Statement of Work - Linearity Calibration Verification and Competency Assessments_draft.docx

Statement of Work Linearity/Calibration Verification and Competency Assessments Background As required by VHA Handbook 1106.1

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:

a) Ensure reliability of patient testing in the laboratory and

b) Meet accreditation requirements (in this case College of American Pathologists Accreditation Standards)

2. 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.

3. Accreditation requirements include performing Calibration Verification for many tests and Validation of the Analytical Measurement range (sometimes called the reportable range).

4. 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:

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. Contractor 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.

2. Linearity/ Calibration Verification samples should be liquid and ready to use.

3. 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.

4. 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.

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. The contractor will have a method that allows the laboratory to transmission of the results for each of the Calibration Verification/ AMR kits electronically.

8. 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) 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.

DELIVERY SCHEDULE

Medicine Competency Assessment

All items should be delivered to VA Medical Center at 1111 East End Boulevard, Wilkes-Barre, Pa. 18711 between the hours of 8am-4pm Monday through Friday and not on Federal Holidays. POC for deliveries is Elizabeth Disimoni at 570-824-3521 ext. 24014 email Elizabeth.Disimoni2@va.gov and Elizabeth Brown at 570-824-3521 ext. 27541 email Elizabeth.Brown4@va.gov Period of Performance The contract period of performance shall be tentatively January 16, 2026 through January 15, 2027 for 5-year contract that may be unilaterally exercised at the Government’s discretion to extend the contract through the calendar year 2031.