Checklist Information Management
Does the laboratory have a fixed format for the Result Report? |
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Does the Result Report include at least the following elements: [tick off]
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Was the format of the Result Report discussed with regular clients of the laboratory during development? |
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Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information? |
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Is the laboratory archive lockable? |
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Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.? |
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Is access to the laboratory archive controlled? |
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Is a procedure in place that ensures verification of correct transcription of results on reports? |
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Is a procedure in place for authorizing Result Reports for release only if review of results has taken place and correct transcription of correct results and other important information to the report has been confirmed? |
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Is the computerized system properly protected by a firewall? |
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Is the computerized system scanned for viruses on a weekly basis by a proper, up to date virus scanner? |
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Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities? |
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Are the Personal Job Descriptions adapted of the staff members who are authorized to access or access and change laboratory information? |
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Does the laboratory have a procedure to ensure immediate notification of the requester in case results fall within critical intervals? |
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Does the laboratory record the occurrences in which results fall within critical intervals and requesters have to be notified directly (for verification purposes)? |
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Is a documented contingency plan present in the laboratory that should be followed in case of downtime of the computerized information system, to ensure access to laboratory information at all times? |
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Does the laboratory use a method for sending the Result Reports to the requesters with a minimum risk for losing reports? |
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Does the laboratory use a method for sending the Result Reports to the requester that ensures that reports are delivered as soon as possible? |
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Has the laboratory standardized the procedures for information management in an SOP? |
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Does the SOP on management of laboratory information include at least the following procedures:
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Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored securely, protected from unauthorized access? |
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Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored in a logical way enabling quick and easy retrieval of data? |
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Does the laboratory have an SOP for Recording, Reporting and Archiving of Results, describing at least the following procedures:
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Are the procedures in the SOP for Recording, Reporting and Archiving of Results routinely and correctly implemented in practice? |
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Are all staff members that are involved in any way in recording, reporting and archiving of results aware of the contents of the SOP for Recording, Reporting and Archiving of Results? |
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Is the laboratory able to trace back the staff members who signed documents based on the signature or initials? |
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Have all laboratory staff members signed a confidentiality agreement? |
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If the laboratory stores information digitally: are weekly backups being made? |
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Are backups of the computerized system stored behind lock and key in another building than the laboratory building where the computerized system is? |
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