36C25221Q0627 Perfusion.docx

36C25221Q0627

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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

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20.

21.

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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

36C25221Q0627 06-22-2021 Antanette Shellaugh, Contract Specialist 414-844-4814 06-28-2021 :00

CDT

36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X X 561320 $30 Million N/A X 36C607 Department of Veterans Affairs William S. Middleton VA Hospital 2500 Overlook Terrace Madison WI 53705-2254 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 The William S. Middleton VA Hospital (Madison VA Hospital) located in Madison, WI is seeking Perfusion Services in accordance with the pricing, specifications, terms, and conditions contained herein.

This procurement is a 100% set aside for Service Disabled Veteran Owned Small Businesses that are verified in the Vendor Information Pages (VIP) database.

X X one Patrice Bond Contracting Officer Table of Contents

SECTION B – CONTINUATION OF SF1449 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 CPARS 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) 844-4891

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:

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 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://authentication.tungsten-network.com/login. 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.

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 SERVICES/PRICE

Authority: This procurement is being conducted under the authority of Title 38 U.S.C. 8153, Sharing of Healthcare Resources and in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items. As such, the Government will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

Services: The contractor shall furnish all personnel to provide services necessary to perform on-site Perfusion Services by Board Certified Cardiovascular Perfusionists to support the heart surgery program at the William S. Middleton Memorial Veterans Hospital (hereinafter called Madison VA Hospital). 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. 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.

Place of Performance: Services shall be provided on-site at the Madison VA Hospital, 2500 Overlook Terrace, Madison, Wisconsin 53705.

Period of Performance: Five Year Ordering Period. The quantities listed on the Price Schedule are the Government’s estimated annual volumes. The government does not guarantee to order these quantities.

The resultant award will be fixed price Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

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

Government’s Minimum and Maximum: The Government’s guaranteed minimum to be ordered during the fiscal year in which the contract is awarded is $1,000.00. The contract shall not exceed $3,000,900.00.

Pricing Instructions: Offerors are to provide firm-fixed (unit) pricing in accordance with the estimated annual volumes of Line Item Numbers (LINs) listed below for each Ordering Period.

In accordance with FAR Part 13.5 Simplified Procedures for Certain Commercial Items, the Great Lakes Acquisition Center is seeking a Service-Disabled 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.

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 as listed in clause 52.212-2 Evaluation-Commercial Items. Contract will be firm-fixed (unit) price by LIN.

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 submissions are found under clause 52.212-1, ADDENDUM TO FAR 52.212-1 - INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS.

PRICE SCHEDULE

ORDERING YEAR ONE – JULY 1, 2021 THROUGH JUNE 30, 2022

LIN

DESCRIPTION

UNIT

PRICE

ESTIMATED TOTAL

Name: ____________________

Hour

Perfusionist 2

Weekly Maintenance

On-Call Services

Call Back Coverage

Orientation / Training

ORDERING YEAR TWO – JULY 1, 2022 THROUGH JUNE 30, 2023

UNIT

PRICE

ESTIMATED TOTAL

Perfusionist 2

ORDERING YEAR THREE – JULY 1, 2023 THROUGH JUNE 30, 2024

UNIT

PRICE

ESTIMATED TOTAL

Name: ____________________

Name: ____________________

Weekly Maintenance

On-Call Services

Call Back Coverage

Orientation / Training

ORDERING YEAR FOUR – JULY 1, 2024 THROUGH JUNE 30, 2025

UNIT

PRICE

ESTIMATED TOTAL

Perfusionist 1

Name: ____________________

Perfusionist 2

Name: ____________________

ORDERING YEAR FIVE – JULY 1, 2025 THROUGH JUNE 30, 2026

UNIT

PRICE

ESTIMATED TOTAL

Perfusionist 1

Name: ____________________

Perfusionist 2

Name: ____________________

TOTAL ESTIMATED CONTRACT PRICE FOR ALL ORDERING YEARS: _____________

NOTE: Pricing must be all inclusive (travel, lodging, etc.). Contractor must provide a complete price schedule.

(End of B.2)

B.3 STATEMENT OF WORK

1. Contractor shall provide the services of two (2) Part-Time Board Certified Perfusionists for cardiovascular perfusion (heart pump team) necessary to support the heart surgery program at the Madison VAH.

2. Contractor shall provide the services of two (2) Part-Time Board Certified Perfusionists Monday and Thursday from 7:00 a.m. – 3:30 p.m., On-call Perfusionists Monday, Wednesday and Thursday from 3:30 p.m. – 7:00 a.m., and on-call services 24/7 on Tuesday and Friday through Sunday. An additional eight hours of on-site weekly equipment maintenance is required. Services are required on Federal holidays.

3. The on-call Board Certified perfusionists 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 45 minutes of initial call for call back perfusion services to include the following:

a. 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. Perfusionists 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.

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

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

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

e. 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.

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

g. 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.

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

ii. 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.

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

h. 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:

i. balloon pumps

ii. heart-lung machines

iii. Auto transfusion/cell savers

iv. VADS (ventricular assist devices)

v. CPB Certified Heart, Deep Hypothalamic Circulatory Arrest (DHCA)

vi. Extra Corporeal Membrane Oxygenation (ECMO) machines

vii. HEPCON hemodynamic monitoring system (HMS)

a. Quality control and preventative maintenance aforementioned equipment.

viii. Independently responsible for a wide range of mechanical life support systems

ix. Monitors and maintains many patient parameters during cardiopulmonary bypass (CPB)

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

xi. Constantly assess mechanical parameters of circuits

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

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

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

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

xvi. 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.

xvii. Perfusionist shall inform Madison 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.

xviii. 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.

xix. The VA Attending Perfusionist, along with the Operating Room (O.R.) 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.

i. DEFINITIONS/ACRONYMS

i. "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.

ii. "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.

iii. “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.

[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 52.212-4(c), Changes) and, prior to becoming effective, shall be properly executed. 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 Statement of Work. 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 for services in all states where services are rendered by the provider.

e. The services to be performed by the contractor will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of the 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.

f. Contractor shall provide the required services listed herein throughout the contract. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

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

2. TERM OF CONTRACT

This contract is effective for an estimated period of July 1, 2021 through June 30, 2026. The contractor shall perform no services after expiration of any performance period or any option period unless and until the Contracting Officer authorizes such services in writing.

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 (CR) 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 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. BUSINESS HOURS

Business hours for cardiac surgery is Monday and Thursday, 7:00 a.m. to 5:30 p.m. and Friday, 7:00 a.m. to 3:30 p.m. The VA Heart Teams assembles at 6:00 a.m. on Mondays and Thursdays for scheduled cardiac surgeries. Contract perfusionists shall report and be prepared to work at 7:00 a.m.

3.1. WORK SCHEDULE

· Monday & Thursday: 7:00 a.m. to 3:30 p.m. – Two Perfusionist for scheduled procedures

· Any weekday: 7:00 a.m. to 3:30 p.m. – One Perfusionist for on-site equipment maintenance. The cleaning of the equipment shall not exceed eight hours weekly. The 8-hour shift time is negotiable.

· On-call Services: Monday, Wednesday and Thursday from 3:30 p.m. – 7:00 a.m. and 24/7 on Tuesdays and Friday through Sunday.

· Call Back Coverage is required.

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.

3.2 FEDERAL HOLIDAYS

Contractor is required to provide services on Federal holidays.

The 11 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), Juneteenth Day (June 19th) 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.

4. QUALIFICATIONS OF PERSONNEL

a. Personnel assigned by the contractor to perform the services covered by this contract shall have all licenses, permits, and certifications as required by law and this contract. Contract Perfusionists shall be board certified as perfusionist as recognized by the American Board of Cardiovascular Perfusion. The Contractor is responsible for keeping the VA Contracting Officer Representative (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.

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 necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English (38 USC 7402).

d. 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.

e. Contractor’s assigned personnel must be computer literate as patient documentation is directly inputted in the patient’s electronic medical record. Proficiency in the use of the Veterans Health Information Systems and Technology Architecture (VISTA) system and the Computerized Patient Record System (CPRS) are preferred. Contractor’s assigned personnel shall be certified in Basic Life Support BLS (CPR). Certifications must be obtained or issued by the American Heart Association (AHA), an organization recognized by the AHA, or Military Training Network (MTN) and maintained during their work at the VA.

f. 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. 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.

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. 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:

· 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.

· 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.

· 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.

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

· 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:

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

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

2. When working in an enclosed office alone.

3. 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.

4. 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.

Contract employees shall follow current masking guidance.

· 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 (Contractor shall comply with most current facility guidelines) 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 (in accordance with CDC or facility guidelines)

· 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. CREDENTIALING

a. Credentials Requested: An application package may 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, CPR/BLS, competencies, statement that candidate does not have any physical or mental health conditions that would adversely affect his/her ability to carry out assigned duties, and any additional credentialing and privileging forms.

Candidate 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: 607.

b. 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 hold clinical privileges are properly screened through the NPDB.

6. APPROVAL OF CONTRACTOR PERSONNEL

The VA reserves the right to refuse acceptance of any contractor employee or subcontractor employee under this contract when that individual does not qualify under the requirements of VHA Handbook 1100.19 (https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910) 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 of any contractor employee or subcontractor employee under this contract 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. The Contracting Officer and the Contracting Officer’s Representative (COR) shall deal with issues raised concerning contract personnel’s conduct. The final decision maker on questions of acceptability is the Contracting Officer.

7. KEY PERSONNEL & PERSONNEL SUBSTITUTIONS

a. During the first ninety (90) days of performance, 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 5 calendar days after the occurrence of any of these events and provide the information required by paragraph (b) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (b) to the Contracting Officer at least 15 days prior to making any permanent substitutions. 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.

c. Prior to rendering services, substitutes must be credentialed and privileged by the medical facility and obtain a medical staff appointment, in accordance with VA Bylaws, Rules and Regulations.

8. 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 employ or enter into contract 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.

9. 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 the Joint Commission on Accreditation of Healthcare Organizations, 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 neither able to nor is the contractor required to make clinical competence determinations on behalf of the VA.

10. PERSONNEL POLICY

a. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, to the extent required by law, the contractor shall provide the following for these personnel:

· Workers’ compensation

· Professional liability insurance

· Health examinations/immunizations/vaccinations

· Income tax withholding, and

· Social security payments.

b. The parties agree that the contractor, its employees, agents and subcontractors 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 Guidelines 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 subcontractor’s employee(s) return.

11. RECORD KEEPING SYSTEM - CONTRACTOR

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

12. MEDICAL RECORDS

Clinical or other medical records of VA veteran patients treated by Contractor under this contract are VA records.

13. CONFIDENTIALITY OF PATIENT RECORDS

a. The contractor, as a VA provider, will assist in the provision of health care to patients seeking such care from or through VA. As such, the contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA provider for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, contractor 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 contract, the contractor is 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.

14. 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 services on the VA’s behalf – therefore, no BAA is required.

15. 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 contract. 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.

16. CONTRACT PERFORMANCE MONITORING

a. Contractor's employee(s) shall report to the COR or designee, upon arrival at the VA. The reporting instructions will be provided at time of award.

b. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. 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. The COR will be responsible for verifying contract compliance. 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 COR will perform periodic spot checks and document with the using service to ensure records are properly monitored. 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. Chief of Staff's office reviews monitoring data. An internal time-keeping form is maintained and reviewed for total number of hours worked per month.

4. The using service, through the COR, will provide a written statement annually 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 20 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

c. Contractor's employee(s) may not certify bills for payment.

17. QUALITY ASSURANCE MONITORING

a. Contractor shall maintain a Quality Control Program related to perfusionist services covered under this contract. The results of all Quality Improvement activities performed by the Contractor involving VA patients will be shared with facility staff. This will include, but not be limited to, quality improvement plans, minutes of staff meetings where quality improvement has been discussed and which include practitioner-specific findings, conclusions, recommendations, written plans for actions taken in response to such conclusions and recommendations, and evaluation of those actions taken. Monitors should reflect at a minimum, issues related to quality care and appropriateness of referral.

b. Copies of provider licensure/certification are also required to be submitted annually to the COR. In addition, updated Joint Commission survey results for the contractor, if Joint Commission certified, shall be forwarded to the COR upon receipt.

c. The contractor will meet or communicate with the facility staff for process review and improvement of contract performance on an as needed basis.

d. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, availability of contract staff, security/privacy, patient satisfaction, Ongoing Provider Performance Evaluation (OPPE), Qualifications of Key Personnel, Licensing/Registration/Certification, Response Times, Punctuality, Patient Safety Incidents, Mandatory Training/Privacy/ Confidentiality and HIPAA, Clinical Information Return, Documentation/Timesheet.

e. Reporting Adverse Events: The contractor shall have an established program to monitor 100% of adverse events (including patient injury or death, or unusual situations in which the patient may be involved) associated with care of VA patients. The contractor shall collect and report the program information on a quarterly basis. The contractor shall notify the VA of adverse events (as defined above) involving VA patients during perfusion services. The VA may review specific findings, conclusions, recommendations, written plans for corrective action taken in response to conclusions and recommendations and evaluation for those corrective actions.

f. These measures, standards, and monitoring procedures are illustrated in the following Performance Requirements Summary Matrix:

Direct Observation and periodic inspection

18. PROHIBITION OF CONTRACT PERFORMANCE OUTSIDE THE U.S.

The entire performance of the contract shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico.