Inspection Preparation, Process, and Corrective Action

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Author: Sheryl A. Whitlock, MA.Ed, MLS(ASCP)BB
Reviewer: Judi Bennett, BSM, MLS(AMT), MLT(ASCP)

This course discusses how to plan for a laboratory inspection. Different laboratory agencies are presented along with regulations, requirements, standards, etc. on which inspections are based. The course also covers the role of laboratory staff in the inspection process and how an inspection report is structured, interpreted, and how a laboratory may respond to inspection citations (corrective action).

Continuing Education Credits

Objectives

  • Outline a plan to prepare for an inspection.
  • Discuss agencies that inspect laboratories.
  • Differentiate regulations, requirements, standards, etc. on which inspections are based.
  • Describe staff involvement in inspections.
  • Discuss the lab inspection process.
  • Discuss inspection reports structure and interpretation.
  • Discuss corrective action and response.

Course Outline

  • Inspection Agencies
      • Introduction
      • CLIA and Associated Federal Agencies
      • Types of CLIA Certificates
      • Terminology
      • A medical laboratory scientist is completing a mock survey checklist. When documenting the CLIA information on the posted certificate, they noticed th...
      • A laboratory manager oversees satellite clinics. These clinics have various levels of CLIA certificates. Which of the following certificate levels are...
      • Agencies that Require Inspections and Deemed Authorities
      • Summary of Accreditation Agencies
      • The laboratory director has announced that an accreditation visit will be made in the next three months. Which of the following is a correct statement...
      • The transfusion service supervisor receives a call from the reception desk that an FDA inspector is requesting entry. Which of the following is a corr...
      • True or False: All laboratories in the United States are subject to CLIA regulations.
  • Preparation for Inspection Process
      • Staff Preparation and Involvement
      • Developing a Pre-Inspection Plan
      • A laboratory is within its inspection window. A staff meeting will be held to review the necessary preparatory steps with the staff. Which of the foll...
      • Tools for Inspection Preparation
      • Common Citations
      • Common Citations: Personnel Qualifications and Personnel Files
      • Common Citations: Training and Competency
      • Common Citations: Proficiency Testing Pitfalls
      • In preparing for an upcoming inspection, the laboratory manager has reviewed all personnel files. Which of the following represents possible citations...
      • The laboratory management is reviewing personnel files before an inspection. Which of the following scenarios would result in a citation for incomplet...
      • Mock Inspection
      • Mock Inspection Tips
      • The lead technologists are conducting a mock survey utilizing appropriate regulatory checklists. Which of the following would be an appropriate order ...
      • A laboratory manager is organizing a mock inspection. Which of the following would be correct statements related to an appropriate process?
      • True or False: Testing personnel should be included in the mock survey process.
      • Organize and Review Documentation
      • Laboratory personnel organize documentation in each department since the laboratory is within its inspection window. Which of the following are correc...
      • Two testing personnel in the chemistry department are reviewing quality control documentation that includes summary printouts and Levey-Jennings graph...
      • Reagents, Materials, and Proper Labeling Review
      • A lead tech is conducting a survey of items in the laboratory in anticipation of an upcoming compliance visit from the state Department of Health. Whi...
      • Two chemistry medical laboratory scientists are assisting with inspection preparation. They inspect all reagents, quality control reagents and calibra...
  • Inspection Process
      • Develop an Inspection Plan
      • The main hospital laboratory has been notified that the accreditation agency will be visiting in 10 days. Which of the following represents an appropr...
      • True or False: In planning for an on-site inspection, all management staff should be included, while testing personnel do not need to have a role in t...
      • Tracers: What to Expect
      • Examples of Generic Questions That May Be Asked By the Surveyor
      • The preliminary inspection paperwork stated that tracers would be performed as a part of the inspection. In preparation, the laboratory is running a p...
      • In preparing for the inspection, a tracer experiment is conducted by a team of testing personnel with a representative from each major laboratory depa...
      • The Inspection Process
      • An inspector arrives at the reception window of the laboratory unannounced. The assistant at the window requests guidance regarding whether to allow t...
      • A physician's office laboratory has received notice of an upcoming survey. Which of the following represents appropriate steps for the day of inspecti...
  • Corrective Action
      • Corrective Action
      • Corrective Action, continued
      • A laboratory had an inspection conducted by a CLIA inspector. At the summation conference, the deficiencies were summarized. The inspector listed 3 st...
      • An inspector is surveying the laboratory in a new acute care hospital. While observing the blood bank, the inspector noted that the transfusion produc...
      • True or False: Both standard and conditional citations require a plan of correction.
  • References
      • References

Additional Information

Level of Instruction: Intermediate

Intended Audience: Medical laboratory scientists and medical laboratory 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: Judi Bennett, BSM, MLS(AMT), MLT(ASCP), is an Education Developer with MediaLab by Vastian, bringing over 30 years of experience as a medical laboratory scientist. Before joining MediaLab in 2010, she held key leadership roles, including Clinical Laboratory Manager, Microbiology Supervisor, and Senior Systems Analyst at Gwinnett Health System in Lawrenceville, Georgia. Her extensive knowledge of laboratory operations and a strong commitment to health care quality and education fuel her passion for developing engaging and effective learning tools for the next generation of laboratorians.
Course Description: This course discusses how to plan for a laboratory inspection. Different laboratory agencies are presented along with regulations, requirements, standards, etc. on which inspections are based. The course also covers the role of laboratory staff in the inspection process and how an inspection report is structured, interpreted, and how a laboratory may respond to a corrective action.

This course is part of:
Compliance & CE
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Six Evaluation Typer Required by CLIA
Organize and Review Documentation Wide
Figure 4. Inspection