As a part of inspection preparation, the laboratory should review retained documentation in all departments/specialties. The purpose of this process is to "clean house." While an electronic or hard copy document control and storage plan may be in place in the laboratory, there are times when documents are improperly filed/stored/retained. Ideally, the laboratory should include this type of organizational review as an ongoing process as a part of the Quality Management (QM) plan. Various workplace hindrances may provide random gaps in the documentation process.
Pre-inspection preparation is a time to verify that all documentation is easily accessible and complete. While it may not be possible to recreate missing documentation, it is likely that missing documents are misfiled, have not been filed, or awaiting review or signature.
| Note: If documentation appears to be missing, the appropriate manager should be notified, and appropriate corrective action should be taken. The laboratory staff should not create any documentation during this process but rather note issues and refer them to management. |
An additional point to the organization and review of documentation is to familiarize the staff with the location of all documents that are likely to be requested by the surveyors. For the laboratory to present an organized process for the surveyors on the day of the survey, it provides a positive survey atmosphere.
Specific documents for review and organization may include but are not limited to the information summarized in
Table 2.
Table 2. Documents for Review and Organization.| Profiency Testing | Vendor registration; initial documentation received with shipment; all testing printouts; documentation of information received; signed attestation statements; final report; signed review of final report; signed corrective action plan and documentation of completion of corrective action; evidence of staff retraining or other specific steps included in corrective action process. |
| Quality Control | All appropriate instruments and methods, including waived and point-of-care testing instrumentation and methods; documented review monthly as per compliance and accreditation requirements. |
| Quality Management | Appropriate documentation for quality management program with evidence of scheduled reviews and oversight by laboratory director. |
| Calibration / Calibration Verification | All appropriate instruments and methods; including waived and point-of-care testing instrumentation and methods. |
| Instrument Maintenance and Repair Records / Temperature Records | Instrument maintenance records / temperature records / repair records; documented review monthly as per compliance and accreditation requirements. |
| Personnel Records | Signed job description; qualifying documents (diplomas, licenses, etc.); training and competency documentation; appropriate institution-specific checklists. |
| Policy and Procedure | Policy and procedure for all departments; verify that all have initial approval by the laboratory director and documented timely review as required by compliance and accreditation agencies. |
| Package Inserts | All appropriate instruments and methods, including waived and point-of-care testing instrumentation and methods; quality control materials; calibration and calibration verification materials; testing kits. |
| New Instrument Validation | As required by Accreditation agency, CLIA, and other required regulatory agencies, such as FDA; state and local compliance agencies; general documentation requirements include Accuracy, Precision, Reportable Range; normal range verification; correlation studies; all documents must be reviewed, approved, and signed by laboratory director or designee, if appropriate. |
| Retired Policy, Procedures, and Documents | All documents required for compliance/accreditation require archiving once they are retired; time frame is typically 2 years from retirement but may vary with accreditation or state or local requirements. |
