A list of urgent diagnoses and significant, unexpected diagnoses is an important aspect of diagnoses reporting policy. However, there is considerable disagreement about which diagnoses should be included in those lists.1 The most relevant guideline, the “Consensus Statement on Effective Communication…” from CAP/ADASP,* does not define either urgent diagnosis or significant, unexpected diagnosis. Instead, it recommends that pathology departments develop their own lists of urgent diagnoses and provide examples of significant, unexpected diagnoses.2
Lists of Urgent Diagnoses and Significant, Unexpected Diagnoses
* CAP/ADASP Statement
For the purposes of this article, the most relevant guideline for Surgical Pathology and Cytopathology is the “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” (CAP/ADASP Statement).
In creating lists of urgent diagnoses and significant, unexpected diagnoses, pathologists and pathology laboratory administrators may find helpful a generic list of urgent diagnoses and significant, unexpected diagnoses that was published in various articles in 2006.3 There has been disagreement over whether some of the diagnoses should have been included in the list.4 Despite the disagreement, the 2006 list is summarized below for illustrative purposes:5,6
Findings with immediate clinical consequences:
- Crescents in over 50% of glomeruli in a kidney biopsy
- Leukocytoclastic vasculitis
- Uterine contents without villi or trophoblast in the setting of suspected pregnancy
- Fat in an endometrial curettage specimen
- Mesothelial cells in a heart biopsy
- Fat in colonic endoscopic polypectomies
- Transplant rejection
- Malignancy in superior vena cava syndrome
- Neoplasms causing paralysis
More Information About Communicating Critical Findings along the Continuum of Care
Part 1: From Radiology to ED
- Closed Claim Case Study: Failure to Communicate Critical Radiology Findings Leads to Loss of Testicle
- Closed Claim Case Study: Failure to Close the Loop on Critical Findings Leads to Negligent Patient Death
- Closed Claim Case Study: Ambiguous Radiology Report Results in Below-the-Waist Paralysis
- Closed Claim Case Study: Failure to Follow Critical Results Reporting Policy Leads to Incorrect Diagnosis and Patient Death
- Best Practices: Develop a Process for Communicating Results Based on Criticality to Improve Clinical Decision-Making
Part 2: From Anatomic Pathologist to Ordering and Primary Care Physician
- Closed Claim Case Study: Prioritizing Urgent Diagnosis List Over Medical Judgment Leads to Patient Death
- Closed Claim Case Study: Failure to Directly Communicate Unexpected Cancer Finding Leads to Delayed Treatment
- Closed Claim Case Study: Failure to Communicate a Significant Diagnosis Change Leads to Worsened Prognosis
- Closed Claim Case Study: Failure to Communicate a Positive Biopsy Leads to Delayed Cancer Diagnosis
- Best Practices: Avoid Ambiguity in Pathology Reports to Improve Communication
Part 3: From Primary Care Physician to Patient
- Closed Claim Case Study: Lack of Redundancy and Coverage Contributes to Patient Death
- Closed Claim Case Study: Inadequate Follow Up on Abnormal Labs Leads to Permanent Injuries
- Closed Claim Case Study: Poor Test Result Communication Process Leads to Patient Injury
- Closed Claim Case Study: Failure to Convince Patient of Urgency of Follow Up Leads to Patient Death
- Closed Claim Case Study: Lack of Follow Up with “No Doc” ED Patient Leads to Patient Injury
- Closed Claim Case Study: Pre-Surgery Delay in Processing Abnormal Results Leads to Patient Death
- Bacteria or fungi in cerebrospinal fluid cytology
- Pneumocystis, fungi, or viral cytopathic changes in bronchoalveolar lavage, bronchial washings, or brushing cytology specimens
- Acid-fast bacilli
- Bacteria in a heart valve or bone marrow
- Candida in placental membranes
- Herpes in PAP smears of near-term pregnant patients
- Fungi in fine needle aspiration (FNA) or any invasive organism in any specimen from immunocompromised patients
- Significant disagreement between frozen section and final diagnosis
- Significant disagreement between immediate interpretation and final FNA diagnosis
- Unexpected malignancy
- Significant disagreement or change between primary and consulting pathologist
As for a timetable for communicating urgent and significant, unexpected diagnoses, the CAP/ADASP Statement asserts that urgent diagnoses “demand immediate communication as soon as the diagnosis is known.”2 The CAP/ADASP Statement states that significant, unexpected diagnoses do not need to be communicated with the same sense of urgency as an urgent diagnosis. However, both types of diagnoses should be directly communicated.1
Consider the following recommendations for creating an urgent or unexpected diagnoses list:1,3
- Formulate the list based on a consensus with colleagues, administrators, and referring physicians as to what types of diagnoses are urgent or unexpected.
- In determining what to include, analyze specific requests from clinicians and institutional factors such as the scope of services provided, case mix, and acuity level.
- Create a list that includes a sufficient number of diagnoses to enhance patient safety while still being short enough to use easily.
- Compare the list with practice parameters, consensus documents, and lists of other pathology practices.
Policies and Procedures for Urgent and Significant, Unexpected Diagnoses Communication
Pathology laboratories must develop and put into practice policies for urgent diagnoses and significant, unexpected diagnoses. In anatomic pathology, most patient harm results from failure to communicate a diagnosis at all rather than failure to communicate the diagnosis within a narrow time frame.2 According to the CAP/ADASP Statement, “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.”2
Similar to the subject of what belongs on a critical value list, there is no consensus on the method or timing of reports of urgent or significant, unexpected diagnoses. Most pathologists surveyed for the CAP/ADASP Statement felt there was inherent value in direct physician-to-physician communication of urgent diagnoses or significant, unexpected diagnoses. From a patient safety and liability risk management perspective, direct communication of urgent or significant, unexpected diagnoses is likely to be more effective than other forms of communication.1
Pathologists should be cognizant of the possibility that an ordering clinician may have a different opinion about what diagnoses warrant an immediate telephone call.4 For example, in one study all of the ordering physicians wanted direct notification of a diagnosis of neoplasm causing paralysis, while only 80% of the pathologists believed direct communication of the diagnosis was necessary.4 Consequently, it’s important to include ordering clinicians in the dialogue when creating urgent or significant, unexpected diagnoses communication policies and procedures. An urgent and significant, unexpected diagnosis policy should answer the following questions:1,3,4,5,7,8
- What are urgent diagnoses and significant, unexpected diagnoses?
- Create a list and examples.
- Who should receive urgent diagnoses and significant, unexpected diagnoses communication?
- Who should receive the results when the ordering clinician is not available?
- How should the efforts to communicate diagnoses be documented?
- At what point in the escalation process should the patient be contacted?
- Consider developing algorithms.
- What method of communication should be used?
- When should the pathologist directly contact the ordering clinician, the primary care physician, or the patient?
- Require “read-back” of the results when they are directly communicated.
- What is an acceptable time frame in which the diagnosis notification to ordering and primary care clinician should occur?
- How and where should communication be documented?
- Documentation should include the date, time, pathologist reporting, and clinician receiving the notification.
- Written documentation of direct or other communication provides evidence that the diagnosis was communicated.
- When does the pathologist need to obtain additional clinical information (e.g., to determine whether the diagnosis is unexpected)?
- How will the communication system be maintained and evaluated?
- How will the pathologists and staff know how to follow the policy and procedures?
- Provide ongoing education to pathologists and laboratory staff on communication.
- How will relevant clinicians on the patient’s treatment team be identified?
- Require ordering clinicians to list a patient's relevant clinicians on requisition forms.
Many pathology laboratories post their policies online, which may facilitate policy development for those laboratories in need of creating or updating such policies.3
1. Raouf E. Nakhleh. “Quality in Surgical Pathology Communication and Reporting.” Archives of Pathology & Laboratory Medicine. 2011;135:1394-1397. DOI: 10.5858/arpa.2011-0192-RA
2. Raouf E. Nakhleh, Jeffrey L Myers, et al. “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.” Archives of Pathology & Laboratory Medicine. 2012;136(2):148-154. DOI: 10.5858/arpa.2011-0400-SA
3. Jonathan R. Genzen, Christopher A. Tormey. “Pathology Consultation on Reporting of Critical Values.” American Journal of Clinical Pathology. 2011;135(4):505-513. DOI: 10.1309/AJCP9IZT7BMBCJRS
4. Christopher N. Chapman, Christopher N. Otis. “From Critical Values to Critical Diagnoses: A review with an Emphasis on Cytopathology.” Cancer Cytopathology. 2011;119(3):148–57 DOI: 10.1002/cncy.20158
5. Susan C. Lester. Manual of Surgical Pathology. 3d. 2010. Elsevier. Philadelphia, PA. “Chapter 4: The Surgical Pathology Report.” (not available online at the time of publication)
6. Association of Directors of Anatomic and Surgical Pathology. “Critical Diagnoses (Critical Values) in Anatomic Pathology.” American Journal of Clinical Pathology. 2006;125:815-817. DOI: 10.1097/01.pas.0000213287.73530.0a
7. Doris Hanna, Paula Griswold, et al. “Communicating Critical Test Results: Safe Practice Recommendations.” Joint Commission Journal on Quality and Patient Safety. 2005;31(2);68-80. DOI: 10.1016/s1553-7250(05)31011-7
8. Sharon C. Zehe. “Establishing and Communicating Critical Laboratory Values: The Mayo Clinic Approach.” Journal of Health & Life Sciences Law. 2012;6(1):173-195. Published at StudyLib.