36C25521R0004.docx

36C25521R0004

PA

GE

1OF

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

36C25521R0004 Osborn, Ashley 913-946-1112 2-

5PM

CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 621511 $35 Million N/A X Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S. 4th Street Leavenworth KS 66048 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page Contractor shall provide Referral Laboratory Testing Services in accordance with the Performance Work Statement.

Under the authority of Public Law 104-262, the contractor is to provide non-personal health care resources in accordance with the terms, conditions, and prices stated herein.

This solicitation shall establish a Firm Fixed Price Indefinite Delivery / Indefinite Quantity (IDIQ) contract to provide referral laboratory testing services to the VISN 15 Medical Centers located in Kansas, Missouri, Illinois, and Indiana.

$0.00 X X Ashley Osborn Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C25521R0004

Page 1 of Page 1 of

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT:

Contracting Officer 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX

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

B.2 SCHEDULE OF SERVICES

Item Description of Quantity Unit Number Supplies/Services

0001 Lab Testing Services 12.00 MO _________

Contractor shall provide Referral Laboratory Testing Services to Veterans Integrated Services Network (VISN) 15 in accordance with the Performance Work Statement.

Estimated Quantities: See Attachment 1, Test Schedule Contract Period: Base PoP Begin: April 27, 2021 PoP End: April 26, 2022

0002 Unscheduled Pick-up Service 84.00* YR _________

The Contractor shall accommodate additional specimen pick-ups for unscheduled and STAT testing, twenty-four (24) hours a day, seven (7) days a week, for each facility. Courier response time must be within one (1) hour after notification by a Medical Center. *This CLIN is priced per unscheduled pick-up, estimated at seven (7) pick-ups per month.

Contract Period: Base PoP Begin: April 27, 2021 PoP End: April 26, 2022

1001 Lab Testing Services 12.00 MO _________ to Veterans Integrated Services Network (VISN) 15 in accordance with the Performance Work Statement.

Estimated Quantities: See Attachment 1, Test Schedule Contract Period: Option 1 PoP Begin: April 27, 2022 PoP End: April 26, 2023

1002 Unscheduled Pick-up Service 84.00* YR _________

The Contractor shall accommodate additional specimen pick-ups for unscheduled and STAT testing, twenty-four (24) hours a day, seven (7) days a week, for each facility. Courier response time must be within one (1) hour after notification by a Medical Center. *This CLIN is priced per unscheduled pick-up, estimated at seven (7) pick-ups per month.

Contract Period: Option 1 PoP Begin: April 27, 2022 PoP End: April 26, 2023

2001 Lab Testing Services 12.00 MO _________ to Veterans Integrated Services Network (VISN) 15 in accordance with the Performance Work Statement.

Estimated Quantities: See Attachment 1, Test Schedule Contract Period: Option 2 PoP Begin: April 27, 2023 PoP End: April 26, 2024

2002 Unscheduled Pick-up Service 84.00* YR _________

The Contractor shall accommodate additional specimen pick-ups for unscheduled and STAT testing, twenty-four (24) hours a day, seven (7) days a week, for each facility. Courier response time must be within one (1) hour after notification by a Medical Center. *This CLIN is priced per unscheduled pick-up, estimated at seven (7) pick-ups per month.

Contract Period: Option 2 PoP Begin: April 27, 2023 PoP End: April 26, 2024

3001 Lab Testing Services 12.00 MO _________ to Veterans Integrated Services Network (VISN) 15 in accordance with the Performance Work Statement.

Estimated Quantities: See Attachment 1, Test Schedule Contract Period: Option 3 PoP Begin: April 27, 2024 PoP End: April 26, 2025

3002 Unscheduled Pick-up Service 84.00* YR _________

The Contractor shall accommodate additional specimen pick-ups for unscheduled and STAT testing, twenty-four (24) hours a day, seven (7) days a week, for each facility. Courier response time must be within one (1) hour after notification by a Medical Center. *This CLIN is priced per unscheduled pick-up, estimated at seven (7) pick-ups per month.

Contract Period: Option 3 PoP Begin: April 27, 2024 PoP End: April 26, 2025

4001 Lab Testing Services 12.00 MO _________ to Veterans Integrated Services Network (VISN) 15 in accordance with the Performance Work Statement.

Estimated Quantities: See Attachment 1, Test Schedule Contract Period: Option 4 PoP Begin: April 27, 2025 PoP End: April 26, 2026

4002 Unscheduled Pick-up Service 84.00* YR _________

The Contractor shall accommodate additional specimen pick-ups for unscheduled and STAT testing, twenty-four (24) hours a day, seven (7) days a week, for each facility. Courier response time must be within one (1) hour after notification by a Medical Center. *This CLIN is priced per unscheduled pick-up, estimated at seven (7) pick-ups per month.

Contract Period: Option 4 PoP Begin: April 27, 2025 PoP End: April 26, 2026

GRAND TOTAL: $____________________

Under the authority of Public Law 104-262 and FAR Part 15, the Contractor agrees to furnish all labor, supplies, equipment, and qualified personnel to provide laboratory testing services to the Veterans Integrated Service Network (VISN) 15 Medical Centers listed herein in accordance with the performance work statement and at the price(s) awarded.

1. Pricing Instructions

1.1. The pricing information is located at Attachment 1, Test Schedule, which is located in Section D of the solicitation and/or contract and shall be referenced for all pricing information. Addendum 1 is the Panel Test with Components definitions.

1.2. Attachment 1, Test Schedule shall not be altered in any way, including by adding or deleting information, without prior approval from the Contracting Officer.

1.3. The Contractor shall provide a standard price list of all testing services per the Test Schedule. Pricing shall include discounted pricing offered to VISN 15 Medical Centers. All relevant information including the following shall be provided in the proposal documents:

1.3.1. Contractor’s Test Code Number

1.3.2. Maximum turnaround time (TAT) from pick-up of specimen to reporting of results, excluding time required for repeat assay.

1.3.3. Test Methodology

1.3.4. Identify the Lab’s Testing Site such as when not performed at the Contractor’s main laboratory facility.

1.3.5. Availability of STAT/Emergency Testing

1.3.6. Days and Times Test Performed

1.4. The initial performance period for this contract shall be one (1) year from the award effective date and is renewable in four (4) one-year option periods exercised at the sole discretion of the Department of Veterans Affairs.

1.5. All orders placed against this IDIQ contract are subject to the terms and conditions of the IDIQ contract and all clauses and provisions in full text or incorporated by reference herein. This IDIQ contract does not obligate any funds. The Government is obligated only to the extent of authorized task orders actually issued under the IDIQ contract by the Contracting Officer.

1.6. Any testing procedures that are not specifically listed on the Attachment 1 Test Schedule will be added to the contract through a modification on an annual basis. The rate will be established in the same manner as the contract rates were established.

1.7. Guaranteed Minimum and Contract Maximum:

1.7.1 The Guaranteed Minimum is applicable during the base period of the fiscal year in which award was made. The Guaranteed Minimum is $10,000.00.

1.7.2 The Contract Maximum is $68,000,000.00.

1.8 Only government contracting officers representing VISN 15 are authorized to place task orders under this IDIQ contract. Any authorized user shall only be allowed to issue an order under this contract if funds are certified and a task order number is assigned. Contractor shall not accept or perform any purported order that does not contain a task order number issued by a VISN 15 NCO contracting officer.

B.3 PERFORMANCE WORK STATEMENT

VISN 15 REFERRAL LABORATORY TESTING

1. GENERAL REQUIREMENTS:

1.1. The Department of Veterans Affairs, Veterans Integrated Services Network (VISN) 15, requires laboratory testing services. The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by VA Medical Centers (VAMC) in VISN 15 within the VISN 15 geographic areas needed during the contract period. The contractor shall provide all personnel, transportation, equipment, supplies, facilities, supervision, other items and non-personal services necessary to provide/perform the supplies/services defined in this Performance Work Statement. The contractor assumes all liability risks for the work performed under the contract/order. The contractor must assume total liability for all contractor employees. Services shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory(s), performance of pre-analytical specimen processing support services, the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results, and consultative services as required to provide the full scope of its laboratory services to the ordering facility. The Contractor shall provide varying levels of support service depending on the unique characteristics presented by each Medical Center or Outpatient Clinic.

1.2. Services to be furnished under this contract shall be ordered by issuance of a task order by the ordering activity for results to be delivered to the site designated on the task order and in accordance with standards, clauses and provisions of this document.

1.2.1. One Task Order will be issued for each location.

1.2.2. Participating Medical Centers:

1.2.2.1. VA Medical Center, 800 Hospital Drive, Columbia, Missouri 65201-5275

1.2.2.2. VA Medical Center, 4801 Linwood Blvd, Kansas City, Missouri 64128- 2226

1.2.2.3. VA Medical Center, 4101 S. 4th Street, Leavenworth, Kansas 66048-5014

1.2.2.4. VA Medical Center, 2401 West Main St., Marion, Illinois 62959-1188

1.2.2.5. VA Medical Center, 1500 N. Westwood Blvd., Poplar Bluff, Missouri 63901-3318

1.2.2.6. VA Medical Center, John Cochran Division, 915 N Grand Blvd, St. Louis, Missouri 63106-1621

1.2.2.7. VA Medical Center, 2200 Gage Blvd., Topeka, Kansas 66622-0001

1.2.2.8. VA Medical Center, 5500 East Kellogg, Wichita, Kansas 67218-1607

1.2.2.9. VA Health Care Center, 6211 E. Waterford Blvd., Evansville, Indiana 47715-2869

1.2.2.10. VA Medical Center, 1 Jefferson Barracks Drive, St. Louis, MO 63125-4181

1.3. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements:

1.3.1. Ordering Code (Contractor’s Identification Code)

1.3.2. LOINC – Logical Observation Identifier Names and Codes

1.3.3. CPT Code – Current Procedural Terminology

1.3.4. Interface Code/Test Mapping

1.3.5. Test methodology

1.3.6. Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement

1.3.7. Therapeutic or diagnostic reference ranges (when appropriate)

1.3.8. Specimen collection and handling requirements

1.3.9. Test result interpretation or interpretive remarks, if appropriate

1.4. All testing shall be performed on the Contractor’s premises, or within the Contractor's network of laboratories (affiliate or qualified Subcontractor). Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America. Contractor referrals to a secondary (Subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes and shall be at the Contractor’s expense. Subcontractors shall be held to the same quality standards as specified in the contract.

1.5. Citizenship related Requirements: While performing services for the VA, 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. The Contractor must return a signed certification at the time of proposal 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 the VA. 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 (http://uscode.house.gov/) and is applicable to the entire POP.

GENERAL QUALIFICATIONS:

1.6. Licensing and Accreditation

1.6.1 Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/SubContractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

1.6.2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer (CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification.

1.6.3. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

1.6.4. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA).

1.6.5. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the contract within 24 hours of notification of an investigation or suspension.

1.6.6. Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.

1.6.7. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

1.6.8. The Contractor must have at least three years of experience providing laboratory services and must have at least one-year experience in transporting biomedical materials.

1.6.9. CLIA certifications shall include:

1.6.9.15. Immunohematology Antibody Detection (transfusion) (520)

1.6.9.16. Immunohematology Antibody Detection (non-transfusion) (530)

1.6.9.17. Immunohematology Antibody Identification (540)

1.6.9.18. Immunohematology Compatibility Testing (550)

1.6.9.19. Histopathology (610)

1.6.9.20. Oral Pathology (620)

1.6.9.21. Cytology (630)

1.6.9.22. Radiobioassay (800)

1.6.9.23. Cytogenetics (900)

1.6.10. The Contractor is required to provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

1.6.11. The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s).

1.7. Authority: Public Law 104-262, Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority, FAR Part 12 & 15, and VAAR 873.

1.8. Policy/Handbooks:

1.8.1. VHA Handbook 1100.17: National Practitioner Data Bank Reports - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

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

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

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

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

1.8.5. VHA Handbook 1106.01: Pathology and Laboratory Medicine Service (P&LMS) Procedures https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

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

1.9.1. BLS: Basic Life Support

1.9.2 CDC: Centers for Disease Control and Prevention

1.9.3. CDR: Contract Discrepancy Report

1.9.4. CMS: Centers for Medicare and Medicaid Services

1.9.5. 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.

1.9.6. 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.

1.9.7 CPARS: Contractor Performance Assessment Reporting System

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

1.9.9. 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.

1.9.10. EKHCS: Eastern Kansas Health Care System

1.9.11. HHS: Department of Health and Human Services

1.9.12. HIPAA: Health Insurance Portability and Accountability Act

1.9.13. ISO: Information Security Officer

1.9.14. POP: Period of Performance

1.9.15. PWS: Performance Work Statement

1.9.16. QASP: Quality Assurance Surveillance Plan

1.9.17. STLHCS: St. Louis Health Care System

1.9.18. TAT: Turnaround Time is defined as the time between pick-up of specimen and receipt of results by a Government facility.

1.9.19. VAMC: VA Medical Center

1.9.19. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers in the VISN 15 geographic location.

2. KEY PERSONNEL: ON-SITE PROCESSORS

2.1. The Contractor shall provide On-site Processors at St. Louis, Columbia, and Marion VA Medical Centers. Other determinations whether a VA Medical Center requires an On-site Processor shall be determined by the Contractor. Once a determination has been made, the Contractor shall coordinate with the COR and CO. This service shall be provided at no additional cost to the Government.

2.2. On-site processors and alternates shall be identified as key personnel and shall complete all required training and background checks prior to performing services on-site. On-site Processors shall be issued a Personal Security Verification (PIV) card. Key personnel are not required to attend New Employee Orientation training.

2.2.1. Key Personnel: The following contracted On-site Processors are assigned by

VAMC.

St. Louis John Cochran VAMC

Alternate On-Site Processor St. Louis John Cochran VAMC

Columbia VAMC

Primary #2 On-Site Processor

Alternate On-Site Processor

Marion VAMC

2.2.2. 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.

2.2.3. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable 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.

2.2.4. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a 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.

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

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

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

2.2.8. 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.

2.3. Permitted On-site Processor Services:

2.3.1. Collect specimens that are sent to referral testing.

2.3.2. Prepare specimens for shipment to referral testing.

2.3.3. Enter billing information or demographic information related to laboratory testing services into a referral laboratory billing information system.

2.3.4. Retrieve billing information, test results or demographic information relating to laboratory testing results from a referral laboratory billing information system.

2.3.5. Complete a Send Out requisition based upon information provided by a client on a script or encounter form.

2.3.6. Perform other activities that are directly related to referral laboratory testing services but that are not activities that would normally be performed by the client or client’s staff.

2.3.7. The onsite processer shall stock depleted send out supplies and if needed, those VA supplies used for processing the referral specimens.

2.3.8. To assist the VAMC the processor may access the patient chart only when attempting to assist in interpreting unclear provider orders for referral testing; however, all findings must be relayed to the VA facility staff for final determination of need.

2.3.9. Shall provide responses for referral laboratory related phone inquiries.

2.3.10. On-site Processors at the St. Louis VAMC shall collect the hard reports produced from the referral laboratory printer and file in alphabetical order by month in the Send Out report filing cabinets.

2.3.11. On-site Processors at the Columbia VAMC shall print the hard reports from the referral laboratory website. The On-site Processor shall ensure the results have crossed into the VISTA system and will then place the hard copy printouts in the shred bin for destruction. If the results have not crossed, the On-site Processor shall place the printouts in a folder for review by and Ancillary Testing Coordinator.

2.3.12. Shall receive testing results and auto release reportable results using the interface electronic system.

2.3.13. Shall provide the VAMC staff technologist overseeing fee basis testing or the VAMC laboratory supervisor a copy any infectious disease printed report immediately upon receipt.

2.3.14. Within the same sample collection time, as indicated by the Send Out sample accession for the missing, quality insufficient or otherwise inadequate sample, the on-site processor is authorized to use the remainder of a completed sample previously utilized for in-house testing to complete the Send Out request. Samples from different draw times may also be used but must first be approved by the VAMC staff overseeing the fee basis section or the VAMC laboratory supervisor.

2.3.15. When reviewing specimen acceptability, the on-site employee will exhaust all primary and alternative tubes options against the most up-to-date reference laboratory guidelines prior to requesting cancellation for improper specimen type.

2.4. Prohibited On-site Processor Services:

2.4.1. Processors shall not evaluate, interpret results, or review diagnosis codes.

2.4.2. Processors shall not perform receptionist duties.

2.4.3. Processors shall not perform any services related to a non-referral laboratory. This includes performing tests, entering billing information, test results, billing information or other information related to the non-referral laboratory.

2.5. Alternate On-site Processors:

2.5.1. Shall serve as a substitute when the designated On-site Processor is unable to report for duty.

2.5.2. Alternate On-site Processors shall be identified as key personnel.

2.5.2.1. St. Louis VAMC shall have alternate processors processed and trained.

2.5.2.2. Columbia VAMC shall have alternate processors.

2.5.2.3. Marion VAMC does not require alternate processors.

2.5.2.4. Alternate On-site Processors must complete the background and TMS training requirement before performance on-site is authorized through a contract modification.

2.5.2.5. Alternate On-site Processors shall not access patient’s charts.

2.6. On-site Processors call-in and leave process:

2.6.1. The patient service representative shall notify the site designee within one hour of processor start time if sick leave or unscheduled absence is requested.

2.6.2. The patient service representative shall notify the site designee as soon as possible when a processor has scheduled leave.

2.6.3. The On-site Processor shall not miss more than two unscheduled (2) shifts per year or shall not be tardy more than three (3) shifts per year. The COR will contact the Contractor directly with the first occurrence of a missed shift or tardiness and any repeated occurrences shall be documented with a Contract Discrepancy Report (CDR) processed through the Contracting Officer. See Attachment 2, QASP - Contract Discrepancy Report (CDR), located in Section D of the solicitation.

2.7 Laboratory Specimen Processing Equipment for On-site Processors

2.7.1. The Contractor shall provide laboratory specimen processing equipment at VAMC locations for use by their own staff assigned as on-site processors.

2.7.2. The laboratory equipment is only for contracted personnel use.

2.7.3. The Contractor has the right to inspect, maintain, repair, or replace the equipment at any reasonable time.

2.7.4. The Government shall immediately report to the Contractor if the laboratory equipment is damaged or stolen.

2.7.5. The laboratory equipment shall be maintained in a secure area.

2.7.6. The laboratory equipment shall not be removed or relocated except by the Contractor’s personnel.

2.7.7. The Contractor shall retain title and ownership of their laboratory equipment.

2.7.8. If the contract is terminated or expires, the laboratory equipment shall be removed from the premises by the Contractor within two (2) business days.

2.8. Health Care Requirements for On-site Processors

2.8.1. The Contractor shall perform required services in accordance with the standards of The Joint Commission (TJC) and established principles and ethics of the medical profession. The Contractor shall adhere to Veterans Health Administration (VHA) regulations, policies, procedures, and regulations. This shall include all Contractor employees to wear an appropriate VA name badge at all times while on the grounds of the VAMC.

2.8.2. The Contractor shall perform required services in compliance with all VA security policies and applicable confidentiality statutes, including 38 U.S.C. 5701, 38 U.S.C. 5705, 38 U.S.C. 7332, 5 U.S.C. 552a (Privacy Act), as well as 45 C.F.R. Parts 160, 162 and 164 (Health Insurance Portability and Accountability Act).

2.8.3. Services under this agreement are provided at facilities that are subject to VA’s Drug-Free Workplace Policy. As such, Contractor is expected to provide personnel consistent with the aim of that policy, i.e., personnel that are drug free. Contractor is expected to have its own guidelines in place to promote the utilization of drug free personnel, including the ability to administer drug testing on their personnel during situations of “reasonable suspicion” of drug use and testing following any incidents of “accident or unsafe practices”. It is also recommended that Contractor have procedures in place for random drug testing. Contractor personnel reasonably suspected by the VA to be in violation of the VA’s Drug Free Workplace Policy shall be immediately removed from the respective VAMC facility and may not be eligible for continued contract performance at VA facilities.

2.8.4. Infection Control Compliance: Contractor shall provide written certification of training compliance with the Blood borne Pathogens Standards, 29 CFR Part 1910.1030 to the COR.

2.8.5. Contractor shall be required to complete all mandatory training as outlined by medical center policy. This training is computerized. The Contractor’s employees shall also be required to attend equipment orientation, and/or be assessed for equipment use competency prior to beginning contract services. Contractor employee’s will be involved in direct patient care and will therefore abide by (CDC) Centers for Disease Control guidelines on hand hygiene in health care settings.

2.8.5.1. Do not wear artificial fingernails or extenders when providing patient care.

2.8.5.2. Keep natural nails less than one quarter (1/4) inch long.

2.8.5.3. If hands are not visibly soiled, an alcohol-based waterless antiseptic agent is to be used where hand washing sinks are not available or when there is high volume, high intensity patient load.

2.8.5.4. Hand lotions or creams may be used to minimize the occurrence of irritant contact dermatitis associated with hand antisepsis or hand washing, however, these must be compatible with antimicrobial soaps/gels used, use to latex gloves and ideally would be single user specific. Hand lotions will be provided by the VA.

2.8.6. Interferon Gamma Release Assay (IGRA) Tuberculosis (TB) Testing: Contractor shall provide evidence to the COR of the following:

positive IGRA. The on-site processor shall provide a copy of the negative test report.

2.8.6.2.1. IGRA is a TB blood test. Example of acceptable tests include Quantiferon and T-SPOT.

2.8.6.2.2. Negative TB skin tests results shall not be accepted.

2.8.6.3 The TB test shall be repeated annually or sooner if there is a concern of exposure or for personnel having a positive IGRA. Contractor shall provide evidence of retests to COR within ten (10) calendar days of retest.

2.8.7. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all site processors

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all site processors {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.

2.8.12. 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.

2.9. 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).

2.10. Citizenship related Requirements:

2.10.1. 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;

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.

2.11. 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.

2.11.1. 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.

2.11.2. 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.

2.12. 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:

(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.

3. FACILITY ADMINISTRATIVE HOURS & FEDERAL HOLIDAYS:

3.1. Administrative hours for the VAMC are Monday through Friday, 8:00 a.m. - 4:30 p.m.

3.2. Federal Holidays observed by the Department of Veteran Affairs:

3.2.1. New Year’s Day;

3.2.2.