General

Guideline Title

Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology.

Bibliographic Source(s)

Nakhleh RE, Myers JL, Allen TC, DeYoung BR, Fitzgibbons PL, Funkhouser WK, Mody DR, Lynn A, Fatheree LA, Smith AT, Lal A, Silverman JF. Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology. Arch Pathol Lab Med. 2012 Feb;136(2):148-54. [34 references] PubMed

Guideline Status

This is the current release of the guideline.

The College of American Pathologists reaffirmed the currency of the guideline in June 2017.

This guideline meets NGC’s 2013 (revised) inclusion criteria.

Recommendations

Major Recommendations

Note : Please refer to Table 6 in the “Supplemental Material”” document (see the “Availability of Companion Documents” field) for an explicit linkage between the guideline recommendations and the supporting evidence.

Definitions

Urgent Diagnosis : A medical condition that, in most cases, should be addressed as soon as possible. Significant, Unexpected Diagnosis : A medical condition that is clinically unusual or unforeseen and should be addressed at some point in the patient’s course.

Consensus Statements

Each institution should create its own policy regarding Urgent Diagnoses and Significant, Unexpected Diagnoses in Anatomic Pathology. This policy should be separate from critical result or panic value policies in clinical pathology with the expectation of a different time frame for communication.
Pathology departments should determine specific urgent diagnoses in collaboration with the clinical staff. These diagnoses should include situations in which urgently conveying the information may directly affect patient care. An example of an urgent diagnosis is an unknown life-threatening infection in an immune-compromised patient. Pathologists, however, should use their experience and judgment to communicate any diagnoses, even if not included in the policy. In hospital practice, approval by the appropriate institutional governing body is recommended.
Determination of a significant, unexpected diagnosis is heavily dependent on the pathologist’s judgment as a physician. By their nature, significant, unexpected diagnoses cannot always be anticipated. Examples such as a frozen section–permanent section discordance that affects patient care or a clinically unsuspected malignancy may be listed in the policy.
Pathologists should communicate urgent diagnoses as soon as possible because it may directly affect patient care, but each institution should establish a reasonable time frame. The consensus statement authors recommend no longer than the same day on which the diagnosis is made. Communication of significant, unexpected diagnoses should occur as soon as practical; pathologists may exercise their judgment as to the appropriate timing of communication.
Pathologists should communicate verbally and directly with physicians, but other satisfactory methods of communication may be established and validated by each institution. Backup communication plans should be developed for those circumstances in which a physician is not available.
Pathologists should document the communication. This can be done in the original pathology report, as an addendum, in the electronic medical record, or by another mechanism. Documentation should include the person with whom the case was discussed, the time and date, and when appropriate, the means of communication.

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

Patients with urgent diagnoses and significant, unexpected diagnoses

Note : 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.

Guideline Category

Diagnosis

Clinical Specialty

Pathology

Intended Users

Health Care Providers
Hospitals
Physicians

Guideline Objective(s)

To promote effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology

Target Population

Patients with urgent diagnoses and significant, unexpected diagnoses

Interventions and Practices Considered

Creating of institution-specific policy
Determination of specific urgent diagnoses by pathology department and clinical staff
Communication of urgent diagnoses as soon as possible
Verbal and direct communication with physicians with backup plan in place
Documentation of communication

Major Outcomes Considered

Effectiveness of communication of diagnosis
Timeliness of communication of diagnosis

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

2012 Guideline

Literature Search

The Work Group 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 Work Group requested the George D. Lundberg 1972 article “When to Panic Over Abnormal Values.” 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.

2017 Reaffirmation

For the assessment and reaffirmation process, the original search strategy was rerun in Ovid MEDLINE on 11/1/2016 with the date parameters set to capture articles published from 2/1/2011 through 11/1/2016. In addition, a citation search was run in Scopus on 11/1/2016, and guideline repository and systematic reviews Web sites (i.e., National Guideline Clearinghouse, Guideline International Network, Cochrane Library, Prospero) and relevant organizations’ Web sites (i.e., Clinical Laboratory Standards Institute, Royal College of Pathologists) were hand searched. Supplemental searches were completed in PubMed and Scopus, with a title screen completed for relevant articles.

Number of Source Documents

2012 Guideline

Nine studies underwent data extraction to capture evidence in support of the recommendations.

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Not Given)

Rating Scheme for the Strength of the Evidence

Not stated

Methods Used to Analyze the Evidence

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

2012 Guideline

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 (in the original guideline document) 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 Scottish Intercollegiate Guideline Network (SIGN) 50 instrument (SIGN, Edinburgh, Scotland), and its quality was poor. The scientific quality of the time series was determined using the Ramsay et al instrument, and the quality of both studies was good. However, both studies lacked comparative control groups.

Based on the data extraction of nine studies and relevance to the recommendations, the overall strength of evidence was poor. For a detailed analysis of the evaluation of the strength of evidence, please refer to the “Supplemental Material” document (see the “Availability of Companion Documents” field).

2017 Reaffirmation

A total of forty articles were loaded into DistillerSR (Evidence Partners, Ottawa, Canada) and a dual review of titles and abstracts was completed using a signals approach, with only those with the potential of providing data that could strengthen, contradict, or diminish the original statements included for further review. Fifteen articles were selected to undergo a full text review.

Upon review, none of the reviewed articles were felt to contradict or diminish the original recommendations, nor did they provide objective data that would change the original statements in any way. All of the original consensus statements were reaffirmed by both reviewers.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

2012 Guideline

Panel Composition and Process

The College of American Pathologists (CAP) Center and Association of Directors of Anatomic and Surgical Pathology (ADASP) convened a work group 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 work group (WG) members.

The WG met in September 2010; additional work on the project was completed through teleconference Webinars, collaboration site access (Oracle WebCenter Spaces v11.1.1.2.0, 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 member.

2017 Reaffirmation

A summary document was created outlining the updated literature search and the citation list of all full text articles reviewed, and distributed to all members of the original expert panel and guideline authors. After review, all nine expert panel members formally approved and reaffirmed the consensus statement.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

External Peer Review
Internal Peer Review

Description of Method of Guideline Validation

2012 Guideline

Feedback of the draft recommendations was solicited from Association of Directors of Anatomic and Surgical Pathology (ADASP) members, College of American Pathologists (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.

2017 Reaffirmation

The College of American Pathologists’ Center Committee, which provides oversight to all guideline and consensus statement development processes, unanimously approved the consensus statement’s reaffirmation on January 28, 2017. The College of American Pathologists’ Council on Scientific Affairs voted unanimously to bestow final approval of the consensus statement’s reaffirmation on February 18, 2017. The Association of Directors of Anatomic and Surgical Pathology confirmed their approval of the document’s reaffirmation on April 22, 2017.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

Table 2 in the original consensus statement provides a description of the nine studies that underwent data extraction. Table 6 in the “Supplemental Material” document (see the “Availability of Companion Documents” field) provides an explicit linkage between the guideline recommendations and the supporting evidence.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

2012 Guideline

Effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology

2017 Reaffirmation

The potential benefits of this consensus statement include providing clarification of the concept of critical values in relation to anatomic pathology, promoting the effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology, and reducing the risk of patient death or serious harm due to lack of communication of these diagnoses.

Potential Harms

2012 Guideline

See “Cautionary Notes” in the original guideline document for situations that may be problematic and not easily addressed by policy.

2017 Reaffirmation

Potential harms of this consensus statement are difficult to assess but may result during problematic situations that are not easily addressed by policy. A false sense of security may occur when a communication plan is developed but results are communicated to someone who fails to broadcast the message to other providers directly responsible for diagnostic or therapeutic decision making. The consideration of alternative methods of communication and contact with primary treating clinicians for all direct time-sensitive communications is emphasized. Laboratories must be diligent when developing and implementing a communication plan for urgent or significant/unexpected diagnoses. A more detailed discussion of potentially problematic situations can be found under “Cautionary Notes” in the original document.

Qualifying 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.
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 College of American Pathologists (CAP)/Association of Directors of Anatomic and Surgical Pathology (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.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Quick Reference Guides/Physician Guides
Resources

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better
Living with Illness
Staying Healthy

IOM Domain

Effectiveness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)

Nakhleh RE, Myers JL, Allen TC, DeYoung BR, Fitzgibbons PL, Funkhouser WK, Mody DR, Lynn A, Fatheree LA, Smith AT, Lal A, Silverman JF. Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology. Arch Pathol Lab Med. 2012 Feb;136(2):148-54. [34 references] PubMed

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released

2012 Feb (reaffirmed 2017 Jun 26)

Guideline Developer(s)

Association of Directors of Anatomic and Surgical Pathology - Professional Association
College of American Pathologists - Medical Specialty Society

Source(s) of Funding

College of American Pathologists

Association of Directors of Anatomic and Surgical Pathology

Guideline Committee

College of American Pathologists (CAP)/Association of Directors of Anatomic and Surgical Pathology (ADASP) Work Group

Composition of Group That Authored the Guideline

Work Group Members : Raouf E. Nakhleh, MD, Department of Pathology, Mayo Clinic Florida, Jacksonville; Jeffrey L. Myers, MD, Department of Pathology, University of Michigan Medical Center, Ann Arbor; Timothy C. Allen, MD, JD, Department of Pathology, University of Texas Health Science Center, Tyler; Barry R. DeYoung, MD, Department of Pathology, University of Iowa, Iowa City; Patrick L. Fitzgibbons, MD, Department of Pathology, St Jude Medical Center, Fullerton, California; William K. Funkhouser, MD, Department of Pathology, University of North Carolina, Chapel Hill; Dina R. Mody, MD, Department of Pathology, The Methodist Hospital, Houston, Texas; Amy Lynn, MD, Department of Pathology, Consultants in Pathology, Toledo, Ohio; Lisa A. Fatheree, BS, SCT(ASCP), CAP Pathology and Laboratory Quality Center, College of American Pathologists, Northfield, Illinois; Anthony T. Smith, MLS, CAP Pathology and Laboratory Quality Center, College of American Pathologists, Northfield, Illinois; Avtar Lal, MD, PhD, Contracted methodologist for the College of American Pathologists, London, Ontario, Canada; Jan F. Silverman, MD, Department of Pathology, Alleghany Medical Hospital, Pittsburgh, Pennsylvania

Financial Disclosures/Conflicts of Interest

All members of the Work Group (WG) complied with the College of American Pathologists (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 (see Supplemental Material document [see the “Availability of Companion Documents” field] for details). All WG members were required to disclose any new conflicts continuously, and no conflicts were disclosed throughout the project.

Guideline Status

This is the current release of the guideline.

The College of American Pathologists reaffirmed the currency of the guideline in June 2017.

This guideline meets NGC’s 2013 (revised) inclusion criteria.

Guideline Availability

Available from the College of American Pathologists Web site.

Availability of Companion Documents

The following are available:

The College of American Pathologists (CAP) and Association of Directors of Anatomic and Surgical Pathology (ADASP): consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology. Assessment and reaffirmation summary – June 26, 2017. Northfield (IL): College of American Pathologists. Available from the College of American Pathologists (CAP) Web site.
The College of American Pathologists (CAP) and Association of Directors of Anatomic and Surgical Pathology (ADASP): effective communication of urgent and significant unexpected diagnoses in surgical pathology and cytopathology. Supplemental material. Northfield (IL): College of American Pathologists. Available from the CAP Web site.
Summary of consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology. Summary. Northfield (IL): College of American Pathologists; 2012 Feb. 1 p.

The appendix of the original guideline document contains information on the legal and regulatory standards as of July 2011.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on March 6, 2013. The information was verified by the guideline developer on March 15, 2013. The currency of the guideline was reaffirmed by the developer in June 2017 and the summary was updated by ECRI Institute on August 1, 2017.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.

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