S02 - 36C24823R0127_Solicitation.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

675-23-4-2213-0020

36C24823R0127 07-12-2023

Peter Bedard 860-351-3008 07-31-2023

16:00 EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

X

621991

$35 Million

N/A

X

516/673/675

Department of Veterans Affairs Bay Pines VA Healthcare System James A. Haley Veterans Hospital Orlando VA Medical Center

FL

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Tampa FL 33637

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The contractor shall provide estimated on-site Blood Compatibility Testing Services in support of the Bay Pines VA Healthcare System, Orlando VA Medical Center, and James A Haley Veterans Hospital.

Indefinite Delivery Indefinite Quantity (IDIQ) is for one

(1) base year, with four (4) - one (1) year options

Period of Performance will be 09/01/2023 - 08/31/2028.

Reference pages 5 - 9 for Price Schedule.

Reference pages 10 - 52 for the Performance Work Statement.

The current wage determinations 2015-4571 + 2015-4553 will be contract and updated if option years are exercised.

See CONTINUATION Page 516-23-3-037-0011 673-23-4-103-0019 675-23-4-2213-0020

X X

X 1

Yamil Gomez

36C24823R0127

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE SCHEDULE

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 52

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.10 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.11 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.12 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS

EVALUATION FACTORS (JAN 2023)(DEVIATION)

C.13 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.14 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (NOV 2022)

C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.16 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.17 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.18 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.19 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

C.20 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

Attachment 1 - Conflict of Interest Attachment 2 - Certification of Immigration and Nationality Act Attachment 3 - Contractor Rules of Behavior

Attachment 4 - Wage Determination Attachment 5 - Past Performance Questionnaire Attachment 6 - Subcontracting Plan Template Attachment 7 - QASP

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.7 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020) .. 82

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C248 Yamil Gomez

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

Yamil.Gomez@va.gov

813-525-1815

Contract Specialist: Peter Bedard

Department of Veteran Affairs

Network Contracting Office 8 (NCO 8)

Peter.bedard@va.gov

860-351-3008

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

6. CONFORMITY TO REGULATIONS: The contractor and his/her operations shall conform to all regulations, Federal, State and Local governing the performance of contracted services.

7. MANDATORY WRITTEN DISCLOSURES: Mandatory written disclosures required by FAR clause 52.201-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OUG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on “FAR Clause 52.203-13 Reporting”. If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

8. CAUTION: Late submissions, modification, and withdrawals: See Provisions FAR 52.212-1

9. POST AWARD ORIENTATION: The contracting officer will schedule a post award orientation conference for contract orientation purposes as required by https://www.va.gov/oal/library/vaam/vaamM842.asp#M84250270.

B.2 PRICE SCHEDULE

The contractor shall furnish all personnel, equipment, and location to provide services necessary to perform Blood Compatibility Testing Services for Homeless Veterans to eligible beneficiaries of the Department of Veterans Affairs Healthcare System, Bay Pines VA Healthcare System (BPVAHCS), Orlando VA Medical Center (OVAMC) and the James A. Haley Veterans Hospital (JAHVH) as specific herein. All services shall be performed at the contractor’s facility.

Contract Type: The Government intent is to award one (1) Indefinite Delivery Indefinite Quantity (IDIQ) contract type.

Minimum and Maximum Quantity: The guaranteed minimum amount to be ordered for this procurement is $2,500.00 total – inclusive of the base period and all option periods. The contract maximum is $18,000,000.00 total – inclusive of the base period and all option periods.

If the maximum aggregate amount of $18,000,000.00 is reached prior to the end date of the final period of performance, not further task order will be issued on the contract.

Task Order Procedures: Task Orders will be issued by NCO 8 Contracting Officers.

Pricing: Price schedule for Line-Item Number (LIN) for the base year and each option year includes the following: estimated quantity, unit, proposed unit price, proposed total annual price for each LIN, and the estimated grand total.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

EST.

QUANTITY UNIT UNIT PRICE AMOUNT

0.00 EA _______________ _______________

Blood Compatibility Testing Products and Services

Bay Pines/Orlando/Tampa Contract Period: Base POP Begin: 09-01-2023 POP End: 08-31-2024

0001A

6,500.00 EA _______________ _______________

Bay Pines Contract Period: Base

0001B

Orlando Contract Period: Base

0001C

14,000.00 EA _______________ _______________

Tampa Contract Period: Base

Base Year

Total _______________

Bay Pines/Orlando/Tampa Contract Period: Option 1 POP Begin: 09-01-2024 POP End: 08-31-2025

1001A

Bay Pines Contract Period: Option 1

1001B

Orlando Contract Period: Option 1

1001C

Tampa Contract Period: Option 1

Option 1

Bay Pines/Orlando/Tampa Contract Period: Option 2 POP Begin: 09-01-2025 POP End: 08-31-2026

2001A

Bay Pines Contract Period: Option 2

2001B

Orlando Contract Period: Option 2

2001C

Tampa Contract Period: Option 2

Option 2

Bay Pines/Orlando/Tampa Contract Period: Option 3 POP Begin: 09-01-2026 POP End: 08-31-2027

3001A

Bay Pines Contract Period: Option 3

3001B

Orlando Contract Period: Option 3

3001C

Tampa Contract Period: Option 3

Option 3

Bay Pines/Orlando/Tampa Contract Period: Option 4 POP Begin: 09-01-2027 POP End: 08-31-2028

4001A

Bay Pines Contract Period: Option 4

4001B

Orlando Contract Period: Option 4

4001C

14,000.00 EA __________________ __________________

Tampa Contract Period: Option 4

Option 4

GRAND TOTAL __________________

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The James A. Haley Veterans’ Hospital (JAHVH), Orlando VA Medical Center (OVAMC) and Bay Pines VA Healthcare System (BPVAHCS) have an ongoing requirement for blood compatibility testing services. The services shall be provided on a 24-hour, 7 day a week basis (including holidays) by a blood bank entity registered and/or licensed by the Food and Drug Administration (FDA), and accredited and compliant with the American Association of Blood Banks (AABB). Contractor shall provide all blood transfusion and transfusion-related services, including without limitation, compatibility testing, licensed personnel, supplies and equipment. These services include the use of a contractor provided Pathologist as needed. Compatibility testing shall be defined to include all crossmatching, all type and screen, all antibody identifications, set up of all antibody elution’s, and all reference laboratory workups.

Services shall include all Qualified Technical staff (including a medical director), reagents and supplies, proficiency materials, licensure and accreditation, set-up, and supervisory oversight. The contractor shall monitor blood and blood product inventories and maintain minimal levels. The contractor shall also process orders that are input into VBECS (Vista Blood Establishment Computer Software) by VA healthcare providers, to include orders from the Whole Blood Products contract.

1.2. Place of Performance: Contractor shall furnish services at the following locations.

1.2.1. Orlando VA Medical Center, 13800 Veterans Way, Orlando, FL 32827.

1.2.2. James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Boulevard, Tampa, FL 33612.

1.2.3. C. W. Bill Young VA Medical Center, 10000 Bay Pines Blvd, Bay Pines FL 33744

1.3. Authority: It is VA’s intention to solicit proposal in accordance with all terms, conditions, provisions, specifications, and schedules of this solicitation and award a contract under the authority of Title 38 U.S.C. Section 8153, Federal Acquisition Regulation (FAR) 15 Contracting by Negotiations, and FAR Part 12 Acquisition of Commercial Items.

1.4. Policy/Handbooks: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.4.1. VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.4.2. VHA Directive 2010-018 “Facility

Infrastructure”www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227

1.4.3. VHA Directive 1192 “Seasonal Influenza Prevention Program” https://www.publichealth.va.gov/docs/flu/VHA_Directive_1192_Sep

1.4.4. VHA DIRECTIVE 1106 Pathology and Laboratory Medicine Service

1.4.5. VHA Directive 1220: Facility Procedure Complexity Designation Requirements to

Perform Invasive Procedures in Any Clinical Setting:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

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

1.4.7. VHA Handbook 1100.19 Credentialing and Privileging -

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.8. Privacy Act of 1974 (5 U.S.C. 552a) as amended

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.9. Joint Commission - http://www.jointcommission.org/standards/

1.4.10. HHS OIG Website – http://oig.hhs.gov/exclusions/index.asp

1.4.11. American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.4.12. VA Directive 1663: Health Care Resources Contracting – Buying:

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.13. VHA Directive 1907.01: VHA Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.14. VHA Directive 1100.20 Credentialing of Health Care Providers:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

1.4.15. VHA Directive 2012-030 Credential of Health Care Professionals:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

1.5. Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. AABB: Association for the Advancement of Blood and Biotherapies

1.5.2. CAAHEP: Commission on Accreditation of Allied Health Education Programs

1.5.3. CDC: Centers for Disease Control and Prevention

1.5.4. CDR: Contract Discrepancy Report

1.5.5. CEU: Certified Education Unit

1.5.6. CMP: Civil Monetary Penalty

1.5.7. CMS: Centers for Medicare and Medicaid Services

1.5.8. Contracting Officer – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.9. COR: Contracting Officer’s Representative – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.10. COS: Chief of Staff

1.5.11. CPARS: Contractor Performance Assessment Reporting System

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

1.5.13. DEA: Drug Enforcement Agency

1.5.14. ED: Emergency Department

1.5.15. EMR: Electronic Medical Record

1.5.16. HHS: Department of Health and Human Services

1.5.17. HIPAA: Health Insurance Portability and Accountability Act

1.5.18. HR: Human Resources

1.5.19. IDIQ: Indefinite Delivery Indefinite Quantity

1.5.20. ISO: Information Security Officer

1.5.21. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

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

1.5.23. OSHA: Occupational Safety and Health Administration

1.5.24. OIT: Office of Information and Technology

1.5.25. OPM: Office of Personnel Management

1.5.26. PA: Physician Assistant

1.5.27. PIV: Personal Identity Verification

1.5.28. POP: Period of Performance

1.5.29. PPD: Purified Protein Derivative

1.5.30. PWS: Performance Work Statement

1.5.31. QASP: Quality Assurance Surveillance Plan

1.5.32. RFP: Request for Proposal

1.5.33. VAMC: Veterans Affairs Medical Center; Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the VA Medical Center.

1.5.34. Veterans Health Administration (VHA): The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, D.C.

1.5.35. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.5.36. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

2. Facility: Facility must meet the following: (a) the standards of Life Safety Code (National Fire Protection Association (NFPA)) #101; (b) the fire and safety code imposed by State Law; and

(c) City, State, and Federal requirements concerning licensing and health codes.

3. Licenses and Accreditation: All residents’ settings must be licensed as required for the particular setting under State or Federal authority and available when requested. Accreditation by the Joint Commission and/or Commission on Accreditation of Rehabilitation Facilities (CARF) is evidence of internal quality assurance mechanisms and is desirable but is not required.

Where applicable, the resident setting must have a current occupancy permit issued by the authority having jurisdiction.

4. Hours of Operation: 24 hours/7 days per week.

5. QUALIFICATIONS:

5.1 Staff/Facility

5.1.1 License: Contractor will attain and provide proof of all certifications (includes CLIA certificate for high complexity testing, FDA registration for blood bank and attain AABB accreditation). Contractor must meet all requirements of Federal, State, or local laws, codes, and/or regulations regarding the operation of this type of service

5.1.2 Board Certification: Contractor will have proof of personnel’s current national board certification/ state licensure or eligibility for technologist staff that satisfies requirements for High Complexity Testing under CLIA Amendments, https://www.flrules.org/gateway/RuleNo.asp?id=64B3-5.003. For Medical Director must possess a M.D. or D.O degree with board certification in Clinical Pathology, Internal Medicine or Hematology and sub-specialty in Blood Banking/Transfusion Medicine by a Board registry recognized by the American Board of Medical Subspecialties. Minimum of three (3 years) experience as a physician in a transfusion medicine/blood banking setting required. Familiarity with therapeutic apheresis, stem cell transplantation and research. All continuing education courses required for maintaining certification must be kept up to date at all times.

Documentation verifying current certification shall be provided by the Contractor to the VA COR as requested for each year of contract performance.

5.1.3 Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 and VHA Directive

1100.20 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s physician(s) prior to obtaining approval by the corresponding VA facilities’ (Orlando, Tampa, Bay Pines) Professional Standards Board, Medical Executive Board and Medical Center Director.

5.1.3.1 If a contractor’s physician(s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

5.1.4 Technical Proficiency: The contractor is required to develop and maintain the following documents for each Contractor employee working on the contract:

credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for age specific patient populations, as appropriate.); proof of current licensure/certification, a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation;

and listing of relevant continuing education for the last two years. The Contractor will provide current copies of these records at the time of contract award and annually, should the contract be extended by the Option to Extend Services Clause, on the anniversary date of contract award to the VA Contracting Officers Representative (COR), or upon request, for each Contractor employee working on the contract.

5.1.5 Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contractor’s physician(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contractor’s physician(s).

5.1.6 Training:

5.1.6.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: The VA will provide all required IT security related training to the contractor employees.

5.1.6.2 Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

5.1.6.3 Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

5.1.6.4 Successfully complete the appropriate VA Privacy training and annually complete required privacy training; and

5.1.6.5 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800- 16, Information Technology Security Training Requirements.

5.1.6.6 The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

5.1.6.7 Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

5.1.6.8 TUBERCULOSIS TESTING: Contractor shall provide proof of current or previous PPD test from employees. Contractor personnel having exposure to biological or pathological specimens shall be immunized against, be granted an immunization waiver or have documented proof of immunity to rubella, mumps, polio and Hepatitis B. In addition, contract health providers shall be free of infectious disease (to include but not limited to active Tuberculosis and Viral Hepatitis) that might reasonably be expected to place other workers, patients or the public risk.

5.1.6.9 MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

5.1.6.10 VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

5.1.6.11 ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

5.1.6.12 INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

5.1.6.13 OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s personnel {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan;

maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

5.1.6.14 The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel ( as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

5.2 National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

5.3 Conflict of Interest: The Contractor and all contractor’s personnel are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D of the solicitation document.

5.4 Citizenship related Requirements:

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

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

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

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

5.4.5 The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

5.5 Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

5.5.1 Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s physicians (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

5.5.2 By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

5.6 Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19 and VHA Directive 2012-030. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

5.7 Non-Personal Healthcare Services: The parties agree that the Contractor and all contractor’s personnel shall not be considered VA employees for any purpose.

5.8 Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

5.9 Prohibition against Self-Referral: Contractor’s physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

5.10 Inherent Government Functions: Contractor and Contractor’s physician(s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

5.11 No Employee status: The Contractor shall be responsible for protecting Contractor’s personnel furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

5.11.1 Workers’ compensation

5.11.2 Professional liability insurance

5.11.3 Health examinations

5.11.4 Income tax withholding, and

5.11.5 Social security payments.

5.12 Tort Liability: The Federal Tort Claims Act does not cover Contractor or contractor’s personnel. When Contractor or contractor’s personnel has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contractor’s physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

5.13 Key Personnel:

5.13.1 The VA Full Time Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

5.13.2 A minimum of one Board Certified /Board Eligible medical director (Board certified in Clinical Pathology with subspeciality in Blood Bank Transfer Medicine) to provide coverage and consultation for Transfusion medicine needs when needed (24hrs/7 days).

5.13.3 The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled physician is unable to complete an assigned shift, the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) at the site impacted immediately of the schedule change.

5.13.4 Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within fifteen calendar day(s) after the occurrence of any of these events and provide the information required below.

After 90 days, the Contractor shall submit the information required below to the CO at least fifteen calendar days prior to making any permanent substitutions.

5.13.4.1 The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within fifteen calendar days after receipt of all required information of the decision on the proposed substitutes.

The contract will be modified to reflect any approved changes of key personnel.

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

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

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

Number of staff members determined by the contractor to endure fulfillment of services required in the PWS.

Key Personnel Title Name # of Staff Members Medical Director Oversite

Supervisory Medical Technologist

QM and/or Lead Medical Technologist

Medical Technologist

6. VA HOURS OF OPERATION/SCHEDULING:

6.1 VA Business Hours: Orlando, Tampa, and Bay Pines VAMC laboratory requires Blood Bank/Transfusion Services 24 hours/7 days per week.

6.1.1 Work Schedule: Applicable cost per test charges will be based on hours of coverage, staffing requirements, test volume and other supplies within the scope of the contract.

6.1.2 Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

New Year’s Day President’s Day Martin Luther King’s Birthday George Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Any day specifically declared to be a national holiday

6.2 Cancellations: The contractor must provide an equivalent substitute in a timely manner (within 2 hours prior to the start of the scheduled tour of duty) if the phlebotomist(s) scheduled cannot work.

6.3 Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

7. CONTRACTOR RESPONSIBILITIES

7.1 SERVICES REQUIRED: Contractor shall provide all blood transfusion and transfusion-related services, including without limitation, compatibility testing, and all personnel, supplies and equipment. Compatibility testing shall be defined to include all crossmatching, all type and screen, all antibody identifications, set up of all antibody elutions, and all reference laboratory workups. Such services shall be provided to the BPVAHCS, OVAMC, JAHVH, as needed according to acceptable AABB Accreditation Standards, including emergency situations.

Services shall include all Qualified Technical staff (including a medical director). A minimum of one (1) Board Certified/ Board Eligible medical director to provide coverage and consultation for transfusion medicine needs when needed (24/7).

All services provided by the contractor shall be provided in a proper manner consistent with all laws, rules, regulations and community standards, and on a timely basis, routine requests not to exceed 8 hours and emergency (stat) requests shall be not to exceed 1 hour after receiving a valid specimen and request unless an atypical antibody workup prevents meeting these expected times.

The contractor will perform compatibility testing services on-site in laboratory space provided by Pathology & Laboratory Medicine Service. The Contractor shall input data in real-time into the VA VISTA Blood Bank Establishment Computer Software (VBECS) mutually agreed to by the VA Medical Center and the Contractor. This requirement shall be performed by qualified Medical Technologists. The VA will provide the equipment and training necessary for the Contractor employees to input data into

VBECS.

The contractor shall provide and supply all other appropriate blood bank equipment (not provided by the VA) for transfusion services; storage and dispensing of product at the VA’s location; all necessary supplies; computer and office equipment, appropriate office furniture, and computer/electronic accesses to accomplish the work at the VA’s location. Such equipment shall be installed by the contractor at each VA Medical Center identified in this PWS, in a location mutually agreed upon and coordinated with impacted VA Medical Center Information Technology Department.

7.1.1 STANDARDS OF PRACTICE: Contractor shall be responsible for meeting or exceeding VA and Joint Commission (or equivalent) standards. The contractor shall provide its services as specified in the current Accreditation Manual of the Joint Commission, AABB and FDA Standards. The following items are expected of the Hospital or Provider Health Agency in order to meet the Joint Commission accreditation:

7.1.1.1 Patient Samples: The VA is responsible for the collection, verification, patient identification, requisition and all associated Joint Commission standards for blood samples for compatibility testing. There must be proper identification of the patient.

The identifying information on the patient armband, the blood specimen label, and the requisition must agree. The VA phlebotomist must verify, agree with, and sign the requisition. In cases of discrepancy or doubt as to the positive identification of the recipient, they will be fully resolved prior to collecting the sample. If there any discrepancies between the patient ID, the sample labels and the requisition, samples will NOT be accepted by the contactor for transfusion testing. The blood samples taken from the recipient for compatibility testing must be labeled immediately and adequately at the time it is collected by the VA phlebotomist. There must be positive identification of the sample. Blood samples shall be obtained in stoppered tubes, identified with a firmly attached label bearing at least the recipient's first and last names, patient identification number and date. The completed label shall be attached to the tube before leaving the side of the recipient and the requisition signed by the person who collected the blood. Requisition of blood components and accompanying blood samples from the recipient must contain sufficient information for positive identification of the recipient. The tube and the requisition shall be sent to the contractor. Incomplete or illegible requisitions will not be accepted.

7.1.1.2 Blood Storage: Blood and blood components must be stored and handled in such a manner that they retain their maximum potency and safety. The refrigerators used for the routine storage of blood components containing red blood cells shall maintain a temperature uniformly between 1° and 6° C. The freezers used for routine storage of frozen components shall maintain a temperature of -18° C or colder. Platelets shall be maintained at the temperature between 20° and 24° C. All regulated temperatures will be monitored 24 hours a day by both internal and external temperature monitoring devices. The monitoring of temperatures is the responsibility of the contractor.

7.1.1.3 Identification of Recipient and Blood: Positive identification of the recipient and the blood unit is essential. Immediately before transfusion, the transfusionist, in the presence of the recipient, shall verify in writing that all information on the unit and Transfusion Record have been matched with the intended recipient item by item. The transfusion record with the recipient's first and last names, identification number and unit number shall remain attached to the container at least until the transfusion has been complete. There shall be no tampering or alteration of unit labels.

7.1.1.4 Administration of Blood: Blood and components shall be maintained in a controlled environment at optimal temperature until released for transfusion. They must be transfused through a sterile, pyrogen-free transfusion set which has a filter capable of retaining particles potentially harmful to the recipient.

7.1.1.5 Warming of Blood: Warming of blood toward body temperature may be appropriate in situations such as rapid or massive transfusion, exchange transfusion or in patients with potent cold agglutinins. At such times, warming of blood should be accomplished during its passage through the transfusion set. The warming system must be equipped with an audible warning system and quality controlled on a quarterly basis or as recommended by the manufacturer. Blood must not be warmed above 40°C. Once blood is warmed, it must not be returned to the refrigerator for future transfusion.

7.1.1.6 Addition of Drugs or Solutions: Drugs or medications1 including those intended for intravenous use, must not be added to blood or components. Only 0.9% sodium chloride injection, USP may be added to blood or cellular blood components to increase the volume and to facilitate administration. Other solutions intended for intravenous use may be in contact with blood or blood components in the infusion set, provided adequate evidence of safety is available.

7.1.1.7 Irradiation: It may be appropriate to irradiate blood or components in order to reduce the risk of graft-versus-host disease in selected immunosuppressed recipients. The Blood Bank will perform this procedure upon request.

7.1.1.8 Transfusion Reactions: The administration of blood must be monitored to detect an adverse reaction as soon as it occurs. Personnel who monitor blood transfusions must be trained to recognize or suspect adverse reactions. Personnel must have a written plan of action to follow in the event of such a reaction and must report any such reaction as soon as possible to the blood transfusion service and to the physician responsible for the patient. The interpretations of all tests performed by the Blood Bank, in the evaluation of an actual or suspected blood transfusion reaction, shall be made a permanent part of the patient’s medical record. The contractor shall provide a Pathologist with a specialty in Blood Banking for consultation of transfusion reactions or other blood related problems at their own facility.

7.1.1.9 Transfusion Associated Disease: Reported cases of suspected transfusion transmitted diseases must be evaluated. If confirmed, the Blood Bank must be notified.

7.1.1.10 Documentation of Policies and Procedures: Current written policies and procedures for blood transfusion should conform to the current AABB Standards for Blood Banks and Transfusion Services and be…