SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform offsite Pathology & Laboratory Medicine Services to eligible beneficiaries of the Veterans Affairs Nebraska Western Iowa Health Care System, Omaha Division (hereinafter referred to as “VA NWIHCS”). The contractor’s physician(s)’ care shall cover the range of Pathology & Laboratory Medicine Services in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the College of American Pathologists (CAP) Homepage | College of American Pathologists.

Place of Performance: Services shall be provided at Contractor’s Site, with the exception of as needed autopsies to be performed on-site at VA NWIHCS, Omaha Division, 4101 Woolworth Avenue, Omaha, NE 68105.

Authority: Under the authority of 38 USC 8153, the Contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to the Nebraska-Western Iowa VA Health Care System (NWIVAHCS).

Pricing Instructions:

The offeror is instructed to edit the number of Line-Item Numbers (LINs) to correspond with the number of CPT codes required on contract.

PRICE SCHEDULE:

PERFORMANCE WORK STATEMENT

1. GENERAL REQUIREMENTS:

1.1. Services Required: The Department of Veterans Affairs, VISN 23 Midwest Healthcare System, has a requirement for medical laboratory and testing analysis services. The Contractor may be responsible for performing pre-analytic processing as defined in its laboratory manual, analysis, and reporting of analytical results and interpretation for clinical and anatomical pathology specimens as requested by participating facilities (listed below) during the contract period. The contractor shall provide Pathology and Laboratory Medicine Services, on a scheduled basis, in accordance with the specifications, terms and conditions herein. VA will be responsible for specimen collection, preparation, grossing (with the exception of cytology specimens), VistA accessioning, preservation and storage of final slides and blocks. All slides and blocks must be returned to the VA for permanent storage

1.2. Lab Referral Services: Lab Referral Services will be provided for the Department of Veterans Affairs, VISN 23 Midwest Healthcare System Services for the following participating facilities:

1.2.1. Omaha VA Medical Center – Man Laboratory

(4101 Woolworth Avenue Omaha, Ne 68105)

1.2.2. Lincoln Community Based Outreach Clinic (CBOC) – Main Laboratory (420 Victory Park Drive Lincoln, Ne 68510)

1.2.3. Grand Island Community Based Outreach Clinic (CBOC) – Main Laboratory (2201 North Broadwell Avenue Grand Island, Ne 68803)

1.3. Authority: Title 38 USC § 8153, Health Care Resources (HCR) sharing Authority and Federal Acquisition Regulation (FAR) Parts 12, 13, 15, and VAAR Part 873

1.4. Policy/Handbooks: The Contractor shall be subject to the following policies and regulations including any subsequent updates during the period of performance of this contract. Copies of most current VA and VHA publications are located at: https://www.va.gov/vapubs/ and http://www.va.gov/vhapublications/.

1.4.1. VA Directive 1663: Health Care Resources Contracting - Buying

1.4.2. VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards

1.4.3. VHA Directive 1100.21(1) Privileging 17 QM Quality Management

1.4.4. VHA Directive 1106, “Pathology and Laboratory Medicine Service

1.4.5. VHA Directive 1907.01(1): VHA Health Information Management and Health Records-

1.4.6. Privacy Act of 1974 (5 U.S.C. 552a) as amended

1.4.7. VA Directive 6004, “Configuration, Change, and Release Management Programs”

1.4.8. VA Directive 6300, “Records and Information Management”

1.4.9. VA Directive 6371, “Destruction of Temporary Paper Records”

1.4.10. VA Directive 6500, “VA Cybersecurity Program”

1.4.11. VA Directive 6517, “Risk Management Framework for Cloud Computing Services”

1.4.12. VA Directive 6513, “Secure External Connections”

1.4.13. VA Handbook 6300.1, “Records Management Procedures

1.4.14. VA Handbook 6500, “Risk Management Framework for VA Information Systems, VA Information Security Program”

1.4.15. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information”

1.4.16. VA Handbook 6500.3, “Certification and Accreditation of VA Information Systems

1.4.17. Cancer Protocol Templates | College of American Pathologists

1.4.18. Title 42 CFR 415.170 Code of Federal Regulations (CFR) Section

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

1.5.1. AABB: Association for the Advancement of Blood & Biotherapies

1.5.2. ACO: Administrative Contracting Officer

1.5.3. ANSI: American National Standards Institute

1.5.4. AP: Anatomical Pathology

1.5.5. AMA: American Medical Association

1.5.6. ASCP: American Society for Clinical Pathology

1.5.7. BAA: Business Associate Agreement

1.5.8. BBA: Balanced Budget Act

1.5.9. C&A: Certification and Accreditation (Authorization)

1.5.10. CAP: College of American Pathologists

1.5.11. CBOC: Community Based Outpatient Clinic

1.5.12. CDC: Centers for Disease Control and Prevention

1.5.13. CDR: Contract Discrepancy Report

1.5.14. CEU: Certified Education Unit

1.5.15. CFR: Code of Federal Regulations

1.5.16. CASA: Cisco Adaptive Security Appliance

1.5.17. CLIA: Clinical Laboratory Improvement Act of 1988

1.5.18. CME: Continuing Medical Education

1.5.19. CMP: Civil Monetary Penalty –(42 U.S.C. § 1320a-7a)

1.5.20. CMS: Centers for Medicare & Medicaid Services

1.5.21. CO: Contracting Officer- The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

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

1.5.23. COS: Chief of Staff

1.5.24. COTR: Contracting Officer Technical Representative

1.5.25. CP: Clinical Pathology

1.5.26. CPARS: Contractor Performance Assessment Reporting System

1.5.27. CPT: Current Procedural Terminology

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

1.5.29. Critical Value/Test: A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to VISN 04 upon request.

1.5.30. DEA: Drug Enforcement Agency

1.5.31. DOB: Date of Birth

1.5.32. DMS: Data Management System

1.5.33. ESCCB: (VA) Enterprise Change Control Board

1.5.34. EHR: Electronic Health Record – Electronic Health Record system used by the VA

1.5.35. EMR: Electronic Medical Record

1.5.36. FAPIIS: Federal Awardee Performance and Integrity Information System

1.5.37. FAR: Federal Acquisition Regulation

1.5.38. FDA: Food and Drug Administration

1.5.39. FISMA: Federal Information Security Management Act

1.5.40. FOIA: Freedom of Information Act

1.5.41. FSC: Financial Services Center

1.5.42. FTCA: Federal Tort Claims Act

1.5.43. HCR: Health Care Resources

1.5.44. HCS: Health Care System

1.5.45. HEDIS: Health Plan Employer Data and Information Set

1.5.46. HHS: Department of Health and Human Services

1.5.47. HIPAA: Health Insurance Portability and Accountability Act

1.5.48. HIS: Hospital Information System

1.5.49. HL7: Health Level Seven

1.5.50. IDIQ: Indefinite Delivery Indefinite Quantity

1.5.51. ISO: Information Security Office or Officer

1.5.52. LIN: Line-Item Number

1.5.53. LIS: Laboratory Information System

1.5.54. LOINC: Logical Observation Identifier Names and Codes

1.5.55. NARA: National Archives and Records Administration

1.5.56. NCQA: National Committee for Quality Assurance

1.5.57. NIST: National Institute of Standards and Technology

1.5.58. NPI: National Provider Identifier: NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.59. NWIHCS: Nebraska-Western Iowa Healthcare System

1.5.60. OIG: Office of Inspector General

1.5.61. OIT: VA Office of Information and Technology

1.5.62. OMB: Office of Management and Budget

1.5.63. OSHA: Occupational Safety and Health Administration

1.5.64. PHI: Protected Health Information

1.5.65. PLMS: Pathology and Laboratory Medicine Services

1.5.66. POC: Point of Contact

1.5.67. POP: Period of Performance

1.5.68. PPIRS: Past Performance Information Retrieval System

1.5.69. PWS: Performance Work Statement

1.5.70. QA/QI: Quality Assurance/Quality Improvement

1.5.71. QC: Quality Control

1.5.72. QASP: Quality Assurance Plan

1.5.73. QM/PI: Quality Management/Performance Improvement

1.5.74. RA: Regulatory Agency

1.5.75. RFP: Request for Proposal

1.5.76. Routine Test: A test that is usually performed at high volume in which the result is required in 24 hours generally.

1.5.77. SF: Standard Form

1.5.78. OI: Security Office Identifier

1.5.79. SON: Submitting Office Number

1.5.80. Special Handling: Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

1.5.81. SSN: Social Security Number

1.5.82. STAT: A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases.

1.5.83. TAT: Turnaround Time - The length of elapsed time between pick-up or dispatch of specimen from the contractor’s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab.

1.5.84. TC: Technical component (CMS pricing) of a service or procedure and includes the cost of equipment and supplies to perform that service or procedure.

1.5.85. TIC: Trusted Internet Connection

1.5.86. TJC: The Joint Commission

1.5.87. VA NWIHCS: The Department of Veterans Affairs Medical Center, Nebraska-Western Iowa Health Care System.

1.5.88. VAMC: Veterans Affairs Medical Center

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

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

1.5.91. VISN: Veterans Integrated Services Network - The regional oversight for the VA medical centers

1.5.92. VistA: Veterans Integrated Systems Technology Architecture - A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system

1.6. Regulatory Compliance: Contractor shall be responsible for maintaining contractor’s facility in regulatory compliance with respect to VA, Federal and State regulatory agencies including but not limited to: VA Office of Inspector General (OIG), Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) as well as to accrediting entities such as but not limited to College of American Pathologists (CAP), American Association of Blood Bankers (AABB), Occupational Safety and Health Administration (OSHA) and Joint Commission (JC). These responsibilities include, but are not limited to, assuring acceptable levels of risk for Veteran safety, maintaining adequate quality of services to facility providers and their Veterans, and working with VA to minimize inappropriate utilization of laboratory resources through utilization review and consultation. Contractor shall be required to report all findings and actions to the VA periodically to assure contractor and VA compliance with regulations and by-laws.

1.7. Facilities: The contractor shall provide and maintain facilities including, but not limited to buildings, utilities, environmental control, communications, and information systems for the execution of professional services in such a state as to assure continuity and level of quality required to maintain regulatory compliance. The right is reserved to thoroughly inspect and investigate the establishment, facilities, business reputation and other qualifications of any bidder and to reject any bid, irrespective of price, that shall be administratively determined, lacking in any of the essentials necessary to assure acceptable standards of performance.

1.8. Equipment: The contractor shall provide and maintain laboratory testing instruments and other ancillary equipment at contractor’s site in support of professional services in such a state as to assure continuity and level of quality required to maintain regulatory compliance. Equipment provided by the Contractor for use at the VA NWI facility will be returned to the Contractor when requested, or at the end of the contract

1.9. Supplies: The contractor shall provide all supplies necessary to support professional services in such quantities and state of condition as to assure continuity of said services to the facility’s practitioners at a level of quality required to maintain regulatory compliance. This includes all materials necessary to collect, preserve, transport (this includes containers of various sizes for the specimens, collection containers (of such quality that specimens will not be compromised, i.e., polypropylene)/kits for both surgical and cytopathology specimen(s) immunofluorescent preservative, EM fixative, flow cytometry preservative, etc.), and process specimens examined at the contractor’s facility as part of the provision of the professional services. A detailed list is provided:

1.10. The Contractor shall contact the assigned point of contact for each participating facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies, communication terminal and connections, and the installation of equipment.

1.11. The Contractor shall provide each participating facility supplies and equipment within five (5) business days after receipt of the order. The assigned point of contact for each facility will request replenishment of supplies from the Contractor on an as needed basis.

1.12. Personnel: The contractor shall provide all personnel necessary at contractor’s site to support technical services in such number and level of professional experience as to assure continuity and level of quality as established by this facility to meet regulatory requirements by VA and JC regulations. The contractor shall have adequate personnel to be able to provide the full schedule of services within established turn-around times. All personnel shall be properly trained, boarded, professional personnel to provide services as necessary to support the VA Nebraska-Western Iowa Health Care System mission.

1.13. Oversight: To the degree the contractor maintains authority over its personnel, in cooperation with the VA, the contractor shall provide all necessary administrative and personnel management resources to maintain appropriate professional behavior to ensure continuity and level of quality as established by this facility to meet regulatory requirements by VA and Regulatory Agencies. In addition, the contractor will be responsible through an appointed medical director to provide supervisory oversight to personnel at contractor’s facilities

1.14. Term of Contract: ORDERING PERIOD I is effective April 1, 2027, through March 31, 2028, plus 4 One-Year ORDERING PERIODS that may be exercised by the VA. No services are to be performed after the end of the contract period (March 31) until the Contracting Officer (CO) authorizes such services in writing.

2. CONTRACTOR QUALIFICATIONS:

2.1. Licensing and Accreditation:

2.1.1. The Contractors' Laboratory Director, Medical Technologists, Medical Technicians, Cytotechnologists and Pathologists shall meet and maintain the Personnel qualifications required by CLIA. Further, the Contractor will provide evidence of the Contractors’ current compliance thereof. All Staff shall be appropriately licensed/accredited by the College of American Pathologists (CAP), The Joint Commission or (other Accreditation Body). In addition, the laboratory must be certified and maintain certifications meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2.1.2. All professionals providing services under the terms of this contract will be appropriately certified and/or licensed as described herein and possess the requisite skills and experience to perform P&LM services. The contractor will be responsible for ensuring that contractor employees performing work on this contract are fully trained and competent to perform the required work. The contractor is required to develop and maintain the following documents for each contractor employee working on the contract: credentials and qualifications for the job; a current competency assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required in this solicitation; a list of relevant continuing education for the last two years, and a current provider license is required. Contractor will ensure that VA NWIHCS always has a current copy of provider license(s).

2.1.3. License: All licenses held by the contractor staff working on this contract shall have a full and unrestricted valid medical license to practice medicine in a state, Territory or Commonwealth of the U.S. or in the District of Columbia. The physician must maintain a current registration in the State of licensure if this is a requirement for continuing active/current licensure. Contractor staff must submit evidence of at least one full, active, current and unrestricted licensure, registration, certification, and/or other relevant credentials, for verification prior to appointment and throughout the employment process, as requested by the Contracting Officer’s Representative (COR). Contractor is responsible for keeping the VA COR apprised of anything that would adversely affect or otherwise limit their clinical privileges. NOTE: Failure to keep VA fully informed on these matters may result in administrative or disciplinary action.

2.1.4. The Contractor is responsible to ensure that all personnel (1) possess the requisite credentials to practice at the full performance level of their profession. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor, or any discovery of any disciplinary action taken against laboratory/laboratories performing under the contract within 24 hours of notification of an investigation or suspension.

2.1.5. The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license and or accreditation (Clinical Laboratory Improvement Amendments (CLIA) certification, COLA, CAP, JC, etc.) The Contractor shall provide a copy of the renewed licenses to the Contracting Officer before expiration.

2.1.6. Professional Liability Insurance: The Contractor shall provide and maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage.

2.1.7. Board Certification/Eligibility: All contract Pathologists must have current American Board of Pathology specialty and/or subspecialty certification (AP/CP certification is preferred). Certification must be maintained throughout the course of the contract. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification must be provided by the contractor on an annual basis. Cytotechnologists must be American Society for Clinical Pathology (ASCP) certified.

2.1.8. Pathologists: The Contractor shall sufficient Pathologist coverage, who will regularly consult with VA Pathologists and other associated Healthcare Providers at the participating facilities cited in Section 1.2. The Contractors Pathologists shall have graduated from an approved School of Medicine or Osteopathy; and shall have completed a residency or fellowship in Pathology acceptable to the United States Surgeon General and shall possess a valid license to practice clinical reference laboratory services from a United States jurisdiction.

2.1.9. The Contractor shall provide the following information prior to contract award, and upon proposed change of any Key Personnel:

2.1.9.1. Provider Name with their Title/Position and Grade/Rank

2.1.9.2. Curricula Vitae, (Not to Exceed 2 pages, per ) – Is this required?

2.1.9.3. Technical Staff Competency Skills Assessment

2.1.9.4. CAP and or any Proficiency Exam participation for the last two (2) years

2.1.9.5. Proficiency Examination Exception Reports for the past two (2) years

2.1.10. Technical Proficiency: Contractor’s physician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to read, write, speak, and comprehend the English language, fluently. Contractor will provide documents upon request from the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Education: Contractor staff must possess a degree of Doctor of Medicine or an equivalent degree resulting from a course of education in medicine or Osteopathic Medicine. The degree must have been obtained from one of the schools approved by the Secretary of Veterans Affairs for the year in which the course of study was completed.

2.1.11. Continuing Medical Education (CME)/Certified Education Unit (CEU) Requirements: Contractor will provide the COR copies of current CMEs/CEUs as required or requested by the VA NWIHCS. Contractors registered or certified by national/medical associations shall continue to meet the minimum standards for CMEs/CEUs to remain current. These documents are required for both privileging and re-privileging. Failure to provide will result in loss of privileges.

2.1.12. Conflict of Interest: The Contractor and all Contractor’s employee(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 and fully outlined in response to the subject attachment in Section D (Attachment D.4) of the solicitation document.

2.1.13. Citizenship-Related Requirements:

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

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

2.1.13.3. 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(s) where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

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

2.1.13.5. 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 (Attachment 3) in Section D of the solicitation document.

2.1.14. Annual Office of Inspector General (OIG) Statement:

2.1.14.1. 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 shall not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.14.2. Therefore, the Contractor shall review the OIG List of Excluded Individuals/Entities on the OIG website at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractors and/or firm(s) are not listed. Contractors 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 or entity 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 contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

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

2.1.14.4. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.14.5. DEA: Contractor shall provide copy of current DEA certificate (if applicable) for Nebraska where services will be provided under this contract.

2.2. TECHNICAL DIRECTION: The qualifications of contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Technical direction of all clinical personnel covered by this contract will be provided by the VA NWIHCS COS and/or the Chief of the Service or his/her designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request during the administration of the resultant contract.

2.3. NON-PERSONAL SERVICES: This contract is a non-personal healthcare services contract. “Non-personal services contract means a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.” The parties agree that the contractor, all contractor staff, agents and sub-contractors shall not be considered VA employees for any purpose.

2.3.1. Inherent Government Functions: Contractor and contractor staff 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, 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.

2.3.2. No Employee status: The contractor shall be responsible for protecting the contractor’s staff furnishing services. To carry out this responsibility, the contractor shall provide or certify that the following are provided for all of their staff providing services under the resultant contract:

2.3.2.1. Workers’ compensation

2.3.2.2. Professional liability insurance

2.3.2.3. Health examinations

2.3.2.4. Income tax withholding, and

2.3.2.5. FICA and Medicare tax withholding

2.3.3. Tort Liability: The Federal Tort Claims Act does not cover contractor’s or sub-contractor’s staff. When a contractor or a member of their staff has been identified as a provider in a tort claim, the contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a contractor’s staff action or non-action is the responsibility of the contractor and/or insurance carrier.

2.3.4. Malpractice Claims: The NWIHCS Facility Director or designee will provide written notification to all licensed practitioners when a claim for medical malpractice is filed with respect to care provided by that practitioner (reference VHA Directive 2009-032). Such notification must be provided within 30 days from the date Regional Counsel notifies the facility Director that a claim for medical malpractice has been filed under the Federal Tort Claims Act (FTCA), Title 28 United States Code (U.S.C.) 1346(b), 2671-2680. Please reference: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=361153&FileName=VA263-12-R-0372-005.PDF

2.4. GENERAL:

2.4.1. The Government may evaluate the quality of professional and administrative services provided but retains no control over the medical or professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment).

2.4.2. To the extent that this contract is subject to Section 952 of the Omnibus Reconciliation Act of 1980, 42 U.S.C. 1395(v)(1)(I), and the regulations promulgated hereunder, and the cost or the value or the services provided is $10,000 or more over a 12-month period, the contractor shall allow the Comptroller General and their duly authorized representatives to have access to the contractor’s contract, books, documents and records until the expiration of four years after the services are furnished under the Agreement. FAR subpart 4.7. Subpart 4.7 - Contractor Records Retention | Acquisition.GOV

2.5. KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS:

2.5.1. During the first ninety (90) 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 provided the information required below. After the initial 90-day period of the contract the contractor shall submit the information required below to the CO at least 25 days prior to making any permanent substitutions. NOTE: Contractor will not be reimbursed for any services performed by a contractor not identified on the contract.

2.5.2. The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, with complete resumes for the proposed substitutes, and any additional information required 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.

3. CONTRACTOR RESPONSIBILITIES:

3.1. SERVICES REQUIRED: Contractor shall provide Pathology and Laboratory Medicine services for VA beneficiaries. All work is to be performed at the contractor’s site. Contractor is responsible for providing and delivery of all supplies, materials, equipment, and labor to perform the services.

3.2. Procedure Guidance:

3.2.1. The testing methodology and reference ranges for a test must be defined in the Contractor’s laboratory user manual and shall be available online for reference. The Contractor shall provide change notice prior to implementation of each new/updated/retired medical procedure and service. The Contractor’s laboratory user manual shall be made available to a Contracting Officer’s Representative if requested.

3.2.2. The Contractor shall ensure that all tests performed meet the currently acceptable standard deviation and that have daily controls conducted 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.

3.2.3. Tests referred within the Contractor-owned laboratory network or subcontracted laboratories shall be at no additional transfer charge or confirmation charge to the Government.

3.2.4. The contractor shall provide timely and appropriate testing of patient specimens, according to the below requirements, as requested by VA NWIHCS Pathology & Laboratory Department.

3.2.5. Services shall include:

3.2.5.1. Transportation of clinical laboratory specimens, originating from the Omaha VA Medical Center, Grand Island and Lincoln Community Based Outpatient Clinics (CBOCs) to the contractor’s site, contracted commercial reference laboratory or designated site. All specimens picked up from Grand Island and Lincoln CBOCs will be transported to the Omaha VA.

3.2.5.2. Performance of pre-analytical testing samples shall be labeled 100% correctly all of the time to include case number OR patient full name and full SSN OR full DOB.(See 3.4.3)

3.2.5.3. Execution and/or reporting of analytical testing.

3.2.5.4. The contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

3.2.6. Histology:

3.2.6.1. Slides will be cut and labeled with appropriate identification labels. The slides must be returned to NWIHCS-Omaha Main Lab by 9:00 a.m. daily for assessment and reporting and for permanent storage.

3.2.6.2. Permanent storage of blocks & slides as requested will be the responsibility of the contractor if they perform the professional component. A block/slide request must be fulfilled by the contractor and have said block(s)/slide(s) returned to the VA within 24 business hours (Mon-Fri) of request. If contractor does not perform the professional component all blocks/slides will be returned.

3.2.6.3. Contractor to provide the VA Pathologists with an accurate, reliable, and seamless method to process requests to order special stains, extra cuts, etc. Ordering additional studies on tissue blocks will include, but not be limited to:

· Recuts

· Levels

· Special Stains

· Immunohistochemical Stains

· Send Out to Third Party Reference Laboratory for Specialty Studies

· Return of tissue blocks to VA within 24 hours of request.

· Routine cases, that require additional studies, i.e., cuts, stains, etc., will be turned around in the next business day of the request.

· Listing of supplies to be furnished by VA and contractor (reference table in paragraph 1.1.5.)

3.2.7. Cytology:

3.2.7.1. VA will send specimen and requisition with information needed to order in contractor’s LIS with a routine courier.

3.2.7.2. Contractor staff will accession cases in contractor’s LIS.

3.2.7.3. Contractor cytotechnologists will transcribe into contractor’s LIS. The contractor will perform both the technical and professional components (to be billed using the applicable component rates)

3.2.7.4. Internal Consults and Second Signature Consults as requested - Attachments 8 and 9.

3.2.8. Global Case Review:

3.2.8.1. If there are anatomic pathology global cases, the contractor must review 10% of all global cases monthly per accrediting agency guidelines.

3.2.8.2. Any discrepant results must be communicated by telephone or in person within one (1) working day to a VA Pathologist and be included in the monthly report.

3.2.9. Autopsies: The Administrative Officer of the Day, (AOD) shall coordinate the dignified transfer of Veteran remains for anatomic pathology autopsy, pick-up and delivery to contractors site.

3.2.9.1. The majority of autopsies will be performed at Contractor’s site. There is potential that some autopsies may be performed on-site in the future.

3.2.9.2. The provisional anatomic diagnoses must be provided to the VA within two (2) working days via encrypted e-mail and secured fax.

3.2.9.3. The completed post-mortem exam, with final copy of succeeding pages, must be submitted to the VA within 30 working days unless exceptions for special studies are established by the medical staff.

3.3. SERVICES – CERTIFIED LABORATORY(s):

3.3.1. In order to perform the full scope of work required under the solicitation and resultant contract, the Government requires all potential offerors’ CLIA accreditation reflects that the offeror is accredited in all of the following categories both at proposal, and at award. All accreditations must be current and non-expired.

3.3.2. The reference laboratory(s) must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) or must demonstrate accreditation by regulatory agency(s) with deemed status from the Centers for Medicare and Medicaid Services, e.g., The College of American Pathologists, and/or other statute regulatory agencies, as appropriate, and as mandated by federal and state statutes.

3.3.3. In the event a CPT code cannot be performed at the contractor’s facility, tests can be referred out to a certified laboratory facility. Contractor will provide all supplies necessary to transport specimens including, but not limited to: shipping containers, tapes and labels. Tests that are sent out will be reimbursed at contractor’s cost. An administration fee will not be charged. A copy of the current fee pricing and/or invoice for send-out/referred testing fees will be submitted with invoice for documentation.

3.3.4. Copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded contractor must supply a copy to the Contracting Officer. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. The contractor must notify the Contracting Officer of the expiration or the revocation of any of these licensures.

3.4. TEST RESULTS:

3.4.1. Non-emergent/Routine Cases and Emergent (STAT):

3.4.1.1. Non-Emergent/Routine Surgical Cases: Test results shall be received at the Omaha VA within 3 working days of specimen receipt and within 5 working days of specimen receipt for complicated cases.

3.4.1.2. Non-Emergent/Routine Cytology Cases: Cytopathology test reports of Gynecology specimens are to be completed within 14 working days of receipt. Test reports for non-Gynecology specimens are to be completed within 5 working days.

3.4.1.3. Emergent (STAT) specimen processing – Omaha VA only: Contractor shall pick-up specimens and provide results within 2 hours of request. Results will be communicated via telephone call (CP results will be called to the VA Main Laboratory and AP results will be called to the on-call VA staff pathologist) with fax to immediately follow. Failure to meet this requirement could result in review of contract compliance.

3.4.2. Critical Values: The Contractor shall immediately telephone the assigned point of contact for the applicable facility, requesting Clinician or designee, when results of certain tests fall within established alert/critical ranges or when the test result may indicate a life-threatening condition.

3.4.2.1. Delays in Reporting Test Results: If for any reason, there will be a delay in reporting of test results, the Contractor will contact the VA as soon as they are aware that a delay will occur. Such notification shall be made by telephone or facsimile to the Processing Department, POC and the Contractor will provide an estimated time for delivery of delayed results. Email notification will not be accepted.

3.4.3. Each test result shall, at a minimum, include the following information.

NOTE: There will be no charge to the VA for any retesting due to contractor’s error.

· Patient’s name (first and last), full SSN and/or full Date of Birth (DOB) or identification number (i.e., case number)

· Physician’s name (if supplied)

· VA NWIHCS medical record number or laboratory accession number (if supplied)

· VA NWIHCS facility name

· Patient’s location (clinic/ward) (if supplied)

· Test ordered.

· Date/time of specimen collected (when available)

· Date/time test completed.

· Test result.

· Reference Intervals

· Toxic and therapeutic ranges, if applicable.

· Reference laboratory specimen number

· Name of testing laboratory (if other than contractor)

· Any other information the laboratory has that may indicate a questionable validity of test results.

· Unsatisfactory specimen shall be reported with documentation supporting it’s in suitability or testing.

3.5. SPECIMEN HANDLING

3.5.1. Storage of Specimens: The Contractor shall store all specimens as required by the regulatory agencies.

3.5.2. Upon request by the participating facility COR (or designee), the Contractor shall provide a copy of the regulatory requirements for each Regulatory Agency (RA).

3.5.3. In absence of RA requirements, the Contractor shall store specimens, after all testing has been concluded for the following periods:

3.5.3.1. The Contractor shall store the specimens a minimum of seven (7) to ten (10) days after the test is reported in the event that subsequent action is necessary (i.e., problem solving, add-on test, and/or repeat testing).

3.5.3.2. All Cytology and histopathology slides shall be stored for 25 years.

3.5.3.3. Minimum Period of Retention of Laboratory Records and Materials (or subsequent release) and ANP 12500 Record Retention Phase II (or subsequent release).

3.5.4. If the laboratory ceases operation, the specimens, slides, blocks, and documentation must be transferred to the VA facility where the testing was originally requested.

3.5.5. The Contractor shall provide a copy of the specimen rejection policy.

3.5.6. Quality Assurance:

3.5.6.1. Cytology Report Completion: Gynecological (GYN) within 14 working days of receipt; NON-GYN within 5 working days.

3.5.6.2. When a second signature and/or internal consult is required, VA Staff will initiate the Internal Consult Form and/or the Second Signature Form (see Attachments 8 and 9). The form(s) and specimens will be sent to contractor and contractor Pathologist(s) will complete and return the form(s) and slides to VA Staff within 24 hours.

3.5.7. While the Cancer Protocol Templates are guidelines, the VA requires that the most current protocols that are applicable for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care, are to be followed. CAP Protocols/Guidelines are listed on the CAP website. Any deviation from the CAP Protocols/Guidelines must be noted in the patient’s final report.

3.6. COURIER SERVICES (Contractor will not be reimbursed for travel/courier costs; these services are to be performed as part of the all-inclusive CPT code pricing):

3.6.1. Contractor shall provide a courier service between contractor’s facility and the following VA sites (at the designated location) to include but not be limited to: Omaha VA Medical Center, Lincoln Community Based Outpatient Clinic and Grand Island Community Based Outpatient Clinic. The courier service shall include, but is not limited to one or more vehicles, fuel, drivers, and liability insurance shall be maintained to ensure continuity of service.

3.6.1.1. Lab specimens will be picked up once per day (at the end of the workday and delivered to Omaha Laboratory). Routine transportation services shall occur 4 times per day Monday-Friday, with pick-up occurring:

(1) mid-morning (8:30 -10:00 AM),

(2) late morning (11:00 AM – Noon),

(3) mid-afternoon (2:00 – 3:00 PM) and

(4) late afternoon (4:15 - 5:00 p.m.), and upon request on weekends and federal holidays at the Omaha VA.

Grand Island, NE 68803

Lincoln, NE 68510

Omaha, NE 68105

Note: Address to locations may be subject to change.

3.6.2. Transported items will be primarily biomedical materials (patient specimens). These items are classified as Hazard Materials, Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 will be transported.

3.6.3. If there are reasons for potential delays for delivery and/or pick-ups, the contractor shall contact and inform the COR or designee of the situation. Drivers shall not make non-emergent stops. Communication needs to occur when instruments are down to let us know when there are potential delays affecting patient care.

3.6.4. Laboratory specimens, i.e., body fluids (blood, urine and stool), will be properly packaged by VA personnel…