S02 36C25220Q0434.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 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 93

36C25220Q0434 06-25-2020

Kristine Sutton, Contract Specialist 414-844-4876 07-16-2020

10AM LOCAL

36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

X

621399

$8 Million

NET 30

N/A

36C695

Department of Veterans Affairs Clement J. Zablocki VA Medical Center 5000 West National Avenue

Milwaukee WI 53295

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

See CONTINUATION Page

Contractor to provide Board Certified Perfusion Services at the Clement J. Zablocki, VA Medical Center, Milwaukee Wisconsin 53295. In accordance with the specifications terms and conditions contained herein.

See Pages 7-8 for Price Schedule

X ONE

Patrice R. Bond Contracting Officer

36C25220Q0434

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES AND PRICE

B.3 PERFORMANCE WORK STATEMENT (PWS)

B.4 SPECIAL CONTRACT REQUIREMENTS

B.5 CONTRACT SECURITY REQUIREMENTS

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND

REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR

2014)

C.4 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER

CONTENT PAPER (MAY 2011)

C.5 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (JAN 2011)

C.6 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

C.7 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE

(JUL 2016)

C.8 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

C.9 52.216-18 ORDERING (OCT 1995)

C.10 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.11 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.12 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.13 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) .44

C.14 52.224-1 PRIVACY ACT NOTIFICATION (APR 1984)

C.15 52.224-2 PRIVACY ACT (APR 1984)

C.16 52.227-14 RIGHTS IN DATA—GENERAL (MAY 2014)

C.17 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN

1997)

C.18 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.19 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

C.20 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.21 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.22 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND

COMPLIANCE (JUL 2018)

C.23 VAAR 852.237-72 CRIME CONTROL ACT—REPORTING OF CHILD ABUSE

(OCT 2019)

C.24 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.25 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (MAR 2020)

E.2 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

E.3 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING

(JUL 2016)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.8 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (MAR 2020)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACT ADMINISTRATION MATTERS WILL BE HANDLED BY:

a. 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:

Patrice R. Bond Kristine Sutton Contracting Officer Contract Specialist

(414) 844-4806 (414) 844-4876 Patrice.Bond@va.gov Kristine.Sutton@va.gov

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.

mailto:Patrice.Bond@va.gov mailto:Kristine.Sutton@va.gov mailto:VA.Registration@tungsten-network.com

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. SUBCONTRACTORS:

Any subcontractor utilized by the Contractor for the provision of services required under this contract must meet the same qualifications as specified herein for the Contractor. A subcontracting plan is required in accordance with Federal Acquisition Regulation 19. Any proposed subcontracting plan must be submitted. The VA’s current departmental goals are:

Service Disabled Veteran Owned Small Business

Veteran Owned Small Business

Small Disadvantaged Business

Women Owned Small Business

Certified HUBZone Small Business

Small Business

3.00% 5.00% 5.00% 5.00% 3.00% 17.5%

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

AMENDMENT NO DATE

[End of Contract Administration Data] https://portal.tungsten-network.com/Login.aspx

B.2 SCHEDULE OF SERVICES AND PRICE

AUTHORITY: Under the authority of Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153, the Great Lakes Acquisition Center is seeking quotes for Perfusionist services for the Clement J. Zablocki VA Medical Center (Milwaukee VAMC) located at 5000 W. National Avenue, Milwaukee, WI 53295.

BACKGROUND: The Milwaukee VAMC has a Cardiothoracic Surgery Program, but it does not have its own perfusionists on staff. Historically, 116 cases were performed in 2019, 143 in 2018 and 154 in 2017. Cell saver cases will not be performed by the contract perfusionists. Although ECMOs are not currently performed, contract perfusionists may be required to provide support for ECMO in the Operating Room and the Intensive Care Unit in the future. Contract Perfusionists would not be required to do any Chemo cases for cancer treatments. The Milwaukee VAMC does not do TAVR cases nor ventricular assist devices (VADs). However, future use is anticipated as technology progresses and new devices in this category are developed. Contract Perfusionist must possess VAD experience.

PURPOSE: To provide on-site perfusion services to eligible beneficiaries of the Milwaukee

VAMC.

Period of Performance: The estimated period of performance will be a one (1) year base period with four (4) option periods of one (1) year each, to be exercised at the Government’s discretion.

The qualities listed on the Price Schedule are the Government’s estimated annual volumes.

The Government does not guarantee to order these quantities.

General Ordering Authority & Process: An order is deemed placed when a VA practitioner orders perfusionist services or schedules perfusion-related clinical and administrative tasks.

Pricing Instructions: Offerors are to provide firm-fixed (unit) pricing in accordance with the estimated annual volumes of Contract Line Item Numbers (CLINs) listed below for the Base Year and Option Years 1 through 4.

The Government’s guaranteed minimum to be ordered during the fiscal year in which the contract is $50,000. The Government’s contract ceiling amount is $1,370,524.89.

This acquisition is being processed in accordance with FAR 13.5 – Simplified Procedures for Certain Commercial Items and therefore, will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

BASIS FOR AWARD

One award will be made to the offeror whose quote represents the best value to the Government considering price and non-price factors. The following information or factors shall be used to evaluate offers: Qualification and quality of Perfusionists, Perfusionist Availability, Past Performance, Socioeconomic Status, Price. Contract will be firm-fixed (unit) price by CLIN.

The Government may award a contract on the basis of initial quotes received, without discussions. Therefore, each initial quote should contain the offeror’s best terms from a price and technical standpoint. Instructions to offerors on price quotes and technical proposal submissions are found under clause 52.212-1, ADDENDUM TO FAR 52.212-1 –

INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS.

PRICE SCHEDULE

BASE YEAR

CLIN DESCRIPTION

Est.

Qty

Hrly Unit Cost

Total Costs

CLIN 0001 Perfusionist Services / Monday through Friday 7:00 a.m. – 5:00 p.m. 2,500 $ $

CLIN 0002 Call-back Urgent/Emergent (evenings, weekends, holidays) 164 $ $

CLIN 0003 On-call 24/7 8,736 $ $

Estimated Total Base Year $

OPTION YEAR 1

CLIN DESCRIPTION

Est.

Qty

Hrly Unit Cost

Total Costs

CLIN 1001 Perfusionist Services / Monday through Friday 7:00 a.m. – 5:00 p.m. 2,500 $ $

CLIN 1002 Call-back Urgent/Emergent (evenings, weekends, holidays) 164 $ $

CLIN 1003 On-call 24/7 8,736 $ $

Estimated Total Option Year 1 $

OPTION YEAR 2

Est.

Qty

Hrly Unit Cost

Total Costs

CLIN 2001 Perfusionist Services / Monday through Friday 7:00 a.m. – 5:00 p.m. 2,500 $ $

CLIN 2002 Call-back Urgent/Emergent (evenings, weekends, holidays) 164 $ $

CLIN 2003 On-call 24/7 8,736 $ $

Estimated Total Option Year 2 $

OPTION YEAR 3

CLIN DESCRIPTION

Est.

Qty

Hrly Unit Cost

Total Costs

CLIN 3001 Perfusionist Services / Monday through Friday 7:00 a.m. – 5:00 p.m. 2,500 $ $

CLIN 3002 Call-back Urgent/Emergent (evenings, weekends, holidays) 164 $ $

CLIN 3003 On-call 24/7 8,736 $ $

Estimated Total Option Year 3 $

OPTION YEAR 4

Est.

Qty

Hrly Unit Cost

Total Costs

CLIN 4001 Perfusionist Services / Monday through Friday 7:00 a.m. – 5:00 p.m. 2,500 $ $

CLIN 4002 Call-back Urgent/Emergent (evenings, weekends, holidays) 164 $ $

CLIN 4003 On-call 24/7 8,736 $ $

Estimated Total Option Year 4 $

[End of Schedule of Services and Price]

B.3 PERFORMANCE WORK STATEMENT (PWS)

Contractor shall provide Perfusion personnel fully certified by the American Board of Cardiovascular Perfusion and possessing a minimum of one (1) year experience. Contractor shall provide personnel trained and experienced in all aspects of Perfusion who are capable of performing as specified herein.

The VA attending physician, along with operating room (OR) designees, will contact contractor personnel to schedule perfusion services. Schedules will be based upon the OR schedule, patient preference and availability. As a matter of necessity, contractor Perfusionists must be flexible enough to accommodate emergencies as they arise without prior notification. Contractor Perfusionists shall support non-emergent surgeries, on-call services and call-back Perfusion services as defined below.

1. Definitions

Scheduled/Non-Emergent. Contractor shall provide Perfusionist services on-site at the Milwaukee VAMC. These services will be scheduled by VAMC on a non-emergent basis a minimum of one (1) week in advance of planned surgeries conducted during standard tour hours (7:00 a.m. through 5:00 p.m.). Multiple Perfusionists may be scheduled in the event of more than one (overlapping or concurrent) surgery being scheduled.

On-call. Contractor shall provide on-call Perfusionist coverage both during standard tour hours and non-standard tour hours (evenings, weekends and holidays). On-call coverage shall be in addition to “scheduled/non-emergent” Perfusionist(s) twenty-four (24) hours per day; seven (7) days per week, (24/7/365).

Call-Back. Contractor on-call personnel shall provide call-back Perfusion services for urgent/emergent, surgeries, as required. Presumed to be during non-duty hours, weekends and holidays. Contractor shall respond to call-back requests for coverage as follows:

a. Return/confirmation phone call within fifteen (15) minutes.

b. On-site report for duty within thirty (30) minutes (or as otherwise instructed via confirmation phone call).

2. Tasks & Duties Contractor Perfusionists shall monitor and maintain many patient parameters during cardio-pulmonary bypass (CPB). These Perfusionists shall regulate blood pressure, heart rate, urinary output, arterial and venous blood gases, acid/base status, blood coagulation, temperature and myocardial protection. They shall constantly assess mechanical parameters of circuits. As a minimum, contractor Perfusionists shall be proficient in the performance of typical tasks identified below.

a. Set up, program, prime and operate appropriate extra-corporeal equipment for use in the Operating Room Suite (operating rooms, post anesthesia care unit, perfusionist room, and other rooms necessary for perfusionist work), intensive care unit, cardiac cath suite, and other post-surgical areas. Such invasive procedure related equipment, processes, and areas for use may include:

1) Cardiopulmonary bypass machine

2) Off-pump coronary artery bypass (Op-Cab)

3) Ventricular assist device (VAD) and setup – (not currently used – future use is anticipated)

4) Extracorporeal membrane oxygenation (ECMO)

5) Mechanical circulatory support devices

6) Cardiopulmonary support (CPS) devices

7) Cath lab support

8) Percutaneous transluminal coronary angioplasty (PTCA)

9) Valvoplasty and rotoblation

10) Balloon pumps with daily monitoring and additional monitoring as required for patient safety

11) Cell savers

12) Platelet gel preparation

13) Periodic assessment of supply inventories

14) Other administrative services integral to perfusion support

b. Operate and maintain the extra-corporeal equipment and circuit during any medical situation where it is necessary to support or replace the patient’s cardiopulmonary/circulatory function, including transport through the hospital to other locations or in preparation for patient transfer to another hospital. Ensure proper management of physiologic functions by monitoring the necessary variables.

c. Administer the cardioplegia with an understanding of delivery rates, antegrade and retrograde routes during myocardial protection procedures.

d. Independently operate an auto-transfusion device during intraoperative auto-transfusion procedures, ensuring a safe blood product.

e. Independently monitor and adjust timing for proper inflation and deflation of intra-aortic balloon pump devices during implantation procedures; trouble-shoot the device during any malfunctions.

f. Notify the Milwaukee VAMC Biomedical Section, Engineering Service, when maintenance is required on any of the Government-owned devices and equipment associated with Perfusion services.

g. Periodically review lists of Government-owned perfusion-related equipment, devices and supplies and make recommendations appropriate to achieve and maintain optimum performance and support.

h. Remain sufficiently versed in the operation of all related equipment in order to improvise repairs on an emergent basis if required.

i. Provide platelet gel preparations to clinical areas outside of the operating room-related areas (noted in 2.a) upon request and as logistically feasible. Such areas could include outpatient surgical clinicals, surgical procedure rooms and Dental Clinic, to support the needs of our veterans.

3. Professional Capabilities Contractor Perfusionists shall possess an in-depth understanding of cardiac, congenital, pulmonary, vascular and orthotopic transplantation procedures. Contractor shall submit documentation that the Perfusionists assigned to this contract have demonstrated, as a minimum, the professional characteristics listed below.

a. A high degree of innovation and organizational skill.

b. A high level of accountability for independent and interdependent decision-making under minimal oversight.

c. Fully trained and prepared to evaluate and interpret any patient or mechanical response

d. Alert, attentive and able to respond quickly and appropriately to changes and problems encountered during and after surgery.

e. Vigilance and sensitivity to changes in patient vitals and condition during surgery.

f. Awareness, knowledge and expertise to promptly rectify any potentially life-threatening situations/ scenarios.

g. Proficiency in standard perfusion practices and conformity to established protocols.

[End of Statement of Work]

B.4 SPECIAL CONTRACT REQUIREMENTS

1. SERVICES

A. The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4I, Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

B. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the Contractor or the Contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, Contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of Contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services.

The Government retains the right to reject services for contractual non-performance.

C. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

D. Contractor is required to maintain medical liability insurance for the duration of this contract.

Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider.

E. 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.

F. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contractor’s perfusionists. When a Contractor or contract perfusionist(s) has/have been identified as a provider(s) 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 perfusionists] action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

G. The services to be performed by the or will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of each VA facility (copies and/or links will be provided upon request). In all cases, dignity of the patient shall be given the highest regard and the precepts of the American Hospital Association’s “Bill of Rights for Patients” shall be observed.

H. Contractor shall provide the required services listed herein throughout the contract period.

Other necessary personnel for the operation of the services contracted for at the VA will be provided by the VA at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

I. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

J. Prohibition of Referrals: Neither the Contractor nor its employees shall refer VA patients to the Contractor’s facilities, other Non-VA providers, or their own practice for medical care.

K. Inherent Government Functions: Contractors and their contract provider(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. TERM OF CONTRACT

A. This contract is effective for the period of one year, and any exercised option periods. The Contractor shall perform no services after the end of the performance period, until the Contracting Officer authorizes such services in writing.

B. Availability of Funds during a Continuing Resolution: At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution and only be funded for a limited period of time rather than for the entire fiscal year. If, at any time, funds for this contract are provided under a Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government’s obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.

3. WORK SCHEDULE

The perfusionist schedules are Monday through Friday from 7:30 a.m. – 5:30 p.m. Call-back urgent/emergent hours (evenings, weekends, and holidays) are on an as needed basis. On-call hours are 24/7/365.

4, FEDERAL HOLIDAYS

The 10 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

5. QUALIFICATIONS OF PERSONNEL

a. Personnel assigned by the contractor to perform the services covered by this contract shall have a full and unrestricted license in a State, Territory, or Commonwealth of the United States or the District of Columbia. Contractor Perfusionists shall be fully certified by the American

Board of Cardiovascular Perfusion. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approved by the VA Facility Director. The qualifications of such personnel shall also be subject to review by the VA Surgery Department Supervisor.

b. The Contracting Officer will be notified prior to any changes in personnel. VA reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

c. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

d. Contractor’s assigned personnel must possess a minimum of three (3) years’ experience demonstrating a thorough understanding of mechanical parameters of circuits and an in-depth understanding of cardiac, congenital, pulmonary, vascular and orthotopic transplantation procedures.

e. Contractor shall certify that each provider proposed possesses a minimum of one (1) year of experience and active/current certification in each of the following elements of perfusion:

1) CPB (Certified Heart, DHCA)

2) Auto transfusion/cell saver

3) ECMO (Extra Corporeal Membrane Oxygenation)

4) VADS (Ventricular Assist Devices)

5) ISABP (Intra-Aortic Balloon Pump)

6) DHCA (Deep Hypothelmic Circulatory Arrest)

7) HEPCON HMS – Quality Control

f. Contractor’s assigned personnel must be computer literate as patient documentation may be directly input in the patient’s electronic medical record.

g. The contracted individual will be required to show two proofs of identification on their first day of work. Acceptable proof of identification is listed below:

Acceptable PICTURE IDs:

• State-issued Driver’s License

• State DMV-Issued ID Card

• US Passport

• Military ID/Dependents Card

• Foreign Passport

• Permanent Resident

Card/Alien Registration Card w/Photo

Acceptable NON-PICTURE IDs:

• Social Security Card

• Certified Birth Certificate

• State Voter Registration Card

• Native American Tribal Document

• Certificate of US Citizenship

• Certificate of Birth Abroad Issued by

Dept of State

h. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within established timeframes.

i. Continuing Medical Education/Certified Education Units Requirements: All continuing education courses required for maintaining certification must be kept up to dates. Contractor and/or its providers shall provide the Clinical POC/COR copies of current CMEs as required or requested by the VA. Contractors or providers registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current.

j. Physical Requirements: The contractor must provide documentation that demonstrates that all contractor employees have a satisfactory health status including a current physical, which includes the following:

a. 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.

b. 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.

c. 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.

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

e. 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 during the Influenza season.

f. 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.

SPECIAL NOTICE: COVID-19

Due to the current pandemic, contractor employees entering VHA facilities will wear a mask (either personal or facility issued). Masks must be worn in all public and patient care areas throughout the hospital. Contractor employees will be screened for COVID-19, which, at a minimum, should include:

• Fever (100.4 F or 38 C)

• New or worsening cough or difficulty breathing

• New symptoms of COVID-19, 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.

6.CREDENTIALING

a. An application package will be provided by the Credentialing Coordinator and shall be completed by the provider(s) working under this contract and returned within two weeks of receiving the application package. This includes: Facility-specific paperwork, curriculum vitae/resume, current references, signed release of information from candidate, licenses or certifications, competencies, statement that candidate does not have any physical or mental health condition that would adversely affect his/her ability to carry out assigned duties, and any additional credentialing and approval forms.

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Candidate(s) will also be required to complete an application through the VetPro Internet process within two weeks of being enrolled in VetPro. Candidate will need to be enrolled in VetPro by VA personnel. The website address is: https://fcp.vetpro.org. Facility ID number is as follows: 695.

b. National Provider Identifier (NPI): Prior to starting work, the contracted individual or contractor must provide the VA with the contracted individual's National Provider Identifier (NPI) number. If the contracted individual does not have an NPI number, he/she must make application and receive the number prior to beginning work at the VA. The website for an on-line application is: https://nppes.cms.hhs.gov/NPPES/Welcome.do. It may take up to a few weeks to receive the NPI number - so early application is advised. NPI number is required as part of the VetPro application.

c. In accordance with the requirements and procedures of the Health Care Quality

Improvement Act of 1986 – Title IV (Public Law 99-660), which established the National Practitioners Data Bank (NPDB), the Facility Director will ensure that all individuals who perform clinical services are properly screened through the NPDB.

7. APPROVAL OF CONTRACTOR PERSONNEL

The VA reserves the right to refuse acceptance of any Contractor employee or sub-contractor employee under this contract when that individual does not qualify under the requirements of VHA Handbook 1100.19 (http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806) and/or the specific VA Hospital/Medical Center Policy on Credentialing and Privileging or fails to perform at the proficiency level expected by the VA Facility Director.

In addition, VA reserves the right to restrict the services or require dismissal any Contractor employee or sub-contractor employee under this contract after performance begins, if personal or professional conduct jeopardizes patient care. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, physical or verbal abuse, or other conduct resulting in formal complaints by the patient(s). Standards of 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 provider, s/he may request, without cause, immediate replacement of said contract provider. The Contracting Officer and the Contracting Officer’s Representative shall deal with issues raised concerning contract personnel’s conduct.

The final decision maker on questions of acceptability is the Contracting Officer.

8. KEY PERSONNEL & PERSONNEL SUBSTITUTIONS

a. The Contractor shall make NO changes of key personnel unless the change is necessitated by the individual’s illness, death, or termination of employment or if mutually agreed upon by the Contracting Officer and the Contractor. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (b) below. The Contracting Officer must approve all substitutions.

b. 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 Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 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.

https://fcp.vetpro.org/ https://nppes.cms.hhs.gov/NPPES/Welcome.do http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

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

d. Prior to rendering services, substitutes must be credentialed and approved by the medical facility in accordance with VA Bylaws, Rules and Regulations.

e. Because continuity of care is an essential part of VA medical services, contractors shall have a contingency plan in place to be utilized if the contract provider leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

9. HHS/OIG

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this contract. 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. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employs or enters into contracts, orders, or agreements with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the Contractor’s proposal have been compared against the OIG list and are NOT listed as of the date the offer was signed.

10. JOINT COMMISSION STANDARDS

Although Joint Commission accreditation is not required, the Contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

The Contractor will be responsible to ensure the contractor employees or subcontractors providing work on this contract are fully trained and completely competent to perform the required work. Contractor will gather all credentialing documents requested by the VA as well as any other documentation that the carrying out of this contract may require. However, the contractor is not able to nor is the contractor required to make clinical competence determinations on behalf of the

VA.

11. PERSONNEL POLICY

a. The Contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for all staff performing services:

• Workers’ compensation

• Professional liability insurance

• Health examinations/immunizations:

• Income tax withholding, and

• Social security payments.

https://exclusions.oig.hhs.gov/

b. The parties agree that the Contractor, its employees, agents and sub-contractors shall not be considered VA employees for any purpose.

c. The VA shall notify the Contractor of any significant communicable disease exposure as appropriate. The Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (AIJC 1998: 26:2890354) for disease control. The Contractor shall provide follow up documentation of clearance to return to the workplace prior to contractor’s or sub-contractor’s employee(s) return, and ensure that proper follow-up evaluation is provided following an exposure incident.

12. RECORD KEEPING - CONTRACTOR

Contractor must establish a record keeping system of contractor employee hours worked.

13. MEDICAL RECORDS

The VA shall establish and maintain a record keeping system that will record the hours worked by contractor employee(s). Contractor employee(s) shall report to the Operating Room/Intensive Care Unit/Catheterization Laboratory (OR/ICU/Cath Lab) upon arrival at the Milwaukee VAMC.

a. Start Time: Services for which the contractor shall be paid at an hourly rate that is generally calculated from the time the contractor Perfusionist enters the OR to prepare for the procedure. Exceptions to this general rule are listed below and apply only to procedures that are non-emergencies, meaning they have been scheduled for a week or more in advance.

(1) The Perfusionist shall be paid for no more than fifteen (15) minutes prior to the time a non-emergency procedure is scheduled to begin, allowing the Perfusionist any set-up time necessary.

(2) In the event a non-emergency (scheduled) procedure has been delayed through no fault of the Perfusionist, the start time for pay calculation shall begin at the time the procedure was originally scheduled unless:

a) The Perfusionist arrives later than the originally scheduled time in which instance the pay calculation shall commence at the time the Perfusionist arrives; or

b) The VA is able to contact the Perfusionist before he/she arrives at the VA and inform him/her that the procedure has been rescheduled for a later time.

b. End Time: Calculation of the time the contractor Perfusionist shall be paid concludes when the patient is settled in the Operating Room/ ICU unless the surgeon requests, he/she remains until the surgeon declares that the patient is stable.

c. Quarter Hours: Payment shall be calculated for each full quarter hour worked. Quarter hours will commence and end on the hour in 15-minute increments – e.g., 8:00, 8:15, 8:30 and 8:45.

d. Log Sheets: Contractor personnel shall sign in and out on log sheets provided for the purpose of tracking attendance and calculating time eligible for payment. These log sheets shall be submitted with invoices for payment. Contractor employees must sign in and out based on the start and end times defined above.

Log sheets will also reflect the tasks inherent to the Perfusionist occurring outside of the surgical arena – i.e., balloon pump checks, inventory reviews and recommendations, etc. The Log Sheets shall be completed to reflect actual hours worked and other pertinent data as indicated.

14. CONFIDENTIALITY OF PATIENT RECORDS

a. The Contractor is a VA Contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor and its providers are considered as being part of the Department health care activity. Contractor and its providers are considered to be a VA Contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor and its providers are considered to be a VA Contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, the contractor or contract provider may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor and it providers are restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

b. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with 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) and federal laws, rules and regulations. 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.

15. HIPAA COMPLIANCE

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). Contractor is conducting health care, Perfusionist Services, on VA’s behalf - therefore, no BAA is required.

16. DESIGNATION OF CONTRACT REPRESENTATIVE

Name and contact information for the Contracting Officer’s Representative (COR) designated to represent the Contracting Officer will be provided at the time of contract award. The COR will furnish technical guidance and advice regarding the work being performed under this task order.

The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of this designation will be provided in the COR Delegation Memo.

17.CONTRACT PERFORMANCE MONITORING

a. Contractor's employee(s) shall report to the Milwaukee VAMC OR/ICU Charge Nurse/Team Leader or the Cardiothoracic Surgery Coordinator upon arrival at the VA.

b. Monitoring of Contractor’s performance shall be demonstrated through clinical and administrative record reviews. The COR/Clinical POC will be responsible for verifying contract compliance. The COR will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2. Documentation of services performed will be reviewed prior to certifying payment. The Clinical POC will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3. The using service, through the COR, will provide a written statement to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 30 days prior to expiration of contract (and/or prior to election of option renewals, if applicable).

4. The COR will submit reports to the CO upon request (or at least quarterly) indicating contractor performance

c. Contractor's employee(s) may not certify bills for payment. All contract administration functions will be maintained by VA.

18. QUALITY ASSURANCE MONITORING

a. Quality Program. Contractor shall maintain a Quality Control Program related to Perfusion covered under this contract. The results of all Quality Improvement activities performed by the Contractor involving VA patients will be shared with facility staff.