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1335
Perspective
To Telephone Standard? Leonard
or Not to Telephone:
How High Is the
Berlin1
How
deep
How
high
How
much
I’ll tell you -Irving
is the
graphic examination, filling out the appropriate form and mdicating as recipient-to-be 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 previously 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. There was no contact, either by telephone or in person, between the nurse and her family doctor or his office personnel until 14 months later, when, in March 1 989, the nurse visited the physician in his office because she felt a lump in her right breast. During the doctor’s examination of the nurse, in which he confirmed the presence of a mass in the breast that required biopsy, he noticed that the January 1 988 mammographic report was in the patient’s chart, but told the nurse that he had never noticed it before, since he had had no occasion to look at the chart before the nurse’s visit. Shortly thereafter, the patient underwent biopsy and eventual 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 defend-
ocean
is the sky do I love
you
no lie. Berlin,
‘
How Deep
Is the Ocean”
The Case No one ever questioned the good intent of the Missouri hospital’s management or its radiologists when they decided to undertaken a breast cancer screening program for the hospital’s female employees in January 1 988, but, as we shall see, a malpractice lawsuit filed as a result of the program led to a costly indictment of the manner in which they implemented it. 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 breast radiographs to the hospital’s radiologists for interpretation. As part of its registration and record-keeping procedures, the mobile company provided a form on which the patients would be asked to fill in certain demographic and historical data, along with the name of a physician to whom the mammographic report should be sent. On January 6, 1988, a 40-year-old female nurse employed by the hospital registered for the mammoReceived May 2, 1 992; accepted after revision June 4, 1992. ‘ Department of Radiology. Rush North Shore Medical Center. requests to L. Berlin. AJR 159:1335-1339,
December
1992 0361-803X/92/1596-1335
9600
Gross
© American
Point
Rd. . Skokie,
Roentgen
IL 60076,
Ray Society
and Rush
Medical
College.
Chicago.
IL. Address
reprint
Downloaded from www.ajronline.org by 69.3.140.154 on 11/13/15 from IP address 69.3.140.154. Copyright ARRS. For personal use only; all rights reserved
1336
BERLIN
ants 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 1 988 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 had no reason to look at the chart prior to the nurse’s visit to him 14 months later because he had never actually ordered the mammogram in the first place, and therefore was not expecting to receive one. The nurse herself stated in her deposition that she never bothered to call the physician about her 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 being 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 con-
tacted
another
radiologist,
however,
who in his deposition
stated that the defendant radiologist had acted in accordance with the overwhelming majority of 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 adjudicating the case 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
afterward,
the radiologist’s
attor-
ney 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’s 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
AJR:159,
telephone
the family
doctor
with the abnormal
December
1992
mammographic
results. Although
this settlement
sets
theless does have far-reaching
no legal
precedent,
it never-
impact on the manner in which
radiologists deal with mammography, of the standards of practice against
and on the very nature which radiologists are
measured. The Aftermath:
The Role of the Radiologist
This case brings into play in medical practice duties are, and to whom
sharp focus what role radiologists today, what their moral and legal they owe them. Traditionally, radi-
ologists 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, physician.
invariably
by first-class
mail,
to the
ordering
Historically it has been believed by the medical community that the radiologist’s duty to communicate results stopped with the sending of the radiologic 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 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 were received, that the referring physician would not bother to act on it [2]. The same could be said of any nonradiologic consultant: there has never been an established duty for surgeons, internists, and other medical specialists to telephone or otherwise communicate the results of their consultations to referring physicians beyond sending out written reports. This seems to be borne out in a study reviewing all of the nearly 1 400 malpractice lawsuits filed involving radiologists in the Chicago area during an 1 1 .5-year period [3, 4]. This study revealed that less than 1% of the lawsuits were related to
communications
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. Indeed, I stated in 1 990 [5] that I had never seen a case in which a radiologist was held liable for failure of a referring physician to receive a radiologic 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 being asked to perform mammography on patients
who were sent by their doctors and
in some
cases,
simply for screening
on patients
who
came
purposes,
on their
own,
Downloaded from www.ajronline.org by 69.3.140.154 on 11/13/15 from IP address 69.3.140.154. Copyright ARRS. For personal use only; all rights reserved
AJR:159,
December
NOTIFICATION
1992
OF
MAMMOGRAPHIC
without even being referred by a specific physician. The difference was clear: In the “traditional” referral, the #{231}ioctor suspected an abnormality, earmarked a specific radiol#{243}gic 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 file on a patient 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 radiologic report indicating an abnormality would be most unlikely, and therefore 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, probably everything was alright. Perhaps it was because of these perceptions that in 1985 the ACR published and distributed to its members a then little-noticed two-page document, Policy Statement: Breast Cancer Screening Centers [6]. 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.” The College’s policy covered radiologic facilities that performed mammography on patients who were self-referred or physician referred. It decisively placed a duty on radiologists with which they had never been formally charged before, namely, to seek confirmation that their report was not only 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 patient 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 both?
Current
Guidelines
1337
FINDINGS
cation 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 radiologic literature. Bird and McLelland [9] in 1 986 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. [1 0] 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. Brenner [1 1 ] in 1 989 admonished that direct communication between the radiologist and the referring physician is “most likely required” whenever there is the finding of a suspicious lesion on a mammogram, and in a later 1 992 article [1 2] 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 limited to mammography, Liston [1 3] recommended that radiologists should telephone the referring physician before sending a formal report, and Schwinger [1 4] 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 1 987 New Jersey appellate decision stated: “Communication of an unusual finding in an X-ray . . . . is as important as the finding itself” [1 5}. 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 [16], 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.
and Standards
Since 1985, both the ACR and authors in professional journals have had much to say about how and when radiologists should communicate mammographic findings. The ACR Standards for the Performance of Screening Mammography [7], published in 1 990, state: “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.” In its 1991 ACR Standard for Communication: Diagnostic Radiology publication [8], the College 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 communi-
Negligence: A Deviation from Guidelines?
from
Standards
or a Deviation
Medical negligence, or malpractice, is legally defined as a breach from standard practice that is the proximate cause of a patient’s injury [1 7]. While we have thus far been discussing 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” [1 8]; “The law requires a surgeon to possess the skill and learning which is possessed by the average member of the medical profession” [1 9]; “If a physi-
1338
BERLIN
cian 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” [20]; and “Elements of proof of negligence in a medical malpractice case include . . . a deviation or departure from acceptable practice” [21]. What permeates these and other court decisions is the concept that in order for physicians to be found negligent, they must have been shown to have deviated from the usual or ordinary practices, or the standard practices, of the membars 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 theoretical “standard” by an expert familiar with the profession in question. The expert explains to the judge and/or jury what the average or ordinary physician would have done under a comparable circumstance, and then offers an opinion as to whether the physician defendant acted within or below that standard [22]. Real standards of practice do not derive from any external authority 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 [23]. It is a valid question, then, to ask ourselves whether a guideline, standard, or parameter published by a professional society or the American Medical Association, or an opinion stated by an authority in a journal, which 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 the College’s mission, namely, to “improve radiologic service to the patient” [24]. But whether the College’s standards set new standards, or simply reflect existing ones, is certainly not very 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.” While 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. While 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 dictated 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
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.
.
.
.
.
AJR:159,
December
1992
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 ofthe 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 say he should have telephoned the doctor, and possibly the preponderance of opinion in today’s climate in the radiologic 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 1 988 under similar circumstances, and, more fundamentally, whether by not telephoning the doctor, the radiologist was truly guilty of malpractice. Although there is no formal judicial finding in this case, it is reasonable to conclude that the defense attorney was quite 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 probably no lawsuit, would have occurred in the first place. Under our legal system, radiologists are guilty of malpractice if it is proved that they have conducted themselves below the standard of their profession. The standard is what our professional organizations, which are 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 geometric 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? REFERENCES 1 . Berlin L. The 1977:128:702
radiologist:
doctor’s
doctor
or
patient’s
doctor?
AJR
2. Robertson CL, Kopans DB. Communications problems after mammographic screening. Radiology 1989; 1 72 :443-444 3. Berlin L. Malpractice and radiologists. AJR 1980; 1 35 : 587-591
AJR:159,
December
NOTIFICATION
1992
4. Berlin L. Malpractice
and radiologists.
update
OF
MAMMOGRAPHIC
1 986: an 1 1 .5 year perspec-
Downloaded from www.ajronline.org by 69.3.140.154 on 11/13/15 from IP address 69.3.140.154. Copyright ARRS. For personal use only; all rights reserved
tive. AJR 1986:147:1291-1298 5. Berlin L. A doctor’s doctor practices good medicine or good law. ACR Bull July 1990:32. 34 6. Policy statement: breast cancer screening centers. Reston, VA: American College of Radiology. 1985 7. ACR standards for the performance of screening mammography. Reston,
VA: American College of Radiology,
1990
8. ACR standard for communication: diagnostic radiology. Reston, VA: American College of Radiology. 1991 9. Bird RE, McLelland R. How to initiate and operate a low-cost screening mammography center. Radiology 1986:161:43-47 1 0. Potchen EJ, Bisesi MA, Sierra AE, Potchen JE. Mammography and malpractice. AJR 1991:156:475-480 1 1 . Brenner RJ. Medicolegal aspects of screening mammography. AJR 1989:153:3-56 1 2. Brenner RJ. Medicolegal aspects of breast imaging. Radio! C/in North Am
1992;30:277-286
1339
FINDINGS
13. Liston SE. A new type of cancer lawsuit
is emerging.
ACR
Bull
April
1990:14
14. Schwinger HN. Liability problems in radiology communications 15. 16. 17.
exist. ACR Bull July 1990:33 Jenoff v. Gleason, 521 A2d 1323 (NJ 1987) Conditions for coverage of screening mammography. Federal Register December 31 , 1990:55:53523 Berlin L. Does the missed’ radiographic diagnosis constitute malpractice? Radiology 1977:123:523-527 Ritchey v. West, 23 IL 385-387 (IL 1860) MacKenzie v. Carman, 92 NY Supp 1063-1067 (NY 1905) Spike v. Sellett, 430 NE2d 597 (IL 1981) Ams!er V. O’Hara, 1 19 App Div 2d 786 (NY 1986)
18. 19. 20. 21 . 22. Hirshfeld EB. Practice parameters cians. JAMA 1990:263:1556-1562 23.
and the malpractice
liability of physi-
Eurrow BR, Johnson SH, Jost TS, Schwartz RL. Health law: cases. materials and problems. 2nd ed. St. Paul: West Publishing. 1991:36 24. ACR bylaws, article II. Reston, VA: American College of Radiology. 1989
1335
Perspective
To Telephone Standard? Leonard
or Not to Telephone:
How High Is the
Berlin1
How
deep
How
high
How
much
I’ll tell you -Irving
is the
graphic examination, filling out the appropriate form and mdicating as recipient-to-be 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 previously 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. There was no contact, either by telephone or in person, between the nurse and her family doctor or his office personnel until 14 months later, when, in March 1 989, the nurse visited the physician in his office because she felt a lump in her right breast. During the doctor’s examination of the nurse, in which he confirmed the presence of a mass in the breast that required biopsy, he noticed that the January 1 988 mammographic report was in the patient’s chart, but told the nurse that he had never noticed it before, since he had had no occasion to look at the chart before the nurse’s visit. Shortly thereafter, the patient underwent biopsy and eventual 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 defend-
ocean
is the sky do I love
you
no lie. Berlin,
‘
How Deep
Is the Ocean”
The Case No one ever questioned the good intent of the Missouri hospital’s management or its radiologists when they decided to undertaken a breast cancer screening program for the hospital’s female employees in January 1 988, but, as we shall see, a malpractice lawsuit filed as a result of the program led to a costly indictment of the manner in which they implemented it. 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 breast radiographs to the hospital’s radiologists for interpretation. As part of its registration and record-keeping procedures, the mobile company provided a form on which the patients would be asked to fill in certain demographic and historical data, along with the name of a physician to whom the mammographic report should be sent. On January 6, 1988, a 40-year-old female nurse employed by the hospital registered for the mammoReceived May 2, 1 992; accepted after revision June 4, 1992. ‘ Department of Radiology. Rush North Shore Medical Center. requests to L. Berlin. AJR 159:1335-1339,
December
1992 0361-803X/92/1596-1335
9600
Gross
© American
Point
Rd. . Skokie,
Roentgen
IL 60076,
Ray Society
and Rush
Medical
College.
Chicago.
IL. Address
reprint
Downloaded from www.ajronline.org by 69.3.140.154 on 11/13/15 from IP address 69.3.140.154. Copyright ARRS. For personal use only; all rights reserved
1336
BERLIN
ants 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 1 988 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 had no reason to look at the chart prior to the nurse’s visit to him 14 months later because he had never actually ordered the mammogram in the first place, and therefore was not expecting to receive one. The nurse herself stated in her deposition that she never bothered to call the physician about her 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 being 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 con-
tacted
another
radiologist,
however,
who in his deposition
stated that the defendant radiologist had acted in accordance with the overwhelming majority of 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 adjudicating the case 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
afterward,
the radiologist’s
attor-
ney 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’s 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
AJR:159,
telephone
the family
doctor
with the abnormal
December
1992
mammographic
results. Although
this settlement
sets
theless does have far-reaching
no legal
precedent,
it never-
impact on the manner in which
radiologists deal with mammography, of the standards of practice against
and on the very nature which radiologists are
measured. The Aftermath:
The Role of the Radiologist
This case brings into play in medical practice duties are, and to whom
sharp focus what role radiologists today, what their moral and legal they owe them. Traditionally, radi-
ologists 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, physician.
invariably
by first-class
mail,
to the
ordering
Historically it has been believed by the medical community that the radiologist’s duty to communicate results stopped with the sending of the radiologic 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 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 were received, that the referring physician would not bother to act on it [2]. The same could be said of any nonradiologic consultant: there has never been an established duty for surgeons, internists, and other medical specialists to telephone or otherwise communicate the results of their consultations to referring physicians beyond sending out written reports. This seems to be borne out in a study reviewing all of the nearly 1 400 malpractice lawsuits filed involving radiologists in the Chicago area during an 1 1 .5-year period [3, 4]. This study revealed that less than 1% of the lawsuits were related to
communications
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. Indeed, I stated in 1 990 [5] that I had never seen a case in which a radiologist was held liable for failure of a referring physician to receive a radiologic 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 being asked to perform mammography on patients
who were sent by their doctors and
in some
cases,
simply for screening
on patients
who
came
purposes,
on their
own,
Downloaded from www.ajronline.org by 69.3.140.154 on 11/13/15 from IP address 69.3.140.154. Copyright ARRS. For personal use only; all rights reserved
AJR:159,
December
NOTIFICATION
1992
OF
MAMMOGRAPHIC
without even being referred by a specific physician. The difference was clear: In the “traditional” referral, the #{231}ioctor suspected an abnormality, earmarked a specific radiol#{243}gic 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 file on a patient 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 radiologic report indicating an abnormality would be most unlikely, and therefore 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, probably everything was alright. Perhaps it was because of these perceptions that in 1985 the ACR published and distributed to its members a then little-noticed two-page document, Policy Statement: Breast Cancer Screening Centers [6]. 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.” The College’s policy covered radiologic facilities that performed mammography on patients who were self-referred or physician referred. It decisively placed a duty on radiologists with which they had never been formally charged before, namely, to seek confirmation that their report was not only 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 patient 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 both?
Current
Guidelines
1337
FINDINGS
cation 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 radiologic literature. Bird and McLelland [9] in 1 986 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. [1 0] 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. Brenner [1 1 ] in 1 989 admonished that direct communication between the radiologist and the referring physician is “most likely required” whenever there is the finding of a suspicious lesion on a mammogram, and in a later 1 992 article [1 2] 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 limited to mammography, Liston [1 3] recommended that radiologists should telephone the referring physician before sending a formal report, and Schwinger [1 4] 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 1 987 New Jersey appellate decision stated: “Communication of an unusual finding in an X-ray . . . . is as important as the finding itself” [1 5}. 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 [16], 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.
and Standards
Since 1985, both the ACR and authors in professional journals have had much to say about how and when radiologists should communicate mammographic findings. The ACR Standards for the Performance of Screening Mammography [7], published in 1 990, state: “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.” In its 1991 ACR Standard for Communication: Diagnostic Radiology publication [8], the College 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 communi-
Negligence: A Deviation from Guidelines?
from
Standards
or a Deviation
Medical negligence, or malpractice, is legally defined as a breach from standard practice that is the proximate cause of a patient’s injury [1 7]. While we have thus far been discussing 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” [1 8]; “The law requires a surgeon to possess the skill and learning which is possessed by the average member of the medical profession” [1 9]; “If a physi-
1338
BERLIN
cian 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” [20]; and “Elements of proof of negligence in a medical malpractice case include . . . a deviation or departure from acceptable practice” [21]. What permeates these and other court decisions is the concept that in order for physicians to be found negligent, they must have been shown to have deviated from the usual or ordinary practices, or the standard practices, of the membars 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 theoretical “standard” by an expert familiar with the profession in question. The expert explains to the judge and/or jury what the average or ordinary physician would have done under a comparable circumstance, and then offers an opinion as to whether the physician defendant acted within or below that standard [22]. Real standards of practice do not derive from any external authority 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 [23]. It is a valid question, then, to ask ourselves whether a guideline, standard, or parameter published by a professional society or the American Medical Association, or an opinion stated by an authority in a journal, which 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 the College’s mission, namely, to “improve radiologic service to the patient” [24]. But whether the College’s standards set new standards, or simply reflect existing ones, is certainly not very 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.” While 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. While 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 dictated 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
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.
.
.
.
.
AJR:159,
December
1992
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 ofthe 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 say he should have telephoned the doctor, and possibly the preponderance of opinion in today’s climate in the radiologic 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 1 988 under similar circumstances, and, more fundamentally, whether by not telephoning the doctor, the radiologist was truly guilty of malpractice. Although there is no formal judicial finding in this case, it is reasonable to conclude that the defense attorney was quite 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 probably no lawsuit, would have occurred in the first place. Under our legal system, radiologists are guilty of malpractice if it is proved that they have conducted themselves below the standard of their profession. The standard is what our professional organizations, which are 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 geometric 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? REFERENCES 1 . Berlin L. The 1977:128:702
radiologist:
doctor’s
doctor
or
patient’s
doctor?
AJR
2. Robertson CL, Kopans DB. Communications problems after mammographic screening. Radiology 1989; 1 72 :443-444 3. Berlin L. Malpractice and radiologists. AJR 1980; 1 35 : 587-591
AJR:159,
December
NOTIFICATION
1992
4. Berlin L. Malpractice
and radiologists.
update
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1 986: an 1 1 .5 year perspec-
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tive. AJR 1986:147:1291-1298 5. Berlin L. A doctor’s doctor practices good medicine or good law. ACR Bull July 1990:32. 34 6. Policy statement: breast cancer screening centers. Reston, VA: American College of Radiology. 1985 7. ACR standards for the performance of screening mammography. Reston,
VA: American College of Radiology,
1990
8. ACR standard for communication: diagnostic radiology. Reston, VA: American College of Radiology. 1991 9. Bird RE, McLelland R. How to initiate and operate a low-cost screening mammography center. Radiology 1986:161:43-47 1 0. Potchen EJ, Bisesi MA, Sierra AE, Potchen JE. Mammography and malpractice. AJR 1991:156:475-480 1 1 . Brenner RJ. Medicolegal aspects of screening mammography. AJR 1989:153:3-56 1 2. Brenner RJ. Medicolegal aspects of breast imaging. Radio! C/in North Am
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13. Liston SE. A new type of cancer lawsuit
is emerging.
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1990:14
14. Schwinger HN. Liability problems in radiology communications 15. 16. 17.
exist. ACR Bull July 1990:33 Jenoff v. Gleason, 521 A2d 1323 (NJ 1987) Conditions for coverage of screening mammography. Federal Register December 31 , 1990:55:53523 Berlin L. Does the missed’ radiographic diagnosis constitute malpractice? Radiology 1977:123:523-527 Ritchey v. West, 23 IL 385-387 (IL 1860) MacKenzie v. Carman, 92 NY Supp 1063-1067 (NY 1905) Spike v. Sellett, 430 NE2d 597 (IL 1981) Ams!er V. O’Hara, 1 19 App Div 2d 786 (NY 1986)
18. 19. 20. 21 . 22. Hirshfeld EB. Practice parameters cians. JAMA 1990:263:1556-1562 23.
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Eurrow BR, Johnson SH, Jost TS, Schwartz RL. Health law: cases. materials and problems. 2nd ed. St. Paul: West Publishing. 1991:36 24. ACR bylaws, article II. Reston, VA: American College of Radiology. 1989
