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Q508--Therapeutic Apheresis Services Jesse Brown VAMC & Hines VA Hospital
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36C25220Q0649

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

36C25220Q0649 06-24-2020 Carol Felgenhauer, Contract Specialist 414-844-4893 06-29-2020 Noon Local 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X 561320 $30 Million N/A X 36C537 Department of Veterans Affairs Multiple VA Sites

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 Contractor to provide Therapeutic Apheresis Services at Edward J. Hines, Jr. VA Hospital and Jesse Brown VA Medical Center in accordance with Blanket Purchase Order (BPA) specifications, terms and conditions contained within.

X X

ONE

PATRICE R. BOND

Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCK4
B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA4
B.2 SCHEDULE OF SERVICES/PRICE6
B.3 STATEMENT OF WORK (SOW)8
B.4 SPECIAL BPA REQUIREMENTS12
B.5 BPA SECURITY REQUIREMENTS20
SECTION C - CONTRACT CLAUSES26
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)26
C.2 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)31
C.3 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)33
C.4 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)34
C.5 52.216-18 ORDERING (OCT 1995)36
C.6 52.216-19 ORDER LIMITATIONS (OCT 1995)36
C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)37
C.8 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)37
C.9 52.224-1 PRIVACY ACT NOTIFICATION (APR 1984)38
C.10 52.224-2 PRIVACY ACT (APR 1984)38
C.11 52.227-14 RIGHTS IN DATA—GENERAL (MAY 2014)39
C.12 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)44
C.13 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)44
C.14 VAAR 852.237-72 CRIME CONTROL ACT—REPORTING OF CHILD ABUSE (OCT 2019)45
C.15 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)45
C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)45
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS54
D.1 Attachment A - Immigration Certificate.54
SECTION E - SOLICITATION PROVISIONS55
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (MAR 2020)55
E.2 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)60
E.3 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)61
E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)63
E.5 52.216-1 TYPE OF CONTRACT (APR 1984)64
E.6 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)64
E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (MAR 2020)64

SECTION B - CONTINUATION OF SF 1449 BLOCK

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

1. BPA 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. Government:
Patrice BondCarol Felgenhauer
Contracting OfficerContract Specialist
(414) 844-4806(414) 844-4893
Patrice.Bond@va.govCarol.Felgenhauer@va.gov

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, BPA number, Task Order Number, appropriate obligation number, description of services provided, provider name, number procedures performed, unit price 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. BPA ADMINISTRATION NOTICE: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this BPA. The contractor shall communicate with the Contracting Officer on all matters pertaining to administration. Only the Contracting Officer is authorized to make commitments or issue changes that will affect price, quantity or quality of performance of this BPA or subsequent orders. In the even the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made to the order price to cover any increase in cost incurred thereof.

5. CONTRACT TYPE: Single Award BPA. Orders against the BPA shall be fixed price.

6. BPA/ORDERING PERIOD: The resultant BPA will be a five (5) year ordering period. The Government will conduct an annual review of the established BPA. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to continue with performance of the BPA via funding of the pre-priced ordering periods.

7. GENERAL ORDERING AUTHORITY: Pathology and Laboratory Medicine Services (PLMS) Medical Technologists and Pathologists are authorized to order services under this contract.

8. GENERAL ORDERING METHOD: The Contracting Officer will provide the contractor a list of individuals authorized to place orders under this agreement. An order is initiated when the authorized individuals place a phone call or submits a fax to the Contractor and requests services of a preapproved provider. The order is in process when the provider provides services at the designated VA medical facility and ends when services are no longer required of the provider.

9. EXTENT OF OBLIGATION: The Government is obligated only to the extent of authorized purchases actually made under the BPA. This agreement may be terminated upon 30 days written notice by either party.

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

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

AMENDMENT NO
DATE

[End of BPA Administration Data]

B.2 SCHEDULE OF SERVICES/PRICE

1. AUTHORITY: This procurement is being conducted under the authority of 38 U.S.C. 513, Contracts and Personal Services.

2. PURPOSE: To provide Therapeutic Apheresis Services in support of pathology services at Edward J. Hines, Jr. VA Hospital (HVAH) located at 5000 South 5th Avenue, Hines, Illinois 60141-3030 and Jesse Brown VA Medical Center (JBVAMC) located at 820 South Damen Avenue, Chicago, Illinois 60612-3728 (Facilities). This BPA will be utilized when VA beneficiaries require apheresis services.

A BPA is not a contract but is a simplified method of filling repetitive needs for supplies or services by establishing “charge accounts” with qualified vendors. A BPA contains (1) the terms and conditions applying to future orders between the parties during its term, (2) a description of the services to be provided, and (3) methods for pricing, issuing, and accepting future orders under the BPA. The establishment of a BPA does not obligate funds, rather the VA is only obligated to the extent that an authorized order is placed under the BPA. The VA does not guarantee or imply that any orders for services will be placed under this BPA. The VA requirement is an “as needed” basis only, there are no guaranteed number of procedures for this BPA.

3. PRICING: Firm-fixed (unit) pricing with estimated annual volumes of Contract Line Item Numbers (CLINs). Cumulative annual totals are listed below. The CLIN unit prices will apply to the quantities actually ordered by each facility. The quantities identified by the Facilities are the Government’s estimated annual volumes. The Government does not guarantee to order these quantities.

4. PRICE SCHEDULE:

a. Ordering Period One: August 1, 2020 to July 31, 2021

CLIN
DESCRIPTION
ESTIMATED QUANTITY
RATE
ESTIMATED COST
0001
Therapeutic Apheresis Procedure at Jesse Brown
25
$
$
0002
Therapeutic Apheresis Procedure at Hines
10
$
$
ESTIMATED YEAR ONE TOTAL
$

b. Ordering Period Two: August 1, 2021 to July 31, 2022

CLIN
DESCRIPTION
ESTIMATED QUANTITY
RATE
ESTIMATED COST
1001
Therapeutic Apheresis Procedure at Jesse Brown
28
$
$
1002
Therapeutic Apheresis Procedure at Hines
11
$
$
ESTIMATED YEAR TWO TOTAL
$

c. Ordering Period Three: August 1, 2022 to July 31, 2023

CLIN
DESCRIPTION
ESTIMATED QUANTITY
RATE
ESTIMATED COST
2001
Therapeutic Apheresis Procedure at Jesse Brown
31
$
$
2002
Therapeutic Apheresis Procedure at Hines
12
$
$
ESTIMATED YEAR THREE TOTAL
$

d. Ordering Period Four: August 1, 2023 to July 31, 2024

CLIN
DESCRIPTION
ESTIMATED QUANTITY
RATE
ESTIMATED COST
3001
Therapeutic Apheresis Procedure at Jesse Brown
34
$
$
3002
Therapeutic Apheresis Procedure at Hines
13
$
$
ESTIMATED YEAR FOUR TOTAL
$

e. Ordering Period Five: August 1, 2024 to July 31, 2025

CLIN
DESCRIPTION
ESTIMATED QUANTITY
RATE
ESTIMATED COST
4001
Therapeutic Apheresis Procedure at Jesse Brown
37
$
$
4002
Therapeutic Apheresis Procedure at Hines
14
$
$
ESTIMATED YEAR FIVE TOTAL
$

f. ESTIMATED TOTAL (Years 1-5): ______________________

Provide the names and titles of candidates proposed to perform services under the BPA:

NAME
TITLE

5. BPA MINIMUM/CEILING AMOUNTS: The Government’s guaranteed minimum to be ordered during the fiscal year in which the BPA is awarded is $100.00. The Government’s BPA ceiling amount is $225,000.00

Orders placed under this BPA will be firm-fixed price and are subject to the specifications, terms, and conditions of the established BPA. If there are any discrepancies between the BPA Order and the BPA, the BPA Order will take precedence.

A binding obligation is formed only when a Contracting Officer or authorized PLMS staff places an order and the contractor accepts the order by signature or beginning performance. An individual order under this BPA shall not exceed $11,000.

6. 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. BPA will be firm-fixed (unit) price by CLIN.

The Government may award a BPA on the basis of initial quotes received, without exchanges. Therefore, each initial quote should contain the Offeror’s best terms from a price and technical standpoint. Instructions to Offerors on price and technical quote submissions are found under clause 52.212-1, ADDENDUM TO FAR 52.212-1 – INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS.

[END OF SCHEDULE OF SERVICES/PRICE]

B.3 STATEMENT OF WORK (SOW)

1. OVERVIEW: Contractor shall provide all material, supplies (except replacement fluids [albumin or plasma]), equipment and qualified personnel who are required to provide routine and urgent on-site Therapeutic Apheresis Services at the Hines VAH and Jesse Brown VAMC.

The Contractor shall comply with all Occupational Safety and Health Administration (OSHA), federal, state, and local regulations. Accreditation with the standards and guidelines of organizations such as the American Association of Blood Banks (AABB), College of American Pathologists (CAP), Foundation for the Accreditation of Cellular Therapy (FACT), and American Society for Apheresis (ASFA) is preferred but not mandatory.

2. THERAPEUTIC APHERESIS PROCEDURES: The responsibilities of the Contractor’s therapeutic apheresis staff shall include, but are not limited to the following:

a. The Contractor shall establish an appropriate clinical relationship with the patient to be treated, including answering questions the patient or patient’s family may have regarding the processes specific to the procedure the patient is undergoing.

b. The Contractor shall set up the apheresis equipment and assure proper functioning prior to beginning the therapeutic apheresis.

c. The Contractor shall assess the patient just prior to therapeutic apheresis, to assure adequate hematocrit, vital signs, and overall clinical stability.

d. The Contractor shall establish a vascular access and notify VA clinical personnel when the procedure has been completed.

e. The Contractor shall perform the requested therapeutic apheresis procedure and maintain fluid balance as required.

f. The Contractor shall monitor the patient clinically during the therapeutic apheresis. This should include periodic recording of vital signs and monitoring for adverse effects of the therapeutic apheresis (e.g. citrate toxicity) and transfusion reactions.

g. The Contractor shall monitor equipment function, respond to alarms, and maintain vigilance for malfunctions or any adverse clinical reactions (i.e. lead, return site hematoma) that may not trigger alarms.

h. The Contractor shall take corrective action for detected patient adverse events to the extent qualified or call for VA clinical personnel assistance, if needed.

i. The Contractor shall create and complete a written record of each therapeutic apheresis procedure performed. The Contractor shall document the following:

i. Patient identification

ii. Diagnosis

iii. Type of apheresis performed

iv. Equipment serial number

v. Operator

vi. Vital signs before and after the procedure

vii. Date and time the procedure started and ended

viii. Extracorporeal blood volume (if applicable)

ix. Blood fraction and volume removed

x. Type and volume of replacement fluid(s)

xi. Medications administered

xii. Lot numbers of disposables and replacement fluids

xiii. Patient monitoring

xiv. Reactions and treatment, if any

j. Upon completion of the procedure, the Contractor shall submit all documentation to Laboratory personnel prior to leaving the facility.

3. CUSTOMER SERVICE: Contractor shall provide customer service between the hours of 8:00 a.m. and 4:30 p.m. local time, Monday through Friday that is accessible by telephone to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this BPA.

4. SCHEDULING: The Contractor shall provide on-demand apheresis services 24 hours per day, seven days per week, 365 days per year including Federal holidays.

a. TELEPHONE:

i. The Contractor will be contacted telephonically by the Hines VAH or Jesse Brown VAMC authorized Laboratory personnel only, requesting to schedule a therapeutic apheresis procedure. The Contractor may perform the therapeutic apheresis only after receiving the order by the VA’s authorized Laboratory personnel.

ii. The Contractor shall provide a verbal confirmation to the Government of all routine therapeutic apheresis service appointments within two (2) hours following receipt of order. Contractor shall provide a verbal confirmation to the Government within 30 minutes after receipt of order for all emergency therapeutic apheresis service requests.

iii. The Contractor will respond to orders for services as follows:

1) For routine services, the Contractor will be given, at minimum, 12-hour notice from the time of the VA facility’s telephone order until the on-site service is provided. The Contractor shall then arrive at the VA facility within two hours of any scheduled, routine appointment.

2) For emergency services, the Contractor shall arrive on-site to perform urgent (emergency) procedures within four (4) hours of the time of the VA facility’s telephone call.

b. FACSIMILE (FAX):

i. The Contractor will be contacted by facsimile/fax (CONTRACTOR TO PROVIDE FAX NUMBER TO BE USED: ________________________) by the Hines VAH or Jesse Brown VAMC authorized Laboratory personnel only, requesting to schedule a therapeutic apheresis procedure. The Contractor may perform the therapeutic apheresis only after receiving the order by the VA’s authorized Laboratory personnel.

ii. The Contractor shall provide a verbal confirmation to the Government of all routine therapeutic apheresis service appointments within two (2) hours following receipt of order. Contractor shall provide a verbal confirmation to the Government within 30 minutes after receipt of order for all emergency therapeutic apheresis service requests.

iii. The Contractor will respond to orders for services as follows:

1) For routine services, the Contractor will be given, at minimum, 12-hour notice from the time of the VA facility’s faxed order until the on-site service is provided. The Contractor shall then arrive at the VA facility within two (2) hours of any scheduled, routine appointment.

2) For emergency services, the Contractor shall arrive on-site to perform urgent (emergency) procedures within four (4) hours of the time of the VA facility’s fax.

c. DELAYED ARRIVAL(S): The Contractor shall notify the Blood Bank personnel at the ordering facility immediately of any delay (e.g., arrival for scheduled appointment, starting the procedure).

5. CONTRACTOR EQUIPMENT: Contractor shall maintain its equipment in good working order and in accordance with the specifications of the manufacturer and in compliance with applicable safety regulations. Equipment quality assurance/calibration shall also be performed in accordance with manufacturer's specifications. Records of equipment quality assurance/calibration activities shall be made available to VA for review upon request.

Contractor shall have a contingency plan to address any equipment failures to ensure that VA requirements are met.

6. QUALIFICATION OF PERSONNEL:

a. MEDICAL DIRECTOR: Medical Director with oversight responsibility for contractor-performed services shall possess a M.D. or D.O. degree.

i. The Medical Director shall be Board Certified medical physician and licensed in the State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the Hines VAH and Jesse Brown VAMC Chiefs of Staff and approved by the Hines VAH and Jesse Brown VAMC Facility Directors or designee.

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

iii. The Medical Director is responsible for the oversight of the services provided and the staff providing those services. The Medical Director or his/her designee must be available to the Hines VAH and Jesse Brown VAMC’s medical staff 24 hours a day / 7 days a week / 365 days a year.

b. THERAPEUTIC APHERESIS STAFF: Registered Nurse(s) or other allied health professionals assigned to perform services shall hold a current unrestricted license in the State of Illinois (as applicable), shall be trained in therapeutic apheresis techniques and must possess the following competencies:

i. Operational knowledge with specific instruments used by the Contractor through documented training and competency records.

ii. Knowledge of the basic principle of separation.

iii. Knowledge of transfusion of blood components and the requirements of fluid replacement after removal or exchange.

iv. Expertise in the management of adverse effects of therapeutic apheresis and transfusions.

c. LIFE SUPPORT TRAINING: Contractor’s employees performing direct patient services under this BPA shall maintain current Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) certification and provide a copy of the certification upon renewal.

7. CONTRACTOR LIAISON: The Contractor shall identify one person, who shall serve as liaison between the Contractor and the Hines VAH and Jesse Brown VAMC. The liaison shall ensure that the Contractor performs services in accordance with BPA specifications. The Contractor’s liaison shall be available during the VA’s administrative tour of duty from 8:00 a.m. to 4:30 p.m., Monday through Friday. The designee will be contacted for any problems or issues that arise in the performance of the BPA.

Name: _________________________________

Phone Number: __________________________

[End of Statement of Work]

B.4 SPECIAL BPA REQUIREMENTS

1. SERVICES

a. The services specified herein may be changed by written modification to this BPA. 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 BPA. 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 BPA 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 BPA 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 BPA. 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 BPA period. 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 BPA.

2. BPA TERMS

This BPA is effective for a five-year ordering period, excluding any exercised options. The contractor shall perform no services after expiration of the base year 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 BPA are provided under a CR, funds will only be available for performance under this BPA up to and including the expiration date of the CR, and any extension thereof. The government’s obligation for performance of this BPA beyond that date is contingent upon the availability of appropriated funds from which payment for BPA purposes can be made. No legal liability on the part of the government for any payment may arise for performance under this BPA 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: Therapeutic Apheresis Services must be available twenty-four hours a day, seven days a week, 365 days per year.

a. FEDERAL HOLIDAYS: Contractor is required to provide on-call services on Federal holidays as needed.

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.

4. GENERAL QUALIFICATIONS OF PERSONNEL

a. Personnel assigned by the Contractor to perform the services covered by this BPA shall be subject to review by the VA Chief of Staff and approved by the VA Facility Director or designee. 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 BPA.

b. Personnel assigned by the Contractor to perform the services covered by this BPA shall be proficient in written and spoken English (38 USC 7402).

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

d. The contracted individuals 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

e. 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 during the Influenza season.

· 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 who enter VHA facilities shall wear a mask (either personal or facility issued). Masks must be worn in all public and patient care areas throughout the VHA facilities.

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

· Fever (100.4 F or 38C)

· New or worsening cough or difficulty breathing

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

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

5. APPROVAL OF CONTRACTOR PERSONNEL

The VA reserves the right to refuse acceptance of any contractor employee under this BPA when that individual does not qualify under the requirements of VHA Handbook 1100.19 (https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910) 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 under this BPA if personal or professional conduct jeopardizes patient services. 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 veteran’s family. 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 personnel’s conduct. The final decision maker on questions of acceptability is the Contracting Officer.

6. 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 BPA, 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 BPA 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.

7. HHS/OIG

To ensure that the individuals providing services under the BPA 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 BPA. 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 BPA 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 contracts 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.

8. 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 providing work on this BPA 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 BPA may require. However, the contractor is neither able to nor is the contractor required to make clinical competence determinations on behalf of the VA.

9. PERSONNEL POLICY

a. The contractor shall be responsible for protecting the personnel furnishing services under this BPA. 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

· Income tax withholding, and

· Social security payments.

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

10. RECORD KEEPING SYSTEM - CONTRACTOR

Contractor must establish a record keeping system of Therapeutic Apheresis Services performed.

11. MEDICAL RECORDS

Contractor’s employee will not have access to any VA system under this BPA.

12. 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 BPA, 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.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of Claimants Records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of Certain Medical Records) 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.

13. 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, a BAA is not required.

14. DESIGNATION OF CONTRACT REPRESENTATIVES

Names and contact information for the Contracting Officer’s Representatives (CORs) designated to represent the Contracting Officer will be provided at the time of BPA award. The CORs will furnish technical guidance and advice regarding the work being performed under this BPA. 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 BPA. 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 Memos.

15. BPA PERFORMANCE MONITORING

a. Contractor's employee(s) shall report to the COR or designee, upon arrival at the VA.

1) Hines VAH: Blood Bank, Building 200, Room A104, phone: (708) 202-2237.

2) Jesse Brown VAMC: Administrative Officer for Pathology & Laboratory Medicine Service, Anatomic Pathology Department, 4th Floor, Room #4510, phone: (312)569-6718.

b. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying BPA 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 BPA have been received by VA in a timely manner. The COR will be responsible for verifying BPA 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 CORs 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. BPA 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. Procedures are tracked quarterly and reported annually to the Chief of Staff’s Office.

4. The using service, through the CORs, 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 BPA have been fulfilled as agreed. This summary evaluation will be submitted 20 days prior to expiration of BPA (and/or prior to election of any extensions, if applicable).

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

16. QUALITY ASSURANCE MONITORING

a. Copies of provider certification are also required to be submitted annually to the CORs.

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

c. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: response times, quality of work, quality of documentation and accuracy of invoicing. These monitoring procedures are further illustrated in the following Performance Requirements Matrix:

Measurement
Requirement
Acceptable Performance
Surveillance Method
Disincentive
Patient Complaints or Adverse Incidents
No more than two (2) substantiated patient complaints or incidents within each Ordering Period
95%
Actual
Unfavorable Contractor Performance Evaluation
Provider Timely Arrival
· Within two (2) hours +/- for routine scheduled appointments

· Within four (4) hours for emergency appointments

98%
Actual
Unfavorable Contractor Performance Evaluation
Quality of Documentation
Complete, Clear and Concise Documentation
95%
Laboratory Manager Discretion
Unfavorable Contractor Performance Evaluation
Proper Invoicing
Invoices are submitted timely and accurately
98%
Actual
Unfavorable Contractor Performance Evaluation

d. Reporting Adverse Events: The contractor shall have an established program to monitor 100% of adverse events. 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). 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.

17. PROHIBITION OF BPA PERFORMANCE OUTSIDE THE U.S.

The entire performance of the BPA shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico. The Contractor shall not access any VA data/information (for example, by remote computer access) from locations that are outside the above-stated borders.

Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any VA data/information to locations outside the above-stated borders.

18. CONTRACTOR CERTIFICATION: CITIZENSHIP RELATED REQUIREMENTS:

The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under BPA or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this BPA for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The certification shall be made as part of the offerors response to the RFQ using the subject attachment in Section D of the solicitation document.

19. PAYMENT

a. Contractor’s employees must be present at the VA facility and must be actually performing the required services for the period specified within the BPA or the BPA cost will be decreased accordingly during each billing cycle. BPA providers shall be responsible for reporting worked accurately. The Contractor shall be paid for actual work performed.

b. The VA agrees to reimburse the contractor for services performed, minus any deductions, monthly in arrears, upon receipt of a properly prepared invoice submitted by the contractor. Payments made by the VA under this BPA shall constitute the total cost of services provided by the contractor. The contractor hereby agrees; that in no event, shall contractor bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary, the beneficiary’s family, private insurer, Medicare or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this BPA. Billings rendered by the contractor to the VA for services furnished a VA beneficiary under the terms of this BPA shall be billings in full. This provision shall survive the termination or ending of the BPA.

c. The payment for any leave, to include sick leave, annual leave, administrative leave, and holidays, are the responsibility of the contractor.

[End of Special BPA Requirements]

B.5 BPA SECURITY REQUIREMENTS

1. GENERAL

Contractors and contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Failure to comply with the contractor personnel security requirements may result in termination of the BPA for default.

SAC

All Contractor Employees who require access to the Department of Veterans Affairs computer systems or who…

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