICT OF INTEREST: The Contractor and all Contractor staff 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 sub-Contractors who shall provide services. The Contractor must also provide relevant facts that show how it is organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest.

0. Citizenship related Requirements: While performing services for the VA, 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. The Contractor must return a signed certification at the time of proposal 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 the VA. 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. 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 and is applicable to the entire POP. (Contractor Certification Immigration and Nationality Act attached in Section D).

0. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT:

8. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA 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.

8. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed Contractors and/or firm(s) are not listed. Contractors 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 or entity 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 Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

8. By submitting their proposal, the Contractor certifies that the 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.

1. TECHNICAL DIRECTION: The qualifications of contract perfusionist are subject to review by the VA Hospital’s COS or his/her clinical designee and approval by the Hospital Director as provided in VHA Handbook 1100.19. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request during the administration of the resultant contract.

1. NON-PERSONAL SERVICES: The parties agree that The Contractor, all Contractor staff, agents and sub-Contractors shall not be considered VA employees for any purpose.

2. Government Inherent Functions: Contractor and Contractor staff 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, 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. No Employee status: The Contractor shall be responsible for protecting the Contractor’s staff 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:

0. Workers’ compensation

0. Professional liability insurance

0. Health examinations

0. Income tax withholding, and

0. Social security payments.

2. TORT LIABILITY: The Federal Tort Claims Act does not cover Contractors or Contractor’s staff. When a Contractor or a member of their staff has been identified as a provider in a tort claim, The Contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s staff) action or non-action is the responsibility of The Contractor and/or insurance carrier.

2. 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.

1. Key Personnel:

3. The Contractor shall provide on-call perfusionist for non-scheduled time. On-call is to carry a beeper or cell phone and be available to provide phone consultation and report to the Hines Hospital and the summoning Surgeon within 30 minutes of the receiving call or text. The provider must be within a 30-minute radius of the hospital.

3. Personnel Substitutions: The Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 30 calendar day (s) 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 2 calendar days prior to making any permanent substitutions.

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 2 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.

1. For temporary substitutions where the key person shall not be reporting to work for three 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.

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

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

HOURS OF OPERATION:

1. BUSINESS HOURS: Business hours for Cardiothoracic Surgery is Monday thru Friday, 7:00 a.m. to 3:30 p.m. The VA Heart Teams assemble at 6:00 a.m. on Monday thru Friday for scheduled cardiothoracic surgeries. Contract perfusionists shall report and be prepared to work at 7:00 a.m. when scheduled.

1. WORK SCHEDULE: The contractor shall provide coverage:

5. On call Monday - Thursday 3:30 p.m. to 7:00 a.m.

5. On call Weekends – Friday 3:30 p.m. to Monday 7:00 a.m.

5. Back-up coverage to cover VA employee vacations and sick days up to 10 days for each ordering period.

5. Call back coverage from 7:00 a.m. to 3:30 p.m.

1. CANCELLATION POLICY: Unless a state of emergency has been declared or procedures are otherwise cancelled by the VAH, the Contractor shall be responsible for providing services. VA will provide advanced notice of any cancellations when possible.

1. FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans Affairs and the contractor is required to provide services:

Federal Holidays may be scheduled New Year’s Day, Washington’s Birthday, Martin Luther King’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas and any day specifically declared by the President of the United States to be a national holiday.

1. CONTRACTOR RESPONSIBILITIES

2. SERVICES REQUIRED: The contractor shall provide on-call, back-up and call-back coverage as detailed in Section 2.6 and shall respond at the VA Hospital within thirty (30) minutes from the time of receipt of notification that services are required.

2. STANDARDS OF PRACTICE: Contractors care shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care must be equal or exceed VA Standards.

1. Performance shall be according to the requirements contained in this SOW and equal to that of the professional standards of TJC.

2. MEDICAL RECORDS

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

2. The resultant contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractor by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’(24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor’s provider at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

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

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3025 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1423

2. Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAH.

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

Jennifer Buford Privacy Officer/Information Security Officer

2. DIRECT PATIENT CARE: 95% of the time involved in direct patient care

3. Services include selection of VA provided equipment and supplies for extracorporeal circulation (in consultation with the Chief of Cardiothoracic Service), set-up and provide 24 hour trouble shooting for intra-aortic balloon pumps, set-up and operate the heart-lung machine, set-up and run the cell saver and such other extracorporeal circulatory services requested by the operating surgeon, and cleaning the equipment at the end of each case. The assigned Contract Perfusionist shall stock all needed VA furnished supply items so as to guarantee their availability on a 24-hour basis for all elective and emergency cases.

3. Coverage of regularly scheduled percutaneous transarterial catheter angioplasty (PTCA) cases is usually done at the end of the working day without change unless a separate Contract Perfusionist must return to the hospital.

3. It is the Perfusionists responsibility to view the patient record within CPRS prior to the surgery to review the surgeon’s plan of care.

3. Contract Perfusionists will calibrate and maintain VA provided Perfusion equipment in accordance with manufacturer's guidelines and regulatory requirements.

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

4. Contract Perfusionists will generate extracorporeal technology related records and documentation.

2. MANDATORY TRAINING AND ADP SECURITY

5. PATIENT INFORMATION: In performance of official duties, Contractor’s provider(s) have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. Contractor’s provider(s) are responsible for (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion and (2) following all applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in a computer access agreement which contract provider(s) signs.

5. Contractor staff shall complete required security training prior to having access to the VA computer system. Security Training will be accomplished annually. Contractor staff shall select training modules for Privacy Training and Information Security Training. Upon completion of the training, please email training certificates to the Contracting Officer and the COR.

5. In addition, if providing medical services, Contractor staff shall attend CPRS training prior to providing any patient care services. Contractor staff shall document patient care in CPRS to comply with all VA and equivalent Joint Commission standards.

5. RULES OF BEHAVIOR FOR AUTOMATED INFORMATION SYSTEMS: Contractor staff having access to VA Information Systems is required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility ISO, the Rules of Behavior to the Contractor for the respective facility.

5. VA Compliance Business and Integrity (CBI) Training: Contractor shall provide documented proof to the contracting officer or COR that all Contractor’s staff and sub-Contractor Contractors assigned revenue cycle-related work have received their annual CBI Training. The COR will arrange for training from the respective facility compliance officer.

5. Other Mandatory VA training as required. Contractors will be briefed on all required training by the COR upon reporting to VAH. Contractor may invoice for time required to complete mandatory VA training.

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

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

5. Quality Improvement: Contractors shall participate in Quality Improvement, and Performance Improvement activities with staff as required by Joint Commission (or equivalent), and directed by Chief of Service or Chief of Staff or designee. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR) 37.401(b). Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews.

5. Methods of Surveillance/Performance Standards: Contractor shall comply with the required standards as outlined in the Performance Summary Matrix. The Performance Summary Matrix shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

5. The Performance Summary Matrix shall include the following information and will evaluated by the Chief of Cardiothoracic Surgery and given to the COR:

10. Measures: Ability to set up cardiopulmonary bypass circuits

0. Standards: Visualization by attending perfusionist and nursing staff; Mandatory to performance of duties

10. Measures: Ability to assemble, maintain and operate extracorporeal circulation equipment, intra-aortic balloon pumps and other heart assist devices to support or temporarily replace patients' cardiopulmonary functions during open heart surgery.

1. Standards: Visualization by attending perfusionist and nursing staff; Mandatory to performance of duties

10. Measures: Ability to administer blood products, drugs and other substances through heart-lung machines and other devices as directed by cardiac surgeons and anesthetists

2. Standards: Accuracy of drug administration, blood products, and other substances

10. Measures: Ability to operate the heart-lung machine for complex adult cardiac cases such as coronary artery bypass grafting, and valve repair or replacement

3. Standards: Visualization by attending perfusionist and nursing staff; Mandatory to performance of duties

10. Measures: Ability to be on call - day or night, when an emergency or open-heart surgery arises

4. Standards: Response to page

10. Measures: Ability to interpret patients’ medical history and current status, and set-up and test…