Inactive

640-21-1-044-0005 Performance Work Statement SCOPE OF WORK. 1.1 OVERVIEW VAPA HCS has a new requirement for a predictive Bartlett s Esophagus assay (PBEA) which will identify the probability that a pa... 640-21-1-044-0005 Performance Work Statement SCOPE OF WORK. 1.1 OVERVIEW VAPA HCS has a new requirement for a predictive Bartlett s Esophagus assay (PBEA) which will identify the probability that a patient will develop esophageal cancer over a 5-year period. The PBEA must be able to be performed on previously collected gastroesophageal biopsies that have either been processed to slides or are still in formalin-fixed, paraffin embedded (FFPE) tissue block form. The vendor will section these tissue blocks into a form factors as needed to conduct the PBEA. The PBEA results must accurately group patients into 3 cohorts low, intermediate and high risk for developing esophageal cancer customized care plans based on a 1-10 scale. 1.2 WORK DETAILS Specimen Collection and Delivery to Test Lab Vendor Vendor will provide VAPA HCS with pre-paid shipping kits for next day delivery to the vendor s testing facility The shipping kits must maintain the integrity of the esophageal biopsies during transit, accounting for environmental factors such as ambient temperature as well as the normal jostling that the kit would encounter. The vendor must provide shipping kits that will accommodate both the processed specimen slides and the FFPE tissue blocks Within 1 business day of receipt of the specimen, Vendor will confirm the same using either secure fax or encrypted email. 1.3 Specimen Testing and Reporting Vendor will prepare the specimen as needed to conduct the PBEA. Vendor will provide the PBEA results to VAPA no later than 15 business days after receipt of the specimen. Reports are to be sent by either secure fax or encrypted email; information that must be included is detailed below. Specimens that were used to conduct the PBEA will be stored at the vendor s storage location in accordance with normal industry practices, regulatory agency requirements, and certifying authorities. If the supplied specimen form was tissue block, the portion of the block not used in the PBEA process will be returned to the provider who initially ordered it at no cost to VAPA. The return shipping kits must maintain the integrity of the tissue block during transit, accounting for environmental factors such as ambient temperature as well as the normal jostling that the kit would encounter. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. Each test report shall at minimum indicate the following information: Patient's name and/or identification code (Social Security number) Physician's name Medical record number (if supplied) Date/time specimen received in Reference Lab Test ordered Date/time of specimen collection (when available) Date test completed Test result Testing laboratory specimen number Name of testing laboratory (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. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. PERIOD OF PERFORMANCE Base Year: April 1, 2021 to March 31, 2022 CLIN No. Description Annual Qty. Unit Unit Cost Annual Cost 0001 Predictive Esophageal Cancer Test 100 EA TOTAL FOR BASE YEAR Option Year 1: April 1, 2022 to March 31, 2023 CLIN No. Description Annual Qty. Unit Unit Cost Annual Cost 0001 Predictive Esophageal Cancer Test 100 EA TOTAL FOR Option Year 1BASE YEAR Option Year 2: : April 1, 2023 to March 31, 2024 CLIN No. Description Annual Qty. Unit Unit Cost Annual Cost 0001 Predictive Esophageal Cancer Test 100 EA TOTAL FOR Option Year 1BASE YEAR Option Year 3: : April 1, 2024 to March 31, 2025 CLIN No. Description Annual Qty. Unit Unit Cost Annual Cost 0001 Predictive Esophageal Cancer Test 100 EA TOTAL FOR Option Year 1BASE YEAR Option Year 4: : April 1, 2025 to March 31, 2026 CLIN No. Description Annual Qty. Unit Unit Cost Annual Cost 0001 Predictive Esophageal Cancer Test 100 EA TOTAL FOR Option Year 1BASE YEAR LICENSING AND ACCREDITATION Staff/Laboratory Licenses/Certifications 1.1 Laboratory License: The Contractor shall make sure the laboratory has all licenses, permits; accreditation and certificates required by law and specifically maintain current certifications/accreditation through: CAP (College of American Pathologists) CLIA (Clinical Laboratory Improvement Act) All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP). Contractor is to provide evidence of such accreditation to COR within 30 days of contract start date. Any recertification updates will be given to the COR within 30 days of receiving them. Staff License: The Contractor shall make sure testing staff have current and valid professional state and or federal certifications. Technologists, medical technicians, and cytotechnologists shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology, be Clinical or Anatomic Pathology board certified and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction The laboratory Director shall be a licensed American Board of Pathology certified pathologist. Anatomic Pathology & Clinical Laboratories testing staff will work under the general direction of a qualified clinical or anatomic pathologist who specializes in the requested testing discipline and the supervisory technologist. CONTRACTOR RESPONSIBILITIES The Contractor shall not introduce new medical procedures and services for specimens provided by VAs without prior recommendation to, and approval of, the COTR, or authorized laboratory representative. The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer s technical representative. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion, fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered. MONTHLY TESTS SUMMARY The Contractor shall provide to VAPA a cumulative (year-to-date) monthly report of all tests received during the month and for all outstanding results. The report shall identify the tests that were received to include accession number, patient s name, Social Security Number, and specimen collection and test report dates required by accreditation agencies. The Contractor report shall indicate the requesting physician, tests, TAT for each test, corresponding cost per test and a STAT charge. SERVICE The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and 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. 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 VA upon adverse action by a regulatory agency. Contractor shall assign a specific account representative Contractor shall advise facility of any changes in methodology, procedure, delays in testing, and any new tests introduced. DO WE NEED A STATEMENT THAT IF THE TEST RESULT REPORTING METHODOLOGY/SCALE CHANGES THEY MUST TELL US? GOVERNMENT RESPONSIBILITIES. Specimen Preparation and Packaging: VAPA will a test order and package laboratory specimens for overnight shipment according to the contractor's test ordering process. The contractor shall provide an adequate supply of test order forms, shipping kits, re-usable cooling packs and any other supplies, consumables required to ship specimens. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the designated Contracting Office4r. Contracting Officer The Contracting Officer 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 Contracting Officer shall 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 adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract. COR RESPONSIBILITIES. The COR for this contract is: Dann McLean daniel.mclean1@va.gov 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. 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 includes but is not limited to: enter data that may be collected. The COR will maintain a record-keeping system of services by keeping and maintaining monthly a Running Balance database of services rendered and invoices paid. The COR will review this data on a regular basis when invoices are received and certify all invoices for payment. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. The COR will review and certify invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference. CONTRACTOR PERSONNEL. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months. The Contractor shall provide evidence of reapplication to the VA COTR of any state license, CLIA certification, or clinical pathology certification 60 days before expiration license. The Contractor shall provide a copy of the renewed licenses/certificates to the VA COR before expiration. The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Federal Government, either military or civilian, unless such -person seeks and receives approval according to DOD 5500.7-R, the Joint Ethics Regulation (JER). This policy is available to the Contractor upon request. PERFORMANCE STANDARDS QUALITY ASSUARANCE (QA) AND QUALITY IMPROVEMENT (QI). Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, timely reporting of test results, and maintaining required certifications. Methods of Surveillance: Periodic inspection and monitoring of customer comments/complaints. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. Laboratory Manager Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The COR will assist with communication between CO and Contractor. The CO is final authority on validating complaints. HOURS OF OPERATION. Normal Hours of Operation. The Contractor shall perform the services required under this contract 24 hours a day, 7 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COTR. This includes weekends and federal holidays. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (JCAHO). All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP). Offeror is to provide evidence of such accreditation. MALPRACTICE LIABILITY INSURANCE. Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract. MALPRACTICE CLAIMS. The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an, investigation or suspension. END OF CONTRACT PERFORMANCE. At the end of the period of contract performance, the participating medical treatment facility (VAMC) will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractor provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days. BILLING. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the following month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a proper invoice in accordance with FAR 52.212-4 (g), all invoices must include: Name and Address of Contractor Invoice Date and Invoice Number Purchase/Task Order Number Date of Service Total Price Vendor Electronic Invoice Submission Methods Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below: VA s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, Tungsten Network, to transition vendors from paper to electronic invoice submission. Please go to this website: https://www.tungsten-network.com/customer-campaigns/veteransaffairs/to begin submitting electronic invoices, free of charge. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org). The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10: OB10 e-Invoice Setup Information: 1-877-489-6135 OB10 e-Invoice email: VA.Registration@ob10.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov GENERAL SECURITY REQUIREMENTS 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 contractor/subcontrator 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. 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. 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 U.S. 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 Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (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. Custom software development and outsourced operations must be located in the U.S. 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-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE 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). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. 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. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/s...