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 answers the telephone properly. The total staff on all shifts should be trained to answer the phone. How the individual should answer the phone must be inclusive of appropriate information and compliant with the protocol(s) for all appropriate agencies and institution-specific requirements. The inspectors will verify that specifics for the inspecting agency are fulfilled each time the telephone is answered.
Whether the inspectors arrive for a scheduled or unannounced visit, the survey process will be similar. Upon arrival of the survey team, appropriate management personnel should meet with the team members. 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 a sense of organization.
If the surveyors are present in a window or receptionist area, the individual on duty will follow the appropriate institution-specific protocol for visitors and summon the appropriate person(s) to meet the surveyors or escort the surveyors as designated in preparation. The 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 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. Upon arrival, the surveyors will verify that the work location is satisfactory. Any required adjustments should be made before the start of the survey. Working in the active laboratory may result in a disruption to the testing process and also 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 before the arrival of the survey team but should be summarized and discussed before 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 the testing process during 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 regular work routine while the inspection commences
- Refile all documents when the inspector has completed the review
After 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 promptly to the laboratory director or designee.
