Inactive

SOURCES SOUGHT NOTICE This is a Sources Sought Notice (SSN) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Referen... SOURCES SOUGHT NOTICE This is a Sources Sought Notice (SSN) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Reference Lab Testing for Quantitative Antigen Detection of Pathological Viruses by Nucleic Acid Based Methodology. Potential Contractors are invited to provide a response via e-mail to Contract Specialist Alex Beck at alex.beck1@va.gov by Oct 26, 2023 3:00 pm (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this sources sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued. BACKGROUND: The Portland VA Health Care System, Portland VA Medical Center, Portland Oregon, has a requirement for a Contractor to provide Reference Lab Testing for Quantitative Antigen Detection of Pathological Viruses by Nucleic Acid Based Methodology. Please draft Statement of Work below for requirements. NAICS: Interested potential Contractors please provide the following. 1) Company Name, address, point of contact, phone number, email address, and DUNS Please indicate business size: Small Disadvantage Business (SDB)____ 8(a)____ Historically Underutilized Business Zone (HUBZone)____ Service-Disabled Veteran-Owned Small Business (SDVOSB)____ Veteran-Owned Small Business (VOSB)_____ Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____ Women-Owned Small Business concerns (WOSB)_____ Small Business_____ Large Business_____ Please state if you possess a Federal Supply Schedule (FSS)______. Please state if your FSS Schedule is under Group 66 III Cat 605-2A________ 2) Please submit a brief capability statement (maximum two pages) with enough information to demonstrate to the Veterans Affairs that you have the personnel, qualifications and capabilities to provide all requirements Reference Lab Testing stated in the Draft Statement of Work below. **Draft Statement of Work 1. Contract Title: Quantitative Antigen Detection of Pathological Viruses by Nucleic Acid Based Methodology 2. Background: VA Portland Health Care System (VAPORHCS) requires reference laboratory testing that specializes in the detection of viruses by a nucleic acid-based methodology. Historically, traditional methods such as Direct Fluorescent Antibody (DFA) assay and culture methods have been used to assist physicians in diagnosing viral respiratory tract infections. Nucleic acid sequence-based amplification has shown greater sensitivity than DFA and culture with the additional ability to detect the presence of multiple and emerging viruses rapidly. The ability to identify a particular virus quickly and specifically as the etiologic agent for syndromic diseases like bronchiolitis and pneumonia has been demonstrated to result in reduced hospital stays, decreased use of unnecessary anti-viral medication, and elimination of superfluous diagnostic procedures and laboratory tests. 3. Scope: 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 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. 4. Specific Tasks: The Reference Laboratory shall provide laboratory services to include: pre-analytic 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 volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA. The test list is found within Attachment A. Tests for quantitative analysis for viral testing should have a broad range of detection. The lowest level of detection is ideal. For transplant patients VAPORHCS requires that Plasma/Serum for CMV testing must be detectable at the lowest level of 100 IU/mL or less. All Tests contained within attachment A must yield a quantitative result. Vendor must be able to process the following specimen types: blood, plasma, and body fluids such as CSF, pleural, peritoneal, vitreous/eye, bronchial alveolar lavage (BAL), etc. Refer to Attachment A for the required specimen types per test. Reference laboratory shall meet Turn Around Times required by the VAPORHCS. Refer to Attachment A for the required TAT for each test. 5. ELECTRONIC INTERFACE: Not applicable. 6. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS Identification of Possible Follow-on Work: None Identification of Potential Conflicts of Interest (COI): None Identification of Non-Disclosure Requirements: This medical center provides specific privacy to patients as part of its normal protocols. Packaging, Packing and Shipping Instructions: All specimens will be shipped from VAPORHCS to Reference Laboratory for testing. Specimens will be packaged and shipped in accordance with Department of Transportation regulations for the shipment of biologic substances. 7. RISK CONTROL: None. 8. 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. 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: analyze 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 designee to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration). Customer Service consists of timely responses to questions and concerns within 24 hours. Timeliness of results. Published turn-around times are met. Refer to Attachment A for acceptable Turn Around Time for each test. Timeliness of invoicing. Invoices will be sent within 30 days of completed services. 9. PLACE OF PERFORMANCE Reference Laboratory to be determined. 10. PERIOD OF PERFORMANCE: Base POP: 12/1/23 to 11/30/24. Option Years to Follow: OY 1: 12/1/24 - 11/30/25 OY 2: 12/1/24 - 11/30/26 OY 3: 12/1/25 - 11/30/27 OY 4: 12/1/26 - 11/30/28 11. DELIVERY AND PICK-UP SCHEDULE: Deliver tests results from tests listed on Attachment A to PLMS PVAMC via fax. 12. 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 arrival to when results are available. TAT requirements are established by the VA facility. Acceptable Turn-Around-Time: Within 24 hours of receipt of specimen, with 2 exceptions. Refer to Attachment A, as acceptable TAT is outlined for each test. If testing will not be resulted within TAT, the Reference Lab shall notify the VA Facilities of the new estimated TAT within 12 hours. Testing methodology and reference ranges for a test must be defined in the Reference Laboratory user manual and/or website. Reference Laboratory shall advise 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 Facilities Laboratory Service within 12 hours of any problems with 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. 13. CUSTOMER SERVICE The Reference Laboratory shall provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problem, 24 hours per day, 7 days per week. The Reference Laboratory shall provide names and telephone numbers of technical Directors and Pathologists available to provide information. 14. DELIVERY AND REPORTING 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: 1) Vendor Name 2) Applicable FSS contract number 3) BPA Number, Task order number, and Purchase Order number 4) Date of Purchase 5) Date of Shipment 6) Description of item 7) Quantity of each item 8) 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: Your firm s Tax Payer ID number (TIN) Your firm s Remit Address information The VA Purchase Order (PO) number Your firm s contact information: (Personal Name, Email, and Phone) Your VA point of contact information: (Personal Name, Email, and Phone) The Period of Performance dates (Beginning and Ending) All discount information if applicable (Percent and Date Terms) For additional information, please contact: Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/ 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: Contract number and purchase order number Station ID (648) Date services were requested. Patient name and test 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. 15. LICENSING AND ACCREDITATION Reference Laboratory Contractor shall provide copies of all licenses, permits, accreditation and certificates required by law (please see b. and c. below). The Laboratory Director shall be a licensed American Board of Pathology certified pathologist. 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. 16. PERSONNEL The Reference Laboratory shall make sure employees have current and valid professional certifications or equivalents 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. 17. HOURS OF OPERATION The Portland VA is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times. 18. PATIENT INFORMATION SAFETY 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. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement. The Reference Laboratory) shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors. 19. SECURITY REQUIREMENTS The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. VA Portland Health Care System in coordination with their site Information Security Officer (ISO) shall monitor the work performed by contractor personnel, including sub-contractors, on a periodic basis to make sure contractor personnel are following the stated security requirements. 20. QUALITY ASSURANCE SURVEILLANCE PROGRAM SOW Task# Quality Monitor Format Calendar Days After CO Start Acceptability Level 1 Licensures/Certificates Copies At initial award, and when renewed 100% Received 2 Monthly Test Summary One electronic copy Monthly on the 10th work day 100% Received 3 Contact Phone List One electronic copy At initial award, and when changes occur 100% Received 4 Laboratory User Manual Electronic copy and one hard copy At initial award 100% Received 5 Turn Around Time One electronic copy Monthly 95% meets established limits 21. 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. 22. VA INFORMATION SECURITY LANGUAGE 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/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. 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 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. 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 mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US 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. 23. CUSTODY OF VA INFORMATION Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractor/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 onsite 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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Records Management Procedures. 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. COR will then alert VHAPOR-RecordsManagement@va.gov of the data destruction notice sent by the contractor 30 days after 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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated an appropriate action 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 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, the 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 COR. 24. SECURITY INCIDENT INVESTIGATION The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the Contracting Officer and the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a date breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft, break-in, or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. Liquidated Damages for Data Breach Consistent with the requirements of 38U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under the contract. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date breach for the potential misuse of any sensitive personal information involved in the data breach. The term "data breach" means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of event (loss, theft, unauthorized access); Description of the event, including: Date of occurrence Date elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code. Number of individuals affected or potentially affected. Names of individuals or groups affected or potentially affected; Ease of logical date access to the lost, stolen, or improperly accessed data in light of the degree of protection for the data, e.g. unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of date containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit report monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing disput...