Cytology information system helps improve patient care

Medical Laboratory Observer, Sept, 2004 by Betty Judge

While much diagnostic testing produces numbers or metrics from which a diagnosis is rendered, cytology--the study of exfoliated cells--requires that the cytotechnologist screens slides, determining if changes in the cells are consistent with a certain type of abnormality, then flagging those patients for further testing. Other factors also come into play: slide preparation, work environment, and tools provided. Thus, qualitative cytology testing carries a relatively higher margin of error compared with quantitative-diagnostic tests.

Challenges associated with the screening process can be compounded by a manual reporting system of hard-copy reports and file folders. If a significant Pap-smear abnormality is found, for example, the lab must re-screen the previous five years of negative slides. Sorting through paper files can be cumbersome. Simple clerical errors (like spelling mistakes in a patient's name) and incomplete or misfiled reports can also make it difficult for a tech to review a patient's history--essential in identifying re-screening needs and in determining the aggressiveness of treatment if abnormal cells are present.

Regulatory bodies, which set standards for various areas of the lab, recognize that screening tests are not 100% accurate and have their own measurements for acceptable standards of care. Laboratories that wish to maintain certifications from standards organizations must carefully track, record, and compare the incidence of lab error over time as well as that of the individual techs working in the lab. These reports and the quality certifications granted by such organizations can help protect the laboratory and its staff in lawsuits, minimizing potential for damage. A cytology-information system can help the lab assure higher quality testing and better case-history tracking as well as ensure appropriate follow up with the ordering clinician, resulting in improved patient care.

Potentially serious consequences

Though charges of criminal negligence are rare, lawsuits springing from misdiagnosis are not--even if a laboratory's findings are within the acceptable margin of error. In an extreme case concerning the deaths of two Wisconsin women from cervical cancer, criminal charges were brought against a lab, a technician, and a doctor who, prosecutors contended, each had missed unmistakable signs of cancer during Papsmear screenings. A $4 million settlement awarded in 2000 to the family of a 37-year-old woman who died from cervical cancer in 2000 brought about a St. Louis lab's closing, even though defense experts testified that the presence of abnormal cells in the patient's Pap smear was very low and their presentation unique, thus suggesting that the lab was not negligent.

A similar case at a Rhode Island hospital, in which the lab missed pre-cancerous cells in the Pap smear of a woman suffering from advanced cervical cancer, spurred another local hospital, Kent County Memorial, to invest in a computer system for the cytology lab so its section chief in charge of cytology could begin tracking its 25 to 50 monthly quality assurance (QA) statistical reports and keep a record of QA metrics with Microsoft Excel. Though improved from the manual methods, the reporting was still very time-consuming using the Excel worksheets. Additionally, Kent had a manual paper-based system for cytology-case reporting, consisting of a two-part requisition form, along with a card file to document patient histories of both cytology and surgical case results, hard copies of which were stored off-site.

Better patient care

Seven years ago, with a grant from a local foundation, Kent upgraded its legacy anatomic pathology (AP) information system (IS) to a newer version of AP software, implementing a cytology module. The IS cuts the QA report-generation time from two weeks to a couple of hours of Excel data entry, since the information is already tracked in the system. Tracking the cytotechs' work to ensure that the cases are completed appropriately, signed out, and sent to the clinicians is also made easier.

In addition to productivity and management improvements, another benefit of Kent's cytology system implementation is better patient care. Now, histories are easily accessible, even with clerical errors or patient-name changes, because the system links patients' records by a number of fields. As a courtesy, it generates a monthly list of patients with abnormal Paps for each clinician, ensuring appropriate follow up.

Additionally, the lab is required to obtain patient follow-up information in the event of an abnormal diagnosis. The cytology system automatically produces follow-up letters to clinicians requesting the course of action taken. For QA purposes, the lab uses the IS to track who performed the original screening, the re-screening, and the final screening in order to aid in identifying re-training or additional education needs for a particular tech.

Highly skilled staff, easily accessed patient history, thorough reporting, and follow-up capabilities enable the lab to more quickly and accurately diagnose the presence of potentially life-threatening disease, which empowers the clinician to determine the best and most aggressive treatment possible.