Inspection Preparation, Process, and Corrective Action
Continuing Education Credits
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).
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 that the certificate is a Certificate of Registration. Which of the following is the correct statement related to inspection?
- A laboratory manager oversees satellite clinics. These clinics have various levels of CLIA certificates. Which of the following certificate levels are only inspected randomly and have no scheduled inspections?
- 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 regarding the content of this visit?
- The transfusion service supervisor receives a call from the reception desk that an FDA inspector is requesting entry. Which of the following is a correct statement regarding how the supervisor should address this issue?
- 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 following would be useful to enforce staff commitment to ongoing compliance initiatives?
- 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 incomplete or incorrect documentation in personnel files?
- 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 of steps for the process?
- 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 correct statements regarding document organization?
- Two testing personnel in the chemistry department are reviewing quality control documentation that includes summary printouts and Levey-Jennings graphs. One month of Levey-Jennings graphs is missing from the previous six months, and no supervisor review of the month's documents can be located. Which of the following represents the appropriate next step to correct this missing documentation?
- 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. Which of the following would require corrective action?
- Two chemistry medical laboratory scientists are assisting with inspection preparation. They inspect all reagents, quality control reagents and calibrators, kits, and additional working items in the department. Considering only the information provided, which of the following items represents items that require corrective action?
- 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 appropriate plan for assigning staff to work with the surveyor on the day of the inspection?
- 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 the planning process.
- 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 practice tracer on plasma glucose. Which of the following steps may be included?
- In preparing for the inspection, a tracer experiment is conducted by a team of testing personnel with a representative from each major laboratory department. Which of the following represents the appropriate steps in the tracer process?
- 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 the inspector to enter. How should the assistant be advised?
- A physician's office laboratory has received notice of an upcoming survey. Which of the following represents appropriate steps for the day of inspection?
- 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 standard citations, 1 conditional citation, and 5 recommendations. Which of the following statements is correct regarding the post-inspection follow-up?
- An inspector is surveying the laboratory in a new acute care hospital. While observing the blood bank, the inspector noted that the transfusion product sign-out process was missing steps for proper patient identification. The inspector issued a cease-testing order for the transfusion service. Which of the following would represent the most likely ruling to be issued by the inspector?
- 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.
The author has no conflict of interest to disclose.
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.