Hematology Instrument Validation/Calibration Verification Protocol
Continuing Education Credits
Objectives
- Summarize the protocol for hematology instrument validation
- Describe the purpose of each step in the hematology instrument validation protocol
- Define calibration verification
- Differentiate calibration and calibration verification
- Differentiate calibration verification for automated cell counters and chemistry analyzers
- Describe the calibration verification protocol
Course Outline
- 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 requirements to the accreditation agency requirements. Which of the following reflects the accurate statement(s) related to validation requirements?
- An alternate testing method (backup CBC analyzer) manufactured by the same company is added to the local hospital. You, as a technical consultant, are requested to assist with the validation of the new instrument. Which of the following is appropriate guidance for the laboratory?
- 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 validation of this instrument?
- A new lead medical laboratory scientist in the hematology department is researching the requirements for verification of specifications for the automated cell counter (CBC analyzer). The reference most often cited is the Code of Federal Regulations. Which of the following analyses must be completed prior to reporting patient test results as per the CFR?
- 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 linearity samples?
- True or False: The analytical measurement range is the same as the reportable range.
- True or False: 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 is a requirement for the validation materials?
- 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 g/dL. The manufacturer's limit for accuracy is + 0.3. The following data is obtained. Which statement describes the accuracy and precision of the analyzer? 7.98.48.28.07.98.4Mean: 8.1
- Select the description of accuracy and precision that describes each image.
- Carryover Studies
- A medical laboratory technician is assisting with the validation of a new automated cell counter. She is asked to test each of two samples three times in a specific order. The first sample had values at the high end of the analytic range for all cell types and the second sample had values at the low end of the range for all cell types. Data is analyzed by the technician. What was the purpose of th
- True or False: An appropriate method for conducting a carryover study for a new CBC analyzer employs one normal control sample. The medical laboratory technician tests this sample by evaluating it with multiple repetitions, calculating the mean for each analyte, and comparing it to the actual value of each analyte.
- 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 following may represent the proper source(s)?
- The laboratory is verifying the reference ranges for a new automated cell counter. The laboratory staff on the day shift are responsible for gathering and organizing the data. There are 12 samples from females and 16 samples from males. Which of the following is the most accurate statement for the number of samples necessary for this study?
- 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 serve to eliminate excessive smear review?
- Record Keeping for Instrument Validation Studies
- True or False: 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 established the following acceptable limits for carryover analyses: white blood cell count ≤3.0%; red blood cells ≤1.5%; platelet count ≤4.0%. The following results were obtained: Carryover of red blood cells 1.5%; white blood cells 3
- Calibration Verification
- Differentiation of Calibration and Calibration Verification
- The lead medical laboratory scientist in hematology is training a new employee for instrument calibration. Which of the following statements is reflective of the calibration process?
- 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 you show the inspector?
- A medical laboratory technician has completed the calibration of the CBC analyzer. The spreadsheet being used calculated the means of the calibration runs. The results and the assayed limits are as follows. Which statement is correct regarding the appropriate action to be taken? Assayed LimitsWBC K/µL 6.7 - 7.2 Target 7.2RBC M/µL 4.20 - 4.34 Target 4.27Hemoglobin g/dL 12.3 - 12.7 Target
- The lead medical laboratory scientist 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 for resolving this problem?
- References
- 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:
Joshua J. Cannon, MS, MLS(ASCP)CMSHCM received his Bachelor
of Science and Master of Science in Medical Laboratory Science from Thomas
Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist
and Specialist in Hematology certifications through the ASCP Board of
Certification. He was a professor at Thomas Jefferson University for seven
years before transitioning into his current role as Education Developer at
MediaLab. His areas of expertise and professional passions include clinical
hematology and interprofessional education.
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.
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.