The Inspection Process

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The page below is a sample from the LabCE course Inspection Preparation, Process, and Corrective Action. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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The Inspection Process

All staff should be aware that inspectors may call the general laboratory number in advance of the survey and not identify themselves. The purpose of the call is to verify that all personnel answer the telephone properly. All staff on all shifts should be trained to answer the phone in a manner compliant with information that is protocol for all appropriate agencies and institution specific requirements. The inspectors will verify that specifics for the organization which they are representing are fulfilled each time the telephone is answered.
Whether the inspectors arrive for a scheduled or unannounced visit, the process for survey will be similar. Arrival of the surveyors should be met by appropriate management personnel. If the "greeters" have been determined in advance, they may be involved with meeting the inspectors upon their arrival. This demonstrates a united front and sense of organization.
If the surveyors present to a window or receptionist area, the individual on duty will follow appropriate institution specific protocol for visitors and summon the appropriate person(s) to meet the surveyors or escort the surveyors as designated in advance preparation. Institution specific protocol will also be followed in the process of greeting the inspectors.
The surveyors should provide credentials for verification of identity. If the facility is a hospital facility with rules or requirements for visitors, the personnel designated to meet the survey team will verify that these requirements have been met or will complete the required activities.
A centralized working location for the inspectors/surveyors should be provided and meet with their approval on their arrival. Any adjustments should be made prior to the start of the survey. Working in the active laboratory may result in a disruption to the testing process and may serve as a safety hazard. The management team and additional appropriate personnel should meet with the inspectors to discuss the process for the inspection. This information may have been provided previously but should be summarized and discussed prior to the start of the inspection.
A tour of the facility may be included and most often takes place at the beginning of the inspection.
The overall inspection process will proceed as per the guidelines provided by the inspectors. All laboratory staff should work to make the inspection process seamless and problem free. While management may play a primary role, inspectors may choose to ask non-management personnel questions or observe testing process during the course of the inspection.
Some general guidelines for staff interaction with inspectors include:
  • Provide any information or documentation that is requested by the inspector
  • Do not offer additional information or documentation that the inspector has NOT requested
  • Answer questions succinctly and truthfully
  • Follow all procedures as outlined in the standard operating procedures or manufacturer's instructions
  • Request assistance from management for surveyor questions or requested items for which you do not know the answers or cannot provide the materials
  • Alter or correct deficient items noted by the inspector if it is possible to do that during the inspection
  • Perform normal work routine while the inspection commences
  • Refile all documents when the inspector has completed the review
At the conclusion of the inspection process a summary conference will be conducted. Appropriate invited personnel will participate. At this conference, the inspector(s) will summarize the findings for all present. Staff members attending the conference should take notes and direct specific questions to the inspectors. The findings will be summarized in a written report to be provided in a timely manner to the laboratory director or designee.