B.3 VISN Lab Referral PWS - DRAFT.pdf

B.3 PERFORMANCE WORK STATEMENT

VISN 23 REFERRAL LABORATORY TESTING

1. GENERAL REQUIREMENTS:

1.1. Services Provided: The Department of Veterans Affairs, VISN 23 Midwest Healthcare System, has a requirement for medical laboratory and testing analysis services. The Contractor shall 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. Services shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory/laboratories, 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. Additional required services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; and consultative services. The Contractor shall provide varying levels of support service depending on the unique characteristics presented by each Medical Center or Outpatient Clinic. Services furnished under the contract shall be ordered by issuance of a task order 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. 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. VA Black Hills Health Care System, Hot Springs, SD

1.2.2. VA Black Hills Health Care System, Ft. Meade, SD

1.2.3. Sioux Falls VA Health Care System, Sioux Falls, SD

1.2.4. Fargo VA Health Care System, Fargo, ND

1.2.5. VA Nebraska-Western Iowa Health Care System, Omaha, NE

1.2.6. VA Nebraska-Western Iowa Health Care System, Lincoln, NE

1.2.7. VA Nebraska-Western Iowa Health Care System, Grand Island, NE

1.2.8. St. Cloud VA Healthcare System, St. Cloud, MN

1.2.9. Minneapolis VA Health Care System, Minneapolis, MN

1.2.10. Iowa City VA Health Care System, Iowa City, IA

1.2.11. VA Central Iowa Health Care System, Des Moines, IA

1.3. Authority: FAR Part 12, “Acquisition of Commercial Products and Commercial Services”, FAR Part 15, “Contracting by Negotiation”.

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 0710, “Personnel Suitability and Security Program”

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

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

1.4.4. VA Directive 6500, “VA Cybersecurity Program”

1.4.5. VA Directive 6513, “Secure External Connections”

1.4.6. VA Handbook 6300.1, “Records Management Procedures”

1.4.7. VA Handbook 6500, “Risk Management Framework for VA Information Systems, VA Information

Security Program”

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

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

1.4.10. VHA Handbook 1106, “Pathology and Laboratory Medicine Service”

1.5. Definitions/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 https://www.acquisition.gov/far/part-12 https://www.acquisition.gov/far/part-15 https://www.va.gov/vapubs/ http://www.va.gov/vhapublications/ https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=487&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=997&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=742&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1254&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1449&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11663 language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ACEP: American College of Emergency Physicians

1.5.2. AO: Administrative Officer

1.5.3. AES: Advanced Encryption Standard

1.5.4. ANSI: American National Standards Institute

1.5.5. AMA: American Medical Association

1.5.6. CAP: College of American Pathologists

1.5.7. CDC: Centers for Disease Control and Prevention

1.5.8. CDR: Contract Discrepancy Report

1.5.9. CASA: Cisco Adaptive Security Appliance

1.5.10. CLIA: Clinical Laboratory Improvement Act of 1988

1.5.11. CM: Communication Manager

1.5.12. CMS: Centers for Medicare & Medicaid Services

1.5.13. 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.

1.5.14. 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.

1.5.15. COTR: Contracting Officer Technical Representative

1.5.16. CPARS: Contractor Performance Assessment Reporting System

1.5.17. CPT: Current Procedural Terminology

1.5.18. C2S: Client to Site

1.5.19. 3DES: Triple Digital Encryption Standard

1.5.20. DMS: Data Management System

1.5.21. FOIA: Freedom of Information Act

1.5.22. ESCCB: (VA) Enterprise Change Control Board

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

1.5.24. EMR: Electronic Medical Record

1.5.25. HCR: Health Care Resources

1.5.26. HCS: Health Care System

1.5.27. HIPAA: Health Insurance Portability and Accountability Act

1.5.28. HIS: Hospital Information System

1.5.29. HL7: Health Level Seven

1.5.30. HSS: Health System Specialist

1.5.31. IDS: Internet Database System

1.5.32. IPSec: Internet Protocol Security

1.5.33. ISA: (VA) Interconnection Security Agreement

1.5.34. ISAKMP: Internet Security Association and Key Management Protocol

1.5.35. ISO: Information Security Office or Officer

1.5.36. LEDI: (VistA) Laboratory Electronic Data Interchange

1.5.37. LIS: Laboratory Information System

1.5.38. LOINC: Logical Observation Identifier Names and Codes

1.5.39. NARA: National Archives and Records Administration

1.5.40. NSOC: Network Security and Operations Center

1.5.41. OIT: VA Office of Information and Technology

1.5.42. OSHA: Occupational Safety and Health Administration

1.5.43. POP: Period of Performance

1.5.44. PWS: Performance Work Statement

1.5.45. QA: Quality Assurance

1.5.46. QC: Quality Control

1.5.47. QASP: Quality Assurance Plan

1.5.48. RA: Regulatory Agency

1.5.49. RFP: Request for Proposal

1.5.50. S2S: Site-to-Site

https://www.acep.org/ https://www.ansi.org/ https://www.ama-assn.org/ https://www.cap.org/ https://www.cdc.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.cms.gov/ https://www.cpars.gov/ https://www.foia.gov/ https://www.hhs.gov/programs/hipaa/index.html https://www.archives.gov/ https://digital.va.gov/office-of-information-and-technology/ https://www.osha.gov/

1.5.51. TAT: Turnaround Time

1.5.52. TIC: Trusted Internet Connection

1.5.53. TJC: The Joint Commission

1.5.54. VA BHHCS: The Department of Veterans Affairs, VA Blacks Hills Health Care System

1.5.55. VA NWIHCS: The Department of Veterans Affairs Medical Center, Nebraska-Western Iowa

Health Care System.

1.5.56. VAMC: Veterans Affairs Medical Center

1.5.57. 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.

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

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

1.5.60. VISN 23: VA Midwest Health Care Network

1.5.61. VPN: Virtual Private Network

1.5.62. WAN: Wide Area Network

2. QUALIFICATIONS:

2.1. Licensing and Accreditation:

2.1.1. The Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be 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. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award. Changes to the requirements shall be addressed by bilateral modification.

2.1.3. Contractor Personnel assigned by the Contractor to perform the requirements covered by this PWS 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. Contractor/Contractor Personnel working on this contract shall obtain and maintain all licenses, permits, accreditation and certificates (required by law or by the governing or cognizant licensing board).

2.2. Credentials:

2.2.1. 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.

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

2.3. 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 https://www.jointcommission.org/ https://www.va.gov/black-hills-health-care/ https://www.va.gov/nebraska-western-iowa-health-care/ https://www.va.gov/nebraska-western-iowa-health-care/ https://www.va.gov/health/ https://www.va.gov/HEALTH/visns.asp https://www.va.gov/directory/guide/region.asp?ID=23 https://www.cap.org/ https://www.cap.org/ https://www.hhs.gov/ https://www.hhs.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text 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.

2.4. Citizenship Related Requirements:

2.4.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, Section D (Attachment D.3), 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.

2.4.2. 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 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. 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.

2.4.3. 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 sole 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.

2.4.4. 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 certifier (individual authorized to bind the contractor to subject to prosecution under 18 U.S.C. 1001).

2.4.5. 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 Section D (Attachment D.3) of the solicitation document.

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

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

2.5.2. Therefore, the Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s 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.

2.5.3. 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.

3. CONTRACT REQUIREMENTS

3.1. INTERFACING/COMMUNICATION REQUIREMENTS:

3.1.1. The Contractor shall provide an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing and reporting. As such, the Contractor shall provide and program an https://www.acquisition.gov/vaar/852.209-70-organizational-conflicts-interest.?searchTerms=852.209-70 https://www.uscis.gov/laws-and-policy/legislation/immigration-and-nationality-act https://www.e-verify.gov/ https://www.govinfo.gov/content/pkg/WCPD-1996-02-19/pdf/WCPD-1996-02-19-Pg281.pdf https://uscode.house.gov/view.xhtml?req=49&f=treesort&num=1262 https://uscode.house.gov/view.xhtml?req=49&f=treesort&num=1262 https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html https://www.congress.gov/bill/105th-congress/house-bill/2015/text https://www.hhs.gov/ https://www.hhs.gov/ https://oig.hhs.gov/about-oig/ http://oig.hhs.gov/exclusions/index.asp interface system to electronically transmit orders, specimen status and test results between the Contractor’s host computer system and the VA’s host computer system (VistA).

3.1.2. The Contractor shall have an operational interface connection with all facilities within 45 days of the contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmission through the interface connection will be the joint responsibility of the Government and Contractor.

3.1.3. The expense of the electronic message connectivity leading up to the VA middleware and communicating correctly according to VA protocols is borne by the Contractor.

3.1.4. All electronic messaging between the two (Contractor and VistA) computer systems shall conform to VistA Health Level Seven (HL7) and Laboratory’s HL7 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, is a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards.

Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc website, www.HL7.org.

3.1.5. Data connectivity between the Contractor and the VA will be accomplished through the use of either a Client to Site (C2S) connection, Site to Site (S2S) connection or via the VA’s Private Extranet Internet Cloud according to standards required by the VA’s Network Security and Operations Center (NSOC) and as approved by the VA’s Enterprise Change Control Board (ESCCB) in accordance with VA Directive 6513, “Secure External Connections” (or subsequent release) and VA Handbook 6500, “Risk Management Framework for VA Information Systems, VA Information Security Program” (or subsequent release), requirements.

3.1.6. The Information Security Office will coordinate the requirements with the Contracting Officer Representative (COR) and the Contractor POC for the supporting the contract. Typical connections are by Site-to-Site VPN. Business Partners may access designated internal VA servers if they are granted a Client VPN account. A Client VPN requires signing of VA National Rules of Behavior and VPN Rules of Behavior by each approved user of the connection. However, if there is a large number of Business Partner users that are approved for this, it may be more efficient to build a Site to Site (S2S) VPN with the Business Partner.

3.1.6.1. Each type of connection (C2S or S2S) requires that all contractors must have Background Investigations completed as required by FIPS 201-3; and must initially and annually thereafter participate in the VA Information Security Awareness and VA Privacy training programs.

3.1.6.2. A Site-to-Site VPN enables a VA Business Partner to securely access specific resources on the VA WAN. It does this by establishing a Virtual Private Network (VPN) connection between the Business Partner network and one of the VA Trusted Internet Connection (TIC) Internet Gateways. Traffic that may pass over this connection is limited, so only specific VA and Business Partner systems may communicate with each other. A S2S is used only if business needs cannot be met with a Client to Site VPN connection. The Business Partner must support encryption that is compliant with FIPS 140-2. The Business Partner must sign a legal agreement with the VA (Interconnection Security Agreement (ISA), Memorandum of Understanding (MOU) for a S2S. Communication must be limited to explicit VA and Business Partner systems, using a limited set of ports, protocols and services. A S2S requires an ISA, used to support an MOU that establishes the requirements for data exchange between two organizations. The MOU is used to document the business and legal requirements necessary to support the business relations between the two organizations.

3.1.6.3. Each of the VA TIC gateways has Cisco Adaptive Security Appliance (ASA) devices used for Site-to-Site VPN connections. They use IP Security (IPSec) with Triple Digital Encryption Standard (3DES) or Advanced Encryption Standard (AES) for encryption and Internet Security Association and Key Management Protocol (ISAKMP) for authentication and integrity. The devices are FIPS 140-2 compliant. This capability establishes a secure, end-to-end encrypted tunnel that protects the report Gateway VPNs are configured to allow only Internet Protocol Security (IPSec) protected data flows, and only when originated from and sent to authorized peers. The Business Partner must use a FIPS 140-2 compliant solution for their end of the Site-to-Site VPN. If they do not already have a VPN solution in place, the vendor will work with VA Information Security, Network Security Operations Center (NSOC) and the Enterprise http://www.hl7.org/ https://csrc.nist.gov/pubs/fips/201-3/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final

Security Change Control Board (ESCCB) to establish the appropriate VPN connection type.

The VA is not responsible for problems with equipment owned by the Business Partner.

3.2. 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). After contract award and annually thereafter, the contractor and/or subcontractors shall provide to the VA all necessary laboratory test parameters to insure accurate test result transmission between the VA and the vendor’s database. Required test parameters to include are as follows:

3.2.1. Test name (including synonyms)

3.2.2. Ordering code (Contractor’s Identification Code)

3.2.3. Billing code (if separate from the orderable test code)

3.2.4. LOINC code – Logical Observation Identifier Names and Codes

3.2.5. CPT code – Current Procedural Terminology

3.2.6. Interface code/Test Mapping

3.2.7. Test cost

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

3.2.9. Therapeutic or diagnostic reference ranges (when appropriate)

3.2.10. Reference ranges

3.2.11. Units of measurement

3.2.12. Test result interpretation or interpretive remarks (if appropriate)

3.2.13. Testing site (if not performed at he vendor’s main laboratory facility

3.2.14. Test methodology

3.2.15. Specimen type

3.2.16. Specimen collection and handling requirements

3.2.17. Whether test is a panel or profile test, (list tests included if panel)

(*NOTE: Above parameters are required for each test contained in a panel*)

3.3. The parameters for all tests in the Contractor’s database shall be kept current and be available to the VA sites throughout the performance period of the contract. Updates to the test parameter information must be provided to VA sites prior to any testing changes in the following situations: new tests are developed and introduced into the Contractor’s test menu; testing parameters have changes; or when tests are discontinued or replaced by other tests. The contractor shall provide information to VA sites no less than 2 weeks prior to the implementation of the test change. In an effort to maintain accurate and timely test information, the Contractor shall provide telephone access to a COR to respond to any question(s) regarding the laboratory test parameter information.

3.4. VistA Laboratory Electronic Data Interchange (LEDI) identifies VA-specific content and encoding tables to be used with Health Level 7 (HL7) message protocol conventions. The LEDI specification follows very closely the HL7 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

3.4.1. VistA LEDI identifies to the commercial reference laboratory vendor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format.

3.4.2. VistA LEDI software will provide a HL7 acknowledgement of receipt of data packets. Hard copy specimen results will be required as well as electronic transmission of results. The hard copy must contain VA’s assigned specimen identification where specimen identification is defined as a unique VA-assigned 10-digit number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest during the implementation period. This information is also available in electronic HL7 format if required.

3.4.3. Upon testing completion, a formatted HL7 message containing specimen results with VA’s assigned specimen identification shall be returned to the requesting medical center.

3.5. 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. Subcontractors shall be held to the same quality standards as specified in the contract.

3.6. If a VISN 23 laboratory cannot or chooses not to perform a laboratory test in-house or at another Government-owned laboratory, the facility reserves the right to determine which tests are sent to the Contractor. Tests may be added and removed from the contract via modification.

3.7. Data Management System/Communication Manager or Internet Database System: The contractor shall provide a data management system or internet database system available for each medical facility and outpatient clinic listed. The system shall meet the following requirements:

3.7.1. Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions.

3.7.2. Test definition, test information and test requirements must be complete, available and easily accessible. status and the results of testing must be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion.

3.7.3. Reports of test results must be immediately available upon verification of the test result. The system must be able to print test results and reprint retrospective test results according to a defined timeframe.

3.8. Procedure Guidance:

3.8.1. 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.

3.8.2. 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.

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

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

3.9.1. Requisition forms

3.9.2. Specimen containers

3.9.3. Appropriate shipping container, (if required)

3.9.4. Special instructions

3.9.5. Current list of tests (with reference ranges and specimen requirements)

3.9.6. Specimen carriers

3.9.7. All forms, (including, but not limited to Chain of Custody)

3.9.8. Special media or tubes for samples

3.9.9. All supplies for special tests (e.g. viral studies)

3.10. 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.

3.11. 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.

3.12. Test Results:

3.12.1. 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 or critical ranges.

3.12.2. The Contractor shall provide test results to the ordering facility in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day).

3.12.3. Contractor shall provide electronic transmission (computer to computer transmission required with teleprinter or fax as back-up) of all completed and partial test results to the ordering facility within published Turnaround Time (TAT), except where specified. 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.

3.13. Telephone Consultation: The Contractor shall provide telephone consultation with the assigned point of contact for the participating facility, requesting Clinician, or designee as needed.

3.14. Specimen Rejection: Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering facility, the assigned point of contact for the participating 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 College of American Pathologists Policy PP. Minimum Period of Retention of Laboratory Records and Materials (or subsequent release) and ANP 12500 Record Retention Phase II (or subsequent release). If the laboratory ceases operation, the specimens, slides, blocks, and documentation must be transferred to the VA facility where the testing was originally requested.

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

3.15. Documentation: The Contractor shall ensure that all required documentation is timely, 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. TRANSPORTATION:

4.1. Specimen Pick-up Times:

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

4.1.2. 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, collection kits, or transport media required for specimen preservation. Each ordering facility is responsible for packaging the specimens.

4.2. Shipping Biological and Infectious Substances:

4.2.1. Regulatory Requirements: 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.

4.2.1.1. 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 https://documents-cloud.cap.org/pdf/PubPolicy_PP_Lab_Record_Retention.pdf?_gl=1*1494eq4*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcwNzg0NjIxMC4yLjEuMTcwNzg0NjI5MS4wLjAuMA..

https://documents-cloud.cap.org/pdf/PubPolicy_PP_Lab_Record_Retention.pdf?_gl=1*1494eq4*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcwNzg0NjIxMC4yLjEuMTcwNzg0NjI5MS4wLjAuMA..

https://documents-cloud.cap.org/appsuite/learning/LAP/TLTM/resources/checklists/2020/cl-anp.pdf https://www.transportation.gov/ https://www.iata.org/ https://www.va.gov/ https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I https://www.ecfr.gov/current/title-49/subtitle-B/chapter-III https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-A/part-107 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-171 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-172

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.

4.2.2. Hazardous Materials and Safety 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. Failure to maintain compliance shall be reason for the Government to terminate the contract.

5. SERVICE AND MAINTENANCE:

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 maintain the minimum acceptable service, reporting systems and quality control as specified herein. Within 24 hours, notification must be given to the assigned COR for the applicable facility and Contracting Officer upon adverse action by a regulatory agency. Contractor shall assign a specific local account representative to each ordering activity. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and all new tests.

5.1.3. In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., antibody, purified antigen, etc.), the Contractor shall notify the CO and assigned COR for the applicable facility prior to the intended change. Changes in the assay materials or procedure shall be sufficient cause for changing to an alternate Contractor for the assay(s) for the duration of the contract.

5.2. Maintenance:

5.2.1. The Contractor shall provide preventive and as-needed maintenance on any contractor installed terminal or data fax system at the facility or clinic at no additional charge to the Government. This includes but is not limited to: VA OIT required updates, repair of contractor furnished hardware, software and associated communication lines. Throughout the Period of Performance, the Contractor shall repair or replace any malfunctioning hardware or software. The Contractor shall provide preventative (routine) maintenance within 72 hours of notification by the assigned COR for the applicable facility or designee.

5.2.2. The Contractor shall respond to emergency maintenance calls within 24 hours.

5.2.3. The Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) for test results to be provided to the participating ordering facility or clinic to be used in the case of a failure of the primary system. Specific information regarding when and how the system will be used will be provided to the assigned COR for the applicable facility. The back-up plan is required to comply with all response times required by the contract.

5.2.4. The Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that VA is capable of performing routine servicing of hardware.

5.2.5. The Contractor shall install, and if necessary, remove of all interface communication equipment and associated hardware.

6. QUALITY ASSURANCE (QA), QUALITY CONTROL (QC), QUALITY IMPROVEMENT:

6.1. The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the term of the contract.

https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173 https://www.ecfr.gov/current/title-49

6.2. The Contractor shall comply with all applicable OSHA, Regulatory Agency, and Federal, State, or local laws as required for performing the type of services required.

6.3. The Contractor shall comply with the following Quality Assurance guidelines relating to shipping and test performance:

6.3.1. Number of lost specimens by vendor: 1 per month per facility

6.3.2. TAT: 90% of monthly results will be reported within established contractor published TAT

6.3.3. Revised reports not due to incorrect requisition information: 1 per month per facility

6.4. The assigned point of contact for the participating facility may perform surveillance of services by:

6.4.1. Monitoring turnaround times (TATs)

6.4.2. Observing actual performance;

6.4.3. Checking pick up times by the Contractor;

6.4.4. Inspecting the services to determine whether or not the performance meets the performance standards;

6.4.5. Review of any other appropriate electronic records.

6.5. Quality Improvement:

6.5.1. The Contractor, upon request, shall provide quality data and information related to services provided and participate in the VAMC’s performance improvement programs when requested to do so.

6.6. Registration with Contractor Performance Assessment Reporting System (CPARS):

6.6.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Sea Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

6.6.2. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

6.6.3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

6.6.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

7. GOVERNMENT RESPONSIBILITIES

7.1. Contract Administration/Performance Monitoring: Should the Contact Information for the Contracting Officer (CO), Contract Specialist (CS), and/or Contracting Officer Representative (COR) change, notification will be sent to the Contractor via e-mail; a Contract modification shall not be required.

https://www.acquisition.gov/far/part-42#FAR_Subpart_42_15 http://www.cpars.gov/

After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

7.2. CONTRACTING OFFICER (CO) RESPONSIBILITIES:

Michael Casper Veterans Affairs Contracting Officer, NCO 23 3600 30th Street DesMoines, Iowa 50310 516-699-5999 x5880 – Phone Michael.Casper@va.gov – email

7.2.1. The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract. The services specified in this contract may only be changed by written modification which will be prepared and executed by the VISN 23 Contracting Activity.

7.2.2. The CO shall work with local Laboratory Points of Contact and the COR to resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority no shall be made in the contract price to cover an increase in costs incurred as a result thereof.

7.3. CONTRACT SPECIALIST (CS) RESPONSIBILITIES

Shanna Comparato Veterans Affairs Contract Specialist, NCO 23 316 Robert Street North, Suite 506 Minneapolis, MN 55101 402-995-3692 – Phone Shanna.Comparato@va.gov – email

7.3.1. The CS is the Point of Contact for all Contract Administrative issues. The Contract Specialist reviews any and all issues brought forth by the COR and/or the Contractor.

7.4. CONTRACTING OFFICER’S REPRESENTATIVE (COR) RESPONSIBILITIES

Chasity Vigliotti Contracting Officer’s Representative (COR) VA Sioux Falls Healthcare System 2501 W. 22nd Street Sioux Falls, SD 57117 605-336-3230 x6466 Email: Chasity.Vigliotti@va.gov - email

7.4.1. Pursuant to VAAR Provision 852.201-70, Contracting Officer’s Representative the designated representative for this contract is Chasity Vigliotti, VISN 23 Health System Specialist or designee.

The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer, through the Contract Specialist.

7.4.2. The COR is authorized to act within the limitations specified herein and written restrictions specifically imposed under the terms of the order and by the Contracting Officer.

7.4.3. This designation does not include authority to direct changes in scope, price, terms or conditions of the contract or order. The authority herein also does not include authority to execute modifications to the contract or order, which require the signature of the Contracting Officer, or to bind the Government by agreement in terms of a proposed contract change.

7.4.4. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring.

7.4.5. The COR will review/provide concurrence on Contractor’s submitted invoices prior to the Contractor uploading the invoices into the VA Invoice Payment Processing System (IPPS). The COR will mailto:Michael.Casper@va.gov mailto:Shanna.Comparato@va.gov mailto:Chasity.Vigliotti@va.gov https://www.acquisition.gov/vaar/852.201-70-contracting-officers-representative.?searchTerms=Contracting%20Officer%20Representative maintain a record-keeping system of services through the patient’s electronic medical record (EMR).

The COR will review this data monthly when invoices are received to certify that the same workload documented in the VA record-keeping system is the same as those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

7.4.6. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services defined in the PWS, payments will be adjusted to compensate the Government for the difference.

7.4.7. All contract administration functions will be retained by the VA.

8. SPECIAL CONTRACT REQUIREMENTS:

8.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

8.2. The following table contains brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item:

Table 1 – Deliverable Schedule

What Submit as noted Submit To

Patient Test Report Reference Section 8.3 Contracting Officer Representative

Monthly…