Podcast
Questions and Answers
What is a key issue identified regarding the examination procedure at LBL?
What is a key issue identified regarding the examination procedure at LBL?
- There is a lack of patient identification information.
- Equipment maintenance records are incomplete.
- Samples were not collected according to ethical guidelines.
- Data supporting the use of Method LBL AF2/01 has not been formally reviewed. (correct)
What is missing from the equipment label of thermometer LBL-001?
What is missing from the equipment label of thermometer LBL-001?
- The operational manual.
- The manufacturer's name.
- The model number.
- The date of calibration. (correct)
Which hazard was noted regarding a recently purchased piece of equipment?
Which hazard was noted regarding a recently purchased piece of equipment?
- It operates above acceptable temperature limits.
- It lacks user training documentation.
- It uses a toxic chemical, ethidium bromide. (correct)
- It requires regular maintenance checks.
What aspect of the laboratory’s quality management system does ISO 15189:2012 primarily focus on?
What aspect of the laboratory’s quality management system does ISO 15189:2012 primarily focus on?
Why is it important to have a formal review of data for examination procedures?
Why is it important to have a formal review of data for examination procedures?
What aspect of the quality management system was defined by the laboratory director?
What aspect of the quality management system was defined by the laboratory director?
What has not been estimated for the creatinine test procedures in the laboratory?
What has not been estimated for the creatinine test procedures in the laboratory?
What is lacking in the laboratory regarding handling patient complaints?
What is lacking in the laboratory regarding handling patient complaints?
What was a concern identified regarding the storage of samples in the laboratory?
What was a concern identified regarding the storage of samples in the laboratory?
Which issue was noted regarding alterations to observed data in the laboratory?
Which issue was noted regarding alterations to observed data in the laboratory?
Flashcards
Reviewing Examination Procedure Data
Reviewing Examination Procedure Data
Formal evaluation of data to ensure that a laboratory method meets specific usage requirements.
Equipment Calibration Records
Equipment Calibration Records
Documented evidence of equipment calibration and recalibration dates.
Equipment Usage of Mutagen Ethidium Bromide
Equipment Usage of Mutagen Ethidium Bromide
Requires specific handling precautions because of its hazardous nature.
Laboratory Processes Assessment
Laboratory Processes Assessment
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ISO 15189 Standard
ISO 15189 Standard
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Quality Policy
Quality Policy
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Uncertainty of Measurement
Uncertainty of Measurement
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Patient Complaints
Patient Complaints
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Data Alterations
Data Alterations
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Sample Storage
Sample Storage
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Study Notes
ISO 15189 Assessment Observations
- Data Review: Laboratory has data supporting a method (LBL AF2/01), but no review of examination procedure to demonstrate specific use requirements.
- Equipment Calibration: Thermometer (LBL-001) lacks calibration date and recalibration record. New equipment (ethidium bromide) lacks evaluation of use impact.
- Quality Policy: Laboratory director defined quality policy, but quality manual lacks roles and responsibilities (director and quality manager).
- Supplier Selection: No criteria for selecting microbiological culture media suppliers.
- Measurement Uncertainty: No estimated uncertainty of measurement for blood/urine creatinine test, impacting creatinine clearance measurement reporting.
- Patient Complaints: No documented procedure for handling patient complaints.
- Job Descriptions: Senior mycologist job description outdated.
- Unidentified Samples: Laboratory accepted and tested unlabeled, unidentified samples. No justification given.
- Phlebotomy Improvement: Opportunities for phlebotomy service improvement noted but not addressed as high priority.
- Data Alterations: Observed data alterations obliterate originals; no record of date or person making change.
- Sample Storage: Samples stored in an unlocked fridge, off-main hospital corridor, with no record of analyzer maintenance (LBL/MAIN/008, 010 and 011).
- Critical Interval Results: Ten results in critical values over two months lacked notification and advice to requesting clinicians (despite agreement).
- External Quality Assessment (EQA): Laboratory lacking participation in Sodium EQA schemes.
- Contract Review: No record of reviews on major contracts with external agencies (pharmacy/insurance).
- Equipment Purchase: POVA purchased (micropipettes) based on seasonal discount without documented selection procedure.
- Nonconformity Management: No procedure for managing nonconformities.
- Referral Lab Reporting: Referral lab results (AF/001) not reported to clinicians.
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