Proficiency Test Handling and Communication

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Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB; Zoe Zorka, DBA
Reviewer: Rory Huschka, M.Ed., MT(ASCP)

This course addresses proficiency testing (PT) in the clinical laboratory. It outlines the guidelines for performance, documentation, result reporting, and corrective action of PT samples. The course describes circumstances that constitute PT referral and inappropriate communication related to PT events, the use of alternate PT procedures in laboratory practice, compliant modification in standard PT protocols for multiple testing methods for a single analyte and molecular test methods among other topics.

Continuing Education Credits


  • Outline general regulations regarding proficiency testing (PT).
  • Explain the importance of PT in a laboratory setting.
  • Describe proper handling and storage of PT samples.
  • Outline guidelines for performance, documentation, result reporting, and corrective action of PT samples.
  • Describe circumstances that constitute PT referral and inappropriate communication related to PT events
  • Define and discuss the use of alternate PT procedures in laboratory practice.
  • Identify instances when split sample testing may be used for compliance, including four sources of split sample testing materials.
  • Discuss PT options for laboratory developed testing (LDT).
  • Discuss compliant modification in standard PT protocols for multiple testing methods for a single analyte and molecular test methods.

Course Outline

  • Proficiency Testing
      • Proficiency Testing (PT) Introduction
      • Which laboratories are required by CMS to participate in a CMS-approved proficiency testing (PT) program?
      • Proficiency Testing Overview
      • Which of the following is a CLIA requirement for inclusion in the proficiency testing (PT) plan? (Select all that apply.)
      • A core laboratory associated with a hospital system has three satellite sites with test menus requiring proficiency testing (PT). Which of the followi...
  • Testing, Documenting, and Reporting PT Samples
    • Handling PT Samples
      • Handling of Proficiency Testing Samples
      • If there is one of more samples missing from a shipment, no action is necessary by the facility.
      • A tech arrives back from lunch and finds a PT kit on the counter for another department. The tech is unsuccessful in attempts to make contact with the...
    • Testing Samples
      • Testing Preparation
      • Five freeze-dried PT samples are provided for vitamin D testing. The testing personnel followed the reconstitution instructions for the quality contro...
      • Testing Process
      • Testing procedure for ABC laboratory states that repeat testing is ONLY performed on patient CBC samples that either 1) do not yield analytical result...
      • A laboratory has established glucose levels >750 mg/dL as a critical value. The upper level of instrument linearity = 750 mg/dL and policy indicate...
      • How many times should each PT sample be tested?
      • You can refer a PT sample to another laboratory IF the second laboratory is in the same healthcare system.
      • Proficiency Testing Referral
      • Two satellite clinics that belong to the same hospital system are performing proficiency testing. Which of the following reflects a compliant statemen...
      • A new medical laboratory scientist working in a diagnostic clinic laboratory is completing training and observing proficiency testing by another MLS. ...
    • Reporting PT Sample Results
      • Reporting PT Sample Results
      • The results reported for a recent PT event are graded as a failure for all samples. The reported results each had three digits reported (eg, 161). The...
      • A new laboratory manager submits the PT results and is provided with an attestation statement. What must be provided on the attestation statement?
      • Retention of PT Results, Records, and Data
      • The supervisor is organizing PT records for an upcoming accreditation visit. Several items are missing from retained records. Which of these items is ...
      • Records of all PT testing are retained as per regulations. The supervisor entered the results online, printed them, and has the signed attestation fil...
  • Review and Corrective Action of Proficiency Testing
      • Laboratory PT Results Review
      • Verification of accuracy is NOT required for a regulated test scored as an educational challenge.
      • What is the minimum number of laboratories that must participate in PT of a qualitative test for the test to be scored by the provider?
      • Causes and Possible Consequences of Unsatisfactory PT Results
      • A PT event is scored as unsatisfactory for three chemistry analytes. The previous two events yielded acceptable results for all analytes. Which of the...
      • Which of the following likely represents a cause for possible PT failure? (Select all that apply.)
  • Alternative Assessment Procedures General Information
      • Alternative Assessment Procedure (AAP)
      • Alternative assessment procedures (AAPs) may be used as a replacement for commercially available proficiency testing (PT) for regulated analytes.
      • Which of the following is NOT a situation where a laboratory may employ alternate assessment procedures (AAPs)?
      • Miscellaneous Circumstances where AAP is Acceptable
      • A laboratory has added a new analyte mid-year and all approved commercial proficiency testing programs are oversubscribed. The laboratory may satisfy ...
      • A laboratory has two test methods for the same regulated analyte. One method is the primary test method and the second method is a secondary/back up m...
      • The special chemistry department tests interstitial fluid for protein. The proficiency testing manufacturer provides samples for serum but not for thi...
      • A laboratory that performs microarray testing evaluates commercial proficiency testing samples for all performed test methods. The laboratory was cite...
  • Alternative Assessment Procedures
      • Alternative Assessment Procedure Guidelines
      • A split sample analysis must include an aliquot that is compared to a reference laboratory.
      • Which of the following reflects an advantage of employing patient specimens over commercially prepared materials?
      • Appropriate Use of Split Sample Testing
      • A new laboratory is establishing a PT plan. The laboratory director has requested a list of test methods that are eligible for split sample testing. W...
      • An accredited, high complexity reference laboratory using an appropriate test methodology may be utilized as a split sample comparison laboratory for ...
      • Alternative Assessment Procedural Specifics
      • An unscored event with a score of 100% is posted for a laboratory for a regulated analyte. Which of the following represents an approach to evaluation...
      • An internal split sample analysis is being performed to validate accuracy of a secondary test method. Which of the following samples will be used to p...
      • Which of the following is an appropriate method for assessment of a technique dependent test method?
      • Protocol for Split Sample Testing
      • A laboratory has added a non-regulated analyte to the test menu for which the proficiency testing agency does not provide proficiency testing. The lab...
      • A protocol for split sample testing is being developed for a newly adopted non-regulated analyte. Multiple laboratories are being considered for the s...
      • What is the minimum frequency for performing split sample analysis each calendar year?
  • 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 and a part time technical consultant for McKesson. Sheryl served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. Sheryl received her Master’s degree in Education from Arcadia University in Glenside, Pennsylvania. She has more than 35 years of experience in laboratory science to include management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals as well as having contributed to numerous online and print articles in the field of laboratory medicine.
Author information:  Zoe Zorka holds a Doctorate in Business Administration and a Master's of Business Administration with an emphasis on statistics. She has worked as a technical writer and systems process engineer for the last several years, focusing on regulatory compliance, business development, and training for franchise businesses. She specializes in OSHA regulations and health code compliance. She resides in Salt Lake City, Utah.
Reviewer information: Rory Huschka, M. Ed., MT(ASCP), has over 20 years of experience as a medical technologist, technical supervisor, professor, and manager. He is the former Director of the Clinical Laboratory Science and Medical Laboratory Technician Programs at Brookline College in Phoenix, Arizona. He is currently a Program Director at MediaLab, Inc. Rory holds a BS degree in Medical Technology from North Dakota State University and a Masters in Educational Leadership from Argosy University.

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This course is part of:
Proficiency Testing 1
Proficiency Testing 10
Proficiency Testing
Proficiency Testing complaint
Scientist looking at PT_shutterstock_JB