Q301--Reference Laboratory Services for the Portland VA Medical Center.
STATEMENT OF WORK REFERRAL LABORATORY SERVICES FOR THE DEPARTMENT OF VETERANS AFFAIRS VA PORTLAND HEALTH CARE SYSTEM PATHOLOGY & LABORATORY MEDICINE SERVICE 3710 SW US VETERANS HOSPITAL RD PORTLAND, O... STATEMENT OF WORK REFERRAL LABORATORY SERVICES FOR THE DEPARTMENT OF VETERANS AFFAIRS VA PORTLAND HEALTH CARE SYSTEM PATHOLOGY & LABORATORY MEDICINE SERVICE 3710 SW US VETERANS HOSPITAL RD PORTLAND, OREGON 97239 Remove this section BACKGROUND The VA Portland Health Care System (VHAPORHCS) Pathology & Laboratory Medicine Service (PLMS) requires Referral Laboratory services to provide testing and interpretation to assist in the diagnosis and treatment monitoring of Veterans with cancers, bleeding disorders, and specialized diseases, including organ transplants. Referral (reference) laboratory that specializes with these types of complex tests and provide a quick turn-around-time (TAT) of the test results is required for care. VAPORHCS is a VHA Level 1A facility which are the largest levels of volume and patient risks along with the largest number and breadth of physician specialists. VAPORHCS is also unique with active kidney and liver transplants partnering with its academic affiliate. VAPORHCS requires a full service of Referral laboratory that provides specimen testing, interpretation, testing supplies, customer service, and verification of certification for test results. It is imperative that the Reference laboratory shall perform the following types of testing, to include expert consultation: Immunology, Hemostasis & Thrombosis, Hematology/Oncology, Anatomic Pathology, including Transplant and Renal Pathology, Neuropathology, Neuropathology, Dermatopathology, Cytopathology and Anatomic Pathology, Microbiology/Virology, Molecular, Flow Cytometry, Electron Microscopy, Ophthalmic Pathology and Diseases related testing, and Core Laboratory (Clinical). These requirements must be maintained and will ensure accurate and timely test results are available to healthcare providers that ensure high quality healthcare is provided to the Veteran at the VA Portland Health Care System. PERIOD OF PERFORMANCE: This is a request for an IDIQ award for the period of five years. Ordering period 1: 7/1/26 to 6/30/27 Ordering period 2: 7/1/27 to 6/30/28 Ordering period 3: 7/1/28 to 6/30/29 Ordering period 4: 7/1/29 to 6/30/30 Ordering period 5: 7/1/30 to 6/30/31Any concern here when we will have a dollar limit, not time? SCOPE The Reference Laboratory shall provideProvide services? referral laboratory services in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. The VA Facilities will be responsible for specimen collection and will provide laboratory specimens prepared according to the Reference Laboratory's user s manual, identified, and labeled for testing. SPECIFIC TASKS: The Reference Laboratory shall provide laboratory services to include: preanalytical processing as defined in Reference Laboratory published user s manual; analysis, reporting of analytic results and interpretation of analytic clinical results. The number of tests requested under this contract will change throughout the life of the contract. The Reference Laboratory shall also provide the following support services, supplies, customer service, and reporting services: The Reference Laboratory shall have an online test-directory that supplies relevant information needed for each laboratory test. The online test directory must include: Specimen requirements for specimen collection & specimen processing Expected turn-around times. Methodologies and Reference ranges Requisition forms or an agreed-upon computer ordering system Kidney Biopsy collection materials with a mechanism to send kits directly to patients across the US, that are being monitored at the Portland VA. All required forms, including authorization of consent for genetic testing, informed consent, and chain of custody, if applicable. The Reference laboratory shall provide testing and interpretation services for all tests found within Attachment A. The volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA.Move to section 4.d The Reference laboratory will provide a current list of immunohistochemistry for surgical pathology specimens. The immunohistochemistry may be ordered as staining only (i.e. technical component only and no professional component interpretation) and staining and interpretation (i.e. both technical component and professional component interpretation). Of note, the Referral laboratory must be able to perform Estrogen Receptor (ER), Progesterone Receptor (PR) and Her2 as staining and interpretation. In addition, the Referral laboratory must be able to reflex equivocal Her2 for additional confirmation testing (i.e. Her2 FISH). The reference laboratory shall provide an extensive FISH library for use by VAPORHCS. The entire FISH library offered by the reference lab shall be itemized and added to the original test list prior to award. Note: CD138 plasma cell extraction method is required for the myeloma FISH panel. The Reference Laboratory shall provide flow cytometry test for diagnosis of leukemias and lymphomas on blood, body fluids, fine needle aspiration (FNA) cytology specimens, fresh tissue. In addition, the reference lab via flow cytometry methodology will be able to perform minimal residual disease (MRD) testing for B-cell Acute Lymphoblastic Leukemia (B-ALL), evaluation and screening for Autoimmune Lymphoproliferative Syndrome (ALPS), and monitor patients on Chimeric Antigen Receptors T-cell (CAR T-cell) therapy. The Reference Laboratory shall be the primary provider for consultation services for the Portland VA. These consultation services necessitate the review of diagnostic material by pathologists who are highly specialized, trained, and skilled. Evidence of specialized knowledge includes, but is not limited to, subspecialty fellowship training, board certification (if applicable), publication history within the subspecialty field, and presentations as invited speakers at pathology education conferences and seminars. The subspeciality fields shall include: Neuropathology, including both muscle and nerve biopsies, Renal Pathology, including transplanted organs, Dermatopathology, Cytopathology, Hematopathology, Surgical Pathology subspeciality such as Gastrointestinal Pathology, Breast Pathology, Genitourinary Pathology, etc. Reword this so it flows from black text to blue text Dean Neuropathology - The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology and CVs of their education, training, accomplishments and achievements. Renal Pathology The Reference Laboratory shall provide physicians who are board certified in Anatomic Pathology by the American Board of Pathology AND fellowship trained in Renal Pathology and CVs of their education, training, accomplishments and achievements. Furthermore, pathologists will be available for consultation and presentation of the diagnostic findings with regards to transplant pathology and upon request by the Nephrologists. Dermatopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Dermatology/American Board of Pathology, and CVs of their education, training, accomplishments and achievements. The pathologist will be available upon request for consultation for continuity of care. Cytopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology, and CVs of their education, training, accomplishments and achievements. Hematopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology and CVs of their education, training, accomplishments and achievements. Furthermore, the pathologists will be available for consultation and presentation of the diagnostic findings with regards to transplant pathology and upon request by the Hematologists/Oncologists. Ophthalmology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Ophthalmology and CV s of their education, training, accomplishments and achievements. The pathologist will be available upon request for consultation for continuity of care.Dean - added statement. Review as i just copy.paste from others and not sure it all applies in this case. Surgical Pathology Including Subspecialties All pathologists who report anatomic pathology cases MUST be board certified by the American Board of Pathology. The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Dermatology/American Board of Pathology, and CVs of their education, training, accomplishments and achievements. Subspecialty fellowship training is strongly preferred. For all Anatomic Pathology Services, consultation, presentation and discussion of the case shall be readily available upon request. Present/Participate in Tumor Board. The Referral laboratory must meet any credentialing and/or privileging requirements by VA Portland and its academic affiliateIf we are going to include we need to state who the affiliate is Oregon Health Sciences University. For all Anatomic Pathology services, slides of the cases shall be available upon request (i.e. actual slide or digital images of the case) as these slides/images will be required for tumor board and case discussion. The vendor agrees to consult the VA Portland laboratory prior to performing any reflex tests prompted because of the consultation request. VA Portland must have an opportunity to review the proposed testing for clinical need and whether test is on contract. The reference laboratory, upon review of the proposed test menu, shall: If each CPT code is invoiced and or charged separately, the vendor should ensure that Attachment A is modified to include pricing for each CPT code. This includes panel components charged individually. If any component of a test is charged separately, it must be itemized within Attachment A. If a test is found on attachment A (all tabs) which results in any reflex testing, the vendor will itemize and add the reflex test and any associated charges to the test list. If the vendor charges separately for professional fees, Attachment A should be reviewed to ensure it includes any and all potential line items that would result from any of the tests contained within Attachment A. If the vendor utilizes dot codes for any of the CPT codes, please ensure those are itemized and added to Attachment A. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen receipt by the contractor to when results are available. If testing is going to be delayed and the results will not be within published TAT, notify the VA Portland as soon as possible, of the new estimated TAT. Required TAT is identified on Attachment A. STAT TAT is considered 1 HOUR and Routine testing is 8 Hours. Turnaround time is defined from the time the specimens are received at the testing laboratory until transmission of results. The Reference laboratory shall meet all TAT needs, and stat processing needs. It is necessary for the contracted vendor to be able to provide immediate services for critical testing that must start within 1 hour of specimen collection by VA Personnel. Does this contradict 1 hour TAT of 1 hour giving them 1 hour to start. Total of 2 hours. Contact Seattle to see if they unique language in their UW contract. Back-up testing to critical in-house testing, is needed in case of instrument downtime and essential for operations of a 1A facility. These tests are identified on Attachment A, by the requirement for a STAT TAT of 1 Hour and or a Routine TAT of 8 hours.What tests, all tests? Call out attachment A Coagulation & platelet status must be monitored before, during and after liver transplant and other surgeries to provide immediate adjustment to blood thinners or blood products on a 24/7 basis. Coagulation and platelet function are critical life monitors for patients with liver diseases or other high-risk factors (cancer, cardiovascular disease and serious health conditions). Delays in test results beyond 4-12 hours may result in canceled/delayed surgeries/treatments or serious negative consequences for patients with high risk factors (cancer, cardiovascular disease and other serious health conditions). Tests are required to establish an immediate update/adjustment to dosage and treatment plan for blood clotting disorders, blood products or transplant care. Many specimens are fresh tissue requiring test processing to be initiated within 1 hour of collection to prevent specimen degradation, which leads to unsatisfactory cell recovery or responses giving inconclusive or inadequate diagnoses resulting in delayed treatment with serious consequences for cancer patients. (Muscle and nerve biopsies, and certain flow cytometry results are best if specimens processed within 1 hour of collection). Certain specimens are unique and irretrievable and aid in the diagnosis and staging of malignancies. Requirements for quick initial diagnosis and treatment initiation for new leukemia and aggressive lymphoma patients. Consultation may be required for continuity of care. Testing methodology and reference ranges for a test must be defined in the Reference Laboratory user manual and/or website. Reference Laboratory shall advise the facility of any changes in methodology, procedure, reference ranges and any new tests introduced 30 days in advance. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Exception handling: Reference Laboratory will notify VA Portland as soon as possible of any problems with Same as above, is this requirement helpful if the TAT is 1 hour or 8 hours? specimens received. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user s manual, identified, and labeled for testing. Critical Value test results shall be reported immediately. Stat test results will be faxed or telephoned to Laboratory Service. Telephoned results will be confirmed with a follow-up by vendor via fax. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the tests listed in Attachment A. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the prime contractor.Of prime contractor? The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. COURIER SERVICES The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure stability and integrity of the specimen where applicable. Reference Laboratory shall supply any special preservatives required for specimen preservation. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities but not less than once a day. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required. In order to maintain similar facsimiles to the current agreement, the Referral laboratory will provide courier service including on demand, STAT, rush and short stability specimens. The Referral laboratory shall incur the cost of the courier service. For specimens that have a 1-hour TAT requirement, the courier system must be able to arrive for pickup within 1 hour of the request for pickup. For specimens that have a 1-hour processing requirement, the courier system must be able to deliver the specimen within 30 minutes of the collection time to allow sufficient time for the testing laboratory to initiate processing within 1 hour of the collection time at the Portland VA. If applicable, the Contractor shall be responsible for ensuring that all transport personnel are trained and follow the storage requirements for all laboratory specimens and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This shall include issues such as adherence to regulations for the transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. CUSTOMER SERVICE & PATIENT INFORMATION SAFETY The reference laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problems, 24 hours per day, 7 days per week. The reference laboratory shall provide names and telephone numbers of technical Medical Directors and Pathologists available for questions, discussions and consultations. The reference lab will comply with reporting test results with the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results. Test results shall be reported within specified times established by the reference laboratory. Critical value test results shall be reported immediately by telephone. Results will be sent to the VA via a secure means and in compliance with Health Portability and Accountability Act (HIPPA) guidelines. The contractor will provide test related information that is readily available and easy to access to help select the proper test, interpret results, and build tests in our computer system for interconnection for electronic data interchange (EDI). The contractor will provide a 24-hour response time to all inquiries made by PLMS. VAPORHCS will provide Protected Health Information (PHI) with each submitted specimen to the Reference Laboratory which includes full name, medical record number, social security number, date of birth, ordering provider s name, laboratory accession number, specimen type, and specimen collection date and time. DELIVERY AND REPORTINGIs there standard language related to billing we can utilize? TBH - this is copy and paste from years and years of contract. ni Billing summaries shall begin the first day of the month and include the last day of the month. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. Deliveries must be accompanied by a delivery ticker or sales slip that contains the following information as a minimum: Vendor Name Applicable FSS contract number BPA Number, Task order number, and Purchase Order number Date of Purchase Date of Shipment Description of item Quantity of each item Unit price and extended (quantity x unit price) price for each item The Reference Laboratory shall provide a quarterly and end of year report showing sample issues, facility usage, and cost savings generated during the reporting period. The report will be due 45 days after the close of each government fiscal quarter. Invoicing: An itemized invoice shall accompany each service order from the Contractor. This invoice must show item number, description, quantity, unit, unit price, and totals for each design (advanced and basic) used. All invoices shall include contract number, purchase/delivery order number and detail of services provided. Invoicing: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review How to Create an Invoice within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements: 1.) Your firm s Tax Payer ID number (TIN) Your firm s Remit Address information 3.) The VA Purchase Order (PO) number 4.) Your firm s contact information: (Personal Name, Email, and Phone) 5.) Your VA point of contact information: (Personal Name, Email, and Phone) 6.) The Period of Performance dates (Beginning and Ending) 7.) All discount information if applicable (Percent and Date Terms) For additional information, please contact: Tungsten Support Phone: 1-877-489-6135 Website: https://tungsten-network.my.site.com/contactCustomerSupport/s/? language=en_US Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov Invoices shall be submitted monthly with the following information: 1.) Contract number and purchase order number 2.) Station ID (648) 3.) Date services were requested 4.) Patient name and test 5.) Invoice will be billed as individual line items as they are listed in the price schedule. Monthly invoice(s) will contain only those item numbers used for that month. Invoices not received in proper format will be returned. Marketing: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without consent. PERFORMANCE MONITORING At the time of contract award the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program. For the QUALITY ASSURANCE SURVEILLANCE PROGRAM refer to the QASP for Test and Interpretation Attachment. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyzing all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services have been received. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR or designer to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration). LICENSING AND ACCREDITATION Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law. The Laboratory Director shall be a licensed American Board of Pathology certified pathologist. As the subspeciality of dermatopathology consultation will be requested from the Reference Laboratory Contractor, fellowship training and Board Certification in Dermatopathology from the American Board of Pathology is required. As the subspeciality of Renal Pathology consultation will be requested from the Reference Laboratory, Board Certification in Anatomic Pathology from the American Board of Pathology, and fellowship training in Renal Pathology is required. As the subspeciality of Neuropathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Cytopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Hematopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Ophthalmology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. Dean - added statement. Review as i just copy.paste from others and not sure it all applies in this case. As the subspeciality of Surgical Pathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of pathology is required As per VHA Handbook 1106.01 Pathology and Laboratory Medicine (P&LMS) Procedures, only qualified, licensed, and privileged pathologists certified by the American Board of Pathology in Anatomic Pathology can provide the written report for all surgical pathology, autopsy, diagnostic EM, non-GYN cytopathology and abnormal GYN cytopathology examinations. All pathologists who report the referred/consultation cases must have board certification from the American Board of Pathology. All medical facilities providing laboratory services under the contract must possess a valid state license (if required) and meet CLIA and CMS requirements including CLIA certificate of compliance, and accreditation by the College of American Pathologists (CAP) or equivalent accreditation agency. PERSONNEL The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract. The Reference Laboratory staff shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. The Government s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4. HOURS OF OPERATION VA Portland Health Care System Medical Center is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times. PLACE OF PERFORMANCE Work to be performed on the contractor s site, their affiliates, or other as determined by the contractor based on the services to be provided. Evaluation Criteria: If applicable Technical performance is more important than all other evaluative criteria. Technical performance = 80% Past performance = 10% Price = 10% BACKGROUND INVESTIGATIONS AND SPECIAL AGREEMENT CHECKS All Reference Laboratory employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the work is: Low Risk. This requirement is applicable to all subcontractor personnel requiring the same access. The Reference Laboratory shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the Reference Laboratory shall reimburse the VA within 30 days. VA INFORMATION SECURITY LANGUAGE General Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Access to VA Information and VA Information Systems a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement or task order. b. All contractors, subcontractors, and third party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by executive Order 12829 to ensure that cleared US defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the US to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address ...
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