December 15, 2008

To Call or Not to Call — How High Is the Standard?
By Leonard Berlin, MD, FACR
Radiology Today
Vol. 9 No. 25 P. 24

Editor’s Note: Leonard Berlin, MD, FACR, is a professor of radiology at Rush University Medical College and chairman of the department of radiology at Rush North Shore Medical Center in Skokie, Ill. He began his writing on risk management and malpractice issues in a series of articles in the American Journal of Roentgenology. Those articles became the basis for his well-known book Malpractice Issues in Radiology. This column is drawn from that book. The third edition of Malpractice Issues in Radiology is available from the American Roentgen Ray Society at www.arrs.org.

“How much do I love you? I’ll tell you no lie. How deep is the ocean? How high is the sky?”

— Irving Berlin, “How Deep Is the Ocean”

The Case
No one has ever questioned the good intent of the Missouri hospital’s management or its radiologists when they decided to undertake a breast cancer screening program for the hospital’s female employees in January 1988, but a malpractice lawsuit filed as a result of the program led to a costly indictment because of the manner in which it was implemented. The hospital contracted with a mobile diagnostic imaging company to supply a fully equipped and staffed mammography unit that would be stationed on a given day at the hospital, obtain and develop appropriate film-screen mammograms, and present the radiographs to the hospital’s radiologists for interpretation. As part of its registration and record-keeping procedures, the mobile company provided a form for the patients to fill in certain demographic and historical data, along with the name of the physician to whom the mammographic report should be sent. On January 6, 1988, a 40-year-old female nurse registered for the mammographic examination, filling out the form and indicating as recipient the name and address of a physician who happened to be a family practitioner for whom the nurse had previously worked, and to whom she had gone for occasional medical care. Her mammogram was completed and later that day was interpreted by a hospital radiologist as showing “an ovoid lesion” in the right breast for which “further evaluation” was indicated. The hospital staff mailed the radiology report to the family physician and thereafter had no further communication with the nurse about her mammographic findings.

No contact, either by telephone or in person, was made between the nurse and her family doctor or his office personnel until 14 months later when, in March 1989, the nurse visited the physician in his office because she felt a lump in her right breast. During the examination, in which the doctor confirmed the presence of a mass in the breast that required biopsy, he noticed that the 1988 mammography report was in the patient’s chart but told the nurse that he had never noticed it before because he had no occasion to look at the chart. Shortly thereafter, the patient underwent biopsy and eventually partial mastectomy for breast carcinoma.

Later that year the nurse instituted a malpractice lawsuit against the family physician, the hospital, the mobile imaging company, and the radiologist, claiming that all of the defendants had violated their duty to her by failing to give her timely notification of the abnormal mammographic results. In subsequent discovery depositions, the family physician stated that although the original 1988 radiology report had obviously been received in the mail by one of his office personnel who inserted it into the nurse’s office chart, he himself had no reason to look at the chart before the nurse’s visit 14 months later because he had never actually ordered the mammogram in the first place and therefore wasn’t expecting to receive one. The nurse herself stated in her deposition that she never bothered to call the physician about the report, thinking that he would call her if it showed any abnormality. The radiologist said in his deposition that he did not call the doctor because the report was mailed immediately to him and had no reason to call the patient because he assumed she would be notified of the results by her physician. He denied any negligent act. Representatives of the hospital and the mobile imaging company said in their depositions that they had adhered to all necessary requirements, as documented by the fact that the radiologist’s written report had been received in a timely fashion by personnel in the family doctor’s office.

The attorney defending the radiologist asked a nationally prominent expert in mammography for his opinion of whether the defendant had met the ordinary standards of radiologic practice in this matter, and if the answer were affirmative, whether he would serve as the defendant’s expert witness. The expert responded that he thought the radiologist was negligent because he failed to telephone the mammographic results to the family physician. The defense attorney contacted another radiologist, however, who in his deposition stated that the defendant radiologist had acted in accordance with most of the radiologists in the nation by arranging to have the report of the abnormal findings mailed, thus fulfilling his legal duty, and that he was not required to telephone the report. On the other side of the dispute, the plaintiff’s attorney spoke to still another radiologist experienced in mammography who strongly opined that the defendant was indeed negligent for not having telephoned the family doctor. The attorney also procured copies of American College of Radiology (ACR) guidelines published in 1985 and ACR standards published in subsequent years, which suggested that the radiologist was obliged to telephone the abnormal mammographic results to the patient’s physician in addition to mailing them.

Just before the trial began, all parties agreed to settle the matter for a total payment of $100,000 to the nurse plaintiff. Sixty percent of this amount was paid by the family physician, 20% by the radiologist, 15% by the hospital, and the remaining 5% by the mobile company. When asked about the settlement, the radiologist’s attorney stated that he had deemed it prudent and necessary for the radiologist to pay the $20,000 because, in his opinion, in the face of the ACR written standards and guidelines and the testimony of a radiologist that the defendant had indeed violated those and other published standards, it would have been extremely difficult to convince the jury that the hospital radiologist had not acted in a negligent manner by failing to telephone the family doctor with the abnormal mammographic results.

Although this settlement sets no legal precedent, it nevertheless does have far-reaching impact on the manner in which radiologists deal with mammography and on the very nature of the standards of practice against which radiologists are measured.

The Radiologist’s Role
This case brings into focus the role radiologists play in medical practice today, their moral and legal duties, and to whom they owe these duties. Traditionally, radiologists have considered themselves to be consultants, “doctors’ doctors”1, in the sense that they initiated radiologic examination only on the request of a referring physician and rendered an interpretation for, and transmitted it only to, the same physician. Customarily, the radiographic interpretation has been in the form of a written report. Copies are kept in the radiologist’s files and in hospital records when the examination is performed in a hospital department. Another copy is sent, invariably by first-class mail, to the ordering physician.

Historically the medical community has believed that the radiologist’s duty to communicate results stopped with the sending of the radiology report out of the department, destined to be received by the referring doctor. As a matter of courtesy and good medical practice, the radiologist might decide to telephone the patient’s physician if the radiographic findings seemed to warrant immediate treatment, but this telephone call was not necessarily required. Little attention was given to the possibility that the report might not be received by the referring physician or if it was received, that the referring physician would not act on it.2 The same could be said of any nonradiology consultant: a duty for surgeons, internists, and other medical specialists to telephone or otherwise communicate the results of their consultations to referring physicians has never been established beyond sending written reports.

This duty of communication seems to be borne out in a study reviewing all of the nearly 1,400 malpractice lawsuits involving radiologists filed in the Chicago area during an 11.5-year period.3,4 This study revealed that less than 1% of the lawsuits were related to communication disputes, and not a single allegation was lodged against a radiologist that claimed a violation of the duty or responsibility of making sure that the physician who ordered the examination actually received the report. As I stated in 19905, I had never seen a case in which a radiologist was held liable for failure of a referring physician to receive a radiology report, so long as the radiologist issued the report and sent it out in a timely fashion.

The advent of screening mammography changed traditional thinking. Radiologists, who were accustomed to having patients sent to their offices or hospital departments by referring physicians because of specific clinical symptoms or signs, now were asked to perform mammography on patients who were sent by their doctors simply for screening purposes and, in some cases, on patients who came on their own without being referred by a specific physician. The difference was clear: In the traditional referral, the doctor suspected an abnormality, earmarked a specific radiologic examination, and actively awaited the radiologic results. The doctor was apt to follow up with the radiologist if the written report was not received in timely fashion. “No news” was unacceptable: The physician had essentially asked a question of the radiologist and could not close the patient file until an answer was received. But in the case of mammography, the mechanics were altered: Both physician and patient often became lulled into the belief that because no clinical signs or symptoms were apparent, a radiology report indicating an abnormality would be most unlikely, and the result might not be actively awaited. Indeed, no news would tend to become good news: If the radiologist did not react with a report quickly and directly, everything was probably all right.

Perhaps it was because of these perceptions that in 1985 ACR published and distributed to its members a then little-noticed two-page document, Policy Statement: Breast Cancer Screening Centers. In it appear the following statements:

The radiologist must be certain that the result of a positive mammogram is acknowledged by a primary care physician. … A positive finding should be reported promptly in writing to a physician. In all cases, appropriate acknowledgment of the notification should be sought.

ACR’s policy covered radiology facilities that perform mammography on patients who were self-referred or physician-referred. It decisively placed a new duty on radiologists: namely, to seek confirmation not only that their report was sent but that it had been received. It thus posed the question that is at the heart of the case discussed here: If the radiologist sent the written report but failed to confirm its receipt by the clinician, and if the patent then sustained harm because the physician did not appropriately follow up on the report, would the radiologist be liable, and if so, to whom? To the patient, to the referring physician, or to both?

Current Guidelines and Standards
Since 1985, both ACR and authors in professional journals have had much to say about how and when radiologists should communicate mammographic findings. The ACR Standard for the Performance of Screening Mammography, published in 1990, states:

All reports in the high-probability category should be communicated to the referring physician or his designated representative by telephone, by certified mail, or communicated in such a manner that receipt of the report is assured and documented. ... Self-referred (i.e., those women who have no referring physician) patients should be notified of the results of the screening study by mail. ... Reports in the high-probability category should be communicated to the patient by certified mail.

The 1991 ACR Standard for Communication: Diagnostic Radiology states:

Some circumstances…may require direct communication of unusual, unexpected, or urgent findings to the referring physician in advance of the formal written report. ... The timeliness of direct communication should be based upon the immediacy of the clinical situation.

Statements and opinions concerning means of communicating abnormal mammographic findings are seemingly more specific in the radiology literature. Bird and McLelland6 in 1986 wrote that if the mammogram is “suggestive of malignancy,” the referring physician should receive a “phone report in addition to the written report.” Potchen et al.7 in 1991 wrote regarding mammography that “radiologists should attempt to establish a standard practice of verbal communication whenever a surgical consultation is recommended” and that a notation of the verbal communication be included in the written report. Brenner8 in 1989 admonished that direct communication between the radiologist and the referring physician is “most likely required” whenever a questionable lesion is seen on a mammogram and, in a 1992 article9, added that a “suspicious mammographic finding imposes upon the radiologist a higher duty for directly communicating the results to the referring physician.”

On the subject of communicating radiologic results generally, not just mammographic results, Liston10 recommended that radiologists telephone the referring physician before sending a formal report, and Schwinger11 argued that direct telephone contact should be made because “first-class mail is not always reliable” and “the radiologist frequently cannot depend on the clinician reading a written report.”

Even the court has had something to say on the subject. A 1987 New Jersey appellate court decision stated, “Communication of an unusual finding in an x-ray … is as important as the finding itself” (Jenoff v Gleason).

Notwithstanding pronouncements of the ACR and the professional literature, the United States government is less restrictive on the subject of communication. In the 1990 Federal Register covering “Conditions for Coverage of Screening Mammography” under the Medicare program, the only requirement relating to communication of results is that a written report be made and that it be provided to the referring physician or the patient.

Negligence: A Deviation from Standards or a Deviation from Guidelines?
Medical negligence, or malpractice, is legally defined as a breach from standard practice that is the proximate cause of a patient’s injury.12 Although I have thus far discussed what the ACR and medical authorities consider to be guidelines and standards in radiologic practice, specifically as they relate to communication of results, the standard practice determined in a court of law may not necessarily be the same. Let us examine more closely what is meant by standard practice. Found in many written state appellate and supreme court decisions dealing with medical malpractice are statements such as “A physician is not required to possess the highest order of qualification, but he must possess and exercise that degree of skill which is ordinarily possessed by members of the profession” (Ritchey v West, Illinois, 1860); “The law requires a surgeon to possess the skill and learning which is possessed by the average member of the medical profession” (MacKenzie v Carman, New York, 1905); “If a physician has acted in a manner equal to that ordinarily used by a reasonably well-qualified physician in similar circumstances, the physician is not liable for negligence” (Spike v Sellett, Illinois, 1981); and “Elements of proof of negligence in a medical malpractice case include…a deviation or departure from acceptable practice” (Amsler v O’Hara, New York, 1986).

What permeates these and other court decisions is the concept that for physicians to be found negligent, they must be shown to have deviated from usual or ordinary practices, or standard practices, of the members of their profession; that is, behaved below the average of how their peers would have behaved in similar circumstances. Generally, the court must be instructed as to what constitutes the theoretic standard by an expert familiar with the profession in question. The expert explains to the judge, jury, or both what the average or ordinary physician would have done in a comparable circumstance and then offers an opinion as to whether the physician defendant acted within or below that standard.13

Real standards of practice do not derive from external authorities such as government or professional societies but rather come from interaction among leaders of a profession, journals, meetings, networks of colleagues, flow of reports in the literature, and peer discussions; it is a decentralized process of policy setting.14 A valid question, then, is to ask ourselves whether a guideline, standard, or parameter published by a professional society or by the American Medical Association or an opinion stated by an authority in a journal that purports to tell members of a professional group how they should act, adequately and accurately reflects how the average member of the group indeed does act. Do these published standards portray to the community at large how radiologists realistically do things in today’s world? Do they give the court an accurate indication of a level of average and ordinary practice, below which any conduct would be considered negligent? The express purpose of the standards now being formulated and released by the ACR is to improve quality of care, which is in keeping with ACR’s mission to “improve radiologic service to the patient.”15 But whether ACR’s standards set new standards or simply reflect existing ones is certainly not clear. A disclaimer placed on every page of the ACR standards states that “The standards … are not rules but attempts to define principles of practice…. The standards should not be deemed inclusive of all proper methods of care.” Although this sounds like the ACR is not mandating a standard of practice on its radiologist members, the disclaimer then goes on to read: “It is prudent to document the rationale for any deviation from these suggested standards.”

A debate about whether the legal standard is what we actually do or what we should do is largely academic. Although the courts will theoretically continue to judge defendant radiologists on the basis of whether they did the same or less than what their peers would have done under similar circumstances, rather than on how the ACR or American Medical Association guidelines would have indicated they should have acted, we must be mindful that just as the published standards influence practicing radiologists, so will they greatly influence the courts. Indeed, the ACR’s legal counsel has stated that the plaintiff’s attorney will clearly use those standards as a “weapon” to try to indicate that the defendant radiologist was negligent, and reference to them in court proceedings may well occur with greater frequency in the future. One of the lessons of this case may be that it behooves all radiologists to acknowledge that even if certain of their practice patterns do not conform to the published standards today, they will have to be modified to comply with the standards eventually, not only to improve the quality of service but also to minimize legal vulnerability.

How High Is the Standard?
The attorney defending the radiologist in this case recommended that his client pay one fifth of the total liability because the radiologist did not telephone the abnormal results of a mammogram to the physician listed on the mammogram requisition form, even though he knew the written report would be properly and promptly mailed to that physician. Several leading radiology experts say the defendant should have telephoned the referring doctor, published standards and guidelines suggest he should have telephoned the doctor, and possibly the preponderance of opinion in today’s climate in the radiology community is that he should have telephoned the referring physician. But one must wonder whether most practicing radiologists would actually have telephoned the doctor in 1988 under similar circumstances and, more fundamentally, whether by not telephoning the doctor the radiologist was truly guilty of malpractice. Although no formal judicial finding was reached in this case, it is reasonable to conclude that the defense attorney was correct in his prediction that the radiologist would have been found to have deviated from professional standards and thus to have been negligent. It is also reasonable to conclude that had the radiologist indeed telephoned the family physician with the positive mammographic findings, no malpractice, and no lawsuit, would have occurred in the first place.

Under our legal system, radiologists are guilty of malpractice if it is proven that they have conducted themselves below the standard of their profession. The standard is what our professional organizations, composed of our peers and appointed or elected leaders, say it is. The standard, of necessity, becomes more complex and continuously is elevated to greater heights, parallel to our increase in medical knowledge, our explosive growth in sophisticated electronics and technology, and our relentless effort to constantly improve service to our patients and referring physicians.

At what level is the standard today and how much further can our colleagues and the courts take it? As deep as the ocean, as high as the sky?

Addendum
Indeed, the standards regarding communication of mammographic findings have already changed, as will be noted in subsequent columns that deal with communication of significant but not urgent findings and tracking for breast cancer.

— “To Call or Not to Call — How High Is the Standard?” appeared in its original form in the American Journal of Roentgenology. It is reprinted here with permission of the American Roentgen Ray Society.

References
1. Berlin L. The radiologist: Doctor’s doctor or patient’s doctor? Am J Roentgenol. 1977;128(4):702.

2. Robertson CL, Kopans DB. Communication problems after mammographic screening. Radiology. 1989;172(2):443-444.

3. Berlin L. Malpractice and radiologists. Am J Roentgenol. 1980;135(3):587-591

4. Berlin L. Malpractice and radiologists, update 1986: An 11.5-year perspective. Am J Roentgenol. 1986;147(6):1291-1298.

5. Berlin L. A doctor’s doctor practices good medicine or good law. ACR Bulletin. 1990:32,34.

6. Bird RE, McLelland R. How to initiate and operate a low-cost screening mammography center. Radiology. 1986;161(6):43-47.

7. Potchen EJ, Bisesi MA, Sierra AE, Potchen JE. Mammography and malpractice. Am J Roentgenol. 1991;156(3):475-480.

8. Brenner RJ. Medicolegal aspects of screening mammography. Am J Roentgenol. 1989;153(1):53-56.

9. Brenner RJ. Medicolegal aspects of breast imaging. Radiol Clin North Am. 1992;30(1):277-286.

10. Liston SE. A new type of cancer lawsuit is emerging. ACR Bulletin. 1990;46(4):14.

11. Schwinger HN. Liability problems in radiology communications exist. ACR Bulletin. 1990;46(7):33.

12. Berlin L. Does the”missed”radiographic diagnosis constitute malpractice? Radiology. 1977;123(2):523-527.

13. Hirshfield EB. From the Office of the General Counsel. Practice parameters and the malpractice liability of physicians. JAMA. 1990;263(11):1556-1562.

14. Furrow BR, Greaney TL, Johnson SH, Jost TS, Schwartz RL. Health Law: Cases, Materials and Problems, 2nd ed. St. Paul: West; 1991:36.

15. American College of Radiology. Article II. In: ACR Bylaws. Reston, Va.: American College of Radiology; 1989.