36C25222Q0568_2.docx

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

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

36C25222Q0568 08-26-2022 Becky Cincotta, Contracting Officer 414-844-4822 09-09-2022

1:00 PM

CDT

36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X 541690 $16.5 Million N/A X 36C695 Department of Veterans Affairs Clement J. Zablocki VA Medical Center 5000 W. National Avenue Milwaukee WI 53925-0001 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 Contractor to provide Clinical Microbiologist Services at either the Clement J. Zablocki Veterans Affairs Medical Center (VAMC) or the Edward J. Hines, Jr. VA Hospital in accordance with the specifications, terms, and conditions contained herein.

See Pages 4 through 5 for Price Schedule.

X X Becky Cincotta Contracting Officer

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C25222Q0568

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACT ADMINISTRATION MATTERS WILL BE HANDLED BY:

a. Contractor’s Name/Address/City-State-Zip:

Point of Contact/Title:

Telephone Number: _____________________________________________ Fax Number:

Email: ________________________________________________________ Unique Entity Identifier: ________________________________________ Federal Taxpayer Identification Number: _____________________________

c. Government:

Becky Cincotta Contracting Officer

(414) 844-4822 becky.cincotta@va.gov

Department of Veterans Affairs Great Lakes Acquisition Center 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476

FAX: (414) 844-4891

2. CONTRACTOR REMITTANCE ADDRESS:

All payments by the Government to the contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (31 U.S.C. 3332).

3. INVOICES:

Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.tungsten-network.com/Login.aspx. For questions regarding the submission of VA electronic invoices, Tungsten Corporation customer service may be contacted at 1-877-489-6135.

All invoices shall reference the vendor name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, provider name, number of hours worked, unit price (hourly rate) and the total cost. Invoices shall also include any payment discount terms.

For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791.

4. POST AWARD ORIENTATION:

Post Award Orientation: The Contracting Officer will schedule a post award conference call for contract orientation purposes.

5. SECURE FAX:

The following statement is required to be included on all fax cover sheets: “This fax is only intended for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

6. ACKNOWLEDGEMENT OF AMENDMENTS:

The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

[End of Contract Administration Data]

B.2 SCHEDULE OF SERVICES/PRICE

The Contractor shall furnish all personnel to provide services necessary to perform 0.5 FTE onsite Clinical Microbiology Services to the Department of Veterans Affairs Medical Center (hereinafter referred to as VA). The contractor’s provider(s)’ care shall cover the range of clinical microbiology services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the American Board of Medical Microbiology (ABMM) American Board of Medical Microbiology (ABMM) | ASM.org Authority: This procurement is being conducted under the authority of 38 U.S.C. 513. The Great Lakes Acquisition Center is contracting for services in support of VISN 12 medical facilities and in accordance with FAR 13.5 - Simplified Procedures for Certain Commercial Items. Therefore, VA will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

Place of Performance: Services shall be provided on-site, at either the Clement J. Zablocki VA Medical Center, 5000 West National Avenue, Milwaukee, WI 53295, or the Edward Hines, Jr. VA Hospital, 5000 South 5th Avenue, Hines, IL 60141.

Period of Performance: The contract period of performance will be for a base year: September 26, 2022 to September 25, 2023, with four one-year options to extend at the discretion of the Government through September 25, 2027.

NAICS: The NAICS Code for this solicitation is 541690. In order to be considered a small business under this NAICS Code, your average annual receipts must not exceed $16.5 M.

Pricing Instructions:

Pricing must be all inclusive (travel, lodging, etc.). Contractor must provide a complete Price Schedule. The Contractor shall propose key personnel to be available for scheduling to meet the requirements of the contract.

PRICE SCHEDULE

Base Year – September 26, 2022 through September 25, 2023

Annual Cost

Board Certified /Board Eligible Clinical Microbiologist Key Personnel:

Option Year 1 – September 26, 2023 through September 25, 2024

Annual Cost

Board Certified /Board Eligible Clinical Microbiologist Key Personnel:

Option Year 2 – September 26, 2024 through September 25, 2025

Annual Cost

Board Certified /Board Eligible Clinical Microbiologist Key Personnel:

Option Year 3 – September 26, 2025 through September 25, 2026

Annual Cost

Board Certified /Board Eligible Clinical Microbiologist Key Personnel:

Option Year 4 – September 26, 2026 through September 25, 2027

Annual Cost

Board Certified /Board Eligible Clinical Microbiologist Key Personnel:

ESTIMATED CONTRACT TOTAL VALUE (INCLUDING BASE & ALL OPTION YEARS):

The Government may award on the basis of initial offers received, without exchanges. Therefore, each initial offer should contain the offeror’s best terms from a cost/price standpoint. Award of a contract will be a fixed price award and will be made to the offeror whose quote represents the best value to the Government considering price, candidate qualifications, experience, availability, and other factors.

B.3 PERFORMANCE WORK STATEMENT FOR ON-SITE CLINICAL MICROBIOLOGIST SERVICES

The Contractor shall provide 0.5 FTE Doctorate-level Board Certified/Board Eligible Clinical Microbiologist Services on-site in accordance with the specifications contained herein to the VISN 12 Pathology and Laboratory Medicine Service (P&LMS), Department of Veterans Affairs (VA) at either the Clement J. Zablocki VA Medical Center (Milwaukee VAMC) or the Edward Hines, Jr. VA Hospital (Hines VAH).

1. POLICY/HANDBOOKS the contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 VHA Directive 1088: Communicating Test Results to Providers and Patients: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148 VHA Directive 1192.01: Seasonal Influenza Prevention Program: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948 VHA Directive 1907.01: Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 VHA Directive 2012-030 Credentialing of Health Care Professionals: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815 Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

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

· ABMM: American Board of Medical Microbiology https://asm.org/Certifications/American-Board-of-Medical-Microbiology

· CDC: Centers for Disease Control and Prevention

· CEU: Certified Education Unit

· CME: Continuing Medical Education

· Contracting Officer (CO): 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.

· Contracting Officer’s Representative (COR): 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.

· COS: Chief of Staff

· COVID-19: Coronavirus Disease 2019

· CPARS: Contractor Performance Assessment Reporting System

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

· FTE: Full Time Equivalent

· HHS: Department of Health and Human Services

· HIPAA: Health Insurance Portability and Accountability Act

· HR: Human Resources

· ISO: Information Security Officer

· JC: Joint Commission

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

· POP: Period of Performance

· PWS: Performance Work Statement

· QA/QI: Quality Assurance/Quality Improvement

· QM/PI: Quality Management/Performance Improvement

· QASP: Quality Assurance Surveillance Plan

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

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

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

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

· Veterans Affairs Hospital (VAH): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Edward J. Hines, Jr. VA Hospital.

3. QUALIFICATIONS OF PERSONNEL:

a. Staff

i. Board Certification: All contract personnel shall be Board Certified or Board Eligible by the American Board of Medical Microbiology (ABMM). 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.

ii. Experience: Minimum three-years’ experience within the past 5 years, working in a clinical laboratory setting

iii. Requirements for ABMM Board Eligibility: Contract personnel must have a Doctorate of Philosophy of Doctorate in Science in microbiology or an equivalent degree in one of the related sciences acceptable to the ABMM Board. Other doctorate degrees (e.g., DO, DV, Dental, Doctor of Philosophy in Health Sciences) may be accepted in the additional special training and experience is approved by the ABMM Board. Doctorate of Clinical Laboratory Science and Doctor of Pharmacy are not acceptable.

1. Option 1: Personnel must possess a doctorate (see above) and complete a minimum of three years of experience, which is defined as a full-time postdoctoral training and/or full-time director-level laboratory experience that is directly relevant to the practice of clinical and public health microbiology and its subspecialties

1. Option 2: Personnel must possess a doctorate and complete two years of postgraduate training in a CPEP-approved program https://asm.org/Fellowships/CPEP-Fellowship-Program-Descriptions

1. Option 3: Personnel must possess a doctorate and complete one of the following:

· An ACGME-accredited fellowship program in Medical Microbiology (https://www.acgme.org/residents-and-fellows/the-acgme-for-residents-and-fellows/ )

· A Canadian College of Microbiologists’ (CCM) Fellowship Training Program

· A Royal College of Physician and Surgeons of Canada three-year medical microbiology/infectious disease or five-year medical microbiology residency

iv. The qualifications of such personnel shall be subject to review and approval by the VISN 12 P&LMS Chief Pathologist. The Contracting Officer will be notified prior to any changes in personnel. VA reserves the right to approve the assignment of individual personnel furnished by the contractor to perform the functions specified in the contract.

v. Technical Proficiency – Contract personnel 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 services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contractor’s personnel and contractor’s personnel shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior. Contract personnel must also be computer literate as patient documentation is directly inputted in the patient’s electronic medical health record. Adequate computer skills shall be defined as a working knowledge of Windows environment and the ability to use a mouse to point and click for selection of items desired. Proficiency in the use of the Veterans Health Information Systems and Technology Architecture (VISTA) System and the VA’s Computerized Patient Record System (CPRS) and/or Cerner Electronic Health Medical Record System is preferred.

vi. 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/VAH. Contract personnel registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current.

vii. Training: Contractor shall meet all VA educational requirements and mandatory course requirements; all training must be completed by the contractor’s personnel as required by the VA. All training required for onboarding/access is available online and shall be completed at the expense of the contractor prior to arrival onsite. Other training may become required and shall be completed by the contract personnel within the required timeframes. VA will communicate any changes to the training requirements to the contractor.

VA Privacy & Information Security Awareness & Rules of Behavior (#10176)

Annually

viii. The contracted individual will be required to show two proofs of identification on their first day of work. Acceptable proof of identification is listed below:

Acceptable PICTURE IDs:

· State-Issued Driver’s License

· State DMV-Issued ID Card

· US Passport

· Military ID/Dependents Card

· Foreign Passport

· Permanent Resident Card/Alien Registration Card w/Photo

Acceptable NON-PICTURE IDs:

· Social Security Card

· Certified Birth Certificate

· State Voter Registration Card

· Native American Tribal Document

· Certificate of US Citizenship

· Certificate of Birth Abroad Issued by Dept of State

ix. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel upon request. Tests shall be current within the past year.

· TUBERCULOSIS (TB) TESTING: Contractor shall provide proof of a negative TB Blood Test (also called interferon-gamma release assays (IGRA)) for all contractor employees as a baseline. Two TB blood tests are approved by the FDA: the QuantiFERON – TB Gold In-Tube test (QFT-GIT) and the T-SPOT TB test (T-Spot). Subsequent testing is not required, unless the contractor employee has been exposed to someone with TB. CDC recommendations for TB testing for health care personnel can be found at:

https://www.cdc.gov/tb/topic/infectioncontrol/healthcarepersonnel-faq.htm

· MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all contractor employees, i.e., at least 2 doses of vaccine are required or serologic evidence of immunity.

· VARICELLA: Contractors shall provide proof of immunity for all contractor employees, i.e., at least 2 doses of vaccine are required or serologic evidence of immunity.

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

· HEPATITIS B: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all contractor employees; provide their own Hepatitis B vaccination series (3 doses required) plus a serologic titer (1-2 months after final dose) to document immunity following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

· INFLUENZA: Contractors shall provide proof that all contractor employees have received the annual Influenza vaccine unless it is contraindicated. If the contractor employees have a medical contraindication to the vaccine, they shall be required to wear a mask throughout the Influenza season in any VHA location, including both clinical and non-clinical areas. In addition, the mask shall be worn during performance of their assigned duties and responsibilities. Contract employees in violation of this requirement may be removed from the providing services under the contract.

COVID-19: Due to the current pandemic, Contractor employees who enter VHA facilities shall comply with published CDC guidance for masking and physical distancing, and other guidance per the facility. Contractor employees may be screened for COVID-19, and if results are positive for COVID-19, they shall not be allowed to enter VHA facilities. Contractors shall also comply with VHA Supplemental Contract Requirements for Combatting COVID-19. – See Section D Attachment.

The VAMC/VAH 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 for disease control at http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

x. Conflict of Interest: The Contractor and all contractor’s personnel are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

xi. Citizenship related Requirements:

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. 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.

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.

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

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

xii. 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.

b. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19 and VHA Directive 1100.20. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

c. Non-Personal Healthcare Services: The parties agree that the Contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

d. 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.

e. Prohibition Against Self-Referral: Contract personnel are prohibited from referring VA patients to contractor’s or their own practice(s).

f. Inherent Government Functions: Contractor and Contractor’s personnel 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.

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

i. Workers’ compensation

ii. Professional liability insurance

iii. Health examinations

iv. Income tax withholding, and

v. Social security payments.

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

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

4. KEY PERSONNEL:

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

b. Personnel Substitutions: 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 5 calendar days after the occurrence of any of these events and provide the information required below. The Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions. The CO must approve all substitutions.

c. 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. Prior to rendering services, substitutes must be credentialed and privileged by the medical facility and obtain a medical staff appointment, in accordance with VA Bylaws, Rules and Regulations. The contract will be modified to reflect any approved changes of key personnel.

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

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

5. VA HOURS OF OPERATION:

a. VA Business Hours: Monday-Friday, 7:30 a.m. to 4:00 p.m.

b. Services are not required on Federal Holidays. The 11 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King Jr.’s Birthday (3rd Monday in January), Washington’s Birthday (3rd Monday in February), Memorial Day (last Monday in May), Juneteenth National Independence Day (June 19th) Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

6. WORK SCHEDULE:

Contractor personnel provide services for all medical facilities within VISN 12. In person service will be performed at the “base” location which will be at either the Milwaukee VAMC or Hines VAH. Travel with on-site services may be required to either Milwaukee or Hines, opposite of which site is the “base” location. Travel will not exceed one day per month. Services to Tomah VAMC, Madison VAH, Jesse Brown VAMC, Iron Mountain VAMC, Danville VAMC, and the Federal Health Care Center(FHCC) may be performed remotely.

Normal work schedule will be 20 hours per week. Contractor will work with the COR to determine weekly schedule. This schedule may be flexible as long as 20 hours of work is completed each week during normal business hours.

7. JOINT COMMISSION STANDARDS:

Although Joint Commission accreditation is not required, the contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

The Contractor will be responsible to ensure the contractor employees or subcontractors providing work on this contract are fully trained and completely competent to perform the required work. Contractor will gather all credentialing documents requested by the VA as well as any other documentation that the carrying out of this contract may require. However, the contractor is not able to nor is the contractor required to make clinical competence determinations on behalf of the VA.

8. CONTRACTOR RESPONSIBILITIES:

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

1. Contractor’s microbiologist(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. In the event that the Contract provider works a portion of an hour, time should be recorded in 15-minute increments. Contract providers shall be responsible for reporting time worked accurately.

b. Standards of Care: The contractor’s personnel standard of care shall be of a quality meeting or exceeding currently recognized national standards as established by:

1. The American Board of Medical Microbiology:

https://asm.org/Certifications/American-Board-of-Medical-Microbiology

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

http://www.jointcommission.org/emergency_department/

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

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

4. The VAMC/VAH, and

5. The requirements contained in this PWS.

c. Medical records:

1. Authorities: Contractor’s personnel 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).

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 of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractor’s or Contractor personnel by the VA are covered by the VA Privacy Act 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.

3. Disclosure: Contractor’s personnel may have access to VA 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 Handbook 1907.01, Health Information Management and Health Records and VHA Directive 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. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records and all guidelines provided by the VA: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records 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 Privacy Officer at the VAMC/VAH.

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

d. Scope of Work: While working at the VA, the Microbiologist(s) will be under the general oversight of the VISN 12 Chief of P&LMS. Tasked assignments shall be completed by the due date. The Microbiologist(s) is/are expected to provide consultation, service, and research in the full range of the field of Microbiology, as well as reasonable expertise of the related subgroups for VISN 12, such as Molecular Biology. Additionally, the Microbiologist(s) will coordinate and oversee a full range of diagnostic services in the fields of bacteriology, mycobacteriology, mycology, virology, and parasitology.

The Microbiologist(s) assist(s) the Chief of VISN 12 P&LMS in the broad technical oversight and guidance of the Microbiology and Molecular Pathology programs. The microbiologist(s) will work with VISN 12 P&LMS Microbiology Technical Committee Co-Chairs to identify and deliver new product opportunities and participate in strategic and tactical planning for VISN 12 Microbiology, including new assay development, new testing algorithms, and capital equipment, as well as keep up on the most current testing options and work to help keep VISN 12 at a state-of-the-art level in Microbiology. Desired molecular knowledge includes identification and quantification of HPV, HIV, and HCV.

The Microbiologist(s) provide(s) technical expertise and consultation in clinical Microbiology and Molecular Pathology including identification of unusual organisms, complicated clinical cases, development and implementation of new diagnostic procedures, quality control methodology, and troubleshooting. Consultation requests shall be responded to within the same work day or next business day. Additionally, the microbiologist(s) assist(s) with investigation of problems, including challenging clinical cultures, methodologies, and equipment. The microbiologist(s) shall suggest the addition of new procedures and services, and help to design new techniques or modify current techniques to meet the changing needs of the medical staff.

The Microbiologist(s) serve(s) as a technical authority in clinical molecular microbiology and diagnostics testing. The microbiologist(s) will work collaboratively with P&LMS to assist and lead development of new assays, including Laboratory Developed Tests (LDT), bringing the assays through clinical validation and operational implementation. These assays include, but are not limited to, expansion of the MALDI-TOF, and expansion of antimicrobial testing and rapid susceptibility testing.

Additionally, the microbiologist(s) will assist in providing monthly education to VISN 12 P&LMS staff. This education includes, but is not limited to, case studies, complicated clinical cases, and best practices related to collection.

Contractor personnel shall communicate effectively, professionally, and courteously. Contractor personnel are required to participate in the following meetings

9. QUALITY ASSURANCE MONITORING

a. Contractor shall maintain a Quality Control Program related to the Clinical Microbiology services covered under this contract.

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

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

d. Quality factors/performance measures that VA may consider when monitoring contractor performance may include but are not limited to: attendance, technical expertise, assignment deadlines, consultation requests, customer satisfaction, and security/privacy.

e. The Performance Requirement Summary Matrix below provides additional detail to those performance measures.

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

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

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

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

11. GOVERNMENT RESPONSIBILITIES

a. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

b. CO RESPONSIBILITIES:

CO: Becky Cincotta Department of Veterans Affairs Great Lakes Acquisition Center 115 S. 84th Street, Suite 101 Milwaukee, WI 53214 (414)-844-4822 becky.cincotta@va.gov

i. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

ii. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

iii. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms…