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© 2017 Artel
Best Practices for Equipment Calibration and Analytical Controls in the
Diagnostics Laboratory
George Rodrigues, Artel (slides 2-16)Rebecca Butler, CareDx (slides 17-29)
© 2017 Artel
Liquid handling quality assurance
Metrology - the science of measuring things
Documentary standards - best practices
© 2017 Artel
Congress
Food, Drug & Cosmetics Acthttp://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
Clinical Laboratory Improvement Amendments (CLIA ’88)https://www.cms.gov/clia/
Public Laws
© 2017 Artel
Federal Regulations
CFR – Code of Federal Regulationshttp://www.gpoaccess.gov/cfr/index.html
42 CFR Part 493 – Clinical- CLIA
21 CFR Part 820 – GMP- In vitro
Also know as the QSR, Quality System Requirements.
© 2017 Artel
Program Requirements
College of American Pathologists – CAPhttp://www.cap.org/apps/cap.portal
Clinical Pathology Accreditation - CPA (UK)https://www.ukas.com/services/addreditation-services/medical-laboratory-accredition-iso-15189
Local Quality System Requirements
© 2017 Artel
Consensus Standards & Guides
International Organization for Standardization - ISOiso.org
ISO 15189; ISO 17025
ASTM Internationalastm.org
Many equipment standards
Clinical and Laboratory Standards Instituteclsi.org/standards
Practices, guides, etc.
© 2017 Artel
820.72 Inspection, measuring, and test equipment(b) Calibration. Calibration procedures shall include specific directions and limits
for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Key Calibration Requirements for IVD Makers - 21 CFR
© 2017 Artel
Schedule Calibration
21 CFR 211.160
Perform As Found Calibration
21 CFR 211.68Corrective
Maintenance/Repair
Perform As Left Calibration
21 CFR 211.194
Return to Service
RemedialAction
21 CFR 211.160 (4)
Adjustment/Corrective
Maintenance
CalibrationAlert
Preventive Maintenance
Record21 CFR 211.194
Record21 CFR 211.194
Pass
Fail
Fail
Pass
Calibration Work FlowBest Practices for Pipette Quality Assurance
© 2017 Artel
Best Practices for Pipette Quality Assurance
• Ensure performance is acceptable within the required tolerance limits for intended use
• Comply with regulations
• Save time
• Save money
• Defend data integrity
Why Calibrate?
© 2017 Artel
Best Practices for Pipette Quality Assurance
• Verify Calibration to for Peace of Mind
• Prior to Critical Work
• According to a Designated Schedule
• After Potentially Damaging Activity
• Maintain Records
Interim Verification / Checks
© 2017 Artel
42 CFR 493.801 Enrollment and testing of samples Each laboratory must enroll in a proficiency testing (PT) program that meets the
criteria of this part and is approved by HHS. …
For each specialty, subspecialty and analyte or test, participate for one year before changing program.
The laboratory must test the samples in the same manner as patients' specimens. …
The samples must be tested with the regular patient workload by personnel who routinely perform the testing.
The laboratory must test samples the same number of times that it routinely tests patient samples.
Laboratories must not engage in Inter-laboratory communications pertainent to the results of proficiency testing samples, prior to reporting results.
What if no approved PT program is available?
Key Calibration Requirements for IVD Makers - 21 CFR
© 2017 Artel
42 CFR 493.1236 Evaluation of PT performance The laboratory must verify the accuracy of …
Any analyte or subspecialty … that is not evaluated or scored by a CMS-approved proficiency testing program.
At least twice annually, the laboratory must verify the accuracy of the following:
Any test or procedure it performs that is not included in (PT program)
Key Calibration Requirements for IVD Makers - 21 CFR