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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 06, 2016 FBO #5188
DOCUMENT

66 -- Lab Equip Verification and Competency Proficiency Testing - Attachment

Notice Date

2/4/2016
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4
 

Solicitation Number

VA24416N0514
 

Response Due

2/9/2016
 

Archive Date

3/10/2016
 

Point of Contact

Ronald J Kline
 

E-Mail Address

822-3755<br
 

Small Business Set-Aside

N/A
 

Description

This is a full and open Sources Sought Notice. This is NOT a solicitation for proposals, quotation abstracts, or quotations. This notice is for informational and planning purposes only and shall not be construed as a solicitation or an obligation or commitment by the Government, nor is it a Request for Proposals (RFP) available at this time. The Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) in Wilkes-Barre, PA has a requirement for Proficiency test Kits. Any subsequent procurement will be conducted as a commercial item purchase in accordance with FAR Part 12 and as a Simplified Acquisition Procedure in accordance with FAR Part 13 as a 1 year contract. Interested sources may submit a 1 or 2 page capability statement with enough detail for the Government to make an informed decision regarding such capability. The statement should identify supplier's name, address, point of contact, phone and fax numbers, e-mail addresses and business type and size. Any pertinent GSA Schedule numbers with expiration date should be provided. These statements should be submitted electronically no later than 12:00 noon, Eastern Standard Time on Tuesday, February 9, 2016 to Ronald J. Kline at Ronald.Kline@va.gov. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that the response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to deliver the supplies. Respondents are also advised that the Government is under no obligation to acknowledge receipt of the information or provide feedback about any of the information received. After review of the responses received, the Government may issue a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. No proprietary, sensitive, confidential or classified information shall be included with your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation. Scope Provide Materials that could be used to perform Calibration Verification and Validation of the Analytical Measurement range for various tests. Must also provide a CLIA '88 approved proficiency testing program for Transfusion Medicine that provides for Competency Assessment. Must be able to provide materials that could be used to perform the testing and meet the intent of the following definitions: 1.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: 1. Primary or secondary standards or reference materials with matrix characteristics and target values appropriate for the method. 2.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. 3.Proficiency testing material or proficiency testing validated material with matrix characteristics and target values appropriate for the method. 2.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. 3.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 1. 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. TESTAMR Sodium100 - 200 mmol/L Potassium1.0 - 10.5 mmol/L Chloride50 - 140 mmol/L C025.0 - 50 mmol/L Creatinine0.3 - 25 mg/dl Calcium3.0 - 16.0 mg/dl Phosphorus1.0 - 12.0 mg/dl Total Protein3.0 - 12.0 G/dl Albumin1.0 - 7.0 G/ dl HDLD5.0 - 135 mg/dl Total Bilirubin0.1 - 23 mg/dl Direct Bilirubin0.1 - 8.5 mg/dl Magnesium0.1 - 6.5 IU/L Uric Acid0.5 - 12.0 mg/dl Glucose 20.0 - 600 mg/dl BUN5.0 - 100 mg/dl Cholesterol5.0 - 480 mg/dl Trigliceride10 - 850 mg/dl Lactate0.3-10 mmol/L ALP5 - 850 IU/L ALT5 - 400 IU/L Amylase5 - 800 IU/L AST5 - 400 IU/L TESTAMR CK5 - 1200 IU/L LD5 - 750 IU/L GGT5 - 750 IU/L Lipase10 - 200 IU/L LDLD10 - 550 mg/dl Ammonia9 - 1000 umol/L ETOH5.0 - 600 mg/dl Lithium0.06 - 3.0 mmol/L Urine Sodium20 - 366 mmol/L Urine Chloride20 - 348 mmol/L Urine Potassium7 - 225 mmol/L Urine Creatinine20 - 470 mg/dl Urine Amylase40 - 1530 U/L Urine Protein8 - 220 mg/dl HgbA1C5 - 12% D-dimer0.1 - 3 ug/ml Fibrinogen60 - 900 mg/dl 2.Linearity/ Calibration Verification samples should be liquid and ready to use. 3.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. 4.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. 5.Calibration Verification/ Linearity Kits will be shipped out twice per year. 6.Proficiency testing kits for Competency Assessment will be shipped out three times per year. 7.Have a method that allows the laboratory to transmission of the results for each of the Calibration Verification/ AMR kits electronically. 8.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)A mechanism for the laboratory to compare its test performance and/ or results against peer laboratories using the same instrument/ reagent system. b)Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory. c)A summary of peer participant results. d)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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24416N0514/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-16-N-0514 VA244-16-N-0514.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2544129&FileName=VA244-16-N-0514-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2544129&FileName=VA244-16-N-0514-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: INTEREST WILL ONLY BE ACCEPTED VIA E-MAIL

Zip Code: 18711
 

Record

SN04009853-W 20160206/160204234750-a06bafa1be2879b5141f62bef94a46b7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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