Inactive

RFQ VA Valley Coastal Bend (VCB) Health Care System in Texas is seeking a contractor to provide Lab Linearity Survey

Inactive

Page 6 of 6 THIS IS A SOURCES SOUGHT NOTICE. This is not a request for proposals. The VA Texas Valley Coastal Bend Health Care System (VATVCBHCS), located at 2601 Veterans Way, Harlingen, TX 78550-894... Page 6 of 6 THIS IS A SOURCES SOUGHT NOTICE. This is not a request for proposals. The VA Texas Valley Coastal Bend Health Care System (VATVCBHCS), located at 2601 Veterans Way, Harlingen, TX 78550-8942 is seeking sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 621511. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance (including references); (3) intentions of subcontracting program to include set-asides and (4) any other pertinent company documentation. The response date to this Sources Sought notice is no later than 12 midnight Central Time, December 10, 2019. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or full & open competition, or sole-source procurement is appropriate. Notification shall be e-mailed to Grace Barr, at grace.barr@va.gov. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. Statement of Work Linearity Kits Background Many testing systems within P&LMS require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter. This can be accomplished through purchase of linearity material that is both matrix specific and spans the range of the AMR for each analyte, when required. This is addressed in 42 CFR 493.1255 (b) and the College of American Pathologists (CAP) standard CHM.13600. This Statement of Work (SOW) is requesting the procurement of linearity materials that are not provided through the P&LMS VA Central Office (VACO); but are still required by the guidelines set forth in VA Handbook 1106.01 7.2, 42 CFR 493 Subpart H and K, and many CAP standards. Therefore, procurement of the materials described above is not an option, but a requirement of accreditation for all VA laboratories. Purpose The overall purpose of this requirement is to obtain a vendor to provide CLIA 88-approved proficiency testing and linearity materials, which are not already provided through P&LMS VACO funding. This will ensure that all laboratory testing sites that perform patient testing, within the Veterans Administration Texas Valley Coastal Bend Health Care System (VATVCBHCS), are in compliance with VHA Handbook 1106.01, 42 CFR 493 Subpart H & K requirements, and CAP accreditation standards. Location The proficiency and linearity materials will be utilized for compliance testing in the P&LMS Department of the VATVCBHCS, including: Corpus Christi Specialty Clinic, Harlingen HCC, and McAllen Outpatient Clinic. Corpus Christi Specialty Clinic 205 S. Enterprize Parkway, Corpus Christi, TX 78405 McAllen Outpatient Clinic 901 E. Hackberry Ave., McAllen, TX 78503 Harlingen HCC 2601 Veterans Drive, Harlingen, TX 78550 Period of Performance The Contract period of performance shall be January 1, 2020 through December 31, 2024, which includes a Base year and 4 option years that may be unilaterally exercised at the Government s discretion. Scope VATVCBHCS intends to award a contract to the vendor who can supply the following for the Abbott Architect ci4100: General Chemistry Linearity material for plasma/serum Albumin, Alkaline Phos, ALT, AST, Amylase, Calcium, Chloride, Cholesterol, CK, CO2, Creatinine, Direct Bilirubin, Direct LDL, GGT, Glucose, HDL, LDH, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid linearity/calibration verification (4 kits per year). Linearity material for Ferritin, PSA, and TSH (3 kits per year). Linearity material to monitor Lithium, Ammonia, and CKMB (2 kits per year). Tasks Task 1: Linearity program The linearity program must: Provide at a minimum the following specimens or materials within the VATVCBHCS System: General Chemistry Linearity materials for both plasma/serum that include all listed analytes to be shipped to Harlingen HCC (2), Corpus Christi Specialty Clinic (1), and McAllen Outpatient Clinic (1) each year. Ferritin, PSA, and TSH linearity material to be shipped to Harlingen HCC (2) and McAllen Outpatient Clinic (1) each year. Lithium, Ammonia and CKMB Linearity materials shipped to Harlingen HCC (2) every year. Include a mechanism for the contractor to notify the following in the VATVCBHCS System: VATVCBHCS Contract Officer Representative (COR), VATVCBHCS Laboratory Manager, VATVCBHCS Quality Medical Technologist (QMT), and each individual laboratory point of contact (POC) of any linearity updates. Include a contractor-established event calendar and/or shipping table that identifies the date each linearity is scheduled to be shipped to the laboratory. The contractor is to ensure that linearity materials are shipped at the proper temperature to ensure viability of specimens when they arrive at the testing laboratory. Have a mechanism that allows each individual laboratory to transmit linearity results electronically via a secured website or by facsimile. Include formal evaluation of results for each test. Provide a plan for replacement of defective or damaged linearity materials. Provide a glossary of terms when technical terminology is used in a calibration/linearity verification kit. Have an electronic method (i.e., website, fax, email) for receipt of VA furnished correspondence. Contract prices should include any costs associated with the electronic data transmission. Task 2: Deliverables: Mailed, Written Correspondence, Database Files All Mailed deliverables, which includes linearity materials shall be shipped Freight On Board (FOB) Destination (paid by contractor) and shipped directly to the performing laboratory. Written correspondence may be shipped FOB Destination (paid by the contractor) or delivered electronically to the COR, QMT, Laboratory Manager, laboratory POC, and accrediting agency. The electronic format must mirror the contents of a paper format. Written or electronic correspondence must be sent for the following: Linearity updates will be provided within 10 working days of a change. Linearity manuals, catalogs, and event calendars (with shipping tables) will be made available to all above parties within 10 working days of the award for base and each option year. Linearity formal evaluation reports will be made available to all above parties within 30 calendar days of the evaluation. Database files (i.e., XML, Excel, HTML) shall be submitted to the COR, QMT, and laboratory POCs electronically. Linearity ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to the COR, QMT, Laboratory Manager, and laboratory POC within 10 working days. Summary/Confirmation of all order changes and a running balance report shall be provided monthly (30 calendar days) to the COR and Laboratory Manager. The contractor shall provide linearity performance data in both a paper format and XML format through a secured FTP server connection. The contractor shall submit any required documentation to the laboratory s accrediting organization using a format that is routinely accepted by the accrediting organization. Billing Vendor shall use the Tungsten e-Invoice system for all billings. www.tungsten-network.com Period of Performance shall be indicated on all invoices. A Government customer termination agreement prior to the contract term of five years (60 months) the contract pricing awarded will be adjusted. Pricing published shall be based on a 60 month term. However, upon early termination, alternate pricing, which is part of this contract, shall apply. A CCR number shall be maintained in addition to a current DUNS number for all Contractor information. Licensing and Accreditation The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. Authorized Ordering Offices Task orders, for all individual VATVCBHCS laboratories, will be awarded and managed by the COR. Changes to orders can be made as needed during the course of the contract. Actual (running) balance will be reconciled between the contractor and the COR on a monthly basis. Government Furnished Items Each VATVCBHCS Laboratory will provide linearity testing results to the contractor via electronic method(s) determined by the contractor. VATVCBHCS QMT will provide respective laboratory POC(s) and other demographics using forms provided by the contractor. The COR will provide contact information for the Laboratory Manager post award. The COR will provide the initial linearity material order in the format and time period determined by the contractor, using the forms provided by the contractor. The COR will provide any order changes, via electronic transmission, within a week when needed. Contractor Security Contract 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/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 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 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 operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. NOTE: NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. 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. Linearity Materials Requirements The items listed below are required. Kits must have a stability of at least 6 months so they may be performed twice a year to comply with CAP and VA Regional Commissioners Office (National Enforcement Program) regulations of bi-annual correlations of analyzer performance. The data below is required for one year. Part No. Description QTY location GC1 General Chemistry 4 McAllen, Harlingen, Corpus, Laredo GC2 Co2, Iron, Uric Acid 4 McAllen, Harlingen, Corpus, Laredo GC3 Hepatic 4 McAllen, Harlingen, Corpus, Laredo GC4 DBIL, TBIL 4 McAllen, Harlingen, Corpus, Laredo TDM1 Therapeutic Drugs 2 McAllen, Corpus Anemia B12, Ferr, Folate 3 McAllen, Corpus, Harlingen Tumor marker PSA, 3 McAllen Corpus Harlingen LP Lipoproteins 3 McAllen, Corpus, Harlingen Fertility 1 Testosterone 3 McAllen, Corpus, Harlingen Vit D Vitamin D 3 McAllen, Corpus, Harlingen SP 1 Transferrin 3 McAllen, Corpus, Harlingen UC4 Urine creat 3 McAllen, Corpus, Harlingen UC5 Urine Albumin 3 McAllen, Corpus, Harlingen THY TSH 3 McAllen, Corpus, Harlingen _______________________________ TOTALS 45 Shipping and Handling Free *Harlingen has duplicate instruments as ambulatory surgery center McAllen (14 products): Shipped to: Jorge Rivera, Lab Supervisor, 901 East Hackberry, McAllen, TX 78503 Phone: 956-992-9820 (or 956-618-7100, ext. 67328) Corpus (14 products): Shipped to: Betty Collie, Lab Supervisor, 205 S. Enterprize Parkway, Corpus Christi, TX 78405-4118 Phone: 361-939-6510 (ext. 62644) Laredo (4 products): Shipped to: Amira Rodriguez, MT, 4602 N. Bartlett, Laredo, TX 78041-3803 Phone: 956-523-7850 (ext. 63268) Harlingen (13 products): Shipped to: Obed Valdez-Cabrera, Lab Supervisor, 2601 Veterans Drive, Harlingen, TX, 78550-8942 Phone: 956-291-9279/9281