Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
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Vertical audit
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Name of Laboratory
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Name
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Date audit conducted
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Date
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Name of lab manager
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Lab manager
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Name of test panel
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Test panel names
Previous audit actioned
Pre examination process
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Does the request form have the following information<br>Patient I'd including gender DOB location of patient unique identifier<br>
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Name of requestor
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Type of primary sample
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Test requested
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Relevant clinical notes
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Date of collection
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Date and time of receipt
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Is the procedure for the collection and handling of this test available
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Are transport monitoring records available and do they show that samples were transported within the correct temperature range for the tests requested
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Was the sample traceable to the patient with at least two KIs
Personnel
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Do all of the staff involved with this testing process have training records
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Training for this test
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Competency assessments
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Qualifications
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Previous employment
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Job description
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Induction
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Continuing professional development
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Performance reviews
Accommodation and environmental conditions
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Is there sufficient space in the laboratory to adequately perform the test
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Is the environment suitable for the task being performed
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Are the facilities adequate noise lighting water ventilation
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Is safety equipment provided coats goggles shower fire extinguisher
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Are samples stored according to NPAAC guidelines temp time avoiding cross contamination
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Are samples and reagents disposed of correctly
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Is the laboratory clean and uncluttered
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Are the reagents and consumables stored in accordance with the manufacturers specifications
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Are all new reagent lot numbers verified for performance prior to use
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Where consumables affect the quality of the test eg media are these verified prior to use
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Are new shipments of reagents and consumables segregated/marked from those that have been accepted prior to use
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Are instructions for use of reagents readily available (may be package insert)
Laboratory equipment reagents and consumables
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Does the laboratory have the equipment to perform this test
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Is the equipment in good repair
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Does the equipment have installation verification records
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Does the equipment have a unique I'd eg serial number
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Do the equipment details match the register
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Are instructions available for use of equipment
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Has all equipment used been calibrated
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Are all calibration dates recorded
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Is the next scheduled calibration date recorded
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Has preventative maintenance been been performed according to manufacturers specifiications
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Where required has all daily and weekly maintainence been performed and recorded
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Are reagents and consumables stored according to manufacturers specifications
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Are all new reagent lot numbers verified prior to use
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Examination procedures
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Has the identity of the person performing the test been recorded
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For quantitative methods has the laboratory estimated MU for this test<br>When was this done last
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Are the reference initivals documented for this test
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Are the reference intivalls reported on the final test report
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Are the reference intervals reported on the final test report
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Is the method procedure documented for this test document controlled
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Does the procedure contain purpose of examination
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Principle of procedure
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Method of procedure
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Performance characteristics (verification validation)
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Sample type
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Patient preparation
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Container type and additive
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Required equipment and reagents
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Safety controls
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Calibration procedure
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Procedure steps
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QC procedures
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Interferences( lipaemia haemolytic bilirubin drugs cross reactions etc)
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Principles for calculating results and MU
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Reference ranges
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Reportable interval of results
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Instructions for determining quantitative results when a result is nt within the measurement interval
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Critical values where applicable
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Clinical interpretation
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Sources of variation
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References
Ensuring quality of the examination process
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Was QC run at appropriate intervals for this test
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Are QC concentrations for this test at or near clinical decision values
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Are QC results rejected and patient results retested when QC rules are violated
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Is QC reviewed at regular intervals (eg monthly for biochem by lot for haem)
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Is the lab enrolled in QAP for this test
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Has the staff member performing this test participated in QAP
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Has QAP been reviewed by lab staff
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Has QAP been signed off by pathologist
Post examination processes
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Are all results reviewed and validated
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Are patient samples stored in accordance with NPAAC gudelines
Reporting of results
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Are manual transcription checks performed
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Does the report contain comments on sample integrity that might affect results
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Critical results highlighted
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Interpretative results where applicable
Report contents
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Identification of the examination
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Identification of the lab that issued the report including NATA number
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Patient identification and location on each page
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Name or I'd of requestor and their contact details
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Date and time of sample collection
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Type of primary sample
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Measurement procedure where applicable
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Reference range or clinical decision value
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Results in SI units
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Identification of the person authorising the release of the report
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Interpretation of results where appropriate
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Date and time of issue of report
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Page number and number of pages on each page
Release of results
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Are interim results followed by a final report
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Is evidence of telephoning results recorded in ULTRA
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Does the lab have a procedure for automatic reporting of results
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Re analyser flags transmitted to the interface and/orUltra
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Can automated reporting be suspended rapidly if required
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Is a riskman number generated when results are amended
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Is the requestor notified by telephone of all amended reports
