36C25521R0004 0004.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 111

None

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

To all Offerors/Bidders

36C25521R0004

X

X x

X ONE(1)

This amendment is issued to update the solicitation in its entirety for Referral Lab Services for VISN 15 Medical Centers located in Kansas, Missouri and Illinois.

The solicitation is due on January 14, 2022 by 4:00 PM CST.

Ashley Osborn Contract Specialist

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. 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 110

36C25521R0004 01/02/2022

Osborn, Ashley 913-946-1112 01/14/2022

4:00PM CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15

621511

$35 Million

N/A

Network Contracting Office (NCO) 15

3450 S. 4th Street Leavenworth KS 66048

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15

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.

X X

Ashley Osborn

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES: See Attachment 1, Test Schedule

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

2018)

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

C.3 52.216-18 ORDERING (AUG 2020)

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

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

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

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS (OCT 2018)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.10 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.11 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.12 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.13 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.14 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (DEC 2009)

C.15 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.16 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE

(JUL 2018)

C.17 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.18 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2020)

C.19 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

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

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2020)

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:

b. GOVERNMENT: Contracting Officer

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 36C255

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly - 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:

AMENDMENT NO DATE

B.2 SCHEDULE OF SERVICES: See Attachment 1, Test Schedule

Item Description of Number Supplies/Services

Total Estimated

Amount

0001 Base Period of Performance See Attachment 1, Test Schedule

1001 Option Year 1 Period of Performance

2001 Option Year 2 Period of Performance

3001 Option Year 3 Period of Performance

4001 Option Year 4 Period of Performance

ESTIMATED 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.

1.1. 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.

1.2. 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.

1.3. No later than 120 days prior to the beginning of the next option, the Contractor shall provide any new test(s) that are not listed in Attachment 1. The Contract shall also provide a listing of any tests listed in Attachment 1 that are no longer performed by contractor and shall be removed from Attachment 1. New tests must be added to or removed from the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested.

1.4. Guaranteed Minimum and Contract Maximum:

1.4.1. 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.

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

1.5. 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 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, Outpatient Clinic, or Health Care Center.

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-

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-

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

1.2.2.11. VA Health Care Center, 711 South Mount Auburn Road, Cape Girardeau, Missouri 63703-6393

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

1.3.3. Interface Code/Test Mapping

1.3.4. Test methodology

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

1.3.6. Therapeutic or diagnostic reference ranges (when appropriate)

1.3.7. Specimen collection and handling requirements

1.3.8. 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 The Contractor or its Sub-Contractor shall maintain all licenses, permits, accreditation and certificates required by law. These shall be provided annually to the Contracting Officer (CO). The Contractor’s reference laboratory and its subcontractor’s reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the reference laboratory(s) must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

1.6.2. 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. CLIA certifications shall include:

1.6.8.1. Histocompatibility (010)

1.6.8.2. Bacteriology (110)

1.6.8.3. Mycobacteriology (115)

1.6.8.4. Mycology (120)

1.6.8.5. Parasitology

1.6.8.6. Virology (140)

1.6.8.7. Syphilis Serology (210)

1.6.8.8. General Immunology (220)

1.6.8.9. Routine Chemistry (310)

1.6.8.10. Urinalysis (320)

1.6.8.11. Endocrinology (330)

1.6.8.12. Toxicology (340)

1.6.8.13. Hematology (400)

1.6.8.14. Immunohematology ABO Group & Rh type (510)

1.6.8.15. Immunohematology Antibody Detection (transfusion) (520)

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

1.6.8.17. Immunohematology Antibody Identification (540)

1.6.8.18. Immunohematology Compatibility Testing (550)

1.6.8.19. Histopathology (610)

1.6.8.20. Oral Pathology (620)

1.6.8.21. Cytology (630)

1.6.8.22. Radiobioassay (800)

1.6.8.23. Cytogenetics (900)

1.6.9. 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.

1.6.10. 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.

Key Personnel Official Title

1. Primary On-Site Processor St. Louis John Cochran VAMC Alternate On-Site Processor St. Louis John Cochran VAMC

2. Primary #1 On-Site Processor Columbia VAMC

Primary #2 On-Site Processor Columbia VAMC

Alternate On-Site Processor Columbia VAMC

3. Primary 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:

2.8.6.1. Negative TB test results within one (1) year prior to the on-site processor beginning on-site performance.

2.8.6.2. Medical evidence that personnel are disease free for personnel having a 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 {This is applicable to all health care workers}.

2.8.8. VARICELLA: Contractors shall provide proof of immunity for all site processors {This is applicable to all health care workers}.

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

2.8.10. INFLUENZA: Contractors shall provide proof that all site processors 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}.

2.8.11. 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 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;

2.10.2. 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.

2.10.3. 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.

2.10.4. 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.

2.10.5. 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.

2.11. 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:

2.15.1. Workers’ compensation

2.15.2. Professional liability insurance

2.15.3. Health examinations to include:

2.15.4. Annual TB Test and recent chest X-ray if there is a history of positive TB test

2.15.5. 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

2.15.6. Evidence of a Hepatitis C titer

2.15.7. Varicella titer if contracted employee has not had chicken pox

2.15.8. Income tax withholding, and

2.15.9. Social security payments

2.16. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel

(s). When 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. Martin Luther King’s Birthday;

3.2.3. Presidents Day;

3.2.4. Memorial Day;

3.2.5. Independence Day;

3.2.6. Labor Day;

3.2.7. Columbus Day;

3.2.8. Veterans Day;

3.2.9. Thanksgiving;

3.2.10. Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

3.3. Off-Duty hours: Friday through Monday, 4:31 p.m. – 7:59 a.m.

4. CONTRACTOR’S RESPONSIBILITIES:

4.1. Procedure Guidance:

4.1.1. The testing methodology and reference ranges for a test must be defined in the

Contractor’s laboratory user manual. The Contractor shall provide change notice prior to implementation of each new medical procedure and service. The Contractor’s laboratory user manual shall be made available to a Contracting Officer’s Representative if requested.

4.1.2. The Contractor shall ensure that all tests performed meet the currently acceptable standard deviations and that control materials are tested according to manufacturer’s and regulatory guidelines to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer’s Representative (COR) for the applicable facility and the Contractor shall make available quality assurance information on specific testing procedures for review.

4.1.3. Tests referred by the Contractor to another laboratory shall be at no additional transfer charge or confirmation charge to the Government.

4.2. Supplies: The Contractor shall provide all necessary supplies for testing including:

4.2.1. Requisition forms

4.2.2. Specimen containers

4.2.3. Dry ice and appropriate container

4.2.4. Special instructions

4.2.5. Current list of tests with reference ranges and specimen requirements

4.2.6. Specimen carriers

4.2.7. All forms, to include Chain of Custody

4.2.8. Special media or tubes for samples

4.2.9. All supplies for special tests (e.g. viral studies, special swabs, special containers)