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Test Results, Patients and Doctors:
Legal Status1

View of the court

“After considering all of the evidence, in my view the reasonable standard of care is that a physician and a lab should both have reliable and effective systems with an ‘audit trail’ to follow-up and confirm that significant test have been reported in a timely manner.”2

Introduction

Within the last year there have been two articles in the Messenger, a publication of the College of Physicians and Surgeons of Alberta (CPSA), concerning follow-up of test results to patients. The first publication was issued as a guideline3 and the second was a follow-up4 . In addition, Dr. Philip G. Winkelaar, of the Canadian Medical Protective Association has addressed the issue.5

The purpose of this article is to inform physicians of the views held by courts in Canada in cases where it was alleged that inadequate follow-up systems existed relative to the handling of test results.

Legal Decisions

The following seven cases illustrate the standards set by courts in Canada of the need for physicians to follow-up on laboratory results. These cases cover five provinces from all regions of Canada and span 20 years. The cases highlight the lack of tracking of results from pathologists, laboratories and X-ray departments. The physicians sued ran the gamut from general practice to a variety of specialists.

2000 decision - Pap smear report6

A pap smear result showed abnormal cells of precancerous condition. A pathologist from the department where the smear was read testified the report would have been signed and mailed within 24 hours. The defendant physician who took the smear did not receive the report and no action was taken.

At some point, the result was placed on the patient’s chart at the hospital clinic, following which the clinic at the hospital was closed without the physician seeing the report. The patient was unaware of the result until 11 months after when she consulted a second physician who reviewed her previous medical records. At that point she was diagnosed with advanced cervical cancer and died 18 months later. Expert evidence at trial indicated that if treated, there was almost 100% rate of success.

Much evidence was heard at trial concerning responsibilities of the testing physician vs. responsibilities of the hospital clinic staff regarding follow-up of test results. The hospital lacked a system to track test results. It was the practice of the testing physician secretary to place returned test results before the physician so he could issue appropriate instructions.

The court found no difficulty in finding the physician to be negligent. He was severely criticized for having no independent efficient system in place to ensure that reports were returned to him. Also, he had not made inquires of the hospital to see what system it had in place. In conclusion, the court found that the physician was the source of failure because it was his professional responsibility to have a system in place to ensure reports were returned to him.

Expert medical evidence from peers of the surgeon, accepted by the court, stated that responsibility rested ultimately with the defendant physician and in made no difference that the clinic, where the test was taken, was operated and owned by the hospital.

The defendant physician appealed the decision to the Court of Appeal. That court found that the overwhelming weight of evidence provided ample support for the conclusions reached by the trial judge, although the standard set was too high when she held that the physician was responsible to “...see that a system was in place to ‘ensure’ that a test result was read by the requesting physician.” The Court of Appeal stated the correct standard is that there is a duty upon the physicians to ensure there is a reasonably effective ‘follow-up’ system in place.

2000 Decision - Missing mole biopsy report7

A pathology laboratory failed to send a diagnosis of malignant melanoma arising from analysis of biopsy of a mole, to the requesting physician, and the physician did not follow-up with the laboratory. The laboratory had no system to confirm that the requesting physician had received a report and the physician had no system to follow-up on missing reports. Thus, no action was taken to have the tumor excised. When finally removed 6 years later, the tumor had evolved significantly including involvement of lymph nodes.

The court held the physician and laboratory equally liable. The court stated that the reasonable standard of care is that a physician and laboratory should both have reliable and effective systems with an audit trail to follow-up and confirm that significant test have been reported in a timely fashion.

1998 Decision - RH Antibodies8

This case involved a pregnant patient in 1985 where blood work indicated she had developed RH antibodies, which would present a risk for future pregnancies. Test results were sent to the physician but not reviewed by him as they were simply placed directly on the chart by office staff. The routine at his office was to file reports on the patient’s file as occurred in this case.

Four years later the patient saw the physician on three occasions for birth control. At that time the physician became aware of the RH result, but did not explain the significance or possibility of a Caesarian section increase when RH antibodies existed from a previous pregnancy.

These office visits specifically addressed birth control and the potential risk of pregnancy in her circumstances in relation to malignant hypothermia. The patient specifically sought advice on the impact of becoming pregnant and was not given advice relative to RH. The patient went on to become pregnant a few months later, experienced significant complications and the baby was eventually successfully delivered by Caesarian section.

The court had no difficulty concluding that the obstetrician was negligent as there was a failure to communicate the information at the time results became available. This was compounded when he failed to advise the patient of the results on later office visits, particularly given the purpose of these visits.

1986 Decision - Failed abortion9

A 17-year-old high school student underwent surgery for an abortion. She was to return for a post-operative examination in one to two weeks, but failed to do so. The check-up was arranged for two reasons: to be certain the procedure had been successful, and to review the pathology report of tissue removed during the procedure.

The pathology report indicated no fetal tissue had been removed and the patient remained pregnant. Unfortunately, the pathology report arrived at the surgeon’s clinic when she was moving her practice to another office and it never came to her attention. A short time thereafter, the surgeon completed and signed her report of the abortion operation without seeing the pathology report. As a result, the patient did not discover she was still pregnant until after it was too late to have a second procedure.

The court found the surgeon negligent in failing to ensure that she had examined the pathology report and particularly in signing off the operation report without seeing the pathology report. The court held that a careful practitioner would have seen the pathology report not later than four weeks after the operation, and probably well before that, and would immediately have warned the patient, examined her or at least have had her undergo a pregnancy test.

1983 Decision - Undiagnosed diabetes10

The patient attended with the physician and provided a history of 17 pounds of weight loss in 17 days with fever, frequent urination and thirstiness, A tentative diagnosis of UTI or diabetes, was made.

That same day the physician had the patient undergo laboratory tests for urinalysis and blood. Four days later the physician received the laboratory result which indicated severely elevated blood sugar readings. The physician immediately called the patient and advised he had diabetes, was very sick and should go directly to the nearest hospital. The patient died that afternoon.

It was conceded at trial that had the patient been advised of his condition and hospitalized the day after the test, he would have survived. As a result of his evidence, a factual dispute between the laboratory and the physician arose. The laboratory claimed the physician was advised by telephone of the abnormal results the day after the test while the physician claimed the written report received four days after the test was the first noticed received.

The court rejected the evidence on behalf of the laboratory and favored evidence of the physician that he first became aware of the laboratory results four days later, and he reacted quickly. It was argued, based on evidence of the expert for the patient, that the physician was nonetheless negligent in that he had a duty to diagnose the patients problem.

When diabetes was suspected, he should have performed a dipstick urinalysis in his office or directed the patient to wait for the urinalysis results at the laboratory. Furthermore, he should have followed-up with the laboratory when the results were not received the day after the test.

Given the facts, the physician was not found liable. The court held that he met the standard of a reasonable family practitioner. At the time he saw the patient, the patient did not appear to be seriously ill and did not appear dehydrated. As he had not heard from the laboratory, it was reasonable to assume there were no abnormal results and he could also properly assume that should his patient become remarkably worse, the patient would call him. Having found the physician not negligent, the court found the laboratory and its employee negligent. Protocol at the laboratory was to telephone the requesting physician abnormal results immediately and deliver an interim written report as soon as one could be prepared, one day after the test. The laboratory failed to follow its procedure and was held liable.

1989 Decision - Undiagnosed breast cancer11

A surgeon performed a reduction mammoplasty on a patient and tissue removed at surgery was sent to the pathology department of the hospital. The practice was to place a copy of the pathology report in the surgeon’s box at the hospital but this did not occur.

Eleven months following surgery, the patient reattended with the surgeon complaining of lumpiness and thickening in her breast. At this visit, the surgeon finally obtained the pathology report which specified carcinoma. The surgeon maintained the original operation was cosmetic and did not give rise to any concern. He assumed he had seen the pathology report and it was normal, consequently requiring no action.

The Judge stated the surgeon failed in the standard of care and found him negligent. Tissue sent to pathology for examination by a pathologist required follow-up by the surgeon. It was deemed important to know the pathology finding, whether negative or positive. As absence or presence of cancer was not apparent to the surgeon at the time of the mammoplasty, he should have obtained and read the pathology report and not assumed he had seen it. The surgeon had no system to check whether he received pathology reports following surgical cases. The court viewed this as a simple precaution which needed to taken.

1980 Decision - Misdiagnosed fracture12

The patient attended at hospital where the physician diagnosed a broken wrist and ordered X-rays, but placed the cast on the wrist without viewing the X-rays. The hospital lacked the facilities to have a radiologist view the X-rays until the next working day and results were sent to the patient's regular physician, not to the attending physician.

A dislocation of the lunate bone was disclosed by the X-rays, which required special treatment and a special cast.

The court held the hospital 25% responsible for forwarding the X-ray result to the wrong physician and the physician was appointed 75% of the blame for failure to track the results of the X-rays, properly diagnose the injury and provide appropriate follow-up.

Discussion

It is the usual practice in medical negligence actions for plaintiff patients and defendant physicians to retain experts to comment on standard of care. Experts testifying for the patient and the physician in the above cases testified that the expected standard of care required appropriate mechanisms to follow laboratory, pathology and X-ray reports.

From these decisions, it appears that if a physician does not have a system in place for tracking tests the courts are more likely than not to find the physicians should have such a system. Even where institutions such as hospitals or laboratories were party to the lawsuits, the physician may be held responsible for a portion of the damages awarded to the patient.

There are two areas where difficulties arise in relation to “missed” test results. The first occurs when the physician and/or institution does not have an adequate system in place to assure follow-up of test results. The second is in relation to hospitalized patients.

These patients can be challenges, especially when consultants order tests when involved in their care. In this situation the test results may be forwarded to the patient’s admitting physician, rather than the ordering consultant. Also the tests may not be reported until after the patient is discharged from the hospital. If the test results go to the admitting physician rather than the consultant, it is possible the consultant may not be apprised of the result. The receiver may believe that the ordering physician knows the results and does not discuss the results with the ordering physician or the patient.
Physicians order tests for a reason. Logic dictates the importance of receiving and evaluating the ensuing reports within a reasonable period of time. Following up on test results in an efficient fashion shows consideration for a patient’s well-being.

According to the court decisions presented, it is important for physicians to have a reasonable system in place to ensure that results are followed up on. Whatever system is in place, the process should be explained to patients so they know what to expect in relation to the handling of their results.
It suggested that the process ought to consist of ordering a test, receiving results within a reasonable time, reading the report and advising the patient of the results. If there are delays in receiving results then practical steps should be taken to locate the report and contemporaneous notes should be made in the chart.

Patients often do not understand the possible importance of abnormal test results and rely on the physician to call them. Physicians should consider how to deal with reporting abnormal results to compliant patients. When patient contact is not possible, then the attempts that have been made should be documented.

Another area of concern involves non-compliance of difficult patients. When the patient is non-compliant regarding follow-up, physicians or their staff should note in the chart what attempts have been made to reach the patient to advise them of abnormal results. There is nothing a physician can do if patients fail to go for testing or are recalcitrant. Physicians can only suggest compliance and note such advice in patients’ records.

Physicians who want to review the system they have in place may wish to contact the CSPA and the Alberta Medical Association staff for assistance and guidance.


1 2001 Alberta Doctors’ Digest July/August
2 [2000] N.B.J NO. 156(Q.B.)
3 Preventing follow-up failures when caring for patients, the Messenger, January 2000, P.1
4 Update on prevention follow- up failures, The Messenger, issue 80, p.1
5 Winkelaar, Philip G., Follow-up on the Laboratory results, Canadian Family physician, Vol 45: September 1999
6 [2000] M.J. No. 63 (Mtba.C.A)
7 [2000] N.B.J. No. 156 (Q.B.)
8 [1998] A.J. No. 360 (Q.B)
9 [1986] 5 W.W.R. 222 (B.C.S.C)
10 [1983] O.J. No. 1012 (Ont. H.C.J)
11 [1989] M.J. No.656(Q.B.)
12 (1980), 29 N.B.R. (2d) 340 (Q.B)