Q301--Copy of Long Term Reference Lab Testing (Organ transplant related)| (VA-21-00009535)

Page 10 of 15 The Department of Veterans VA Hospital H J Heinz Campus, 1010 Delafield Rd, Pittsburgh, PA 15215, is conducting a market survey to identify potential sources to provide STAT Laboratory Testing related to organ transplants per statement of work. DISCLAIMER This Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. Submitting information for this announcement is voluntary and VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. The purpose of this market research is to identify capable sources that are both experienced and qualified to provide STAT Laboratory testing as described. The North American Industry Classification System Code (NAICS) is 621511. Based on this information, please indicate whether your company would be a large or small business; and provide the average amount of sales for the last three (3) years or whether you have a socio-economic designation. Limitations on Subcontracting and non-manufacturing rule will apply to the resulting solicitation. Capability Statement and Documentation: Companies are invited to provide their capabilities, experience, and knowledge in providing applicable laboratory testing as attached. Sources must provide the following information: Company name, address, telephone number, website, DUNS number, CAGE code, business type, socio-economic status (e.g., SDVOSB, VOSB, Woman-Owned, Disadvantaged Small Business, 8(a), general small business, large, business, etc.), SAM registration expiration date, and person of contact (including telephone number and email address). Indicate and explain your capability of providing this service in accordance with the Draft Statement of Work (SOW) attached. Indicate your company s size under NAICS 621511. Please indicate any government contracts held including government agency, contract number, dollar value, period of performance, and government contact information. Information regarding your company s capabilities to provide such services are to be submitted electronically on or before Friday, 06/12/2021 by 3:00 PM (EST) addressed to Kevin Balser, Contracting Officer at: and attachmentskevin.balser@va.gov. Performance Work Statement Stat Reference Laboratory Testing Services The VA Pittsburgh Healthcare System (VAPHS) is in need of reference laboratory testing services for stat patient testing that is not performed by VAPHS laboratories. The services required by this contract include the following laboratory disciplines: Miscellaneous STAT Tests Histocompatibility Testing for Solid Organ Transplantation Virology Testing (Including CMV PCRs) Cytogenetic Studies Currently, the VA handles renal and liver transplants. This may be expanded to include other solid organs in the future. The period of performance for base plus four (4) option periods will be May 1, 2021 -April 30, 2026. It is the intent of this office to award a fixed price, Indefinite Delivery, Indefinite Quantity contract (IDIQ) or BPA in response to this requirement. This solicitation will be procured in accordance with FAR Part 12 Acquisition of Commercial Items, and FAR Part 13 Simplified acquisitions Requirements The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical specimens as requested by the VAPHS. Services shall include the transportation of clinical laboratory specimens to the contractor s laboratory, the performance of analytical testing as defined by the Contractor s reference test manual, and the reporting of analytical test results and consultative services as required. The reference laboratory services shall be available twenty-four (24) hours per day, seven (7) days per week, including holidays. VAPHS will be responsible for specimen collection, preparation, and preservation. Services to be furnished under this contract shall be ordered by issuance of an order by the VAPHS laboratory for results to be delivered to a designated printer/fax at the VAPHS University Drive Division in accordance with standards, clauses and provisions of this document. All services will be requested using Contractor-provided or VAPHS-standard requisitions which will accompany the specimens. The attached Schedule of Supplies/Services represents estimated quantities based on historical data. This is not an all-inclusive list of tests, and the volumes are not guaranteed. The list is subject to change based on medical need. For all tests identified in the Schedule of Supplies/Services, the contractor will provide the following information: Ordering Code (Contractor s Identification Code) LOINC Logical Observation Identifier Names and Codes CPT Code Test Description, including reference ranges and units of measurement Test methodology Specimen types Specimen collection and handling requirements Test result interpretation or interpretive remarks, if appropriate Testing site Maximum turnaround time (TAT) for each test listed (NOTE: If the information requested above is identified in Contractor s Directory of Laboratory Services, it is not necessary to provide a separate listing. The Directory of Laboratory Services shall be submitted electronically as part of Contractor s proposal (see Section VI (Contractor s Responsibilities) and FAR 52.212-2 for Evaluation Criteria.) Qualifications Licensing and Accreditation Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed/accredited by The Joint Commission, College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act (CLIA) of 1988. For Histocompatibility testing, the Contractor must maintain accreditation through the American Society of Histocompatibility and Immunogenetics (ASHI). The Histocompatibility Lab must be a member of the Organ Procurement and Transplantation Network (OPTN), and such a laboratory must conform to the Standards for Histocompatibility Testing set forth in Appendix B, Attachment IIA (11A-11N) of the UNOS Bylaws and applicable sub-attachments which are hereby incorporated by reference. Additionally, Histocompatibility Laboratories shall abide by applicable provisions of the National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; the requirements set forth in the OPTN Final Rule, 42 CFR Part 121; these Bylaws; and OPTN policies. Histocompatibility Laboratories shall also submit to reviews (including on-site reviews) and requests for information as may be necessary to determine compliance with the OPTN Final Rule, 42 CFR Part 121; these Bylaws; and OPTN policies. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America along with proposal. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors, if applicable, have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Contractor Laboratory and Personnel 1. The Contractor shall maintain current accreditation and notify the Contracting Officer Representative (COR) of any lapse in state license, CLIA certification, or clinical pathology, Histocompatibility, or Cytogenetics certification. The Contractor shall provide a copy of the renewed licenses/certificates to the COR before expiration. Test Result Reporting Contractor shall provide electronic transmission (i.e., fax or computer via secure email) of all completed and/or partial test results to the ordering activity within awarded Turnaround Time (TAT), except where specified. Contractor is responsible for transmission of all data to be accomplished in a manner that protects the privacy of all personally identifiable patient information. Histocompatibility Testing The Histocompatibility Laboratory must be located within 30 minutes ground transportation time from the VAPHS, University Drive Division, to ensure a turnaround time for cross matches of less than four (4) hours. The Histocompatibility Laboratory must have the capability to directly enter HLAs, PRAs and Unacceptables into UNet SM, UNOS computer-based network for allocating donated organs and managing transplant data. The Histocompatibility Laboratory must be able to report Unacceptable Antigens and perform the Renal Transplant Histocompatibility tests as listed in the attached list of Schedule of Supplies/Services Contractor s Responsibilities Procedure Guidance The Contractor must provide VAPHS a Directory of Laboratory Services. The following information shall be included in the Directory of Laboratory Services. Test-specific specimen collection and preservation requirements for each test or analytic. Test-specific method and interpretation for each test or analytic. Test-specific method reference ranges, adjusted for age, sex, or race, when required. Test-specific method sensitivity and specificity, when required. Test-specific schedule of performance and maximum turnaround time for each. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units). In the event of any change, the information must first be provided to the VAPHS Point of Contact and/or the COR at least fourteen (14) days prior to the Contractor s change. No changes to procedures will be made with less than fourteen (14) days notice. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the VA Pittsburgh Healthcare System. Test Results Turnaround Time STAT. The Contractor shall provide telephonic or fax response within two (2) hours from notification for specimen pick up, unless otherwise agreed, for STAT test results. The Contractor shall report all normal and abnormal test results to ordering laboratory upon completion of testing. RENAL/LIVER TRANSPLANT HISTOCOMPATIBILITIY. A cadaver donor cross match must be completed within four (4) hours from receipt of the specimen, unless otherwise agreed. The Contractor shall provide telephonic or fax response with the results (preliminary or final) of other histocompatibility tests between twenty-four (24) and seventy-two (72) hours, depending on the test requested and the specimen source. The Contractor shall report all normal and abnormal test results to the ordering laboratory upon completion of testing. TELEPHONE CONSULTATION. The Contractor shall consult with the COR, the requesting Clinician, or the designee at the ordering laboratory by telephone as needed. The Contractor shall immediately telephone the VA Pittsburgh Healthcare System Core Laboratory to report Critical Values or test result that may indicate a life-threatening condition. When Critical Values are given, the recipient of the results is required to read the result back to the caller. The information will be documented in the printed report along with the date and time of the call and the identification of the caller and recipient. The Contractor shall provide all confirmatory testing, upon request of the VA Pittsburgh Healthcare System laboratory, at no additional charge to the Government. Reporting of Results. A report is defined as a printed final copy of laboratory testing results. This report shall be received by fax, tele-printer or computer where applicable. If results are previously telephoned, the report must include the name of the individual who was notified of the results. Each test report shall, at minimum, indicate the following information: Patient's name and/or identification code (Social Security number) Physician's name (if supplied) Patient s identification number, (social security number (SSN), medical record number) Submitting facility name Submitting facility account number Patient's location (clinical/ward), (if supplied) Date/time specimen received in Reference Lab Test ordered Date/time of specimen collection (when available) Date/time test completed Test result Flag abnormal results Reference intervals (adjusted for age, sex or race, when appropriate) Toxic and/or therapeutic range, where applicable Flagged abnormal results Reference laboratory accession number Name of testing laboratory and address (Contractor and/or subcontractor) Type of specimen Any additional comments related to test provided by submitting labs. Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission. Documentation The Contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and correctness of all prepared reports. To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract: Coefficient of variation of quality control samples of all tests or specified tests the contract laboratory performs. Proficiency testing data provided to customer will include where challenges failed, a list of tests outside of the + 2SD range for the past two (2) years. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites. Retention of Specimens Upon completion of the testing, the Contractor shall retain all specimens, as required by regulatory agencies (RA). Upon request by the ordering activity, COR, 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 for seven (7) days. Monthly Test Summary The Contractor will provide separate, monthly data summary reports of tests performed for the VAPHS under this contract. The printed or electronic reports will be e-mailed to the COR no later than five (5) working days after the end of each monthly reporting period. The reported information must include subtotals for each test and the test name, CPT code, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year-to-date (per test), and cost year-to-date (per test). This information must be accurate and is mandatory. Invoices The Contractor will provide all-inclusive monthly invoices, in arrears, of tests performed for the VA Pittsburgh Healthcare System under this contract. The invoice must include all charges for both the technical and professional component for all testing performed during the month. The invoice must include all charges from any subsidiary facilities and/or physician practice plans. Contractor shall not invoice for any test unless the final results have been transmitted to VAPHS via fax, tele- printer or computer, as applicable. The Summary monthly submitted into the Veterans Administration Electronic Invoicing system shall contain the following information: Contract Number Purchase Order Number Month Being Billed CPT Codes Test Name Quantity of Test Performed During the Month Unit Price for Each Test Total Price for Each Test Total Charge for All Tests Monthly Charge for Courier Service Grand Total Charge for Month including all Tests and Courier Service A copy of the monthly Summary invoice, along with the following detailed information, must be mailed or faxed to the Contracting Officer s Representative: Patient s Name Predetermined encrypted patient identifier Social Security Number CPT Code List of Tests Performed Specimen Collection date (listed in chronological order) Vendor s Test Code (if different than CPT code) Quantity & Unit Price Total Cost Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not, under any circumstances, be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract. Payments shall be made monthly in arrears upon receipt of a properly prepared invoice. In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with OB10 e-Invoicing network, for submissions of all electronic invoices to VA. OB10 electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with OB10 by submitting an email to VA.Registration@ob10.com or calling 1-877-752-0900 option 2 for Enrollment. Contractor shall submit an electronic invoice by the tenth (10th) of the following month that services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.ob10.com/Login.aspx. For questions regarding the submission of VA electronic invoices, OB10 customer service may be contacted at 1-877-489-6135. For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791 or email vafsccshd@va.gov. Customer Service and Maintenance Customer Service The Contractor shall provide telephone number(s) and contact person to be used by the VAPHS laboratory to make specimen problem inquiries and problem solving at all times, 24 hours a day, 7 days a week, including weekends and holidays. The Contractor shall also include names and telephone numbers of technical Directors and Pathologists available for consultation. For the purpose of Histocompatibility testing for Liver and Renal Transplantation, the Contractor will maintain a relationship and direct interaction with the local organ procurement agency, Center for Organ Recovery and Education (CORE). CORE is responsible for alerting the Contractor of all potential donors and providing the Contractor with sufficient typing samples. The Contractor must have a strong rapport with many members of CORE since there is a need for a significant amount of cooperation between the two entities. Information on CORE may be found on http://www.core.org. The Contractor s Histocompatibility laboratory must be approved by the United Network for Organ Sharing (UNOS) to perform Histocompatibility testing for solid organ transplants. Information on UNOS may be found on http://www.unos.org. The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced. In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the Contractor shall notify the COR prior to the intended change. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the Contracting Officer. The contractor is liable for any excess procurement costs. Maintenance 1. In case of failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) to the VAPHS. Contractor s Quality Control Systems The Contractor must successfully perform external proficiency testing surveys as required by CLIA for all regulated analytes. Upon request, the Contractor must provide the COR with a listing of external proficiency surveys that the laboratory participates, in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties will be provided to COR or designee upon request. The Contractor must operate a successful quality control program as required by CLIA, CAP, ASHI and the American College of Medical Genetics. Upon request of the COR, the Contractor must provide documentation of quality control policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor must provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist. All test methods must be FDA approved, when available. Any non-FDA approved method being performed must have a documented validation plan. Upon request, the validation plan and validation results must be made available to the COR or designee. Nothing herein is intended to preclude subcontracting some of the tests to another laboratory, which is fully qualified and has the same accreditations/certifications as the prime Contractor in accordance with the term of this contract. This must be kept to a minimum for quality control and uniformity purposes. Once a test method is designated for performance by a specific subcontractor, all future performance of that test method must be done by that same subcontractor, unless concurrence to change is received in writing from the Contracting Officer. Consistency and uniformity in testing results is paramount. Specimen Pick-Up/Delivery Courier Service/Specimen Pick-up Times Emergency transportation services shall be available 24 hours per day, seven days per week including Government holidays. Response time for the contractor s emergency transportation services for STAT specimens shall be within 45 minutes after the request for pick up. Emergency response time refers only to the transportation of the specimen(s) and does not include the time for test performance. Specimens shall be picked up at VAPHS, University Drive Division, Room 2NW101, Pittsburgh, PA 15240. Courier service shall comply with all applicable regulatory standards. Sample Preparation 1. The VAPHS laboratories will prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's Directory of Laboratory Services. The Contractor shall provide, at no charge, an adequate supply of requisition forms, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user catalog. The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen. Miscellaneous Responsibilities The Contractor must provide, through a customer service network, access to knowledgeable and responsive laboratory professionals. At the VAPHS expense, a representative(s) from the staff will be given the opportunity to visit the Contractor s testing laboratory to examine the Contractor s facility regarding contract compliance. Compliance visits may occur at any time during normal business hours after award of the contract. (Normal business hours are Monday through Friday, 8 a.m. through 4:30 p.m.). Government Contractor Quality Assurance Surveillance Program (QASP) 1. The Government has created a Quality Assurance Surveillance Program (QASP) to ensure the requirements of this contract are being met. The QASP can be viewed in Section D of this document. Upon contract award, the Contractor will be required to sign the QASP. All changes to the QASP will be documented by the Contracting Officer. Required Registration with Contractor Performance Assessment System (CPARS) 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 thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. The Government will register the contract within thirty days after contract award. 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. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor s designated representative for comment. The contractor s representative will have thirty days to submit any comments and return the report to the VA contracting officer. Failure by the contractor to respond within those thirty days will result in the Government s evaluation being placed on file in PPIRS without contractor s comments. Security Controls Compliance Testing On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. Records Management Security Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Information Security Requirements All samples including PII/PHI must be shipped using a secure tracking mechanism. A Contractor Security Control Assessment (CSCA) is not required since the Contractor is not storing VA data on behalf of VA. A Business Associate Agreement is not required. The following language, taken from VA Handbook 6500.6 (Appendix C), applies to this requirement/contract. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines t...