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Hailing clinical history in the Pap smear requisition

January 2004
Special Section

William J. Frable, MD

CLIA ’88 amendments specify in section 493.1105, Standard; Test Requisition, that the requisition for Pap smears include the date of the last menstrual period, age or date of birth, notation of previous abnormal report, treatment or biopsy, and any additional information relevant to ensure accurate and timely testing. The CAP Laboratory Accreditation Program’s cytology checklist contains a phase II deficiency (CYP. 03400) that reads: "Does the cytopathology requisition include space for the name of the patient, the date of birth or age, the date of specimen collection, the source of the cytologic material, the submitting physician’s name, and pertinent clinical information?"

The importance of supplying pertinent clinical information in Pap smear requisitions, however, seems to have gone largely unrecognized, despite the educational efforts of the American College of Obstetricians and Gynecologists, American Academy of Family Practice, and American College of Physicians. The completion of laboratory requisitions is often left to office personnel, who have many duties and may be unaware of the importance of this information or that it is part of mandated laboratory regulations.

The situation is further complicated by patients’ unwillingness to reveal such information or their belief that such information is not important, often because it dates back many years. Furthermore, patients often switch practitioners in our mobile society. Obtaining old patient records can also be problematic since practitioners retire, move, or sometimes destroy dated records. Patients may have had previous Pap smears or cervical biopsies examined in a number of laboratories at different times, oftentimes as a result of managed care providers abruptly changing laboratories to obtain a better price for services.

The following history and portion of a deposition transcript of a family physician illustrates this problem. A patient had been treated for carcinoma in situ of the cervix by a cold knife conization approximately six years earlier. She had routine annual Pap smears which had been reported as negative until, at the sixth year, one smear was reported as atypical squamous cells of undetermined significance. A repeat smear done approximately six months later and sent to a different laboratory was reported as normal. A year later, another Pap smear, sent to the second laboratory, was reported as no evidence of malignant cells, reactive endocervical cells, blood, and marked inflammation. The patient was experiencing some symptoms of postcoital bleeding and discharge at the time the last smear was taken. The cervix was described as appearing normal. The patient was diagnosed as stage III cervical squamous cell carcinoma approximately nine months later.

Question (plaintiff’s attorney): I obtained these in discovery. I am going to show you requisition forms from the three most recent Pap smears obtained on my client.
Answer: Okay.
Question: Do you recognize these as being the type of requisition form you would submit to the laboratory?
Answer: I don’t do it. I don’t recognize these forms.
Question: Are you aware of the fact that your office would prepare documents like these in the course of obtaining Pap smears?
Answer: Yes.
Question: Do you have any reason to believe that these are not accurate copies of the forms submitted to the laboratory?
Answer: No.
Question: Would you agree with me that in the section that says, "Complete clinical history"-that there is a box that is blank?
Answer: Yes.
Question: Did my client ever report to you that she had had a cervical conization?
Answer: No.
Question: Just so I am correct, you don’t keep any copies of these requisitions forms as a matter of routine in your chart?
Answer: I don’t see them, let alone keep them.

The difficulty the laboratory faces in obtaining pertinent clinical information is obvious. Its absence affects the laboratory in two ways. First, most laboratories have built into their quality control plan either double screening of Pap smears with clinical history of prior abnormal cervical smears or biopsies or automatic pathologist review of smears submitted with this abnormal history, or both types of review. Second, the laboratory is required under CLIA ’88 to include a proportion of high-risk cases in its mandated 10 percent rescreening of smears initially screened as negative. This high-risk category is best identified from pertinent clinical history provided on the requisition form.

What can the laboratory do to meet these requirements for clinical information and identify high-risk patients undergoing Pap smear evaluation? This is a difficult undertaking, but the lab should attack the problem directly. It should provide its clients with a detailed procedure manual that includes instructions for proper collection, identification, preparation and handling, and transportation of the cytologic sample. The manual should stress the importance of providing pertinent clinical information on the Pap smear requisition. It is helpful if the manual includes an example of a requisition for a high-risk patient that has been completed properly. The laboratory should periodically follow up with clients to re-emphasize the importance of these procedures and should consider reviewing the procedures with clients’ office staff.

The ongoing effort put into such educational endeavors should be documented as part of the laboratory’s quality control and quality assurance procedures. Doing so is not only good laboratory practice, but can aid in the defense of a case of alleged mistaken interpretation of a Pap smear.

Dr. Frable, an advisor to the CAP Cytopathology Committee, is professor of pathology at Virginia Commonwealth University Medical Center, Richmond.