Clinical biochemistry changes
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This document discusses quality control procedures for clinical biochemistry testing. It recommends: - Using Grade I/II water for reconstituting reference materials and reagents. - Performing hormone stimulation tests under medical supervision in a hospital lab. - Running a minimum of one control level once daily if less than 25 patient samples are tested, and two control levels once daily if between 25-75 patient samples are tested. For more than 75 patient samples, two control levels should be run twice daily. - For blood gas measurements, running one control every eight hours and one with each patient sample unless the instrument automatically calibrates at predefined intervals.
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The document provides helpful hints and guidelines for hematology, chemistry, and coagulation testing. It discusses rules for validating complete blood count results, the need to calibrate instruments every 6 months or as needed, and tips for resolving low platelet counts or platelet clumping issues. The document also addresses quality control procedures like running controls according to specifications, establishing control ranges, using Levey-Jennings charts to monitor for patterns or shifts, and the importance of documentation and supervisor review for any control failures. It emphasizes treating controls like patient samples and verifying control results before releasing patient results.
Clinical lab-method validation.ppt
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Acusera Third Party Controls
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Overview of Quality Control and its implementation in the laboratory.pptx
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Quality Control in Aseptic Dispensing (1).ppt
This document provides an overview of quality control procedures for aseptic dispensing at Austin Health pharmacy department. It discusses staffing structure and facilities including the aseptic suite, requirements for cleanroom attire and hygiene. Standard operating procedures for training, production, cleaning and documentation are outlined. Environmental monitoring includes air and surface testing with defined microbiological limits. Limitations of testing in a public hospital setting are also noted.
Quality assurance is necessary in blood banking
This document discusses quality assurance in blood banking. It outlines the quality control processes that should be followed at various stages of blood collection and processing, including donor selection, blood collection, component preparation, storage, and transportation. Key aspects of quality control covered are premises and facility requirements, equipment calibration and maintenance, reagent quality control, and infectious disease testing quality assurance. The document provides details on acceptable parameters and frequencies of quality control checks for various blood components.
good laboratory practices
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
GLP
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Quality control laboratory.
This document provides an overview of quality control procedures and responsibilities in a pharmaceutical quality control laboratory. It discusses the roles of the laboratory director and technicians. It describes routine control instruments, reagent handling and labeling procedures, and various sampling plans including single, double, continuous, and sequential sampling. Standard test procedures and documentation requirements are also outlined. The document establishes best practices for ensuring accurate and reliable testing in the quality control laboratory.
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- 1. Clinical Biochemistry Changes NABL 112 Issue 4 Dr. Jayesh Warade
- 2. 5.3 Laboratory equipment, reagents and consumables • A microbial count is not required as long as Grade water I/II is used for reconstitution of reference material and reagents.
- 3. 5.4 Pre-examination processes • Hormone stimulation tests – precautions Hormone stimulation for these tests is to be done under the supervision of a medical doctor in a hospital-based laboratory where emergency services are available for immediate handling of any adverse reactions if and when they occur
- 4. Ensuring quality of examination results • The laboratory shall include a minimum of one level QC at least once a day. • However, where the number of patient samples analysed for any parameter exceeds 25 per day, the laboratory shall employ 2 levels of QC at least once a day for such parameters. • Further, if the number of patient samples analysed for any parameter exceeds 75 per day, the laboratory shall employ 2 levels of QC at least twice a day at appropriate intervals. • Two levels of QC shall be included at least once on the day of performing the test irrespective of the size of the laboratory. • If the laboratory is operational 24X7, two level controls shall be run in the peak hour subsequently one level every 8 hours.
- 5. Ensuring quality of examination results • For blood gas measurements at least one control shall be assayed every eight hours. In addition one control should be run with each patient sample unless the instrument automatically calibrates itself at predefined intervals.
- 6. Ensuring quality of examination results • The laboratory shall employ suitable reference material traceable to International Standards for calibration of measuring systems and methods. • Traceability certificates for calibrators shall be obtained from kit suppliers and appropriately documented. • Alternate methods shall be employed for verifying accuracy of results of those tests for which calibration and control materials are not available.
- 7. Ensuring quality of examination results • For blood gas measurements at least one control shall be assayed every eight hours. • In addition one control should be run with each patient sample unless the instrument automatically calibrates itself at predefined intervals.
- 8. 5.8 Reporting of results • Wherever relevant, reports should have an interpretation.