Context.—Recognizing the difficulty in applying the concept of critical values to anatomic pathology diagnoses, the College of American Pathologists and the Association of Directors of Anatomic and Surgical Pathology have chosen to reevaluate the concept of critical diagnoses.
Objective.—To promote effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology.
Design.—A comprehensive literature search was conducted and reviewed by an expert panel.
Results.—A policy of effective communication of important results in surgical pathology and cytology is desirable to enhance patient safety and to address multiple regulatory requirements.
Conclusions.—Each institution should create its own policy regarding urgent diagnoses and significant, unexpected diagnoses in anatomic pathology. This policy should be separate from critical results or panic-value policies in clinical pathology, with the expectation of a different time frame for communication. Urgent diagnosis is defined as a medical condition that, in most cases, should be addressed as soon as possible. Significant, unexpected diagnosis is defined as a medical condition that is clinically unusual or unforeseen and should be addressed at some point in the patient's course. Further details of this statement are provided.
To comply with regulatory and accreditation requirements, most institutions have adopted policies for communicating critical test results from clinical pathology laboratories, radiology departments, and other testing areas, such as the departments of cardiology and respiratory therapy ( Appendix).1–3 The importance of effectively communicating pathology results is further highlighted by inclusion in the 2011 National Quality Forum's list of Serious Reportable Events of the following item “Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.”4(p2)
In 2006, the Association of Directors of Anatomic and Surgical Pathology (ADASP) published recommendations for critical diagnoses in anatomic pathology.5 These recommendations included many sound elements, but the term critical signifies a need for communication within a short time frame (usually less than an hour).5 The original Lundberg6 definition of critical in clinical pathology implies an imminently life-threatening condition that requires immediate notification of the result. Surgical pathology and cytopathology testing by their nature take at least several hours to a day to complete before materials are ready for examination (aside from frozen sections).7 Although many surgical pathology and cytology diagnoses are actionable and in need of effective communication, few need to be communicated urgently, and they could be termed actionable, noncritical results.8 Furthermore, surveys among clinicians and pathologists also find poor agreement as to what constitutes a critical diagnosis in anatomic pathology.9–14
Recognizing the difficulty in applying the concept of critical values to anatomic pathology diagnoses, the College of American Pathologists (CAP) and ADASP have chosen to reevaluate the concept of critical diagnoses in an effort to promote effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology.
THE CAP PATHOLOGY AND LABORATORY QUALITY CENTER
The CAP developed the Pathology and Laboratory Quality Center (the CAP Center) as a forum to write and maintain evidence-based guidelines and consensus statements. Focused on optimizing patient safety and outcomes, most CAP Center topics originate with practicing pathologists who describe variance in approaches to care, test selection, and diagnosis. The CAP Center aims to develop guidelines that reduce risks for patients, while facilitating the efficient use of resources for timely and accurate diagnosis.
PRACTICE GUIDELINES AND CONSENSUS STATEMENTS
Practice guidelines and consensus statements reflect the best available evidence and majority expert agreement supported in practice. They are intended to assist physicians and patients in clinical decision making and to identify questions and settings for further research. With the rapid flow of scientific information throughout medicine and especially in pathology and laboratory medicine, new evidence may emerge between the time an updated guideline was submitted for publication and when it is read or appears in print or online. These documents are reviewed periodically as well as after the publication of substantive and high-quality medical evidence that could potentially alter the original guideline recommendations. This manuscript and its recommendations are meant only to address the topics within the scope of the guideline or consensus statement. They are not applicable to interventions, diseases, or stages of diseases not specifically identified.
Furthermore, guidelines and consensus statements cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any guideline or consensus statement is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances and preferences. The CAP/ADASP guidelines and consensus statements describe the use of communications of findings, procedures, and therapies in clinical practice and cannot be assumed to apply to the use of interventions in the context of other settings. The CAP and ADASP assume no responsibility for any injury or damage to persons or property arising out of or related to any use of the CAP/ADASP guidelines or consensus statements or for any errors or omissions.
MATERIALS AND METHODS
Panel Composition and Process
The CAP Center and ADASP convened a work group (WG) of experts in anatomic pathology to address what constitutes a critical value in anatomic pathology and how best to ensure proper and timely communication of those results. Both organizations used their respective organization's approval processes in formal review and appointment of the project, chair, and WG members.
All members of the WG complied with the CAP conflicts of interest policy dated April 2010, which requires disclosure of financial or other interests that may have an actual, potential, or apparent conflict. All WG members were required to disclose any new conflicts continuously, and no conflicts were disclosed throughout the project.
The WG met in September 2010; additional work on the project was completed through teleconference Webinars, collaboration site access (Oracle WebCenter Spaces v126.96.36.199.0, Oracle Corporation, Redwood Shores, California), and electronic mail by all members of the WG. The method used to create the recommendations was expert consensus. Resolution of discordant ideas was obtained by majority consensus of the WG members. Feedback of the draft recommendations was solicited from ADASP members, CAP scientific resource committees, CAP members, other pathology societies, and external reviewers via public comment hosted on the CAP Web site (http://www.cap.org/center) from March 11, 2011, through April 10, 2011 (last accessed April 10, 2011). The CAP Center Subcommittee and the ADASP Council provided final review and approval.
We conducted a computerized search during May 2010 to February 2011 of the following electronic databases: Ovid MEDLINE (Ovid, New York, New York), CSA Illumina Conference Papers Index (ProQuest, Ann Arbor, Michigan), and Google Scholar (Google, Mountain View, California), for English language only articles from 1990 through February 2011. All study designs and publication types were included. In addition, the WG requested the George D. Lundberg 1972 article “When to Panic Over Abnormal Values.”6 The search used the following terms:
(Anatomic pathology OR surgical pathology OR cytopathology OR radiology OR cardiology) AND
((Critical OR significant OR unexpected) AND (values OR diagnosis OR results))
Reference lists from identified articles were scrutinized for articles not identified in the above search. A search of the LexisNexis database (Reed Elsevier Inc, New York, New York) was also conducted to evaluate and understand claims, judgments, and settlements against pathologists in which communication failure was the primary reason.
Studies were selected for full-text review based on the following criteria: (1) the abstract referred to pathology (except autopsy or forensic), cardiology, or radiology; (2) the abstract included or implied one or more of the terms critical, panic values, urgent, significant, or unexpected; and (3) the abstract addressed communication or reporting. The 128 studies that met the search term requirements underwent an inclusion-exclusion, dual independent review conducted by the chair and a member, with a third member referee for nonconsensus abstracts. Sixty-four articles (50%) made it through full review, and 19 articles (15%) were determined to have the most relevance. Table 1 includes the criteria for evaluation.
The 19 articles determined to have most relevance were analyzed to determine the strength of evidence for the recommendations. Of the 19, 10 (53%) were eliminated: 8 for study design not of interest and 2 for duplicate data. Of the remaining 9 studies, 6 (67%) represented surveys, 2 (22%) were time series, and 1 (11%) was a randomized, controlled study. These 9 studies underwent data extraction to capture evidence in support of the recommendations. Each study was assessed for strength of evidence, which consists of level of evidence, quantity, size of the effect, statistical precision, and quality assessment (risk of bias), of included studies. Also taken into account were the study components of consistency, clinical impact, generalizability, and applicability to anatomic pathology when determining the strength of evidence score for individual studies. The studies' individual component scores derived from predetermined criteria, generated the overall grade for the strength of evidence. The scientific quality of the randomized, controlled trial was assessed using the SIGN 50 instrument (Scottish Intercollegiate Guidelines Network, Edinburgh, Scotland), and its quality was poor.15 The scientific quality of the time series was determined using the Ramsay et al16 instrument, and the quality of both studies was good. However, both studies lacked comparative control groups.
Draft recommendations were subjected to a public comment period (March 11, 2011, to April 10, 2011). Comments were used to further refine the recommendations.
Most of the literature concerning anatomic pathology “critical diagnoses” was composed of editorials and case reports (n = 20) with calls for effective communication of significant diagnoses. Several recent reports9–14 documented what pathologists and clinicians consider as critical diagnoses in anatomic pathology. There were 9 reports of various types of surveys of practice in clinical pathology.17–25 Five articles described attempts to improve communication of critical values in the clinical laboratory.26–30 There were 3 reports of general recommendations regarding implementation of a critical value policy.21,28,31 The remaining relevant publications consisted of abstracts, presentations, letters to the editor, and trade journal discussions. There were no reports of systematic documentation of failed communications in anatomic pathology with evaluation of the consequences of those failures. Based on the data extraction of 9 studies (Table 2) and relevance to the recommendations, the overall strength of evidence was poor. For a detailed analysis on the evaluation of the strength of evidence, please refer to the “Supplemental Material” file at www.archivesofpathology.org in the February 2012 table of contents.
During the public comment period on the draft recommendations, there were 599 visits to the Web site, with 441 comments (74% left comments). These comments were used to modify the draft recommendations. <~?show=[to]?>Table 3 lists the WG definitions and final consensus statements for effective communication in surgical pathology and cytology.
Critical result policies are mandated to enhance communication among caregivers and to decrease the chance of patient harm ( Appendix). Most institutions have established critical result policies that impose a specific time frame (eg, 30 minutes, 60 minutes) for communication of the result to the responsible caregiver.17,18,20,22,23 Most clinical laboratories comply with those mandates and communicate a high proportion of their designated critical results within 30 minutes.17,18,20–25
Surgical pathology and cytology stand apart for several reasons. First and foremost, routine specimen processing (including adequate fixation) requires up to 24 hours, rendering meaningless a 30 or 60 minute window to report the results. Second, the term critical implies an imminently life-threatening condition. Most diagnoses recommended as critical for surgical pathology and cytology are serious conditions that require attention but are not imminently life threatening. Third, surveys have shown little agreement on what constitutes a critical diagnosis. Fourth, wide use of the term critical has diluted its effectiveness for surgical pathology and cytology. Fifth, most reported cases where patient harm is reported have occurred because of lack of communication or missed communication, rather than from a brief delay in reporting the diagnosis. Sixth and finally, communication in surgical pathology and cytology is usually done to ensure that the written report is not overlooked. Given these considerations, it may be better for policies in anatomic pathology departments to emphasize that effective and timely communication occurs, instead of insisting that communication occurs within 30 minutes or 1 hour. Intraoperative consultation was excluded from this matter because it has well-established expectations for communication and turnaround.
Although we recognize that there are conditions in anatomic pathology that demand immediate communication as soon as the diagnosis is known, we propose using the term urgent diagnosis instead of critical diagnosis because the tissue may have been obtained hours or even days before the diagnosis is rendered. We also believe that pathologists should distinguish urgent diagnoses from significant, unexpected diagnoses that need not be communicated with the same level of urgency. As such, we propose that both the terms urgent diagnosis and significant, unexpected diagnosis be used in surgical pathology and cytopathology. We advocate that each department develop policies and procedures for effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytology that are separate from institutional policies and procedures for critical results.
Given the variability in local practices and expectations and the lack of consensus among pathologists and clinicians on which diagnosis must be included in this policy, each institution should determine its own list of urgent diagnoses. However, pathologists also must use their medical judgment in urgently communicating individual diagnoses any time that safe patient care may be at risk, even if it is a situation not listed in the policy.
Significant, unexpected diagnoses by their nature may not be entirely anticipated, so departments may list examples of significant, unexpected diagnoses to demonstrate such cases. Pathologists should communicate significant, unexpected diagnoses as soon as is practical but may use their judgment to determine the appropriate timing for that communication.
On the other hand, institutions may also choose to have a communication policy regarding specimens or diagnoses other than urgent and significant, unexpected diagnoses on the basis of clinician considerations and preferences. Pathologists and their clinical counterparts may work together to find the most suitable means of ensuring proper communication of such diagnoses. Although this represents good patient care, these types of cases may be designated using other terms (eg, call list) but should NOT be designated as urgent diagnoses or significant, unexpected diagnoses.
In addition, each institution or health care system should develop policies regarding the most appropriate recipient of the information and a process for escalating the results to others should the designated recipient be unavailable or fail to respond.21,28,32 These policies affect providers well beyond the purview of individual pathology departments and must reside with the institutional body charged with quality and safe patient care. In many practice environments, inpatient and outpatient results will require distinct policies and procedures. Policies for effectively relaying urgent diagnoses and significant, unexpected diagnoses should also account for off-hours, including weekends.
Critical clinical laboratory results are typically called to the physician or nurse by a laboratory technician. In surgical pathology and cytology, physicians ordinarily make the call because the diagnoses tend to be interpretive and consultative. Most feel that there is inherent value in direct physician-to-physician communication of urgent diagnoses or significant, unexpected diagnoses. Indeed, there is evidence that direct verbal communication is likely to be more effective than other forms of communication.33 There have been experiences with automated methods of communication for critical values in the clinical laboratory using automated paging systems. These methods appear to be effective in reducing the time it takes to relay critical value to the physician and the time for therapy to be started.21,27,29 However, these methods are untested in anatomic pathology and are based on discrete laboratory values for specific tests, a circumstance that is usually not applicable to anatomic pathology. Nevertheless, communication methods other than direct physician-to-physician dialogue may develop. Any alternative to direct physician-to-physician communication should be validated and audited to ensure ongoing effectiveness.
Written documentation of verbal or other communication is recommended because it provides evidence that direct communication occurred. If the treating clinician cannot be reached in a timely manner, documentation of the communication may be done as an addendum or in a separate (electronic or paper) log. This form of documentation can be the basis of any audit of effective communication practices.
Audits or quality-assurance monitoring of this practice are currently difficult to conduct. The difficulty lies in determining the group of cases to be audited. It is easy to retrieve and demonstrate cases that were documented as urgent diagnoses or significant, unexpected diagnoses. It is much more difficult to audit cases that may have been missed. One approach could be that selected diagnoses listed as urgent diagnoses be retrieved and evaluated for documentation of communication. For example, in a transplant center, severe rejection may be listed as an urgent diagnosis. Retrieving all cases of severe rejection and checking to see whether they were urgently communicated would be an appropriate audit. It is a much more difficult task to survey for significant, unexpected diagnoses because they do not represent a list of specific diagnoses. Different approaches in conducting the audit are in the literature. Huang et al13 retrospectively reviewed all reports for two 6-month periods in 2006 and 2007; more than 3% of cases in those years met the criteria as per their policy, and communication was documented for most cases. Lusky34 describes an ongoing process of case review used by Myers and Visscher at the University of Michigan Hospitals (Ann Arbor) that helps ensure that cases are not missed. Their process involves daily review of cases, examining diagnoses that possibly meet the criteria for inclusion as an urgent diagnosis or a significant, unexpected diagnosis and checking whether communication occurred in those instances.
In our review of cases, we found that there are situations that may be problematic but are not easily addressed by policy; among them, are the following:
A physician performs a biopsy or other procedure but does not participate in the patient's care beyond that point. Sending the surgical pathology report only to the person performing the procedure may result in a delay in follow-up. The laboratory should try to address these situations by having an understanding that all of the patient's relevant providers are included in the requisition, so that reports are sent accordingly. Direct patient access to pathology results may ultimately prove the most effective method for closing the loop on urgent diagnoses and significant, unexpected diagnoses in this sort of scenario.
Changed frozen section or cytology preliminary diagnoses are likely covered by this policy, but pathologists should be particularly alert to situations in which a subsequent procedure may have been tentatively scheduled based on the preliminary result. Communicating an unanticipated change in diagnosis as soon as it is known is essential.
A patient has a procedure and subsequently moves to a different location and is lost to follow-up.
An urgent diagnosis or a significant, unexpected diagnosis is communicated to a member of the health care team who fails to broadcast the message to other providers who may be directly responsible for diagnostic or therapeutic decision making. This occurs, for example, if an unexpected result for a transplant biopsy is communicated to a member of the health care team who rotates off service shortly after receiving the message and fails to document or hand off the message.
A diagnosis is made in the evening or on the weekend and is deemed urgent by the pathologist; he or she calls the hospital operator to page the on-call physician for that service and is informed that there is no on-call person for that service. This emphasizes the need to have alternative methods of communication, as well as a primary treating clinician contact for all direct time-sensitive communications.
From the Department of Pathology, Mayo Clinic Florida, Jacksonville (Dr Nakhleh); Department of Pathology, University of Michigan Medical Center, Ann Arbor (Dr Myers); Department of Pathology, University of Texas Health Science Center, Tyler (Dr Allen); Department of Pathology, University of Iowa, Iowa City (Dr DeYoung); Department of Pathology, St. Jude Medical Center, Fullerton, California (Dr Fitzgibbons); Department of Pathology, University of North Carolina, Chapel Hill (Dr Funkhouser); Department of Pathology, The Methodist Hospital, Houston, Texas (Dr Mody); Department of Pathology, Consultants in Pathology, Toledo, Ohio (Dr Lynn); CAP Pathology and Laboratory Quality Center, College of American Pathologists, Northfield, Illinois (Ms Fatheree and Mr Smith); Contacted methodologist for the College of American Pathologists, London, Ontario, Canada (Dr Lal); and Department of Pathology, Alleghany Medical Hospital, Pittsburgh, Pennsylvania (Dr Silverman).
The authors have no relevant financial interest in the products or companies described in this article.