Ten Steps To Prepare For a Successful Inspection
Utilize these tips to get your laboratory ready for laboratory inspection. The more you prepare the smoother and the more enjoyable the inspection will be.
01
Mock Inspections
Performing a mock inspection will prepare your laboratory for the real thing. You can perform this internally or utilize the services of a consulting group. During these mock inspections, be sure to review each checklist item and involve the laboratory staff so that they are prepared to answer questions from the actual inspectors.
02
Document Organization
Keep a binder with checklist standards and the laboratory's responses, to include supporting documentation. During the inspection, this is a great resource for you and the inspectors, reducing time and stress. Some online document management companies offer services that link procedures to the standards; however, hard copies are easy to navigate and are sometimes preferred by inspectors.
03
Housekeeping
Instruct all employees to check their workstations/areas for expired reagents, unlabeled or illegible containers, posted uncontrolled documents (i.e., cheat sheets, old policies), and disorganized workspaces. Have your safety officer develop a plan to remove all unwanted chemicals. Set a date for a supervisory walkthrough to review the team's progress; this will establish a deadline for the task and convey the importance of this assignment.
04
Maintenance Logs
Review your maintenance logs to ensure that they are properly filled out. Anything that is incomplete or has not been signed/initialed, should have a reason as to why (e.g., holiday or instrument down) written on the log sheet. All documentation should be in blue or black (pencil and red pen are unacceptable). There must be documentation of review or corrective action for out-of-range temperatures or instrument errors/failures.
05
Focus On What is New
Inspectors will often concentrate on new tests, instruments, and antibodies. Inspectors will want to see the validations of these new items. Review the validations to ensure all standards are met (i.e. test numbers, Lab Director signature, etc.) .Your validation summary should match your validation plan and if they do not, an explanation must be provided.
06
Management Team
Meet with the management team monthly starting 6 months ahead of your inspection window. It is a good idea to have seasoned team members mentor new supervisors who are not familiar with the inspection process. At each meeting review standards that could affect all departments, such as All Common and Lab General Checklists. Have each member of the management team perform the inspector training course. This is gives great insight as to what CAP wants their inspectors to focus on.
07
Personnel Files
Review your personnel files to ensure that they are organized and complete. Each manager should be responsible for reviewing their employee folders. Employees that perform high-complexity testing, must have transcripts and/or a diploma on record, as well as yearly competency assessments.
08
Follow a Specimen
Inspectors will often follow a specimen through the lab from the point of receipt to completion. Practice this exercise with a pathologist or fellow manager multiple times prior to inspection. This will help catch any defects in process and give you the experience of showing the process to outsiders.
09
Follow the Trends
Search for what other laboratories to currently being sited for. Online forums such as histonet will often discuss some of the most cited standards. CAP will also list all of the newest standards and historically has divulged a list of the most commonly cited deficiencies for the year.
10
Embrace Your Deficiencies
If your laboratory had deficiencies during your previous inspection, the next set of inspectors will want to see improvements and will scrutinize all aspects of the cited standard. Additionally, if you have had incident reports or sentinel events during the current evaluation period, highlight them; do not hide them. Documentation of corrective action and proper reporting will demonstrate the quality of the lab.
We Can Help!
If your laboratory is struggling to prepare for an inspection or you just want an outside opinion from experienced inspectors/laboratorians please contact us. Fill out the form below and we will set up a meeting to discuss how we can help.