36C25622Q0569.docx

36C25622Q0569

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

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. 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

629-22-2-043-0070 Refer 31c 36C25622Q0569 04-20-2022 Melanie Hawley 228-523-5069 04-29-2022

2:00 PM

CDT

36C256 Department of Veterans Affairs for SLVHCS- New Orleans Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 X X 561320 $30 Million N/A X 36C629 Department of Veterans Affairs SL Veterans Health Care System 2400 Canal Street New Orleans LA 70119 Department of Veterans Affairs for SLVHCS Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically 1-877-489-6135 See CONTINUATION Page THIS REQUIREMENT IS 100% SET-ASIDE FOR SDVOSBs.

Contractor to provide two (2) Medical Technologists/ Clinical Laboratory Scientists to provide services per the terms and conditions herein.

Refer to Section B2 -Price Schedule and B3 Performance Work Statement (PWS) Anticipated period of performance 26 weeks.

See CONTINUATION Page 629-3620160-043-822300-2560 010022390 X X X Melanie Hawley

VA-VHA-2020-AC34AE75

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C25622Q0569

Page 1 of Page 1 of

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR (NAME/ADDRESS/CITY/STATE/ZIP):

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be:

[X] 52.232-33 Payment by Electronic Funds Transfer- System of Award Management

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

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:

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

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

The resultant contract is a nonpersonal services contract in accordance with FAR 37.401.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Medical Technologist (MT)/Clinical Laboratory Scientist (CLS) Anticipate 26 weeks of a time period 6-1-2022 to 11-30-2022.

Contract Period: Base POP Begin: 06-01-2022 POP End: 11-30-2022 Refer to PWS Paragraph 3.1.1. Shifts are determined by need. This doesn't include weekday shifts. Rates shall be all inclusive. Offerors shall provide candidate name ______________________________and provide the shift(s) ______________________ and number of hours ________if different than what is stated.

Medical Technologist (MT)/Clinical Laboratory Scientist (CLS) Anticipate 26 weeks of a time period 6-1-2022 to 11-30-2022.

Contract Period: Base POP Begin: 06-01-2022 POP End: 11-30-2022 Refer to PWS Paragraph 3.1.1. Shifts are determined by need. This doesn't include weekday shifts. Rates shall be all inclusive. Offerors shall provide candidate name ______________________________and provide the shift(s) ______________________ and number of hours ________if different than what is stated.

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The Contractor shall provide two (2) Medical Technologists/Clinical Laboratory Scientists for varying periods of time (shifts as needed) and in various areas of the Pathology & Laboratory Medicine Service laboratory. They shall these Professional Laboratory Services on-site at the Southeast Louisiana Veterans Health Care System (SLVHCS). Contractor’s personnel shall be subject to the quality assurance standards established by The Joint Commission and the Veterans Health Administration and shall perform in accordance with ethical, professional and technical standards of the healthcare industry consistent with VA policy, regulations, procedures and protocol.

1.2. Place of Performance: Contractor shall furnish services at 2400 Canal Street, New Orleans, LA 70119

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing authority and FAR Part 12 in combination with FAR 13.5 procedures will be used.

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 Handbook 1100.19: Credentialing and Privileging: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.3. VHA Directive 1088: Communicating Test Results to Providers and Patients: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.4. VHA Directive 1192.01: Seasonal Influenza Prevention Program: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948

1.4.5. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

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

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

1.4.8. VHA Directive 2012-030 Credentialing of Health Care Professionals: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

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

1.4.10. VHA Directive 1085 Smoke-Free Policy for Patients, Visitors, Contractors, Volunteers, and Vendors at VA Health Care Facilities

HTTPS://WWW.VA.GOV/VHAPUBLICATIONS/VIEWPUBLICATION.ASP?PUB_ID=8242

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

1.5.2. CDC: Centers for Disease Control and Prevention

1.5.3. CEU: Certified Education Unit

1.5.4. CLS: Clinical Laboratory Scientist

1.5.5. CMS: Centers for Medicare and Medicaid Services

1.5.6. 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.

1.5.7. 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.

1.5.8. COS: Chief of Staff

1.5.9. CPARS: Contractor Performance Assessment Reporting System

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

1.5.11. CR: Contract Report formerly Contract Discrepancy Report (CDR) – part of Section D QASP

1.5.12. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.5.13. ED: Emergency Department

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

1.5.15. Full Time Equivalent (FTE): VA’s definition for full time- working the equivalent of 80 hours every two weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

1.5.16. HHS: Department of Health and Human Services

1.5.17. HIPAA: Health Insurance Portability and Accountability Act

1.5.18. HR: Human Resources

1.5.19. ISO: Information Security Officer

1.5.20. Non-Contractor’s provider(s): any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

1.5.21. NPPES: National Plan and Provider Enumeration System

1.5.22. POP: Period of Performance

1.5.23. PPD: Purified Protein Derivative

1.5.24. PWS: Performance Work Statement

1.5.25. QA/QI: Quality Assurance/Quality Improvement

1.5.26. QM/PI: Quality Management/Performance Improvement

1.5.27. QASP: Quality Assurance Surveillance Plan

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

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

1.5.30. 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.

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

1.5.32. 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 New Orleans, Louisiana Medical Center [Southeast Louisiana Health Care System (SLVHCS)].

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. Medical Technologist/Clinical Laboratory Scientists– Contractor’s personnel shall have appropriate current ASCP MT/CLS certification (Refer to Paragraph 4.4.1.2). All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA with offer/quote.

2.1.2. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 and VHA Directive 2012-030 referenced above. The Contractor is responsible to ensure that proposed provider(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any Contractor’s provider(s) prior to obtaining approval by the SLVHCS Professional Standards Board, Medical Executive Board and Medical Center Director.

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

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

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

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

2.1.5.1 MANDATORY TRAINING

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

2.1.5.1.1.1 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

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

2.1.5.1.1.3 Successfully complete the appropriate VA privacy training and annually complete required privacy training

2.1.5.1.1.4 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access as may occur over the life of contract [refer to NIST Special Publication 800-16, Information Technology Security Training Requirements]

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

2.1.5.1.3 Failure to complete the mandatory training and sign the Rules of Behavior initially and annually, within the timeframe required, is grounds for not be given a start date and PIV badge and for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

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

2.1.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s personnel {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

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

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

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

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

2.1.6.6. COVID: Per FAR 52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this contract, for contractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contract

2.1.6.7. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s personnel {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

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

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

2.1.8. Citizenship related Requirements:

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

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

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

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

2.1.8.5. 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.

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

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

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

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

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

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

2.5. Prohibition Against Self-Referral: Contractor’s provider(s) are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. Inherent Government Functions: Contractor and Contractor’s provider(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.

2.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s provider(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:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

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

2.9. Key Personnel (list using ATT D4):

2.9.1. Medical Technologists/Clinical Laboratory Scientists (MTs/CLSs):

2.9.1.1. The VA Full Time Equivalency (FTE) for the services required is two (2) FTE. FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.1.2. The number of MTs/CLSs required to be on-site on a daily basis is defined in Paragraph 3.1 Hours of Operation in this section.

2.9.1.3. 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 scheduled personnel is/are unable to complete an assigned shift, the contractor shall provide replacement personnel coverage within 2 hours and notify the Contracting Office Representative (COR) at the SLVHCS immediately of the schedule change.

2.9.1.4. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within fifteen (15) calendar day(s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 60 calendar days prior to making any permanent substitutions.

2.9.1.5. 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 60 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

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

2.9.1.7. 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 provider(s), s/he may request, without cause, immediate replacement of said Contractor’s provider(s). Any issues concerning Contractor’s provider(s)conduct that is brought to the COR’s attention shall be forwarded to the CO. The final arbiter on questions of acceptability is the CO. If required, a Contract Discrepancy Report shall be issued to the Contractor for response and resolution of issue/problem.

2.9.1.8. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, the Contractor shall have a contingency plan in place to be utilized if the Contractor’s provider(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract. Contractor shall provide this plan with offer/quote.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Contractor shall provide comprehensive and professional Laboratory services covering:

3.1.1. Clinical Core Laboratory Moderate/High complexity testing during specified business hours 24/7, including weekends (at least alternate weekends) and Federal holidays. These hours will be in the overnight shifts (either 8 hour shift 12 am to 8 am OR 12 hour shift 7 pm to 7 am). Not to exceed 80 hours unless OT is approved. There shall be no Overtime (OT) without prior written approval.

3.1.2. The VA is not responsible for notifying the contractor of contractor personnel tardiness or absences. Refer to Paragraph 2.9 – Key Personnel for contractor responsibilities.

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

3.2.1 When a Federal holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a Federal holiday falls on a Saturday, the proceeding Friday is observed as a Federal holiday by U.S. Government agencies. Included also, would be any other day, specifically declared by the President of the United States of America to be a Federal Holiday.

3.2.2 Unless a state of emergency has been declared, the Contractor shall be responsible for providing services or unless notified by COR or CO based upon local VA guidance/direction. Any day specifically declared to be a national holiday.

4. CONTRACTOR CLINICAL RESPONSIBILITIES

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

4.1.1. Contractor will be responsible for providing an advance work schedule for each on-site staff.

4.2. Standards of Care: The Contractor’s personnel’s care shall cover the range of Pathology and Laboratory Medicine 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 and/or exceeding currently recognized TJC, VA and national standards as established by:

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

4.2.2. The College of American Pathologists (CAP):

http://www.cap.org, and,

4.2.3. The requirements contained in this PWS.

4.3 MEDICAL RECORDS

4.3.1 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).

4.3.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment 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 Contractors 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 as discussed in 4.4.4.

4.3.3 Disclosure: Contractor’s personnel may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; 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.

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

4.3.5 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 Release of Information Department at the VA facility were assigned.

4.4 Direct Patient Care: estimated 0% of the time involved in direct patient care. 100% of the time involved in Indirect Patient Care. Per the qualification section of this PWS, the Contractor shall provide the following on-site personnel/staff:

4.4.1 Medical Technologist(s)/Clinical Laboratory Scientist(s) (MT/CLS) requirements:

4.4.1.1 Education and Experience:

4.4.1.1.1 Education Educational Requirements. Medical Technologist(s)/Clinical Laboratory Scientist(s) are required to successfully complete education as required for Certification.

4.4.1.1.2 Experience. Min. of two years of experience as a certified Medical Technologist(s)/Clinical Laboratory Scientist(s).

4.4.1.2 Certification:

4.4.1.2.1 Medical Technologist(s)/Clinical Laboratory Scientist(s) must be currently certified by The American Society of Clinical Pathologists.

4.4.1.3 Knowledge, Skills and Abilities:

4.4.1.3.1 Must have the ability and credentialing to perform all functions necessary to maintain operations in a Moderate/High Complexity CORE laboratory.

4.4.1.3.2 Able to provide specific experience for performing testing on Attachment D1 Current Equipment list.

4.4.1.3.3 Maintain professional customer relations. Meet the needs of customers while supporting VA missions. Consistently communicate and treat customers (veterans, their representatives, visitors, and all VA staff) in a well-mannered, tactful, and respectful manner.

4.4.1.3.4 Provide the customer with accurate information according to established policies and procedures.

4.4.1.3.5 Work closely with COR and staff members regarding administrative issues as early as possible once issues are discovered.

4.4.1.3.6 Must ensure that all certifications are up to date.

4.4.1.3.7 Responsible for maintaining communications and emails on a daily basis.

4.4.1.3.8 Must comply with current standards for medical record documentation, professional accountability, and administrative responsibilities outlined in this performance work statement.

4.4.1.3.9 Must possess knowledge of instrumentation necessary to create diagnostic slides.

4.4.1.4 Contractor Personnel Elements of Competence: Contractor personnel shall have the ability perform laboratory sample testing on a variety of Testing System.

4.4.1.4.1 Contractor proficiency will be monitored by Supervisors in the CORE Laboratory with standard Competency requirements per Testing System.

4.5 Scope of Care:

4.5.1 MT/CLS shall provide the required services for each section as assigned.

4.5.1.1 MLT/CLS will perform all diagnostic testing according to policies and procedures in the area to which they are assigned.

4.5.1.2 Administrative duties:

4.5.1.2.1 QA/QI documentation: The Contract staff shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

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

4.5.1.2.3 The contract staff will be required to complete the VA Talent Management System (TMS) courses for Privacy and HIPAA and Privacy and Information Security and Rules of Behavior. The VA National Rules of Behavior must be signed, and training completed before computer access will be given. The Contract staff will also be required to comply with the Medical Center Information Security Policy

4.6 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

4.6.1 Quality Management/Quality Assurance Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.6.2 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. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.6.3 Performance Standards: Medical Technologist(s)/Clinical Laboratory Scientist(s)

4.6.3.1 Measure: Medical Technologist(s)/Clinical Laboratory Scientist(s) Quality Performance Performance Requirement: All Contractor’s Medical Technologist(s)/Clinical Laboratory Scientist(s) shall perform in accordance with Laboratory standards.

Standard: QA documentation for all (100%) Medical Technologist(s)/Clinical Laboratory Scientist(s) staff providing services under the contract.

Acceptable Quality Level: 100% meet Standards Surveillance Method: Standard Medical Technologist(s)/Clinical Laboratory Scientist(s) competency assessment requirements monitored daily:

A. Accuracy of Sample Accessioning B. Recording of daily QC/Temperatures C. Recording of daily Maintenance D. Compliance with Test System Standard Operating Procedures E. Notification of Critical Test Results F. Accuracy of Sample Reporting G. Notification of Supervisor of incidents affecting patient testing Frequency: Every 2 months

4.6.3.2 Measure: Qualifications of Key Personnel

Performance Requirement: All Contractor Medical Technologist(s)/Clinical Laboratory Scientist(s) shall maintain an up to date certification as an MT/CLS by the American Society of Clinical Pathologists.

Standard: All (100%) Contractor’s Medical Technologist(s)/Clinical Laboratory Scientist(s) maintain current certification as required in PWS.

Acceptable Quality Level: 100% Surveillance Method: Random Inspection of qualification documents Frequency: Initial and Every 2 months

4.6.3.3 Measure: Medical Technologist(s)/Clinical Laboratory Scientist(s) Availability and meeting schedule Performance Requirement: Presence of ASCP certified Medical Technologist(s)/Clinical Laboratory Scientist(s) during normal business hours on scheduled days.

Standard: Presence of ASCP certified Medical Technologist(s)/Clinical Laboratory Scientist(s) during normal business hours (8:00 am – 4:30 pm, M-F (exclusive of federal holidays).

Acceptable Quality Level: Contractor’s Medical Technologist(s)/Clinical Laboratory Scientist(s) is on-time and available to perform services 100% of the time.

Surveillance Method: Periodic inspection Frequency: Every month

4.6.3.4 Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using VA Patient Safety Reporting System. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

Acceptable Quality Level: 100% of patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

Surveillance Method: Periodic Inspection or Random Sampling Frequency: Every 2 months

4.6.3.5 Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per VAMC policy Standard: All (100%) of required training is complete on time by Contractor’s provider(s) Acceptable Quality Level: 100% completions, no deviations.

Surveillance Method: Periodic Inspection or Random Sampling Frequency: Every 2 months

4.6.3.6 Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

Standard: All (100%) contractor provider(s) comply with all laws, regulations, policies, and procedures relating to Privacy, Confidentiality and HIPAA

Acceptable Quality Level: 100% compliance

Surveillance Method: Periodic Inspection or Random Sampling; Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Handbook 6500.6.

Frequency: Every 2 months

4.6.3.7 Measure: Timeliness and Accuracy of Billing

Performance Requirement: The contractor will submit the invoice by the 5th day of each month.

Standard: 100% of the time Acceptable Quality Level: 100% compliance Surveillance Method: IPPS Frequency: Monthly

4.6.4 Registration with Contractor Performance Assessment Reporting System

4.6.4.1 As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates…