What is CAP validation?

What is CAP validation?

Definitions Used in CAP Accreditation Programs. • Validation: provision of objective evidence through a defined. process that a test performs as intended [CLSI] • Verification: an abbreviated process to demonstrate that a test. • Verification: an abbreviated process to demonstrate that a test.

How do you validate a new lab test?

Following steps were taken to validate a new test:

1. Verification or Establishment of Reference Intervals.
2. Verification of Analytic Accuracy.
3. Verification of Precision.
4. Verification of Limit of Detection and Limit of Quantitation.
5. Analytical Sensitivity.
6. Verification of Analytic Interferences.
7. Verification of Reportable Range.

What is AMR in laboratory?

The ANALYTICAL MEASUREMENT RANGE (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process.

What is the purpose of CAP?

The Illinois Client Assistance Program (CAP), established as part of the Federal Rehabilitation Act of 1973, as amended, is a federally funded program designed to help persons with disabilities in understanding and using rehabilitation services.

What are CAP requirements?

CAP accreditation checklists are detailed and stringent, indicating exactly what is required from laboratories to be compliant with the accreditation program. As such, the laboratory is required to have numerous policies and procedures such as those to ensure quality laboratory testing and patient safety.

What does CLIA CAP mean?

In simple terms, being CLIA certified and CAP accredited ensures your test results are meeting and exceeding industry standards for clinical laboratory testing. The College of American Pathologists (CAP) is such an agency. The CAP releases its own requirements building upon CLIA ’88 regulations.

How do you validate reportable range?

Validation can be accomplished using at least three levels of commercial linearity materials, standards or calibrators that span the lower limit, mid-point and upper limit of AMR. AMR validation can also be done by calibration verification (see below).

Is AMR the same as linearity?

Linearity refers to the relationship between the final analytical result for a measurement and the concentration of the analyte being measured. Related to linearity is the concept of the analytical measurement range (AMR).

Where to find correlation testing between two instruments?

Questions pertaining to correlation testing between two instruments can be found in the Quality Management General Issues All Common Checklist.

Is there a CLIA requirement for correlation testing?

Correlation testing is also a CLIA (Clinical Laboratory Improvement Act) requirement under the final rule published in 2003. Resources: Department of Health and Human Services, Centers for Medicare and Medicaid Services.

When do you need to do correlation testing?

The performance of correlation testing between two or more similar instruments is required by CAP, JCAHO and CLIA and it is part of good laboratory practice. Correlation must be performed between all instruments running the same assay in the same laboratory and between a primary laboratory and their back-up laboratory.

When do you need a correlation audit shell?

Correlation is required for all laboratories performing research funded by the NIH Division of AIDS. This procedure assumes that for routine correlation testing, the instruments have been validated, appropriately calibrated and maintained and that internal QC is within acceptable limits. Audit Shell:

What is CAP validation? Definitions Used in CAP Accreditation Programs. • Validation: provision of objective evidence through a defined. process that a test performs as intended [CLSI] • Verification: an abbreviated process to demonstrate that a test. • Verification: an abbreviated process to demonstrate that a test. How do you validate a new lab test?…