Inspection Preparation, Process, and Corrective Action (Online CE Course)

(based on 31 customer ratings)

Author: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB
Reviewer: Cynthia Clawson, MT(ASCP), MBA, HCA; Alexandru Casapu, MBA, MLS(ASCP)CM, PBT(ASCP)CM

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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).

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Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 1.5 hour(s)
Approved through 9/30/2023
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1.5 hour(s)
Approved through 9/1/2022

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.

Customer Ratings

(based on 31 customer ratings)

Course Outline

Click on the links below to preview selected pages from this course.
  • Inspection Agencies
      • Introduction
      • CLIA and Associated Federal Agencies
      • Types of CLIA Certificates
      • Terminology
      • A laboratory technologist is completing a mock survey checklist. When documenting the CLIA information on the posted certificate, she notices that the...
      • A laboratory manager is overseeing satellite clinics. These clinics have various levels of CLIA certificates. Which of the following certificate level...
      • 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 3 months. Which of the following is a correct statement reg...
      • 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...
      • All laboratories are subject to CLIA regulations.
  • Preparation for Inspection Process
      • Staff Preparation and Involvement
      • Developing a Pre-Inspection Plan
      • A laboratory is within their inspection window. A staff meeting will be held to review necessary preparatory steps with the staff. Which of the follow...
      • 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 represent possible citations?
      • The laboratory management is reviewing personnel files prior to an inspection. Which of the following scenarios would result in a citation for incompl...
      • 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?
      • Testing personnel should be included in the mock survey process.
      • Organize and Review Documentation
      • Laboratory personnel are organizing documentation in each department since the laboratory is within their inspection window. Which of the following ar...
      • Two testing personnel in the chemistry department are reviewing quality control documentation that includes summary printouts and Levey-Jennings graph...
      • Reagent, 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 technologists are assisting with inspection preparation. They are inspecting all reagents, quality control reagents and calibrators, kit...
  • 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...
      • In planning for an on-site inspection, all management staff should be included, while testing personnel do not need to have a role in the planning pro...
      • Tracers: What to Expect
      • Examples of Generic Questions That May Be Asked By the Surveyor
      • The inspection preliminary 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 unannounced at the reception window of the laboratory. The assistant at the window requests guidance as to whether to allow the i...
      • A physician's office laboratory has received notice of an upcoming survey. Which of the following represent appropriate steps for the day of inspectio...
  • 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 notes that the transfusion produc...
      • Both standard and conditional citations require a plan of correction.
  • 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. 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 to include 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, MT(ASCP), MBA, HCA received her Masters 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.
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: 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.

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 147 CE courses, most popular
$95Add to cart
Pick Your Courses
Up to 8 CE hours
$50Add to cart
Individual course$20Add to cart
Need multiple seats for your university or lab? Get a quote
Inspection


Organize and Review Documentation Wide


Six Evaluation Typer Required by CLIA