36C25021Q0444.docx

36C25021Q0444

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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.

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

36C25021Q0444 03-15-2021 Karen Williams 614-257-5220 04-15-2021 2:00 pm

EST

36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834 X X 621511 $35 Million N/A X 36C583 Department of Veterans Affairs Richard L. Roudebush VA Medical Center 1481 W. 10th Street Indianapolis IN 46202 36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 Chalmers P. Wylie Outpatient Clinic 420 North James Road Columbus OH 43219-1834

36C250 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 877-353-9791 512-460-5429 See CONTINUATION Page Contractor to provide Phlebotomy Healthcare Services onsite at Veteran Health Indiana located in Brownsburg, IN.

See the Schedule of Services on page 5 and PWS on page 7 See CONTINUATION Page X X Karen Willams Table of Contents

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:

Karen Williams, Contract Specialist Department of Veterans Affairs Network Contracting Office (NCO) 10

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with FAR 52.232-33, Payment by Electronic Funds Transfer – System for Award Management.

3. INVOICES: Invoices shall be submitted in arrears: 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.

Invoicing shall be in accordance with The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

5. SECURE FAX: In accordance with VA Handbook 6500, the following statement is required on all fax cover sheets; if it is determined the ordering process will include a fax: “This fax is intended only 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. 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.

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

8. POST AWARD ORIENTATION: The Contracting Officer will conduct a post-award orientation conference in accordance with VAAM842.5 Postaward Orientation.

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.

36C25021Q0444

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B.2 SCHEDULE OF SERVICES

The Contractor shall furnish an immediate need for four (4) phlebotomists (with a growth potential up to seven (7) phlebotomists) and one (1) supervisor to provide services necessary to perform onsite specimen collection, processing and limited point of care testing services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Richard L. Roudebush (hereinafter referred to as VAMC). The Contractor’s phlebotomist(s) and phlebotomy supervisor’s care shall cover the range of Phlebotomy 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 http://www.cap.org.

Place of Performance: Services shall be provided on-site at the Veteran Health Indiana, 557 Pitt Road, Brownsburg, IN 46112.

Period of Performance: September 15, 2021 through September 14, 2026

Reimbursement will be made to the contractor by issuance of individual task orders during the life of the contract, which will be issued annually for each ordering period. The guaranteed minimum only applies to the ordering period in which the contract is awarded. The total minimum amount, or guaranteed minimum, for the initial year in which this contract is awarded is 40 hours. The total maximum number of hours, inclusive of all ordering periods shall not exceed 100,000 hours.

The Contractor shall propose a minimum of four (4) phlebotomists plus one (1) phlebotomy supervisor (up to either (8) total) to be credentialed and be available for scheduling to meet the requirements of the contract.

Ordering Period 1: 9/15/2021 to 9/14/2022

Annual Cost

Ordering Period 2: 9/15/2022 to 9/14/2023

Annual Cost

Ordering Period 3: 9/15/2023 to 9/14/2024

Annual Cost

Ordering Period 4: 9/15/2024 to 9/14/2025

Annual Cost

Ordering Period 5: 9/15/2025 to 9/14/2026

Annual Cost

Aggregate Total for all Ordering Periods: $_________________________

B.3 PERFORMANCE WORK STATEMENT

PHLEBOTOMY SERVICES

1. GENERAL:

1.1. Services Provided: The contractor shall provide Phlebotomy Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), and the Richard L. Roudebush VA Medical Center.

1.2. Place of Performance - Contractor shall furnish services at the Veteran Health Indiana (VHI) 557 Pit Road, Brownsburg, IN 46112.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and FAR Part 12 in combination with 13

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

1.4.1. VHA Directive 1192: Seasonal Influenza Prevention Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

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

1.4.3. VHA Handbook 1907.01: Health Information Management and Health Records https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.4.4. Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.5. Joint Commission –

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

1.4.6. HHS OIG Website –

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

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

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

1.5.1. ASCP: American Society of Clinical Pathologists

1.5.2. CAP: College of American Pathologists

1.5.3. BLS: Basic Life Support

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CDR: Contract Discrepancy Report

1.5.6. CMP: Civil Monetary Penalty

1.5.7. CMS: Centers for Medicare and Medicaid Services

1.5.8. 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.

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

1.5.10. COS: Chief of Staff

1.5.11. CPARS: Contractor Performance Assessment Reporting System

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

1.5.13. EMR: Electronic Medical Record

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

1.5.15. HHS: Department of Health and Human Services

1.5.16. HIPAA: Health Insurance Portability and Accountability Act

1.5.17. HR: Human Resources

1.5.18. ISO: Information Security Officer

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

1.5.20. OSHA: Occupational Safety and Health Administration

1.5.21. OIT: Office of Information and Technology

1.5.22. OPM: Office of Personnel Management

1.5.23. PIV: Personal Identity Verification

1.5.24. POP: Period of Performance

1.5.25. PWS: Performance Work Statement

1.5.26. QASP: Quality Assurance Surveillance Plan

1.5.27. RFP: Request for Proposal

1.5.28. VAMC: Veterans Affairs Medical Center

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

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

1.5.31. 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.

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

1.5.33. 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 Roudebush VA Medical Center.

1.5.34. iCARE – Integrity, Commitment, Advocacy, Respect, and Excellence

2. QUALIFICATIONS:

2.1 Staff/Facility – The contractor shall provide eight (8) Full Time Equivalency Employees (FTEEs), consisting of seven (7) appropriately qualified phlebotomists and one (1) supervisor located at the Brownsburg, Indiana facility. The immediate need is four (4) appropriately qualified phlebotomists and one (1) supervisor initially with growth potential of up to seven (7) appropriately qualified phlebotomists.

2.1.1 Education & Experience: Phlebotomist(s) assigned by the Contractor to perform the services covered by this contract should have (2) years of experience performing phlebotomy and other specimen collection procedures, accessioning and specimen preparation within a clinical laboratory or medical center/hospital setting. Certification from an approved Phlebotomy Training Program by the National Phlebotomy Association (NPA), ASPT, ASCP or other equivalent certification agency is recommended but not required.

2.1.2 Phlebotomy Supervisor assigned by the Contractor to perform the services covered by this contract shall have formal education/training in phlebotomy as well as at least two (2) years supervisory experience and at least two (2) years’ experience performing phlebotomy and other specimen collection procedures, accessioning and specimen preparation within a clinical laboratory or medical center/hospital setting. Current certification from an approved Phlebotomy Training Program by the National Phlebotomy Association (NPA), ASPT, ASCP or other equivalent certification agency.

2.1.3 Technical Proficiency: Phlebotomist(s) and supervisor shall be fully trained and completely competent to perform the required work. All contract phlebotomist(s) and supervisory 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 to the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including gaps in educational history for all phlebotomist(s) and supervisors. Also, phlebotomist(s) and supervisor shall be responsible for abiding by the Facility’s Medical Staff By- Laws, rules, and regulations (referenced herein) that govern medical staff behavior. In addition, the phlebotomist(s) and supervisor shall have the following skills:

2.1.3.1 Familiar in dealing with hospital patient population, including drawing elderly and difficult patients.

2.1.3.2 Shall have tact and personality conducive to interacting with ill, disoriented, sometimes difficult outpatient population.

2.1.3.3 Phlebotomist(s) and supervisor shall be required to have basic typing and PC computer skills.

2.1.3.4 Phlebotomist (s) and contracted supervisory personnel will utilize patient tracking system as required by facility.

2.1.3.5 Documentation and ordering of test orders shall be done electronically on the Veterans Health Information Systems. As a part of the orientation process, phlebotomist(s) and supervisor shall be required to request and obtain an access code to the computer system. At that time, phlebotomist(s) and supervisor shall have access to training.

2.1.4 Training (BLS, EMR and VA Mandatory): Phlebotomist(s) and on-site supervisory staff needing access to VA information and VA information systems shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the phlebotomist(s) and contracted supervisory personnel as required by the VA to include New Employee Orientation:

2.1.4.1 All contractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

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

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

2.1.4.1.3 Successfully complete the appropriate VA privacy and HIPAA training and annually complete required privacy training; and

2.1.4.1.4 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access

2.2 The Contractor shall provide the COR with certification that phlebotomist(s) and supervisor have completed the medical evaluation required above, including Color Vision Test, minimum of 5 calendar days prior to performance of contract services. This certification shall state the date the examination was completed, the doctor’s name who performed the examination, a statement concerning the physical health of the individual and the following statement: [Name of phlebotomist], is suffering from NO contagious diseases to include but not limited to: Tuberculosis, Hepatitis and Venereal Disease.

2.3 The Government may take nose and throat cultures from phlebotomist(s) and contracted supervisory personnel when required by Government Infection Control Committees (ICC).

2.4 When a phlebotomist(s) has been found medically unfit for providing services required under this contract, the contractor shall direct them to discontinue working immediately. Phlebotomist(s) shall not return to work until given clearance by the appropriate physician.

2.5 Personal Hygiene and Clothing: In performance of this contract, Contractor personnel shall be neat, clean, well-groomed and shall otherwise exercise good personal hygiene. Appropriate and professional attire shall be worn at all times while on duty at Veteran Health Indiana facilities.

2.6 The Contractor shall provide the COR with all the information necessary to ensure that Government records are maintained correctly and in compliance with the Joint Commission (JC), OSHA and the Center for Disease Control (CDC) health records requirements, for each individual phlebotomist(s).

2.7 Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.7.1 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.

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

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

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

2.7.5 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}.

2.7.6 OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s 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.

2.7.7 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.

2.8 Conflict of Interest: The Contractor and all contract personnel (s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of 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.

2.9 Citizenship related Requirements:

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

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

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

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

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

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

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

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

2.11 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. 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.

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

2.13 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.

2.14 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.

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

2.15.1 Workers’ compensation

2.15.2 Professional liability insurance

2.15.3 Health examinations to include:

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

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

2.15.3.3 Evidence of a Hepatitis C titer

2.15.3.4 Varicella titer if contracted employee has not had chicken pox

2.15.4 Income tax withholding, and

2.15.5 Social security payments

2.16 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.

2.17 Key Personnel:

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

2.17.2 The number of Supervisors required to be on site daily is one (1) and the number of Phlebotomists required to be on site daily is four (4) initially with growth to seven (7) as the needs of the clinic increases and as defined in paragraph Hours of Operation of this section.

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

2.17.4 Contractor shall provide the names of the contracted employee(s) assigned to the performance under this contract.

2.18 Emergency Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.18.1 The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.18.2 For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

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

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

2.18.5 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.

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

3 HOURS OF OPERATION:

3.1 VA Business Hours: VA business hours/hours of operation are 8:30 am – 4:30 pm.

3.1.1 Work Schedule: Regular work hours are Monday through Friday for eight (8) hours a day from 7:30 a.m. to 5:30 p.m. Exact schedules during these hours will be determined after award.

3.1.2 The supervisor and phlebotomy services are required Monday through Friday, working eight (8) hour shifts in order to support the Laboratory needs of the facility. The requirement is for the contractor to provide appropriately qualified Phlebotomists and supervisory staff. Federal Holiday and on-call coverage services are not required. Note: There may be a need for coverage during special facility held events.

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 to be a national holiday

3.3 CANCELLATIONS: The contractor must provide an equivalent substitute in a timely manner (within 2 hours of the scheduled tour of duty) if the phlebotomist(s) and/or contracted supervisory personnel scheduled cannot work. Contractor personnel may be released if their services are no longer required, however contract personnel will only be paid for actual hours worked. Any tour of duty for Contractor’s personnel may be canceled prior to assigned shift (without penalty to VA). If it is necessary to release Contractor personnel from duty prior to the end of the scheduled shift the contractors identified Supervisor or Lead will notify the CO and/or COR and Contactor will only be paid for actual hours worked.

4 CONTRACTOR RESPONSIBILITIES:

4.1 PERSONNEL REQUIRED: The Contractor shall provide phlebotomist(s) and supervisory personnel who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.2 FUNCTIONS OF THE CERTIFIED PHLEBOTOMIST

4.2.1 The phlebotomist(s) shall be responsible for accurately identifying patients, obtaining the proper specimens, recognizing and immediately reporting adverse patient reaction to venipuncture procedures to appropriate VA personnel.

4.2.2 Phlebotomist(s) shall be responsible for processing laboratory specimens (to include: aliquoting, storing and preparing for transport to the main laboratory according to DOT and OSHA guidelines), computer related functions such as accessioning specimens and other related tasks. Phlebotomist(s) shall refer problems/inquiries to VA team leaders or supervisors.

4.2.3 Phlebotomist(s) shall be responsible for performance of point of care testing.

4.2.4 Phlebotomist shall participate in performing proficiency testing including entry of results into proficiency testing website.

4.2.5 EQUIPMENT/SUPPLIES/FORMS: The phlebotomist(s) shall have the use of all required equipment, supplies and forms for performing services required by this contract.

4.2.6 Phlebotomist(s) shall complete all Medical Center’s required mandatory education and confirm all laboratory policies and procedures directly related to their job duties.

4.2.7 Phlebotomist(s) shall follow hospital and laboratory policies and procedures, including safety and computer policies.

4.2.8 Staff Meetings: The phlebotomist(s) shall attend staff meetings as required by the Veteran Health Indiana Pathology & Laboratory Medicine Service. Contractor to communicate with supervisor and/or COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.2.9 QA/QI Documentation: The phlebotomist(s) shall participate in all quality and performance improvement activities to ensure compliance.

4.2.10 Patient Safety Compliance and Reporting: The phlebotomist(s) shall follow all established patient safety and infection control standards of care. Phlebotomist(s) shall make every effort to prevent specimen mislabels, multiple venipuncture procedure on the same patient while providing care. All events related to patient injury, and other breeches of patient safety shall be reported to the supervisor and/or COR, as soon as practicable (but within the eight (8) hour shift). Contractors shall notify supervisor of incident and submit a P&LMS Incident /Variance Report, following up with supervisor as required or requested.

4.3 FUNCTIONS OF THE ON-SITE CONTRACTED SUPERVISOR:

4.3.1 The contracted supervisor shall ensure phlebotomist(s) adhere to all VA policies related to specimen collection and accurately identifying patients, obtaining the proper specimens, recognizing and immediately reporting adverse patient reaction to venipuncture procedures to appropriate VA personnel.

4.3.2 Supervisor shall be responsible for ensuring the timely processing of laboratory specimens (to include: aliquoting, storing and preparing for transport to the main laboratory according to DOT and OSHA guidelines), and other computer related functions such as accessioning specimens and other related tasks.

4.3.3 Supervisor will be responsible for any administrative actions including but not limited to reporting requirements ensuring timely transport of specimens via the VAMC courier and other actions which may arise.

4.3.4 Supervisor ensures all staff are trained and competent. Supervisor shall maintain records of training according to VA guidelines.

4.3.5 Supervisor shall communicate problems/inquiries to CO and/or COR.

4.3.6 Supervisor will rotate samples amongst staff per regulatory guidelines and ensure timely completion of proficiency testing samples and return information to the Ancillary Testing Coordinator (ATC).

4.3.7 Upon receipt of proficiency testing samples, the supervisor will check and notify ATC of any issues within 24 hours (notification will be same day if samples are received on Friday).

4.3.8 EQUIPMENT/SUPPLIES/FORMS: The contracted supervisor shall have the use of all required equipment, supplies and forms for performing services required by this contract.

4.3.9 Supervisory staff shall complete all Medical Center’s required mandatory education and confirm all laboratory policies and procedures directly related to their job duties.

4.3.10 Supervisory staff shall follow hospital and laboratory policies and procedures, including safety and computer policies.

4.3.11 Staff Meetings: The supervisor shall attend staff meetings as required by the Veteran Health Indiana Pathology & Laboratory Medicine Service. Contractor to communicate with supervisor and/or COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.3.12 QA/QI Documentation: The phlebotomist(s) shall participate in all quality and performance improvement activities to ensure compliance.

4.3.13 Patient Safety Compliance and Reporting: The contracted supervisory personnel shall follow all established patient safety and infection control standards of care. All events related to patient injury, and other breeches of patient safety shall be reported to on-site VA personnel and/or COR, as soon as practicable (but within the eight (8) hour shift). Contractors shall submit a P&LMS Incident /Variance Report, following up as required or requested.

4.3.14 Patient Safety Compliance and Reporting: The contracted supervisory personnel will ensure phlebotomist(s) follow all established patient safety and infection control standards of care. All events related to patient injury, and other breeches of patient safety shall be reported to on-site VA personnel and/or COR, as soon as practicable (but within the eight (8) hour shift). Contracted supervisor shall submit a P&LMS Incident /Variance Report, following up as required or requested.

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

4.4.1 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.

4.5 Standards of Care: The contract personnel shall cover the range of Phlebotomy and specimen processing 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:

4.5.1 American Society of Clinical Pathologists: http://www.ascp.org

4.5.2 College of American Pathologists: http://www.ascp.org

4.2.3. The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx

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

4.2.5. The requirements contained in this PWS

4.6 MEDICAL RECORDS

4.6.1 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).

4.6.2 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’ (24VA10P2). 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 final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.6.3 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 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.6.4 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: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC.

4.6.5 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. The Contractor may respond to requests for records contained in their non-VA record system, but all requests for VA records will be forwarded to Portland VA Health Care System Release of Information Office (ROI) for response. The ROI office may be contacted via phone at 503-220-8262 extension 55196, and fax at 503-721-1054.

4.6.6 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…