1. Veterinary Practice Laboratory Unit 1 Chapter 5 Quality Control and Record Keeping Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved.

2. Quality Assurance The term quality assurance refers to the procedures established to ensure that clinical testing is performed in compliance with accepted standards and that the processes and results are properly documented Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 2

3. Hallmarks of QA Accuracy How closely results agree with the true quantitative value of a constituent Precision Magnitude of random errors and reproducibility of measurements Reliability Ability of a method to be accurate and precise Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 3

4. Factors Affecting Results Sample collection Care must be taken to ensure proper collection techniques Ensures accurate hematology results Fasting prevents lipemic samples Electrical surges/drops Human error Maintenance and calibration of equipment Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 4

5. Analysis of Control Materials Used for technician and instrument assessment Production of valid results Controls run regularly Each test, day, week Results documented in log or on a chart Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 5

6. Controls Both normal and abnormal concentrations of constituents should be evaluated Assay methods may not perform the same at all concentrations tested by a particular method Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 6

7. Errors Preanalytic variables Biologic Inherent to patient, such as breed, age, gender Collection error – nonfasted animal Nonbiologic Clerical errors – incorrect labeling, etc. Sample collection and handling All samples must be labeled with patient’s name, species, ID number (if available), and date Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 7

8. Errors (cont.) Analytic variables Affect the procedure by which the analyte is measured by the instrument Improper maintenance of equipment Inaccurate standards Sera Reagent instability Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 8

9. Errors (cont.) Postanalytical variables Data entry Inaccurate record keeping Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 9

10. Applied Quality Control Instrument maintenance log Instrument name* Serial number* Model number* Purchase date* Points to check Frequency of checks Record of test readings Changes made to restore accuracy Cost and time associated with repairs Initials or name of person performing maintenance *can be on one page of the log Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 10

11. Laboratory Records Internal records Track assay results SOPs Quality control data Graphs SOP Insert instruction sheets for each test kit Describe on separate page, test not performed with kits Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 11

12. Laboratory Records (cont.) External records Request forms Patient full identification Presenting signs Date Method of collection Pertinent history Tests desired Special notes Report f orms Same information Results with notes of extraordinary findings Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 12

13. Log Books Old school but effective Record test results If original is lost, results are retrievable Always back up computer systems!! Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 13

14. Summary Accuracy, precision, reliability Analysis of controls Errors Applied quality controls Laboratory records Copyright © 2015 by Mosby, an imprint of Elsevier Inc. All rights reserved. 14