S02 - Solicitation_36C24824Q0256.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

36C248-23-AP-6516

36C24824Q0256 12-29-2023

Peter Bedard 860-351-3008 01-12-2024

16:00 EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Peter.bedard@va.gov 860-351-3008

X 100

X

622110

$47 Million

N/A

X

Department of Veterans Affairs Orlando VA Medical Center (OVAMC) 13800 Veterans Way

Orlando FL 32827

36C248

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

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 on-site Autotransfusionist services in support of the Orlando VA Medical Center (OVAMC).

Fixed price contract is for one (1) base year, with four (4)-one (1) year options.

Period of Performance will be 03/07/2024 - 03/06/2029.

Reference pages 6 to 8 for Price Schedule.

Reference pages 9 to 39 for the Performance Work Statement.

The current wage determination, 2015-4553, will be the applicable wage determination in the awarded contract and updated if the option years are exercised.

See CONTINUATION Page

TBD

X X

X 1

Peter Bedard

36C24824Q0256

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 (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)48

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.8 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.9 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C10. 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors

C.11 852.215-71 Evaluation Factor Commitments

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.13 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.14 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.15 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.16 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.17 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

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 Questionaire Attachment 6 - QASP

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

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

SERVICES (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020) .. 73

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

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 (NOV 2023)

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: ___________________________________________

Title: ___________________________________________

Address: ________________________________________

Phone: _________________________________________

Email: __________________________________________

SAM ID: ________________________________________

b. GOVERNMENT: Contracting Officer 36C248 Peter Bedard

Department of Veterans 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. REQUEST FOR QUOTES: Quotes for furnishing services identified within the schedule should be submitted electronically to the Contracting Officer at peter.bedard@va.gov until the date and time specified in block eight (8) of this RFQ.

7. CAUTION: Quoters shall complete and return all information designated in FAR 52.212-1, Instructions to Quoters – Commercial Items, Paragraph (b) prior to the time specified in block 8 of SF1449 in order to be considered for award. Late submissions, Modification, and Withdrawals: See Provision 52.212-1. All quotes are subject to all terms and conditions of this

RFQ.

8. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation conference for contract orientation purposes as required by IL 003A3-12-04.

http://www.va.gov/oal/docs/library/ils/il12-04.pdf

B.2 PRICE SCHEDULE

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Autotransfusionist Services to eligible beneficiaries of the Department of Veterans Affairs, 675, Orlando VA Medical Center. The Contractor’s care shall cover the range of Autotransfusionist Services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceed currently recognized national standards as established by the American Board of Cardiovascular Perfusion http://www.abcp.org.

Place of Performance: Orlando VA Medical Center (OVAMC) at 13800 Veterans Way, Orlando, FL 32827.

Contract Type: The Government intent is to award one (1) Firm Fixed Price (FFP) contract.

Evaluation of Options: Except when it is determined in accordance with FAR 17.206(b) not to be in the government’s best interest, the government will evaluate offers for award purposes by adding the total price for each option period to the total price for the basic requirement.

Evaluation of options will not obligate the government to exercise the option(s).

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

Case Load: Contractor shall cover a case load of up to 120 cases per base period and per any option period exercised thereafter.

Period of Performance

Base Year: 03/07/2024 to 03/06/2025

OPTION YEAR 1: 03/07/2025 to 03/06/2026

OPTION YEAR 2: 03/07/2026 to 03/06/2027

OPTION YEAR 3: 03/07/2027 to 03/06/2028

LIN

No.

SUB-

LIN

Description Qty. Unit Unit Cost Total

Annual Cost

0001 None Provide Autotransfusionist Technician Services

12 MO $ $

TOTAL FOR Base Year $

LIN

No.

SUB-

LIN

Description Qty. Unit Unit Cost Total

Annual Cost

1001 None Provide Autotransfusionist Technician Services

12 MO $ $

TOTAL FOR Option Year 1 $

LIN

No.

SUB-

LIN

Description Qty. Unit Unit Cost Total

Annual Cost

2001 None Provide Autotransfusionist Technician Services.

12 MO $ $

TOTAL FOR Option Year 2 $

LIN

No.

SUB-

LIN

Description Qty. Unit Unit Cost Total

Annual Cost

3001 None Provide Autotransfusionist Technician Services

12 MO $ $

TOTAL FOR Option Year 3 $

OPTION YEAR 4: 03/07/2028 to 03/06/2029

LIN

No.

SUB-

LIN

Description Qty. Unit Unit Cost Total

Annual Cost

4001 None Provide Autotransfusionist Technician Services

12 MO $ $

TOTAL FOR Option Year 4 $

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Background: The Orlando VA Medical Center requires Autotransfusionist services for Operating Room cases. These cases are ones where significant blood loss would otherwise require high volumes of blood from the blood bank. This service allows patient own blood to be purified and reintroduced into the patient.

1.2. Objectives: The Qualified contractor shall provide a certified Autotransfusion Technician to operate VA owned Haemonetic Cell Saver equipment to be used to clean and filter blood from patients, so that it can be given back to them if they need transfusion. All trained staff that will operate any equipment onsite at Corporate Orlando VA Medical Center (VAMC) are required to provide certificates of completed training.

1.3. Type Of Contract: Firm Fixed Price

1.4. Services Provided: The contractor shall provide Autotransfusionist Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), Orlando VA Medical Center.

1.5. Place of Performance: Contractor shall furnish services at the Orlando VA Medical Center 13800 Veterans Way Orlando, FL 32827.

1.6. Authority: Title 38 USC 8153, Healthcare Resources, Federal Acquisition Regulation (FAR) Parts 12 Acquisition of Commercial Items and 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services.

1.7. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.7.1 VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.7.2. VHA Directive 1003.04: VHA Patient Advocacy

1.7.3 VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.7.4 VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.7.5 VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.7.6 VHA Directive 1100.20: Credentialing of Health Care Providers

1.7.7 VHA Directive 1100.21: Privileging

1.7.8 VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.7.9 VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.7.10 VHA Directive 1605.01: Privacy and Release of Information

1.7.11 VHA Directive 1907.01: VHA Health Information Management and Health Records

1.7.12 VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

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

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

1.7.14 Joint Commission:

http://www.jointcommission.org/standards/

1.7.15 HHS OIG Website:

http://oig.hhs.gov/exclusions/index.asp

1.7.16 American Journal for Infection Control - AJIC 1998; 26:289-354:

http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.8. Acronyms/Definitions: 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.

1.8.1. ACLS: Advanced Cardiac Life Support

1.8.2. BAA: Business Associate Agreement

1.8.3. BLS: Basic Life Support

1.8.4. CDC: Centers for Disease Control and Prevention

1.8.5. CEU: Certified Education Unit

1.8.6. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.8.7. CME: Continuing Medical Education

1.8.8. CMP: Civil Monetary Penalty

1.8.9. CMS: Centers for Medicare and Medicaid Services

1.8.10. CO: 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.

1.8.11. 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.

1.8.12. COS: Chief of Staff

1.8.13. CPARS: Contractor Performance Assessment Reporting System

1.8.14. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.8.15. DEA: Drug Enforcement Agency

1.8.16. ED: Emergency Department

1.8.17. EHR: Electronic Health Record - electronic health record system used by the

VA

1.8.18. EMR: Electronic Medical Record

1.8.19. FPPE: Focused Provider Practice Evaluation

1.8.20. FTE: Full Time Employee VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.8.21. HHS: Department of Health and Human Services

1.8.22. HIPAA: Health Insurance Portability and Accountability Act

1.8.23. ISO: Information Security Officer

1.8.24. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.8.25. 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).

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

1.8.27. NP: Nurse Practitioner

1.8.28. NPPES: National Plan and Provider Enumeration System

1.8.29. OIG: Office of Inspector General

1.8.30. OSHA: Occupational Safety and Health Administration

1.8.31. OPPE: Ongoing Provider Practice Evaluation

1.8.32. OR: Operating Room

1.8.33. PA: Physician Assistant

1.8.34. PIV: Personal Identity Verification

1.8.35. POP: Period of Performance

1.8.36. PPD: Purified Protein Derivative

1.8.37. PWS: Performance Work Statement

1.8.38. QASP: Quality Assurance Surveillance Plan

1.8.39. VA: Veterans Affairs

1.8.40. VAAR: Veterans Affairs Acquisition Regulations

1.8.41. VHA: Veterans Health Administration

1.8.42. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.8.43. VISN: Veterans Integrated Services Network

1.8.44. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide three employees Certified Autotransfusionists for scheduled cases and on call for emergent cases.

2.1.1. License: All licenses held by the key personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia.

Contract personnel shall submit evidence of current, full, and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR.

Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.1.1.1. The Autotransfusionist shall have a certification as an Autotransfusionist. All continuing education courses required for maintaining certification must always be kept up to date. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance. A folder with the stated qualifications will be maintained by the COR.

2.1.2. Credentialing and Privileging: Contract Autotransfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each Autotransfusionist shall be credentialed and privileged (if required) prior to providing services and must be found acceptable by the Facility Medical Executive Board and Medical Center Director (or designee). Credentialing and privileging are to be completed in accordance with VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The ability for an individual Autotransfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis for all Autotransfusionists and shall be reported as practitioner specific practice information, in compliance with an accreditation body with equal or better standards to The Joint Commission.

2.1.2.1. If a contract personnel(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.

2.1.3. Technical Proficiency: Contract personnel(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.4. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the facility. Contract personnel(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 contract personnel(s).

2.1.5. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s Autotransfusionists as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training (The following training is mandatory per VHACO for Contracted Technicians)

Frequency (once a year, etc.)

Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior yearly 1

VHA Privacy and HIPAA Focused Training or Mandatory Training for Transitory Parttime and Intermittent Clinical Staff yearly 1

2.1.6. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.):

Contractor shall provide proof of the following for Autotransfusionists 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.

2.1.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s Autotransfusionists upon hire in accordance with CDC guidance.

(This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

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

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

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

2.1.6.5. INFLUENZA: Contractors shall provide proof that all Contractor Autotransfusionists 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}.

2.1.6.6. 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 Autotransfusionists {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.

2.1.6.7. The facility 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.

2.1.7. National Provider Identification (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 quotation.

2.1.8. Conflict of Interest: The Contractor and all contract personnel(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of quotation and during the entirety of contract performance. At the time of quotation, 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.

2.1.9. Citizenship related Requirements:

2.1.9.1. 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.

2.1.9.2. 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.

2.1.9.3. 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.

2.1.9.4. 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.

2.1.9.5. The Contractor agrees to obtain a similar certification from its subcontractors.

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

2.1.10. 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.

2.1.10.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract physician (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.

2.1.10.2. 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.

2.2. 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 Directive 1100.20 and VHA Directive

1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility 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.

2.3. Non- Personal Healthcare Services: The parties agree that the Contractor and all contract personnel(s) shall not be considered VA employees for any purpose.

2.4. 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.

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

2.6. No Employee status: The Contractor shall be responsible for protecting Contract personnel(s) 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:

2.6.1. Workers’ compensation

2.6.2. Professional liability insurance

2.6.3. Health examinations to include:

2.6.4. Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test

2.6.5. Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

2.6.6. Evidence of a Hepatitis C titer

2.6.7. Varicella titer if contracted employee has not had chicken pox

2.6.8. Income tax withholding, and

2.6.9. Social security payments

2.7. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel(s). When Contractor or contract personnel(s) 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 contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.8. Key Personnel:

2.8.1. The number of Certified Autotransfusionists required to be on a scheduled/ as needed basis is three (3) as defined in paragraph Hours of Operation of this section.

2.8.2. 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 provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within two (2) hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.8.3. The Contractor shall provide the names of the contracted employees assigned to the performance:

Key Personnel Title

1. Autotransfusionist

2. Autotransfusionist

3. Autotransfusionist

Substitutes

Autotransfusionist

Autotransfusionist

Autotransfusionist

2.9. 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 15 calendar days 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 15 calendar days prior to making any permanent substitutions.

2.9.1. 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 15 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.

2.9.2. For temporary substitutions where the key person shall not be reporting to work for three (3) 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.

2.9.3. 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 contract personnel(s), s/he may request, without cause, immediate replacement of said contract personnel(s).

2.9.4. The CO and COR shall deal with issues raised concerning Contract personnel(s) conduct. The final arbiter on questions of acceptability is the CO.

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

2.9.6. Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: VA OR business hours/hours of operation are 7:00am to 5:00pm.

3.1.1. Work Schedule: Regular work hours are Monday through Friday for eight (8) hours a day from 7:00 a.m. to 3:30 p.m.

3.1.2. Off-hours Coverage: It is required by the contractor that one (1) of the Autotransfusionist be in an on-call status for 24 hours a day and seven (7) days a week including all Federal Holidays and be within 30 minutes of the facility to support these emergent cases. On-call service is considered part of the Autotransfusionist services and will not be paid separately. Any hours worked during an on-call status for an emergency procedure shall be paid the same rate as regular tour hours.

3.2. Federal Holidays:

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

4. CONTRACTOR RESPONSIBILITIES:

4.1. Clinical Personnel Required: The Contractor shall provide contract personnel(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contract personnel(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

4.2. Standards of Care: The contract personnel(s)’ care shall cover the range of Autotransfusionist services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceed currently recognized national standards as established by:

4.2.1. The professional standards of The Joint Commission (TJC):

http://www.jointcommission.org/standards_information/standards.aspx

4.2.2. The standards of the American Hospital Association (AHA):

http://www.hpoe.org/resources?show=100&type=8

4.2.3. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract personnel(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R.

Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

4.3.3. Disclosure: Contract personnel(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the Facility.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.3.7. Confidentiality: VA will provide the contract personnel(s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel(s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

4.3.8. Personal Identity Verification (PIV): Contract personnel(s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel(s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in the computer security and documentation training.

4.3.9. Contract personnel(s) shall provide medical record documentation in accordance with rules and regulations of the medical staff and medical staff by laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records.

4.3.10. Records created by contract personnel(s) in the course of treating VA patients under this contract are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel(s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the current electronic health record system for review.

4.3.11. Contract personnel(s) shall participate in quality improvement projects, initiatives, and reporting as requested.

4.3.11.1. VA utilizes a fully automated electronic medical record. The EMR consists of two primary components. The first is the Veterans Health Information System and Technology Architecture (VISTA), which consists of commercial hardware and software developed by the VA. VISTA is a collection of over 100 applications that make up a comprehensive hospital information system.

It includes both medical records and clinical applications or packages such as order entry, progress note, laboratory, radiology, and scheduling/admission-discharge-transfer and discharge summary. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EMR. Contract personnel(s) shall be responsible for viewing the patient record within the EHR and will not be utilizing the VISTA system.

4.3.11.2. The second component uses optical disk imaging technology to meet the remaining 20 percent of the EMR information needs such as advance directive/guardianship papers, medical record documentation from non-VA facilities and informed consents.

4.3.11.3. VA will provide the necessary training to contract personnel(s) on the proper use and operation of the current computerized medical records system (Electronic Health Record - EHR). Contractor agrees and shall instruct their employees in signing computer security access agreements and is bound by confidentiality and release of information restrictions. For purposes of clarity, where the VA Forms reference “Contracted Employee Name” it shall mean “Contractor’s Employee Name.”

4.4. Direct Patient Care: 95 % of the time involved in direct patient care. The Autotransfusionists role will be 95% to patient care related.

4.4.1. Scope of Care: Contract personnel(s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Autotransfusionist services, including, but not limited to:

4.4.1.1. The Autotransfusionist is responsible to check the OR schedule daily for surgical procedures requiring Autotransfusionist services; coordinate scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain a record of such; assure a minimum of four complete sets of supplies for open heart and Autotransfusion cases are available at any given time; sets up and operates Autotransfusion pump for surgical procedures other than open heart. Also, generates a record during each surgical case to include the surgical time of the procedure and the amount of autotransfused blood given to Anesthesiology for delivery to the patient and handle breakdown of disposable within autotransfusion pump after completion of each procedure.

4.4.1.2. Reporting Information for Treatment: Access to the VA EHR shall be provided to the Autotransfusionist, including the ability to printout a report of those services provided by the Autotransfusionist. A detailed treatment plan which includes an initial assessment, recommended plan of treatment and expected outcomes will be entered in the patient's clinical record within twenty-four hours of initiating treatment and at a minimum contain the following information:

Patient’s name and identification number

Treating Physician's name and telephone number for follow-up questions

Pertinent History

Physical Findings

Summary of the Recommended Treatment Plan

Date treatment was initiated or is planned

Anticipated or actual date that treatment was completed

Follow-up Recommendations/Results of the Treatment

Instructions given to the patient

4.4.1.3. It is the Autotransfusionists responsibility to view the patient record within the current electronic health record prior to the surgery to review the surgeon’s plan of care.

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

4.5.1. QA/QI documentation: The Contractor’s Technicians shall complete the appropriate QA documentation pertaining to industry standards of blood products and their use in operating room settings. Said documentation will be reported in writing to the Orlando VA Chief of Laboratory services and the COR of this contract.

4.6. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE PLAN

AND QUALITY IMPROVEMENT(QI)

4.6.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance:

Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP).

The QASP shall be attached to…