B.3 PERFORMANCE WORK STATEMENT

VISN 15 REFERENCE 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 63901-3318

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

1.2.2.11. 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

1.3.4. 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

1.3.10. SNOMED codes

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 nonimmigrant who is in violation of 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 noncompliance 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

1.9.20. 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.

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 Key Personnel Official Title

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

2. _ 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 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 reference testing.

2.3.2. Prepare specimens for shipment to reference testing.

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

2.3.4. Retrieve billing information, test results or demographic information relating to laboratory testing results from a reference 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 reference 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 reference testing; however, all findings must be relayed to the VA facility staff for final determination of need.

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

2.3.10. On-site Processors at the St. Louis VAMC shall collect the hard reports produced from the reference 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 reference laboratory website. The On-site Processor shall ensure the results have crossed into the VistA/Oracle Health system and will then save them for review by the Ancillary Testing Coordinators. If the results have not crossed, the On-site Processor shall place the printouts in a folder for review by an 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-reference laboratory. This includes performing tests, entering billing information, test results, billing information or other information related to the non-reference 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 nonimmigrant 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. Juneteenth

3.2.6. Independence Day;

3.2.7. Labor Day;

3.2.8. Columbus Day;

3.2.9. Veterans Day;

3.2.10. Thanksgiving;

3.2.11. 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 manufacturers 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)

4.3. Transportation:

4.3.1 Specimen Pick-up Times

4.3.1.1 Routine: The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the ordering activity. The ordering activity assigned COR for the applicable facility or designee shall notify the Contractor during weekends and Federal holidays, via telephone, when a pick-up courier is required.

4.3.2. Unscheduled: 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. Unscheduled specimen transport costs are priced separately and shall be the only additional charge for unscheduled testing.

4.3.3. Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user’s manual. The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user manual. The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens.

4.3.4. Shipping Biological and Infectious Substances:

4.3.4.1. Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and 173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers For Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs.

4.3.4.2. Hazardous Materials and Security Training. Contractor or Subcontractors transporting or shipping hazardous materials (hazmat) must be aware of the potential use of hazmat for acts of terrorism and are required to have documented transportation security awareness training. As many biological specimens are now classified as hazmat, it is important for all personnel that are involved in the packing and shipping of laboratory specimens to have hazmat training. The Contractor shall ensure that all personnel who deal with specimen transportation and shipment have the training and certification required by law and regulation. Couriers must be trained to handle Biological Specimens. Evidence of such training shall be provided to the assigned COR for each facility and Contracting Officer for review after award and prior to performance. Failure to maintain compliance shall be reason for the Government to terminate the contract.

4.4 The Contractor shall contact the assigned COR for the applicable facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The Contractor shall provide a mechanism for specimen pickup. The Contractor shall provide to the ordering facility the supplies and equipment within two (2) work days after receipt of the task order. The assigned COR for each facility will request replenishment of supplies from the Contractor on an as needed basis.

4.5. Test Results:

4.5.1. STAT/Emergency:

4.5.1.1. The Contractor shall provide telephonic, fax, or electronic transmission within the commercially published emergency Turnaround Time (TAT) of specimen pick up, unless otherwise agreed. The Contractor shall report all STAT and abnormal test results to ordering activity upon completion of testing.

4.5.1.2. The Contractor shall provide all confirmatory testing, upon request of the ordering activity, at no additional charge to the Government.

4.5.1.3. Contractor shall provide a central call-in telephone number and point(s) of contact to include name, telephone number, and email for each medical center serviced under this contract. The purpose is to provide efficient and timely communication for STAT laboratory requirements, laboratory tests with critical values, and for other discussions regarding laboratory testing procedures and results.

4.5.1.4. Contractor shall provide a central call-in telephone number and point(s) of contact to include name, telephone number, and email for the Medical Director or Subject Matter Expert (SME) of the reference laboratory. The purpose is to provide efficient and timely communication when clinical consultations arise.

4.5.2. Routine: The Contractor shall provide routine test results to the ordering activity in accordance with the testing specifications turnaround times defined in the PWS and Test Schedule. The turnaround times should be calculated from specimen pick-up time to result receipt time.

4.5.3. Test Result Reporting

4.5.3.1. Turnaround Times (TAT): Contractor shall provide electronic transmission (i.e. teleprinter, fax, or computer-to-computer via modem response) of all completed and partial test results to the ordering facility.

4.5.3.1.1 Turnaround time report parameters should match times listed in the contractor’s published specimen collection guide.

4.5.3.1.2. As a minimum requirement, the contractor’s published turnaround time shall match VISN 15’s current turnaround time for 90% of the tests (see Addendum 2 Most Commonly Used Testing).

4.5.3.1.3. Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) for test ordering and resulting to the ordering facility or clinic to be used in the case of a failure of the primary system.

4.5.3.2. Telephone Consultation: The Contractor shall consult with requesting Clinician, or designee at the ordering facility by telephone as needed. The Contractor shall immediately telephone the requesting Clinician, or designee to report Critical Values or test result that may indicate a life-threatening condition.

4.5.3.3. Reporting of Results: Contractor shall provide all required hardware, software and related consumable supplies to support the transmission of electronic data for each ordering facility at no additional charge. All necessary “connections” shall be the responsibility of the Contractor (including one commercial phone line for terminal/data fax connection if required).

4.5.3.4. Contractor shall provide electronic transmission (i.e. teleprinter, fax, or computer to- computer via modem response) of all completed and partial test results to the ordering activity within the turnaround times defined in the Contractor’s commercial specimen collection guide. Turnaround time report parameters should match times listed in the Contractor’s published specimen collection guide. Contractor shall provide all required hardware, software and related consumable supplies and training to support the transmission of electronic data for each ordering activity at no additional charge. All necessary “connections” shall be the responsibility of the Contractor (including one commercial phone line for terminal/data fax connection if required).

4.5.3.5. Telephone Consultation: The Contractor shall consult with the assigned COR for the applicable facility, requesting Clinician, or designee at the ordering activity by telephone as needed. The Contractor shall immediately telephone the assigned COR for the applicable facility, requesting Clinician, or designee to report Critical Values or test result that may indicate a life-threatening condition.

4.5.3.6. Reporting of Results: A report is defined as a final copy of laboratory testing results. This report shall be received by remote terminal. If results are previously telephoned, the report must include the name of the individual notified of the results. Contractor shall provide a copy of its policy concerning corrected or amended reports. Contractor will supply a list of critical values. Contractor shall work with each VISN 15 Laboratory to determine a reporting process for Critical Values. Each test report shall indicate the following information:

4.5.3.6.1. Patient's name and identification code

4.5.3.6.2. Physician's name (if supplied)

4.5.3.6.3. Medical record number (if supplied)

4.5.3.6.4. Facility Name

4.5.3.6.5. Patient's location (clinical/ward), (if supplied)

4.5.3.6.6. Date/time specimen received in Reference Lab

4.5.3.6.7. Test ordered

4.5.3.6.8. Date/time of specimen collection

4.5.3.6.9. Date test completed

4.5.3.6.10. Test result

4.5.3.6.11. Flag abnormal values and critical values

4.5.3.6.12. Reference range

4.5.3.6.13. Toxic and therapeutic range where applicable

4.5.3.6.14. Testing laboratory specimen number

4.5.3.6.15. Name of testing laboratory and address (Contractor and Subcontractor)

4.5.3.6.16. Type of specimen

4.5.3.6.17. All additional comments related to test provided by submitting labs.

4.5.3.6.18. All other information the laboratory has that may indicate a questionable validity of test results.

4.5.3.7. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.

4.6. Retention of Specimens:

4.6.1. Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering activity, the assigned COR for the applicable facility, or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall retain specimens after all testing has been completed in accordance with the most current versions of CAP guidelines GEN 20425 Record Retention Phase II and CAP ANP 12500 Record Retention Phase II. If the laboratory ceases operation, the specimens, slides, blocks, and documentation must be transferred to the VA facility where the testing was originally requested.

4.6.2. Rejection of Specimens: The Contractor shall provide its policies for dealing with inappropriate or compromised specimens.

4.6.3. Documentation: The Contractor shall ensure that all required documentation is legible, and accurate. Contractor personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the Contractor personnel’s own signature to the documents and validating their contents.

4.6.4. Monthly Test Summary: The Contractor shall provide to each ordering activity a monthly utilization report. The report shall be electronic and include the following:

4.6.4.1. CPT Code and Contractor’s test code

4.6.4.2. Test name

4.6.4.3. Current test price

4.6.4.4. Monthly test volume

4.6.4.5. Year-to-date test volume

4.6.4.6. Monthly test cost

4.6.4.7. Year-to-date test cost

4.6.5. Quarterly cost savings reports are a significant condition of this contract. If the Contractor fails to provide a complete cost savings report within the allowable time frames, this contract may be terminated by the Government without cost or penalty. The Contractor shall provide a quarterly cost savings report showing the contract price, and total number of individual laboratory tests ordered quarterly to determine savings. The report is due within twenty (20) business days after the close of each quarter’s business. Reports shall be sent to the following address:

Michael Carson Department of Veterans Affairs Network Contracting Office 15 3450 South 4th Street Trafficway Leavenworth, KS 66048-5055 Michael.Carson1@va.gov

4.6.6. Report periods are as shown below:

1st quarter: October 1 – December 31 2nd quarter: January 1 – March 31 3rd quarter: April 1 – June 30 4th quarter: July 1 – September 30

5.0 ADMINISTRATIVE:

5.1 Service

5.1.1. The Contractor shall provide telephone number(s) and contact person to be used by the ordering activity to make specimen problem inquiries and provide problem solving at all times including weekends and holidays. The Contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

5.1.2. The Contractor agrees to…