Return to CAP Home
Printable Version

  Machine? Medical director? What to put in cytology reports

 

CAP Today

 

 

 

January 2011

Ann T. Moriarty, MD
Lydia P. Howell, MD

Sticks and stones will break my bones, but names will never hurt me.
—English proverb

The beginning of wisdom is to call things by their right names.
—Chinese proverb

There is wisdom in every culture, and though a name may not hurt like a stick or stone, as the English proverb claims, painful issues can arise if the names of laboratory professionals are not placed properly in a cytology report. Or, to paraphrase the Chinese, it is wise to identify activities with the right names in the report.

But it is often hard to know what names need to be included and where those names need to be placed in the report. Does the name of the screening cytotechnologist need to appear on a Pap test report? Can the medical director sign a document and include his or her name even if the director did not review the case personally? If an automated system is used, does the name of that device need to be acknowledged on a report, and what about the name of the cytotechnologist who did the verification? What if a cytotechnologist performs an assessment on site of sample adequacy—does that cytotechnologist’s name need to appear in the final report later generated by a pathologist? What is necessary for documentation of location, identifiers, names, and signatures on a cytology report?

Report signatures

Not all names that appear on a cytology report are a signature. A report signature is a unique identifier and an attestation by a cytotechnologist or pathologist of his or her personal review and responsibility for the report’s contents. This signature is required for the release of the report to treating health care providers. In most laboratories today, reports are signed electronically. The electronic signature must contain the name of the signer and the date and time when the signature was executed, in addition to an indication of the level of responsibility (for example, review, authorization, authorship).1 To guarantee security, an electronic signature must use two distinct codes that identify the signer, commonly a name and password.2 No one else is allowed to use another laboratory professional’s codes to provide a signature. For example, if the responsible pathologist is not available to sign and release a report, it is acceptable for another pathologist to do this under his or her own signature after reviewing the report.3 The report must clearly state what the roles of each pathologist were in generating the report. A name or signature is not required on the report when a pathologist performs quality control review, such as the 10 percent negative review for Pap tests.4

Automated or image-guided screening

The name of the screening method used for a Pap test should appear in the final cytology report.5 A special field is the preferred location for this documentation, according to the 2001 Bethesda System for Reporting Cervical Cytology.6 At a minimum, this should include identification of the type of instrument used, whether the slide was successfully processed, and whether automated screening was combined with manual screening. If the machine is fully automated and requires verification, the name of the individual who verified the result must be in the laboratory records but does not need to appear in the report. If a laboratory chooses to include the verifier’s name in the report, it must be clear that the verifier did not review the slide manually.

Screening and on-site adequacy evaluations

It is not necessary to include the name or signature of the screening cytotechnologist on a report for a Pap test or nongynecologic preparation; however, this information must be retrievable in the laboratory’s records. The cytotechnologist’s name, initials, or other identifier can be used to identify the cytotechnologist in laboratory records.7

For FNA procedures where a preliminary intraprocedural assessment of adequacy is made, the result of this assessment needs to be documented. The name of the individual performing that evaluation and the result of the intraprocedural assessment are not required on the final report. The laboratory does need to maintain this information in its records, however, and ensure that it can be linked to the final report.5

The laboratory medical director

It is a common practice to have the medical director of a laboratory identified on the cytology report. If a laboratory follows this practice, the name of the medical director must be distinct from the pathologist responsible for the test results and who signed the report. In other words, it must be clear to the reader that the medical director did not have a role in the review or interpretation of the slides. This distinction is particularly important when reporting Pap test results that are negative for intraepithelial lesion or malignancy, since these do not require a pathologist’s review and the screening cytotechnologist’s name does not have to appear on the report.

Accurately and properly identifying individuals’ roles and responsibilities in a cytology report is not just about meeting laboratory accreditation requirements. Names on a report allow health care providers to seek consultation from the laboratory professionals who are most knowledgeable and who can be most helpful regarding an individual patient’s findings. As Confucius said: “If names are not correct, language will not be in accordance with the truth of things.”

References

1. 21 CFR 11.50 Signature manifestations.

2. 21 CFR 11.200 Electronic signature components and controls.

3. College of American Pathologists Cytopathology Checklist CYP.05332.

4. College of American Pathologists Cytopathology Checklist CYP.05316.

5. College of American Pathologists Cytopathology Checklist CYP.05350.

6. Prey MU. Computer assisted screening. In: Solomon D, Nayar R, eds. The Bethesda System for Reporting Cervical Cytology. New York, NY: Springer; 2004.

7. College of American Pathologists Cytopathology Checklist CYP.05325 (FNA Adequacy Assessment).


Dr. Moriarty, chair of the CAP Cytopathology Committee, is with Ameri-Path-Indiana, Indianapolis. Dr. Howell, a member of the CAP Cytopathology Committee, is professor and chair, Department of Pathology and Laboratory Medicine, University of California, Davis Medical Center, Sacramento.