| The Doctor’s Advocate | First Quarter 2008 |
Key Steps in the Cervical Cancer Screening Process
by Susan Shepard, MSN, MA, RN, Director, Patient Safety Education
This quarter’s article outlines ways that physicians can protect themselves from missing key steps in the diagnostic process. —Robin Diamond, JD, RN; AHA Fellow—Patient Safety Leadership; Senior Vice President, Patient Safety
A 44-year-old female went to her family practitioner for a routine gynecology exam. A Pap test was done and was negative for intraepithelial lesion or malignancy.
One year later, the patient returned for her routine gynecology exam. She had no complaints, normal menses, and the exam was WNL. The Pap test showed atypical squamous cells of undetermined significance (ASC-US). The physician did not recommend follow-up testing. Three months later, the patient returned because of heavy periods and back pain. The exam showed a normal cervix and a borderline-enlarged uterus. A repeat Pap again revealed ASC-US. The physician called the patient and scheduled a repeat Pap test in three to six months. The patient did not return until a year and a half later.
The next time the patient presented, she complained of daily vaginal bleeding. A pelvic ultrasound showed a uterus in the upper limits of normal size and a 3.5 cm mass in the cervix. The physician prescribed Prempro. Two months later, the patient returned with complaints of heavy bleeding and pain. The pelvic exam was WNL. It was at this time that the physician noted that the ultrasound had not ruled out malignancy. A repeat ultrasound was ordered, and the patient was referred to a gynecologist.
The repeat ultrasound showed a 3 cm cervical mass. The patient was seen by the gynecologist six weeks later. A biopsy was done and showed moderately differentiated squamous carcinoma. The patient underwent a radical hysterectomy, chemotherapy, and radiation therapy. Unfortunately, the treatments were not successful.
The Commentary
This case represents a number of system weaknesses (any of which can lead to the failure to diagnose cervical cancer): inconsistent use of protocols, lack of follow-up, and lack of adequate tracking systems.
Consistent Use of Protocols
The use of evidence-based practice guidelines protects the physician from missing key steps in the diagnostic process. For more information on the “2006 Consensus Guidelines for the Management of Women with Abnormal Cervical Cancer Screening Tests,” see Dr. Troxel’s article “Cervical Cancer Screening Guidelines—a 2008 Update” in this issue.
Appropriate Follow-Up
The physician’s lack of a proper follow-up plan (underestimating the importance of follow-up, selecting an inappropriate follow-up interval, failing to document the follow-up plan, failing to schedule a follow-up appointment, and miscommunication of the plan to the patient or other physicians) has been cited as one of the most frequent reasons for breakdown in the diagnostic process.1 Missed or canceled appointments are also a valid liability concern. A physician could be held liable for failing to educate the patient on the need for treatment and for damages that the patient sustains due to failure to obtain medical care.
The courts are requiring the medical practitioner to take a more active role in patient follow-up. It is no longer just the patient’s responsibility to keep appointments or to comply with suggested medical treatment. The physician must take an active role in facilitating follow-up. If the follow-up included additional testing based upon ordered test results, a system should be in place to ensure that the ordered test results are reviewed in a timely fashion and the additional testing is ordered. Reasonable efforts must be made to facilitate patient compliance. The key word here is “reasonable”: How critical it is for the patient to be seen will dictate your course of action.
Telephone follow-up may be invaluable in cases when medications are being used or when a patient is recovering from surgery. Follow-up contact maintains the personal link between the patient and the physician and should always be documented.
There are many plausible reasons why patients miss or cancel scheduled appointments. Many times it is because there is a conflict in their schedule or they just forget. Whatever the reason, a missed or canceled appointment should be recorded in the patient’s chart and reviewed by the physician. If the physician determines that the patient needs to be seen immediately, the patient should be notified and the appointment rescheduled.
If the patient continues to miss or cancel appointments, this should be taken very seriously. Continued noncompliance by a patient should always be called to the doctor’s attention. A certified return-receipt letter expressing appropriate concern for the patient’s welfare and, when indicated, a warning regarding the health consequences should then be considered. If circumstances warrant and the noncompliance continues, the letter should also indicate the withdrawal of the doctor from the patient’s care. Tactful language is imperative. Notations of all actions and copies of all letters sent to the patient should become a permanent part of the patient record. Contact The Doctors Company for more information on terminating a patient from the practice.
Tips
- Always document missed or canceled appointments and attempts to contact the patient.
- Explain the health consequences of continued noncompliance to the patient.
- Note all actions and keep copies of all letters sent to the patient in the medical record.
- Make sure there is a process in place whereby your office staff tracks missed or canceled appointments.
- Be aware that an unscheduled return visit may be a red flag for a previously missed diagnosis or misdiagnosis, an improper or misunderstood medical management plan, patient noncompliance, or a disease state that has simply changed in time. The unscheduled return visit is a gift—don’t look at it as a nuisance.
- Design a reminder system for reasonable follow-up on unresolved problems.
Involve the Patient
In an attempt to assuage concerns, physicians may provide patients with more reassurance than is warranted. Patients should be informed that a nondiagnostic result, such as ASC-US, is not considered normal and that additional testing may be required. Patients who understand that some test results are nondiagnostic may be more likely to comply with long-term follow-up recommendations.
In order for patients to be encouraged to participate in the care process and take responsibility for their health care, they must be fully informed of the issues, as well as the risks, benefits, and alternatives to treatment. In this case, because the Pap test diagnosis of ASC-US was inconclusive, the physician’s duty was to test for high-risk HPV or repeat Pap testing at six and 12 months or to refer for colposcopy—then track the patient’s compliance.
Develop Adequate Tracking Systems
It is particularly important that office staff be alert to laboratory, x-ray, and pathology reports, and to consultation letters from other physicians. Make certain that they are seen, dated, and initialed by the physician before being filed in the patient’s chart. The physician and staff should agree on a routine place on all report forms where the physician should initial or make comments prior to filing. In addition, the physician and staff should agree upon the process for notifying patients of results. The follow-up plan and notification should be documented in the record.
A recall file should be developed and utilized for all tests, procedures, and consults ordered by the physician. It is not sufficient to order a test or procedure and to then assume the results will be returned when completed. They could be misdirected or lost in the mail, or the patient simply may not follow through. In either case, a catastrophic result could be set in motion.
Tickler files should be set up for all tests, procedures, and consultations. These can be either computer-generated or manual. If the tests are not carried out, the physician should be alerted and the patient should be reminded.
Tips- Clarify with the patient how results will be reported.
- Make a reasonable attempt to facilitate patient follow-up.
- Develop a policy to handle follow-up of laboratory, x-ray, and pathology reports.
- Never file a report until it has been seen and initialed by the physician.
- Set up tickler files to track tests, procedures, and requested consultations ordered by the physician.
- Develop a process for informing the patient of test results.
- Document the notification of test results in the record.
- Record patient failure to follow up and all callbacks made by the staff in the patient’s medical record. Do not leave results with family members.
Reference
1.Gandhi T, Kachalia A, Thomas E, et al. Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med. 2006;145(7): 488–96.
About the Author
This article, published in 2008, was written by Susan Shepard, MSN, MA, RN, director, patient safety education.
The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.
The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.
The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
The Doctor’s Advocate is published quarterly by Corporate Communications, The Doctors Company. Letters and articles, to be edited and published at the editor’s discretion, are welcome. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of The Doctors Company. Please sign your letters, and address them to the editor.
