Course Outline
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- Hematology Instrument Validation
- Requirements for Instrument Validation
- The laboratory manager is researching validation requirements for a new analyzer to replace the original analyzer. She is comparing the CFR requiremen...
- An alternate testing method (backup CBC analyzer) manufactured by the same company is added to the local hospital. You, as a technical consultant, are...
- Basic Hematology Instrument Validation Protocol
- The hematology department is installing a new CBC analyzer which will also test body fluids. Which of the statements below are accurate about the vali...
- A new lead technologist in the hematology department is researching the requirements for verification of specifications for the automated cell counter...
- Terminology
- Reportable Range
- The manufacturer of a hematology analyzer requires the analysis of linearity samples. Which of the following statements describes the purpose of the l...
- The analytical measurement range is the same as the reportable range.
- The reportable range published by the manufacturer does not require verification during the instrument validation process.
- The technical supervisor is working to validate a new hematology analyzer. Commercial materials are provided. Which of the following are requirements ...
- Accuracy and Precision
- Accuracy and precision analyses are performed as part of the validation of a new CBC analyzer. The true value of the hemoglobin is 8.3 mg/dL. The manu...
- Select the description of accuracy and precision that describes each image.
- Carryover Studies
- The laboratory technologist is assisting the technician with the validation of the new automated cell counter. She is asked to test each of two sample...
- An appropriate method for conducting a carryover study for a new CBC analyzer employs one normal control sample. The technologist tests this sample by...
- Reference Range (Normal Range) Verification
- When selecting a reference range, the laboratory director researched appropriate options for reference ranges for a new laboratory. Which of the follo...
- The laboratory is verifying the reference ranges for a new automated cell counter. The technologists on the day shift are responsible for gathering an...
- Additional Miscellaneous Studies
- As a part of the validation process for a new hematology analyzer, the laboratory performs additional studies. Which of the following studies would se...
- Record Keeping for Instrument Validation Studies
- All instrument validation records must be retained for a minimum of two years after the instrument has been removed from service.
- The hematology department is acquiring a new backup automated cell counter. The validation studies included carryover studies. The manufacturer has es...
- Calibration Verification
- Differentiation of Calibration and Calibration Verification
- The lead technologist in hematology is training a new employee for instrument calibration. Which of the following statements is reflective of the cali...
- Calibration and Calibration Verification Process for Hematology Instruments
- The accreditation agency inspector asks for the records of calibration verification for the automated cell counter in Hematology. What documents would...
- A technologist has completed the calibration of the CBC analyzer. The spreadsheet being used calculated the means of the calibration runs. The results...
- The lead technologist is writing a protocol for calibration. Which of the following statements should be included in the protocol?
- Complete Calibration Verification Process
- Commercial calibration verification materials are not available for a high point on one of the immunoassays. Which of the following are viable options...
- References
Additional Information
Level of instruction: Intermediate
Intended Audience: Medical laboratory scientists, medical technologists, and technicians. This course is also appropriate for medical laboratory science students and pathology residents.
Author information: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB is the owner of ARK Laboratory Consulting, LLC. She served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. She received her Master’s degree in Education from Arcadia University. She has more than 35 years of experience in laboratory science, including management and education. She has written and published textbooks and laboratory manuals, as well as contributed to numerous online and print articles in the field of laboratory medicine.
Reviewer information: Cynthia Clawson, BSMT(ASCP), MBA, HCA, received her Master's degree from Wilmington College in Wilmington, Delaware, and a Bachelor of Science degree in medical technology from Salisbury State University in Salisbury, Maryland. She is a Clinical Specialist for Point of Care Testing, Quality Assurance, and Regulatory Compliance at the same facility.
Reviewer information: Alexandru Casapu, MBA, MLS(ASCP)CM, has over 20 years of experience as a medical laboratory scientist, section supervisor, and laboratory manager. He is currently a Program Director at MediaLab, Inc. Alexandru holds BS degrees in Biology and Medical Technology from Clark Atlanta University and an MBA from the University of Georgia.
Course Description: The course discusses and describes the processes and criteria for Hematology Instrument Validation and Calibration Verification Protocol for analytical instruments. Hematology instruments are validated at the time of installation. Required and optional protocols for automated cell counter validation testing are included. The calibration verification discussion is not limited to hematology instrumentation which has limited calibration verification requirements. The calibration verification discussion includes a brief reference to the hematology instrument calibration verification and a more extensive discussion of the process and criteria for calibration verification of instruments and methods that are not exempt.
