36C25021Q0582.pdf

PAGE 1 OF 100 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25021Q0582

Brandi Holland 614-257-5537 06-08-2021

11:59p.m. EDT

36C250

Department of Veterans Affairs

Network Contracting Office (NCO) 10

2780 Airport Dr.

Suite 340

Columbus OH 43219-1834

X 100

X

621999

$16.5 Million

N/A

Department of Veterans Affairs

Aleda E. Lutz VA Medical Center

1500 Weiss St.

Saginaw, MI

48602

36C250

Department of Veterans Affairs

Network Contracting Office (NCO) 10

2780 Airport Dr.

Suite 340

Columbus OH 43219-1834

36C250

Financial Services Center

Invoices to be Submitted Electronically www.ob10.com/us/en/veterans-affairs// e-Invoice Setup Info Phone 877-489-6135

877-353-9791 512-460-5429

Contractor to provide 2.0 FTE Medical Technologists to provided Medical Technologist services on-site at the

Aleda E. Lutz VA Medical Center located at 1500 Weiss

Street Saginaw, Michigan 48602

Reference Schedule of Services on page 6 and Performance

Work Statement on page 7.

This acquisition will adhere to the format as defined in

VAAR 873, Part 12 and will be completed using the

Simplified Acquisition Procedures in FAR 13.

Addendum to 52.212-1 is listed in this RFQ and provides instructions to contractor on page 79 through 81.

Brandi Holland

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES AND PRICES……………………………………………...6

B.3 PERFORMANCE WORK STATEMENT………………………………………………….9

B.3 PERFORMANCE WORK STATEMENT

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (JAN 2011)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021)

C.14 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)77

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

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 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021)

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’S NAME/ADDRESS/CITY/STATE-ZIP (Please print or type):

Point of Contact/Title: ____________________________ ____________

Telephone: _______________________________

Facsimile #: _______________________________

E-mail: __________________________________

DUNS NO: ________________________________

b. GOVERNMENT: Contracting Officer 36C250 Brandi Holland; Brandi.Holland2@va.gov

Network Contracting Office (NCO) 10

2780 Airport Dr.

Suite 340

Columbus OH 43219-1834

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.

Department of Veterans Affairs

Financial Services Center

Invoices to be Submitted Electronically www.ob10.com/us/en/veterans-affairs// e-Invoice Setup Info Phone 877-489-6135

5. CHANGES/MODIFICATIONS TO THE CONTRACT: The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this resultant contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, delivery or quality of performance of this resultant contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized by the local VAMC and no adjustment will be made to the contract price to cover any increase in cost incurred as a result thereof.

The Contracting Officer’s Representative (COR) will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

6. SUBMISSION OF QUOTATION: Documents that are to be provided to the Contracting

Officer shall be submitted to the Network Contracting Office, using the appropriate address identif ied in 52.212-1, Instructions to Quoters. Submit all quotation to both addresses referenced in 1b.

7. POST AWARD CONFERENCES: The Contracting Officer will schedule a post award orientation conference for contract orientation purposes as required by PPM 2019-01, post award orientations dated 1/9/2019 that provides documentation requirements for orientation conducted for post award conferences.

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

AMENDMENT NO DATE

9. The Contracting Officer’s Representative (COR) will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

B.2 SCHEDULE OF SERVICES AND PRICES

The Contractor shall furnish all personnel to provide services necessary to perform onsite Medical Technologist Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Saginaw (hereinafter referred to as VAMC). The Contractor’s employee’s duties shall cover the range of Medical Technologist services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by The College of American Pathologists (CAP): http://www.cap.org. Contractor’s employee’s shall not be considered Government employees for any purpose under this solicitation or resultant contract. This Indefinite Delivery, Indefinite Quantity (IDIQ) contract shall be for five (5), one-year ordering periods.

Place of Performance: Services shall be provided on site, VAMC Saginaw, 1500 Weiss Street Saginaw, Michigan 48602.

Pricing Instructions: The quoter is instructed to fill in column Unit Price and Estimated Total columns for the base year including all option years and estimated grand total.

The period of performance for the base ordering period and subsequent years is based on a twelve (12) month period, effective date and end date may change depending on when award will be made but will be based on a twelve (12) month period.

The contractor shall propose a minimum of four (4) key personnel to be credentialed and be available for scheduling to meet the requirements of 2 FTE for 4,160 hours annually. The contractor shall only present pricing for providers being presented for evaluation.

One FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

Quoter shall not exceed 4,160 hours. All unit costs are firm-fixed price.

ORDERING PERIOD 1 - June 2, 2021 (or date of award) – June 1, 2022 (or 364 days)

ORDERING PERIOD 2 - June 2, 2022 (or date of award) – June 1, 2023 (or 364 days)

CLIN

No.

SUB-

Description Est.

Qty.

Unit Unit Cost

Est. Total

Annual Cost

KEY PERSONNEL

0001a

None

Medical Technologist

4,160

Hours

$__________/hr.

ESTIMATED TOTAL FOR BASE

No.

Qty.

Unit Unit Cost

1001a

ORDERING PERIOD 3 - June 2, 2023 (or date of award) – June 1, 2024 (or 364 days)

ORDERING PERIOD 4 - June 2, 2024 (or date of award) – June 1, 2025 (or 364 days)

No.

Qty.

Unit Unit Cost

2001a

No.

Qty.

Unit Unit Cost

3001a

ORDERING PERIOD 5 - June 2, 2025 (or date of award) – June 1, 2026 (or 364 days)

Aggregate Total to include Ordering Periods 1 through 5: $_____________________

The Government’s guaranteed minimum during the life of the contract is One (1) hour. The

Government’s contract ceiling (contract maximum) amount during the life of the contract is

24,960 hours.

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The contractor shall provide up to 2.0 FTE Medical Technologists on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Aleda E. Lutz VA Medical Center Saginaw, Michigan.

1.2. Place of Performance: Contractor shall furnish services at the Aleda E. Lutz VAMC located at 1500 Weiss Street Saginaw, Michigan 48602

1.3. Authority Title 38 U.S.C. 8153, Health Care Resources (HCR) sharing Authority.

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. VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.2. VHA Handbook 1100.17: National Practitioner Data Bank Reports – https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.3. VHA Handbook 1100.19 Credentialing and Privileging -

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

CLIN

No.

Qty.

Unit Unit Cost

4001a https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.4. VHA Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

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

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

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

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

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

1.4.9. VHA Handbook 1106.01: Pathology and Laboratory Medicine Service (P&LMS) Procedures:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8092

1.5. VHA Directive 1899(2, H EALTH CARE PROFESSIONAL PRACTICE IN VA, Amended June 2, 2020 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8794

1.6. VHA 1064 - P&LMS Productivity and Staffing PDF (674.0 KB) http://vaww.lab.med.va.gov/docs/1064_D_2018_09_17.pdf

1.7. VHA 1106 - P&LMS Services PDF (80.0 KB)

http://vaww.lab.med.va.gov/docs/1106_D_2018_07_27.pdf

1.8. VHA Directive 1186 TRANSFUSION VERIFICATION AND IDENTIFICATION

REQUIREMENTS PDF (57.5 KB)

http://vaww.lab.med.va.gov/docs/VHA_Directive_1186_TRANSFUSION_VERIFICATIO N_AND_IDENTIFICATION_REQUIREMENTS.pdf

1.9. 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 th is contract, the language in this section shall govern.

1.9.1. CDC: Centers for Disease Control and Prevention

1.9.2. CDR: Contract Discrepancy Report

1.9.3. CEU: Certif ied Education Unit

1.9.4. CLS: Clinical Laboratory Scientist

1.9.5. CME: Continuing Medical Education

1.9.6. CMP: Civil Monetary Penalty

1.9.7. CMS: Centers for Medicare and Medicaid Services

1.9.8. 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.

1.9.9. 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.

1.9.10. COS: Chief of Staff

1.9.11. CPARS: Contractor Performance Assessment Reporting System https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.jointcommission.org/standards/ http://oig.hhs.gov/exclusions/index.asp http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8092 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8794 http://vaww.lab.med.va.gov/lab/docs/1064_D_2018_09_17.pdf http://vaww.lab.med.va.gov/docs/1064_D_2018_09_17.pdf http://vaww.lab.med.va.gov/lab/docs/1106_D_2018_07_27.pdf http://vaww.lab.med.va.gov/docs/1106_D_2018_07_27.pdf http://vaww.lab.med.va.gov/lab/docs/VHA_Directive_1186_TRANSFUSION_VERIFICATION_AND_IDENTIFICATION_REQUIREMENTS.pdf http://vaww.lab.med.va.gov/docs/VHA_Directive_1186_TRANSFUSION_VERIFICATION_AND_IDENTIFICATION_REQUIREMENTS.pdf http://vaww.lab.med.va.gov/docs/VHA_Directive_1186_TRANSFUSION_VERIFICATION_AND_IDENTIFICATION_REQUIREMENTS.pdf

1.9.12. ED: Emergency Department

1.9.13. EHR: Electronic Health Record – electronic health record system used by the VA

1.9.14. FTEE: Full Time Equivalency Employee is defined by VA as a minimum of 80 hours every two weeks and does not include holidays

1.9.15. HHS: Department of Health and Human Services

1.9.16. HIPAA: Health Insurance Portability and Accountability Act

1.9.17. HR: Human Resources

1.9.18. ISO: Information Security Officer

1.9.19. MLS: Medical Laboratory Scientist

1.9.20. MT: Medical Technologist

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

1.9.22. NPPES: National Plan and Provider Enumeration System

1.9.23. OSHA: Occupational Safety and Health Administration

1.9.24. OIT: Office of Information and Technology

1.9.25. OPM: Office of Personnel Management

1.9.26. OR: Operating Room

1.9.27. PIV: Personal Identity Verification

1.9.28. POP: Period of Performance

1.9.29. PPD: Purified Protein Derivative

1.9.30. PWS: Performance Work Statement

1.9.31. QASP: Quality Assurance Surveillance Plan

1.9.32. RFQ: Request for Quote

1.9.33. VAMC: Veterans Affairs Medical Center

1.9.34. 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.

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

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

1.9.37. VetPro: a federal web-based credentialing program for healthcare providers.

1.9.38. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA Medical Center, for the purpose of this contract, this term shall mean the Cincinnati VA Medical Center.

2. QUALIFICATIONS:

2.1 Staff/Facility – The contractor shall provide 2.0 Full Time Equivalency Medical Technologists (FTEEs) –

The Medical Technologists will be certified by the American Society of Clinical Pathologists (ASCP) or American Medical Technologists (AMT) or an equivalent MT, MLS, or CLS certification with appropriate training and a minimum of one year of experience.

2.1.1. Board Certification: MT’s are not required to be board certified, only certified as a MT, MLS or CLS by the ASCP or AMT. The contractor’s employees and any subcontractors are not required to be Board Certified. They are required to have a Bachelor’s Degree from an accredited college or university in medical laboratory science, medical technology, clinical laboratory or related science. They must also have a completion of medical technology clinical practice program and have all licenses, permits, and certifications as required by law and this contract. All Medical Technologists must have a minimum of one year of experience as a Generalist. A generalist is defined as a Medical Technologist that can perform testing in all areas of the Clinical Laboratory, to include Chemistry, Blood Bank, Hematology, Immunology, and Urinalysis. Additionally, experience in Microbiology is preferred.

2.1.2. Credentialing: Contract Medical Technologist(s) fulfilling the conditions of the contract shall be subject to all bylaws, rules and regulations of the VAMC. Each Medical Technologist(s) shall be credentialed prior to providing services and must be found acceptable by the Medical Staff Office at the Saginaw, Michigan VAMC.

Credentialing is to be completed in accordance with VHA Handbook 1100.19 referenced above. The ability for an individual Medical Technologist to continue to render services under the contract shall be dependent upon demonstration of clinical competence.

2.1.3. If a contract personnel (s) is not credentialed or has credentials suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.4. 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, certif ication 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.

2.1.5. 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. 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 Medical Staff 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).

2.1.6. Training: Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the Contractor’s Medical Technologist(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training Frequency (once a year, etc.)

Annual Hours

Privacy and HIPAA Training Annually 1 Infection Control Annually 1

Compliance and Business Integrity

Annually 1

Ethics Annually 1 VA Privacy and Information Security and Rules of Behavior

Annually 1

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel 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.

2.1.8. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative

Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician (s) (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. The TST or IGRA testing shall be repeated annually.

2.1.9. MEASLES, MUMPS, & RUBELLA TESTING: Contractor shall provide proof of immunity Contractor physicians (this is applicable to all health care workers).

2.1.10. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians (this is applicable to all health care workers).

2.1.11. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor Physicians (this is applicable to all health care workers.

2.1.12. 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).

2.1.13. 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 physician (s) (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.

2.1.14. 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.

2.1.15. 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 (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.16. Citizenship related Requirements:

2.1.17. 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;

2.1.18. 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.

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

2.1.20. This certif ication 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.

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

2.1.22. 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.

2.1.23. 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.

2.1.24. By submitting their quotation, 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.

2.1.25. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by Saginaw VAMC Laboratory Chief or his/her clinical designee and approval by the Laboratory Chief as provided in VHA Handbook 1106.

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

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

2.1.27. 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.

2.1.28. 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.

2.1.29. 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:

Workers’ compensation;

Professional liability insurance;

Health examinations to include:

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

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;

Evidence of a Hepatitis C tier;

Varicella titer if contracted employees has not had chicken pox;

Income tax withholding, and Social security payments

2.131. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel (s). When a 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.

2.2. Key Personnel:

2.2.1. The VA Full Time Equivalency (FTE) for the Medical Technologist services required is for (2) FTEE 408 hours each/year.

2.2.2. Contractor shall provide the names of the contracted employee(s) assigned to the performance. Additional lines are added to the key personnel table below to allow the contractor to submit multiple MTs or HTs, if needed to meet the CLIN requirements; however, it is not a requirement to fill every line. Attach a separate page if additional lines are needed:

Key Personnel/Substitute Name (s)

Official Title Certification Number

1. Medical Technologist

2. Medical Technologist

Substitutes

2.2.3. 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 qualif ications 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.

2.2.4. 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 qualif ied replacement for the key person. The substitute shall have comparable qualif ications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.2.5. 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).

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

2.2.7. 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 contract personnel (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

Note: Evidence of completion of required certification, 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. HOURS OF OPERATION:

3.1 VA Business Hours: VA business hours/hours of operation are Monday – Friday 8:00a –

4:30p.

3.1.1. Work Schedule:

• Regular work hours are 08:00am – 4:30pm: Monday, Tuesday, Wednesday, Thursday and Friday.

• Regular work hours are 7:00am – 3:00pm on weekends.

• Second Shift, work hours are 03:30pm – 11:30pm Monday, Tuesday, Wednesday, Thursday and Friday.

• Second shift 3:00pm – 11:00pm weekends.

• Third Shift, work hours are 9:00pm – 7:00am, Monday, Tuesday, Wednesday, Thursday and Friday, including weekends.

3.1.2. The Medical Technologist service is required for 4160 hours per year on a Monday, Tuesday, Wednesday, Thursday and Friday, including weekends as required, eight to ten hours shift basis to support testing in the Laboratory

The requirement is for the contractor to provide a minimum of two (2) Medical Technologists, each one FTE.

3.2 Federal Holidays

• New Year’s Day

• Martin Luther King’s Birthday

• President’s Day

• Memorial Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Any day specifically declared by the President of the United States to be a national holiday.

If any Federal Holidays fall on a non-workday (i.e. Saturday or Sunday), the Friday before or Monday after will be considered a non-workday.

4. CONTRACTOR RESPONSIBILITIES:

4.1. Clinical Personnel Required: The Contractor shall provide contract personnel (s) who are competent, qualif ied 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

Medical Technologist and Histology Technician services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1 VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service

Standards” (expired but still in effect pending revision) https://www.bing.com/search?q=VHA+Directive+2006-041&src=IE- SearchBox&FORM=IESR4A

4.2.2 The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx https://www.bing.com/search?q=VHA+Directive+2006-041&src=IE-SearchBox&FORM=IESR4A https://www.bing.com/search?q=VHA+Directive+2006-041&src=IE-SearchBox&FORM=IESR4A http://www.jointcommission.org/standards_information/standards.aspx

4.2.3 The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and;

4.2.4 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 U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), 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. Treatment and administrative patient 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’ (24VA19). 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 are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all f inal patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.3.3. Disclosure: Contract personnel (s) may have access to patient medical records:

however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, 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. 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. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall http://www.hpoe.org/resources?show=100&type=8 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address:

Cincinnati VAMC Attn: Privacy/FOIA Officer Deana Bonner (00) 1500 Weiss Street Saginaw, Michigan 48602

4.3.5. 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.

4.3.6. 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.

4.3.7. 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.

4.3.8. Records created by contract personnel (s) in the course of treating VA patients under this agreement 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 EHR system for review.

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

4.3.10. VA utilizes a fully automated electronic health record. The EHR consists of 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. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EHR. Contract personnel (s) shall be responsible for viewing the patient record within the VISTA system.

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

4.4.1.1. Reporting Information for Resulting tests: Access to the VA VISTA shall be provided to the Medical Technologists and Histology Technician, including the ability to printout a report of those services provided by the Technologist and Technician.

▪ Patient’s name and identif ication number

▪ Results of tests after verification of accuracy

▪ Reporting and calling any abnormal results to the provider that ordered the test

4.4.1.2. It is the responsibility of the Medical Technologists to ensure that all results are accurate and meet regulatory requirements.

4.5. ADMINISTRATIVE: estimated 10% of time not involved in direct patient care/laboratory testing.

4.5.1. Staff Meetings: The Contractor’s Medical Technologist(s) shall attend staff meetings as required by the VAMC Chief of Service, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement. List all meetings, associated time and frequency.

Meeting Frequency (once a year, etc.)

Annual Hours

Laboratory Staff meeting Monthly 12

4.5.2. QA/QI documentation: The Contractor’s MT(s) and HT shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

4.5.3. Patient Safety Compliance and Reporting: Contractor’s MT(s) shall follow all established patient safety and infection control standards of care. Contractor’s MT(s) and HT shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

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 testing turnaround time, documentation of calls for abnormal results, documentation of rejected specimens, manual entry errors, patient results review, and mislabeled specimen review. 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 the resultant contract and shall define the methods and frequency of surveillance conducted. Contract monitoring will be accomplished through a record keeping system (attendance log) maintained by the Chief, Pathology & Laboratory Service or their designee in order to reconcile payments.

Contractor’s employees shall sign in and sign out of the attendance log indicating the dates and times worked. Procedure documentation shall be maintained by the contractor and shall be signed by the contractor. The Chief, Pathology & Laboratory Medicine Service & Laboratory Manager are responsible for monitoring the professional components of the contract. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with Joint Commission standards and the policies and procedures of the VAMC. In addition, the Medical Technologists and Histology

Technician will comply with all requirements of accrediting agencies: Association of Blood Banks (AABB), and Federal Drug Agency (FDA).

4.6.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints.