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?
What is missing from the equipment label of thermometer LBL-001?
What is missing from the equipment label of thermometer LBL-001?
Which hazard was noted regarding a recently purchased piece of equipment?
Which hazard was noted regarding a recently purchased piece of equipment?
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
What is lacking in the laboratory regarding handling patient complaints?
What is lacking in the laboratory regarding handling patient complaints?
Signup and view all the answers
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?
Signup and view all the answers
Which issue was noted regarding alterations to observed data in the laboratory?
Which issue was noted regarding alterations to observed data in the laboratory?
Signup and view all the answers
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
This quiz covers key observations from an ISO 15189 assessment regarding laboratory practices. It highlights areas such as data review, equipment calibration, and quality policy deficiencies. Test your knowledge on the standards and requirements necessary for maintaining quality in a laboratory setting.
