Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF NOVEMBER 28, 2019 SAM #6573
SOURCES SOUGHT

H -- Calibration Verification and Blood Bank Competency Assessment for the Wilkes Barre, PA VA Medical Center

Notice Date

11/26/2019 6:36:13 AM
 

Notice Type

Sources Sought
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
 

ZIP Code

15215
 

Solicitation Number

36C24420Q0113
 

Response Due

12/2/2019 8:59:59 PM
 

Archive Date

12/17/2019
 

Point of Contact

Theresa Murraytheresa.murray@va.gov
 

E-Mail Address

theresa.murray@va.gov
(theresa.murray@va.gov)
 

Awardee

null
 

Description

GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORKNOTICE: 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 workThe 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 AssessmentBackgroundAs 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 andMeet 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.ScopeThe 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 VerificationThe 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.TESTAMRSodium100 200 mmol/LPotassium1.0 10.5 mmol/LChloride50 140 mmol/LC025.0 50 mmol/LCreatinine0.3 25 mg/dlCalcium3.0 16.0 mg/dlPhosphorus1.0 12.0 mg/dlTotal Protein3.0 12.0 G/dlAlbumin1.0 7.0 G/ dlHDLD5.0 135 mg/dlTotal Bilirubin0.1 23 mg/dlDirect Bilirubin0.1 8.5 mg/dlMagnesium0.1 6.5 IU/LUric Acid0.5 12.0 mg/dlGlucose 20.0 600 mg/dl BUN5.0 100 mg/dlCholesterol5.0 480 mg/dlTriglyceride10 850 mg/dlLactate0.3-10 mmol/LALP5 850 IU/LALT5 400 IU/LAmylase5 800 IU/LAST5 400 IU/LTESTAMRCK5 1200 IU/LLD5 750 IU/LGGT5 750 IU/LLipase10 200 IU/LLDLD10 550 mg/dlAmmonia9 1000 umol/LETOH5.0 600 mg/dlLithium0.06 3.0 mmol/LUrine Sodium20 366 mmol/LUrine Chloride20 348 mmol/LUrine Potassium7 225 mmol/LUrine Creatinine20 470 mg/dlUrine Amylase40 1530 U/LUrine Protein8 220 mg/dlUrine Albumin1 7 g/dlIron3 500 ug/dlTransferrin70-8500 mg/dlHgbA1C5 12%Reticulocyte Count0.0000 0.7500 X10^6 cells/uLD-dimer0.1 3 ug/mlFibrinogen60 900 mg/dlLinearity/ 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 BelowDelivery Schedule: The schedule of delivery for products for 2020:Name of ProficiencyTests includedProjected Delivery Dates for Testing Challenge 1 Challenge 2 Challenge 3LN2BVSodium, 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, IRONJune 15, 2020December 7, 2020LN3LithiumMay 11, 2020November 16, 2020LN6Urine Chemistry- Urine Sodium, urine Chloride, Urine Potassium, Urine Creatinine, Urine Amylase, Urine ProteinMay 11, 2020November 16, 2020LN7TransferrinApril 20, 2020October 12, 2020LN11AlcoholJanuary 13, 2020July 6, 2020LN15HgbA1cMarch 10, 2020September 15, 2020LN19Reticulocyte CountMarch 16, 2020September 14, 2020LN32AmmoniaMay 26, 2020November 30, 2020LN42D-DimerApril 14, 2020October 12, 2020LN44FibrinogenMay 12, 2020November 10, 2020TMCA-DDAT CompetencyFebruary 22, 2020October 10, 2020TMCATransfusion Medicine Competency AssessmentFebruary 10, 2020June 8, 2020September 8, 2020Delivery 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.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/ec58e7ffc7f14b61b4eb648bbd60e73c/view)
 

Place of Performance

Address: Department of Veterans Affairs;Wilkes Barre VA Medical Center;1111 East End Blvd;Wilkes Barre, PA 18711, USA

Zip Code: 18711

Country: USA
 

Record

SN05504141-F 20191128/191126231632 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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