Richard A. Savage
A: I have several clients who work this way. They indicated that they have reviewed their processes and, in their legal opinion, they are providing quality patient care and laboratory practice since the physician uses the printed, signed report to perform patient care operations. Their anatomic pathology systems have solved the issue by not requiring electronic signature. A “verify process” is used to “release” the report, rather than electronically signing it.
Other vendors solved this problem by assigning a status to a report as “printed for signature.” If it is changed after that status but before it is released or signed out, the system flags the report for followup.
I know of a few pathologists in anatomic pathology labs who do not want to use electronic signature and will physically sign out each case and then let a clerk release an entire batch of reports in one step.
Consulting Services LLC
The CAP does not expressly prohibit batch sign-out of reports, so long as the laboratory has specified procedures that ensure each report has received attention by the signing pathologist and that the report has not been changed from the time of that review until final verification. Pathologists are responsible for the content of those reports, whether they release a single report or a batch of reports at one time.
This is addressed in the CAP anatomic pathology checklist question ANP.12100 Phase II, which reads, “Are all reports reviewed and signed by the pathologist?”
The note to this section reads:
The inspector must review 15–20 recent surgical pathology reports. When diagnostic reports are generated by computer or telecommunications equipment, the actual signature or initials of the pathologist may not appear on the report. It is nevertheless essential that the laboratory have a procedure that ensures and documents that the responsible pathologist has reviewed and approved the completed report before its release. In the occasional situation when the diagnosing pathologist is not available for timely review and approval of the completed report, the laboratory may have a policy and procedure for review and approval of that report by another pathologist. In that circumstance, the names and responsibilities of both the pathologist who made the diagnosis and the pathologist who performs final verification must appear on the report.
You can download a copy of any CAP
checklist questions from the CAP Web site.
The laboratory is advised to consult its risk management and legal representatives in developing such a practice.
Senior Technical Specialist
CAP Laboratory Accreditation Program
Although many clients may use the paper copy for patient care, we must assume that some physicians are relying on an electronic version. If the pathologist is relying on review of the paper copy before sign-out (for most of us, it is easier to review a printed page than a computer screen), a process must be in place to ensure that the computer-based image of that report is not modified after the paper is printed and before it is verified. With such a program feature and with administrative procedures that ensure the clerical staff is verifying only those reports the pathologist has signed, we can be confident that we are complying with regulatory requirements that the pathologist review each report before it is issued.
Raymond D. Aller, MD
Contributing Editor, CAP TODAY
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Raymond D. Aller, MDDavid S.
Wilkinson, MD, PhD
Professor and Chair
Department of Pathology
Virginia Commonwealth University
Member, CAP Chemistry