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GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) to determine capability of potential source... GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) to determine capability of potential sources and is for information and planning purposes only. Veterans Health Administration, Network Contracting Office 4, is issuing this request for information/sources sought notice in order to identify capable vendors to perform Calibration Verification and Blood Bank Competency Assessment for the Wilkes Barre, PA VA Medical Center. Responses must be submitted by 4:00 PM (EST) December 3, 2019. Submit responses to the information requested via email to Theresa.murray@va.gov All capability statements should include detailed information siting capability to perform all aspects of the tentative Statement of Work. All SDVOSB and VOSB firms that respond shall include proof of CVE certification via www.vip.vetbiz.gov. All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with (FAR 4.1102 Policy). While SDVOSB/VOSB contractors are preferred, all capable contractors are encouraged to respond to this sources sought notice for market research purposes, and shall include as part of their response a brief capability statement that covers the information in the following tentative statement of work The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Suggested NAICS: 541380 (Testing Laboratories) Suggested PSC: H166 (Quality Control Instruments and Laboratory Equipment) Open to suggestions from the market as to a more appropriate NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories. SAMPLE / TENTATIVE STATEMENT OF WORK AND PRICE/COST SCHEDULE (BELOW) Calibration Verification/ Linearity Standards and Blood Bank Competency Assessment Background As required by VHA Handbook 1106.1 All Department of Veterans Affairs (VA s) Pathology and Laboratory Medicine Services that perform testing on patients must meet Clinical Laboratory Improvement Act 1988 and amendments (CLIA) 1988 requirements to: Ensure reliability of patient testing in the laboratory and Meet accreditation requirements (in this case College of American Pathologists Accreditation Standards) Laboratories that perform clinical diagnostic tests on human specimens and fail to meet the Accreditation requirements as described in 42 CFR 493, or who have demonstrated deficiencies which pose a direct threat to patients may be instructed to terminate those processes. Accreditation requirements include performing Calibration Verification for many tests and Validation of the Analytical Measurement range (sometimes called the reportable range). Accreditation requirements include Competency Assessment for all tests that are performed by testing personnel. For Clinical Laboratories, Competency Assessment must be done using six elements, one of which is performance of either Proficiency Testing or a Blind Specimen. Scope The overall purpose of this requirement is to obtain a contractor to provide Materials that could be used to perform Calibration Verification and Validation of the Analytical Measurement range for various tests. The contractor must also provide a CLIA 88 approved proficiency testing program for Transfusion Medicine that provides for Competency Assessment. The contractor must be able to provide materials that could be used to perform the testing and meet the intent of the following definitions: Calibration Verification: Calibration Verification denotes the process of confirming that the current calibration settings for each analyte remain valid for a test system. It is required to perform Calibration Verification at least every six months or after major maintenance or service. Materials suitable for Calibration Verification: Primary or secondary standards or reference materials with matrix characteristics and target values appropriate for the method. Third part general purpose reference materials that are suitable for verification of calibration following reagent lot changes if the material is listed in the package insert or claimed by the method manufacturer to be commutable with patient specimens for the method. A commutable reference material is one that gives the same numeric results as would a patient specimen containing the same quantity of analyte in the analytic method; i.e. matrix effects are absent. Proficiency testing material or proficiency testing validated material with matrix characteristics and target values appropriate for the method. Analytical Measurement Range: The Analytical Measurement Range is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration or pretreatment not part of the usual assay process. Minimum requirements can be met by using matrix appropriate materials, which include the low, mid and high concentration or activity range of the AMR and recovering appropriate target values, within defined acceptance criteria. The best practice for AMR verification is to demonstrate a linear relationship, within defined acceptance criteria, between measured concentrations of analytes and expected values for a set of four or more matrix-appropriate samples that cover AMR. The AMR must be verified at least every six months after a method is initially placed in service and following the accreditation criteria. Materials suitable for AMR Verification The materials used for AMR verification must be known to have matrix characteristics appropriate for the method. The matrix of the sample (i.e. the environment in which the sample is suspended or dissolved) may influence the measurement of the analyte. The verification must include specimens, which at a minimum, are near the low, midpoint, and high values of the AMR. Proficiency Testing specimens for Competency Assessment for Transfusion Medicine: Competency Assessment must be done on each person performing patient testing to perform his/ her assigned duties. Competency assessment must include all six elements required by accreditation standards for each test system that the employee has as part of his/ her responsibility. The element that requires this is as follows: Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. Salient Characteristics Contract must provide materials that have the same matrix as patient samples and can provide for both Calibration Verification and Analytical Measurement Range (AMR/ Linearity) for the following analytes and be able to test the full range of the AMR as listed in the table below. The Calibration Verification/ AMR kits will include samples that can be tested at a minimum of three points for each test. TEST AMR Sodium 100 200 mmol/L Potassium 1.0 10.5 mmol/L Chloride 50 140 mmol/L C02 5.0 50 mmol/L Creatinine 0.3 25 mg/dl Calcium 3.0 16.0 mg/dl Phosphorus 1.0 12.0 mg/dl Total Protein 3.0 12.0 G/dl Albumin 1.0 7.0 G/ dl HDLD 5.0 135 mg/dl Total Bilirubin 0.1 23 mg/dl Direct Bilirubin 0.1 8.5 mg/dl Magnesium 0.1 6.5 IU/L Uric Acid 0.5 12.0 mg/dl Glucose 20.0 600 mg/dl BUN 5.0 100 mg/dl Cholesterol 5.0 480 mg/dl Triglyceride 10 850 mg/dl Lactate 0.3-10 mmol/L ALP 5 850 IU/L ALT 5 400 IU/L Amylase 5 800 IU/L AST 5 400 IU/L TEST AMR CK 5 1200 IU/L LD 5 750 IU/L GGT 5 750 IU/L Lipase 10 200 IU/L LDLD 10 550 mg/dl Ammonia 9 1000 umol/L ETOH 5.0 600 mg/dl Lithium 0.06 3.0 mmol/L Urine Sodium 20 366 mmol/L Urine Chloride 20 348 mmol/L Urine Potassium 7 225 mmol/L Urine Creatinine 20 470 mg/dl Urine Amylase 40 1530 U/L Urine Protein 8 220 mg/dl Urine Albumin 1 7 g/dl Iron 3 500 ug/dl Transferrin 70-8500 mg/dl HgbA1C 5 12% Reticulocyte Count 0.0000 0.7500 X10^6 cells/uL D-dimer 0.1 3 ug/ml Fibrinogen 60 900 mg/dl Linearity/ Calibration Verification samples should be liquid and ready to use. Contract must provide for Competency Assessment Proficiency samples for Transfusion Medicine that include testing for ABO/ Rh, Antibody Screen, Crossmatch, Antibody Identification, Direct Antigen Testing (DAT). There will be a minimum of two specimens for each kit sent. The contractor must have an established event calendar and/ or shipping table that identifies the date each Calibration Verification/ Linearity kit and each Proficiency testing will be delivered. Calibration Verification/ Linearity Kits will be shipped out twice per year. Proficiency testing kits for Competency Assessment will be shipped out three times per year. The contractor will have a method that allows the laboratory to transmission of the results for each of the Calibration Verification/ AMR kits electronically. The contractor will include formal evaluation of results for each test for both the Calibration Verification/ AMR kits and the Transfusion Medicine Competency Proficiency testing. Formal evaluation reports must include: A mechanism for the laboratory to compare its test performance and/ or results against peer laboratories using the same instrument/ reagent system. Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory. A summary of peer participant results. As applicable for each analyte: analyte tested, test methodology, reported results, graded score, peer statistics (such as mean standard deviation) and contractor determined intended result. Delivery Schedule Below Delivery Schedule: The schedule of delivery for products for 2020: Name of Proficiency Tests included Projected Delivery Dates for Testing Challenge 1 Challenge 2 Challenge 3 LN2BV Sodium, Potassium, Chloride, CO2, Creatinine, Calcium, Phosphorus, Total Protein, Albumin, HDLD, Total Bilirubin, Direct Bilirubin, Magnesium, Uric Acid, Glucose, BUN, Cholesterol, triglyceride, Lactate, ALP, ALT, Amylase, AST, CK, LD, GGT, Lipase, LDLD, IRON June 15, 2020 December 7, 2020 LN3 Lithium May 11, 2020 November 16, 2020 LN6 Urine Chemistry- Urine Sodium, urine Chloride, Urine Potassium, Urine Creatinine, Urine Amylase, Urine Protein May 11, 2020 November 16, 2020 LN7 Transferrin April 20, 2020 October 12, 2020 LN11 Alcohol January 13, 2020 July 6, 2020 LN15 HgbA1c March 10, 2020 September 15, 2020 LN19 Reticulocyte Count March 16, 2020 September 14, 2020 LN32 Ammonia May 26, 2020 November 30, 2020 LN42 D-Dimer April 14, 2020 October 12, 2020 LN44 Fibrinogen May 12, 2020 November 10, 2020 TMCA-D DAT Competency February 22, 2020 October 10, 2020 TMCA Transfusion Medicine Competency Assessment February 10, 2020 June 8, 2020 September 8, 2020 Delivery of the products is expected to be in advance of required challenge dates. Delivery of the products will be the same for the following four years of the 5-year contract. Task orders awarded will delineate dates. Results: Department of VA Medical Center Wilkes-Barre will enter results onto an E-LAB website within the timeframe specified. Results will be evaluated and returned to VA Medical Center within 60 days. Results will also be available on an E-LAB website.