CMS

Edition 9: Reportable Range

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. COLA revised their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. The new CLIA and COLA regulations require that the laboratory verify the manufacturer’s performance specifications listed in their package inserts. The laboratory must verify accuracy, precision, reference range and reportable range for each non-waived test. This bulletin will address the verification of reportable range.

What is reportable range?
Reportable range is the lowest and highest result the test system can accurately report including all the values in between.…(Read More Here)

Edition 8: Calibration and Calibration Verification

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. Due to the updated CLIA regulations, COLA updated their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. Since the release of both regulations, Vital Diagnostics has received numerous questions regarding the calibration and calibration verification requirements. The intent of this Technical Bulletin is to define calibration and calibration verification, explain the requirements and provide some insight into implementation.

CALIBRATION

What is calibration?
Calibration is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement of the substance being tested and the actual concentration of the substance……(Read More Here)

Edition 9: Reportable Range

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Reportable Range

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. COLA revised their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. The new CLIA and COLA regulations require that the laboratory verify the manufacturer’s performance specifications listed in their package inserts. The laboratory must verify accuracy, precision, reference range and reportable range for each non-waived test. This bulletin will address the verification of reportable range.

What is reportable range?
Reportable range is the lowest and highest result the test system can accurately report including all the values in between.

When is reportable range verification required?
Reportable range verification is required when a lab replaces a test system or instrument, adds a new test or changes the manufacturer of a test system.

NOTE: This requirement applies to all non-waived test systems put in place on or after April 24, 2003. COLA accredited labs need to meet this requirement beginning June 1, 2007. (more…)

Edition 8: Calibration and Calibration Verification

laboratory professionals services elitech

Calibration and Calibration Verification

 

On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003.  Due to the updated CLIA regulations, COLA updated their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007.  Since the release of both regulations, Vital Diagnostics has received numerous questions regarding the calibration and calibration verification requirements.  The intent of this Technical Bulletin is to define calibration and calibration verification, explain the requirements and provide some insight into implementation.

 

CALIBRATION

 What is calibration?

Calibration is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement of the substance being tested and the actual concentration of the substance.

(more…)

Regulatory

Beginning January 2016, EQC (Equivalent Quality Control) will no longer be an acceptable option for laboratories. IQCP (Internal Quality Control Plan) will be replacing EQC. IQCP is not a regulation however it will be an enforceable procedure for equivalent control testing. IQCP includes key concepts from CLSI EP-23 guidelines published in 2011. IQCP pertains to all CMS certified non-waived laboratories. IQCP does not have the same requirements as EQC. If you are following current CLIA and manufacturer’s guidelines for Quality Control testing nothing will change.