Inactive

DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be const... DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI. STATEMENT OF WORK (SOW) 1. Contract Title. Erie, PA VAMC 135 East 38th Street, Erie, PA 16504,TB Testing Services. 2. Background. The Erie, PA VAMC s Pathology and Laboratory Department VAMC is seeking a Contractor to conduct all test analysis in accordance with industry standards does of performing the M. tuberculosis testing for latent TB infection. 3. Scope. The Erie, PA VAMC requests a base year contract with four (4) additional option years for a contractor performing M. tuberculosis testing for latent TB infections. The estimated annual volume of TB testing is roughly 463 tests per year with an estimated annual increase of 60 tests each year. 4. Specific Tasks. The Erie, PA VAMC is seeking a Contractor to conduct all test analysis in accordance with industry standards to include but not limited to Clinical Laboratory Improvement Amendments (CLIA) regulated through The Centers for Medicaid and Medicare Services (CMS) and College of American Pathologists (CAP) Guidelines or Joint Commission standards. Contractor MUST provide copy of CLIA accreditation and as well as accreditations, certifications, or licenses of other applicable accrediting institutions with quote. In addition, as these documents are reissued, reworded, or renewed the awarded Contractor must supply a copy to the Erie, PA VAMC laboratory department. Testing methodology used by the contractor must adhere to the following requirements: Approved for use by the FDA. Interferon Gamma Release Assay (IGRA) for targeted TB testing. Ability to detect latent tuberculosis infection. Sensitivity and specificity must be 95% or greater. Test must be specific for M. tuberculosis with no cross-reactivity with BCG vaccine and non-tuberculosis strains of Mycobacterium. Single test requirement for diagnosis. Contractor is responsible for providing specimen collection kits or supplies necessary for TB testing requirements. In addition, materials will be provided to the Erie, PA VAMC Pathology & Laboratory Medicine department for shipment to the performing laboratory. This includes vacutainer tubes, packaging, seals, absorbent pads and shipping labels complete with the contracting laboratory s address. For replenishment of required materials necessary for specimen collection and shipment, the contractor shall be contacted directly from the Erie, PA VAMC Pathology & Laboratory Medicine department as needed. Payment for shipping charges incurred for specimen transport from the Erie, PA VAMC to the performing laboratory will be the responsibility of the performing laboratory. Educational reference materials for proper specimen collection and shipment will be made readily available to the Erie, PA VAMC staff. This includes posters, reference cards, or on-line resources. Performing laboratory will provide customer support services Monday through Friday via telephone or internet. Contractor must willingly accept delivered routine specimens Monday through Friday from the Erie, PA VAMC. Pertaining to specimens from the Erie, PA VAMC which are rejected by the contractor, telephonic notification must be made to the Erie, PA VAMC Employee Health Nurse or Laboratory Manager by the contractor within 24 hours of specimen receipt. Test results must be available from the contractor within 48 hours of specimen receipt. Contractor must have a reliable method established for reporting results to the Erie, PA VAMC. Both the Employee Health Nurse and Laboratory Manager at the Erie, PA VAMC will have accessibility to all patient reports. In the event contractor services are affected by Food & Drug Administration recalls or productive corrective actions, the Erie, PA VAMC will be sent a description in writing within 10 business days. In addition, any testing sent by the Erie, PA VAMC which may be affected will be disclosed. The Erie, PA VAMC will be provided a fee schedule defining costs related to TB testing services. The contractor will give advance notice to the Erie, PA VAMC pertaining to adjustments to this schedule. 5. Performance Monitoring: The Contractors performance will be evaluated on a quarterly basis during the period of performance. Documentation will be maintained by the COTR on the Contractors Performance report. Failure to meet the performance requirements could result in the loss of future consideration for a contract.  Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the COR for process review and improvement of contract performance on an as needed basis. Copies of licensure/certifications are also required to be submitted upon request by the VA. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc. These monitoring procedures and disincentives for contractor s failure in meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix: PERFORMANCE OBJECTIVE PERFORMANCE STANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL (AQL) MONITORING METHOD Telephonic notification within 24 hours of specimen rejection to Erie, PA VAMC Any rejected specimen must be telephoned to the Erie, PA VAMC lab within 24 hours. 100% of the time Daily monitoring through result review. Test results within 2 days Test results must be received by the Erie, PA VAMC within two (2) days of receipt by the contractor. 100% of the time Daily monitoring through result review. Quality of Services Provided Proof of licensure/accreditation 100% of the time Current copy of CLIA and accrediting agency certificate to be provided on an annual basis If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer COR. Excusable circumstances will be taken into consideration and documented appropriately on the Contractor s Performance Report. 6. Privacy and Security Requirements. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor will not have VPN access, nor come on station to perform any services, or access any VA systems. Contractor will utilize an electronic requisition system that has a secure web-based portal for patient orders. When testing is complete, the VA can sign into the portal and retrieve (print) results from the web-based system. The VA will then manually enter into the patient record the results (there is no interfacing between contractor and Erie, PA VA). The contractor owns the information they generate. The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall require intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required Contractor is considered a covered entity with no access to a VA system/network. As a covered entity the contractor must protect any PHI generated or received in their processes under this contract. It is the sole responsibility of the contractor to ensure their staff protects any patient identifiers or information they possess or generate as a covered entity. As a covered entity the contractor is not required to take VA Privacy/HIPAA or Security training. They must ensure staff involved in the contract work with VA are current on their own company equivalent standard security and privacy training. A Business Associate Agreement is not required for this contract since the contractor is a covered entity. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Any contractor and/or subcontractor retained to do work for VA under this Contract that requires the access, use, storage, modification, or transmission of VA Sensitive Personal Information (SPI) must follow and adhere to the security controls, enhancements, compensating controls, protocols, regulations, and VA directions as the Contracting Officer (CO) shall direct, including, but not limited to those derived from the Federal Information Security Management Act (FISMA), OMB Circular No. A-130, and VA Handbook 6500/6500.6. The contractor must report any data breach according to the protocols and timeframes in HB 6500. If any contractor/sub-contractor retained to do work for VA under this Contract requires access, use, etc., of VA SPI as aforesaid, and if an actionable data breach occurs because of the contractor/subcontractor s acts, omissions, or negligence in following the VA-directed security controls, enhancements, compensating controls, protocols, and/or measures, including, but not limited to the sources above, the contractor/subcontractor is further subject to the statutory requirement to assess liquidated damages against contractors and/or subcontractors under 38 U.S.C. §5725 in the event of a breach of Sensitive Personal Information (SPI)/Personally Identifiable Information (PII). Said liquidated damages shall be assessed at $37.50 per affected Veteran or beneficiary. A breach in this context includes the unauthorized acquisition, access, use, or disclosure of VA SPI which compromises not only the information s security or privacy but that of the Veteran or beneficiary as well as the potential exposure or wrongful disclosure of such information as a result of a failure to follow proper data security controls and protocols. The preceding shall only apply if any contractor/subcontractor retained must access, use, store, modify, or transmit VA-owned SPI in the course of providing services, etc. to VA under this Contract. 7. Other Pertinent Information or Special Considerations. a. Inspection and Acceptance Criteria. The Erie, PA VAMC will identify a COR that will provide acceptance of all invoices submitted against this Services Contract. 8. Place of Performance. The testing will be performed at the Contractors facility. 9. Period of Performance. The Erie, PA VAMC is requesting a base year with four (4) additional option years to be used at the government s discretion. The base year shall commence on 9/1/2022 8/31/2023 Option Year 1: 9/1/2023 8/31/2024 Option Year 2: 9/1/2024 8/31/2025 Option Year 3: 9/1/2025 8/31/2026 Option Year 4: 9/1/2026 8/31/2027 10. Delivery Schedule. Contractor shall notify the Erie, PA VAMC COR in accordance with the Performance Objectives and Performance Standards below. PERFORMANCE OBJECTIVE PERFORMANCE STANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL (AQL) MONITORING METHOD Telephonic notification within 24 hours of specimen rejection to Erie, PA VAMC Any rejected specimen must be telephoned to the Erie, PA VAMC lab within 24 hours. 100% of the time Daily monitoring through result review. Test results within 2 days Test results must be received by the Erie, PA VAMC within two (2) days of receipt by the contractor. 100% of the time Daily monitoring through result review. The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code 621511 3. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: a. Where are the requested items/equipment manufactured? Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice c. Is the Vendor an authorized distributor services which may be required in performance of this requirement? The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following: Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________ Company's business size: ________________________________________________ Data Universal Numbering System (DUNS) #: _______________________________ e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite 621511 NAICS code? Please provide proof of qualifications. f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)? If so, please identify the contract number for the Government to review as part of this Market Research. 4. Opportunity/Market Pricing: The EVAMC is seeking information from potential vendors on their ability to provide the required items/service. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the EVAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation. 5. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 9:00am (EST), June 27, 2022, via email to debra.willard@va.gov no phone calls excepted. 7. Contact Information: Debra Willard debra.willard@va.gov Your response to this notice is greatly appreciated!