CRITICAL RESULT REPORTING

Pathology Consultation / Special ArticlePathology Consultation on Reporting of Critical Values Jonathan R. Genzen, MD, PhD,1 and Christopher A. Tormey, MD,2 for the Education Committee of the Academy of Clinical Laboratory Physicians and Scientists Key Words: Pathology consultation; Critical values; Critical results; Panic values; Laboratory results; Results reporting DOI: 10.1309/AJCP9IZT7BMBCJRS The ASCP is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ASCP designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit ™ per article. This activity qualifies as an American Board of Pathology Maintenance of Certification Part II Self-Assessment Module. The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose. Questions appear on p 643. Exam is located at www.ascp.org/ajcpcme. Abstract Case Scenario Among the most important functions of a pathology or laboratory medicine service is the clear, accurate, and rapid communication of critical test results (critical values) to patient care providers. Pathologists and laboratory professionals are often confronted with many obstacles in the reporting of such critical values, including establishing clinically relevant criteria for critical values, resolving difficulties in locating an ordering provider when a critical value is obtained, and ensuring that the provider understands the severity and implications of a critical result when he or she has questions. This article presents a hypothetical (yet fairly common) clinical case scenario regarding critical values and then provides an up-to-date discussion and review of the literature on the reporting of critical results. A patient with atrial fibrillation who is receiving warfarin has an afternoon cardiology appointment for routine care and anticoagulant monitoring. A basic metabolic profile and prothrombin time are ordered. The specimen is transported to the laboratory by courier, and laboratory testing is completed at 7:30 PM. All values are within normal limits except for an elevated potassium level (K+) of 6.9 mEq/L (6.9 mmol/L; reference range, 3.2-5.2 mEq/L [3.2-5.2 mmol/L]) and a prothrombin time of 64.7 seconds (reference range, 11.1-13.2 seconds), corresponding to an international normalized ratio of 7.4. These results qualify as critical values by your clinical laboratory policy, and the laboratory technologist attempts to contact the ordering clinician by telephone. Calls to the physician’s office are not forwarded to an answering service or covering clinician, but rather directed to an office answering machine. The ordering physician does not respond to pages or telephone calls made to the contact numbers listed in the hospital telephone directory or laboratory information system (LIS). The laboratory technologist contacts the on-call pathology resident and asks for assistance. Questions 1. What are laboratory critical values? 2. What are the requirements for critical value reporting? 3. How should clinical laborattories establish critical value lists and determine appropriate thresholds? 4. Who should make and receive critical value notifications? 5. How might critical value reporting be improved? © American Society for Clinical Pathology Am J Clin Pathol 2011;135:505-513 505 DOI: 10.1309/AJCP9IZT7BMBCJRS 505 505 CME/SAM Upon completion of this activity you will be able to: • define the terms “critical value” and “critical diagnosis.” • examine obstacles associated with reporting critical values and diagnoses in a laboratory setting. • discuss practical solutions for problems associated with critical value reporting. 135:505-513 DOI: 10. the practice of assigning the laboratory director responsibility for creating and refining the critical value list has led to similar overall inclusion of tests between laboratories without there being a universal mandate or requirement.”2 Alternative terms for critical values include critical results. it may seem surprising that regulations do not state which laboratory tests require critical value limits and notification. many clinicians would likely consider a sodium (Na+) level of 168 mEq/L (168 mmol/L) a “critical” value regardless of which laboratory performs the test. individual clinical laboratories face unique challenges that reflect institutional organization. and accreditation programs. and alert values. Aspects of critical value reporting that have been evaluated in the literature are emphasized. instrumentation. as are current technological advances that may change the way in which critical value reporting takes place. the core components are often quite similar.” They have more recently been described as “laboratory results that indicate a life-threatening situation for the patient. regulations.1291 (g)]. Critical value reporting is addressed by the College of American Pathologists (CAP) Laboratory Accreditation Program as part of several checklist components.5 Establishing a Critical Values List Although there are many regulations specifying that laboratories must define and communicate critical values. An individual laboratory director can account for this variability by defining critical ranges consistent with his or her own assays and instrumentation. Such variations have hindered the development of universal standards for critical value reporting across laboratories. The term panic values carries a suggestion of emotional stress and runs against the thoughtful and organized process of communicating important information clearly.” This goal and its specific performance elements were updated in 2010 and are available online.4 Of note. urgent notification of a critical value to the appropriate healthcare professional is necessary. provincial.3-6 Although the content of these policies varies according to institutional needs. Laboratories are required by numerous regulatory agencies to develop and put into practice critical value policies.6 The Joint Commission (TJC) National Patient Safety Goals also address critical value reporting. along with protocols for reporting critical value results [see §493. clinical demand. the read-back requirement for results conveyed by telephone is being changed to a formal standard. this determination is the responsibility of the laboratory director. patient population. Finally. describing critical laboratory values as “values which reflect pathophysiological derangements at such variance with normal as to be life threatening if therapy is not instituted immediately.3 These items delineate the specific requirements for critical value procedures. Current regulations specify that the laboratory manual must address critical values (when applicable to test procedures). and §493. and staffing. virtually all laboratories include Na+ on their critical value list precisely because it is important for patient care. the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) include requirements on critical value reporting. Regulations Critical value reporting is required by a variety of laws. Defining (and then mandating) a universal set of thresholds for tests. In the United States. Inherent variability in assay-specific reference intervals between institutions is also a complicating factor.8 Additional state. it should be made in communication with the clinicians who use © American Society for Clinical Pathology . not communicating a critically elevated Na+ level could have medicolegal ramifications if an adverse clinical outcome occurred. and local regulations regarding critical value reporting may also exist and can be relevant to an individual laboratory’s performance requirements. This information will be followed by a detailed analysis of the fundamental components of critical value notification.1251 (b. The idea of a universal critical value list is appealing to many laboratorians and clinicians. how should the critical high and low thresholds be established? While ultimately. Its use is therefore discouraged. the International Organization for Standardization also includes critical value reporting in its clinical laboratory standard ISO 15189:2007. Goal 2—improve the effectiveness of communication among caregivers—includes “report critical results of tests and diagnostic procedures in a timely basis.7. including documentation of reporting and read-back of verbally communicated results. 11 and 13). This article begins by describing the current regulatory requirements for critical value reporting. however. Because of their critical nature. Indeed. Read-back is imperative 506 506 Am J Clin Pathol 2011. What are the responsibilities of pathologists and laboratory directors in the critical value process? Background Lundberg1 first outlined the fundamental components of critical value reporting in a Medical Laboratory Observer article. would be a daunting task given the scarcity of outcomes-based data on critical value thresholds.1309/AJCP9IZT7BMBCJRS because significant error rates have been detected in the process of telephone result communications. Indeed.Genzen and Tormey / Critical Values 6. panic values. Specifically. As an example. Furthermore. For example. How should a laboratory determine which tests to include on a critical value list? Moreover. Indeed. results are communicated by telephone.15 If the clinician does not confirm receipt in the clinical information system within 60 minutes.27. as a delay in the recognition of lifethreatening laboratory results by clinicians can be disastrous. Not every laboratory test should have critical values associated with it. within what time frame.3. institutional comparison. with some differences between inpatient and outpatient notification. A balance must be achieved. The National Patient Safety Goals state that laboratory procedures must indicate “by whom and to whom” critical results are reported. It should be noted that most published reports focus on critical value notifications in general laboratory testing.2. critical values transmitted from the LIS to a hospital clinical information system trigger the generation of text messages directed to the responsible clinician’s mobile phone and computer.3. medical and surgical section chiefs. Critical value lists are. Repeat testing is not feasible in many circumstances (eg. we have included a number of transfusion medicine–related scenarios that may benefit from rapid communication and discussion with a responsible clinician. hospital administrators. time. and 9% are made by a combination of the two.28 Laboratories face an ever-increasing dilemma in critical value notification—the overall volume of laboratory testing is increasing. by nature. A 2008 survey of 121 institutions found that approximately 90% of calls are made by medical technologists/technicians. The CAP checklist (component GEN. foster a negative attitude toward important laboratory services. limited to not hinder the clinical effectiveness of notification.1309/AJCP9IZT7BMBCJRS 507 507 . Shifting the task of critical value notification away from laboratory technologists may be inevitable at many institutions. This approach improved the speed of communication and allowed for full electronic documentation of critical value reporting. middleware. blood culture results).9 ❚Table 1❚ and ❚Table 2❚2.9 This task may include meeting with relevant physicians.14. The best place to start when establishing or modifying critical value lists is by comparison with previously published lists.26 A 2002 survey of 623 institutions showed similar results. and. and ongoing improvements in laboratory assays may decrease the clinical usefulness of routine repeat testing before reporting. several hospitals have implemented the use of automated notification systems for critical value reporting. the instrument. as well as with a medical review board of the institution. as well as “the acceptable length of time between the availability and reporting of critical results.Pathology Consultation / Special Article laboratory services.22-25 Critical Value Notification Procedures The initial step in the critical value communication process involves identification of an abnormal result by someone in the laboratory. and consensus documents because these sources have been refined with the benefit of time. Laboratory policies must clearly indicate whether the assay should be verified and/or repeated before reporting and. lists that are too exclusive (or with thresholds that are too high or low) might not prevent adverse clinical outcomes.27 The workflow benefits of centralized call centers (and having a laboratory technologist or someone with laboratory expertise involved in the call center mechanism) are well described in the aforementioned survey and a separate 2008 CAP Today feature article. or LIS will notify the laboratory staff (usually the performing technologist) of the critical value. most important. many institutions place their laboratory policies (including critical value lists) online.”3 Laboratory personnel who perform the actual tests are currently responsible for making the vast majority of critical value notifications. At one institution.13 A separate 2008 survey of laboratory professionals and pathologists (at >350 hospitals) revealed that nearly 18% of respondents were using a call center for critical value notifications. facilitating comparison of lists between peer laboratories. Finally. At the other extreme.41330) specifies what information must be documented during critical value notifications.13 That study recommended that critical value notifications should be made by one of the “team members” involved in performing the procedure. © American Society for Clinical Pathology Am J Clin Pathol 2011. and/or nurse managers to discuss critical value policies and to determine if there are any tests that should be included (or omitted) and whether any thresholds should be adjusted according to clinical needs. 1% are made by client services or call center staff. The 1997 American Society for Clinical Pathology “Critical Values Practice Parameter” (published in the Journal) is another outstanding resource.135:505-513 507 DOI: 10.13. [and] person notified. but a continued shortage in the number of laboratory professionals means that fewer people are expected to do more. and clinical performance.16-21 present lists of common tests that frequently have critical values defined. including “date. although several studies of critical diagnoses in surgical pathology and cytology have recently been published and will be discussed later in this article. This is a topic of continued clinical interest and debate. practice parameters.9 For automated assays. responsible laboratory individual.9-18 Several published studies from CAP (Q-Probes and Q-Tracks) have compared critical value reporting across hundreds of institutions and are a valuable resource for critical value policy assessment.”4 Documentation is required.9.1 Critical lists that are too inclusive (or that have critical value thresholds that require excessive notification) place an unnecessary burden on laboratory staff. Although most published critical value lists do not include blood bank testing. if applicable. Such lists annoy clinicians. provide uncertain additional benefit to patient care. if so. 2 2.8) 121 (121) 10 (100) 33 (0.16-18. and Pediatric-Specific Ranges* Chemistry Blood urea nitrogen. it does not include toxicology and therapeutic drug monitoring owing to the diversity of tests performed between individual institutions.7) 7.4) 250 (250) 1.135:505-513 DOI: 10.6) 7 (70) 20 (0. total. mEq/L (mmol/L) Sodium. mg/dL (μmol/L) Hematology/coagulation Prothrombin time.8 (2. neonatal.Genzen and Tormey / Critical Values ❚Table 1❚ Examples of Possible Critical Laboratory Values for Chemistry. CSF (cells/μL) Pediatric-specific ranges Ammonia.8) 10 (10) 75 (75) — 45 (2. mg/dL (μmol/L) Blood urea nitrogen.2 In many cases. × 103/μL (× 109/L) Blasts Organisms/parasites detected on smear review (CSF.3) 6. A discussion of one laboratory’s experience in establishing a troponin critical value cutoff (in collaboration with the emergency department) can be found in a 2008 CAP Today feature article. g/dL (g/L) Hematocrit. mg/dL (mmol/L) Magnesium. † First result observed above an assay or laboratory-defined cutoff for myocardial infarction.6) 3.3) 20 (2. mEq/L (mmol/L) Hemoglobin. cerebrospinal fluid.2) 160 (160) See comment† 13 (773) — — 90 (2. >5) may also be used. neonatal. neonatal.7) — 200 (11. mg/dL (μmol/L) Glucose.14 the ASCP Practice Parameter.0) 200 (11. mEq/L (mmol/L) Chloride.4) 4. neonatal. mg/dL (mmol/L) Total Ionized Carbon dioxide.3) 40 (5. mg/dL (μmol/L) Hemoglobin.6 (3. % (proportion of 1) Platelet count. particularly the outstanding reports from Kost.1) 190 (1.2) 40 (40) 2 (2) — — 30‡ 80 800 (23.2 (6. mm Hg (kPa) pH Potassium.5) 20 (200) 60 (0.20. neonatal. mg/dL (mmol/L) Protein.1309/AJCP9IZT7BMBCJRS © American Society for Clinical Pathology .0 (0. % (proportion of 1) Platelet count.4) 7.2 Système International (SI) conversion factors can be found in textbooks.13.5 (1. pediatric.1) 30. s Partial thromboplastin time.12 and critical values included in the Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. mg/dL (mmol/L) Osmolality. mEq/L (mmol/L) Sodium. Because the table integrates information from multiple studies. mg/dL (mmol/L) Lactate. CSF.33) 50 (50) 154 (110. mg/dL (mmol/L) PO2.5) 40 (2.8 (2. mg/dL (g/L) WBC count. The table is also not inclusive of all tests that may be considered critical. mg/dL (mmol/L) Creatinine. tests (and ranges) may vary from individual sources and may not be representative of the original authors’ opinions.3) 7.0) 100 (13.5) 55 (19. or sterile body fluid) Smear review suggestive of microangiopathic hemolytic anemia (schistocytes and low platelet count) Urinalysis (pathologic crystals) WBC count.2) — 1. mg/dL (mmol/L) Calcium. neonatal. blood. For example. μg/dL (μmol/L) Bilirubin. mEq/L (mmol/L) Troponin I or T Uric acid. mEq/L (mmol/L) Creatinine. mg/dL (mmol/L) Glucose. * Information in this table is meant as a starting point for the evaluation of a laboratory’s critical value list and not as a strict guideline applicable to all clinical scenarios.7) 40 (5.0 (530.9 (2.8 (335. mOsm/kg (mmol/kg) Phosphate.2 (1. × 103/μL (× 109/L) WBC count.8) 120 (120) — — 13 (3. 508 508 Am J Clin Pathol 2011.9) 325 (18.3) 20 (2.000 (1.0 (2.7) 2.9 a pediatric study by Gong and Adeli. Hematology/Coagulation.8) 156 (156) 22 (220) 71 (0.6) 1.2 (0.3) 63 (8.0) 325 (325) 9.0) 15 (256.6) 40 (40) 125 (125) 6. cells/μL 0-1 y 1-4 y 5-17 y Low Threshold High Threshold — 100 (35.9) — 70 (9. neonatal. × 103/μL (× 109/L) CSF Glucose.6 6.000) 40 (40) First observation First observation — First observation — — First observation 5 — — — — 30 (1. SI values have been rounded to 1 decimal point for the purposes of clarity. mm Hg (kPa) Potassium.0 (0.71) 900 (900) 30 (1.21 the College of American Pathologists Q-Probes studies.8 (7. mm Hg (kPa) PCO2. The table incorporates critical value data from the literature.7) 6.9) — — — 30 20 10 CSF. g/dL (g/L) Hematocrit. s Fibrinogen.4) 450 (25. mm Hg (kPa) PCO2.6) 3. mg/dL (mmol/L) PO2. mg/dL (μmol/L) Glucose.19 ‡ An international normalized ratio equivalent (eg. 6 A 2007 survey of 163 clinical laboratories asked the question “Who can receive critical values?” for the inpatient and outpatient settings. A separate 2008 study showed that almost 18% of institutions authorized release to other staff (eg. visible hemolysis in a post–transfusion reaction specimen Positive direct antiglobulin test (IgG and/or C3) in a post–transfusion reaction specimen Evidence of crossmatch incompatibility with a post–transfusion reaction specimen Discrepancy in identifiers noted on a blood product label. critical result. blood.14 Many laboratories. or resident. * Information in this table is meant as a starting point for the evaluation of a laboratory’s critical value list and not as a strict guideline applicable to all clinical scenarios. ordering physician. According to most regulatory agencies. or mycology stains of smears (CSF. Patient privacy requirements should also be considered with automated solutions because data conceivably might be transmitted and stored on nonencrypted devices.135:505-513 509 DOI: 10.10 Laboratory contact information should also be available so that clinicians with additional questions can ask a laboratory professional or medical director as appropriate. To whom should critical values be reported? The rationale stated in the National Patient Safety Goals states that results are to be conveyed to the “responsible licensed caregiver.Pathology Consultation / Special Article ❚Table 2❚ Examples of Possible Critical Laboratory Values for Microbiology and Transfusion Medicine* Microbiology Positive Gram. this would also be an acceptable practice as long as there is documentation that the critical value was then conveyed by the nurse to the ordering physician and/or licensed caregiver. an automated paging system was developed for critical value notification. Implementation of that system increased documentation of critical value receipt by physicians and decreased the median time for notification. the calls made to “other providers” occurred slightly more quickly than those made to licensed caregivers. If the clinician does not respond within 10 minutes (or rejects the notification). and reference range. The clinician must confirm receipt of the critical value by dialing a phone number listed in the message.26 In that study. ward clerks and/or unit secretaries). also permitted administrative personnel (ward clerks or receptionists) to accept critical values for outpatients (48%) and inpatients (27%). on-call physician. although most published critical value lists do not specifically include blood bank testing.”4 The CAP checklists describe notification to a “physician (or other clinical personnel responsible for patient care)” and the “appropriate clinical individual. tag. however.11 In that program. however. At another institution.”3 CLIA refers to “the individual or entity requesting the test and. the call is escalated to a trained group of operators who proceed with telephone notification.14 As expected.30 It should be emphasized that automated solutions should allow for an escalation policy (see the next section) to ensure communication of critical results when clinicians do not acknowledge receipt. † We have included possible transfusion medicine scenarios that would benefit from prompt communication with a responsible clinician. when factoring in the subsequent time it took this other provider to then contact a licensed caregiver.1291 (g)]. if applicable. critical values transmitted from the LIS generate a page containing the patient name. acid-fast bacillus. cerebrospinal fluid. Finally. or container during transfusion reaction evaluation Positive blood cultures from a unit implicated in a transfusion reaction Discovery of a new alloantibody in a patient undergoing surgery CSF. medical record number. some hospital networks have adopted a policy of reporting all critical values generated from the © American Society for Clinical Pathology Am J Clin Pathol 2011.29. device compatibility with alphanumeric characters (particularly units) and character limits should also be evaluated because an inaccurate or incomplete notification could lead to medical error and adverse clinical outcome. The “authorized agent” approach to critical value notification (calling someone whom a licensed caregiver specifies can receive critical value notifications but is not necessarily capable or authorized to act on them independently) should be discouraged. Any timesaving was lost. Several other studies have also evaluated the role of automated paging systems in critical value reporting. answers from virtually all facilities included any licensed caregiver. or sterile body fluid) Positive blood cultures Positive CSF cultures Positive sterile body fluid cultures Positive stool culture for select organisms Positive bacterial antigen tests Transfusion medicine† Gross. As an alternative. who are then responsible for conveying these results to ordering and/or covering physicians.1309/AJCP9IZT7BMBCJRS 509 509 . Many facilities allow for reporting of critical values directly to licensed nurses. the individual responsible for using the test results” [§493. collection time. 13. investigations via the EMR) that are not readily available to bench technologists. if a “physician representing the laboratory” determines that immediate care of the patient may be required.32 The report included algorithms for the inpatient and outpatient settings. normal. This system has an added benefit of bringing the issue of critical value reporting to the attention of a hospital or departmental administrator who might not otherwise be aware of problems associated with the process. particularly because of the extensive electronic medical record (EMR) available to all clinicians. the algorithms include attempting to identify and contact the patient’s primary care provider. a chief of service or chief of staff would ultimately be notified. critical high). however. and as such calls may have diminishing value over time. and/or medical director to assist in critical value notification. This approach works well for Veterans Administration hospitals. In our experience.28 This policy allows the technologist to refocus on the important task of laboratory testing. as with other systems in which the ordering provider is not the physician ultimately receiving the call. and there are minimal data to argue the clinical benefit of one approach vs the other. and/or a medical director in difficult-to-convey critical value calls.33 Such an approach in high-volume laboratories. Critical value lists and procedures should include not just critical ranges but also the frequency of when to call for each given test. an attending pathologist. An escalation policy or a failsafe mechanism can be beneficial in such circumstances.13 Determining whether critical results meet interval criteria might add additional tasks to laboratory technologists. After trying to contact the ordering provider. while others (such as a markedly elevated blood urine nitrogen level) may be called using an interval approach. An escalation policy would direct the laboratory technologist to contact a supervisor.135:505-513 DOI: 10. the pathology and laboratory medicine residents are usually able to contact a covering physician and convey these critical results. It has been our experience that this involvement usually opens avenues (eg. pathology resident.27 For those that do not. As clinicians become quickly annoyed by repetitive calls for critical values. The laboratory policy should also clarify how to handle critical value notification after a subsequent normal result during the same interval (eg. however. some advocate using interval criteria (for example. abandoning the call entirely is almost never an acceptable solution. if a normal test result occurs after a critical result. who can then decide whether to act on these results. although LIS or middleware-based rules can be used to perform comparisons automatically. A fail-safe mechanism (or safety net) can also be used in cases in which notification continues to be unsuccessful. at institutions with less robust EMRs. one study demonstrated that lower rates of undocumented critical value results in the medical record were associated with policies that require calling all critical results. 9 AM. Such a call reporting system may be of limited benefit. a subsequent critical result is considered new and would be called again. If still unsuccessful.13 An approach to dealing with unreachable clinicians was recently proposed in a 2010 article. A laboratory may determine that some tests should be called with each critical value. the laboratory result and patient information might be conveyed to a physician in the ED to contact the patient directly. calling once every 24 hours). In our policies. 8 AM. There are only 3 options: (1) Call only the first critical value. about a patient’s medical history and the potential ramifications of the critical value.9 Of note. one is strongly recommended because it will clarify laboratory technologist responsibility and establish consistency in performance. The laboratory’s policy should be clear for such scenarios. (2) Call each critical value. However. Others have suggested that interval calling is appropriate for only select analytes. this process involves clinicians who may know very little 510 510 Am J Clin Pathol 2011.1309/AJCP9IZT7BMBCJRS Another common problem in critical value reporting is how a laboratory should handle repeat critical values. the standard operating procedure at many Veterans Administration hospitals is to report critical results to an ED attending physician. Verification of clinician notification should be subsequently conveyed back to the laboratory technologist (and entered into the LIS) to comply with TJC and CAP requirements. can be exceedingly burdensome to technologists and clinical staff. Such interventions can ultimately result in more rapid communication to a clinician familiar with the patient involved. then 10 AM. critical high. and it transfers the responsibility for notification to people who may have greater access to an inpatient or outpatient EMR and who can put the finding in a broader clinical context. or subsequent critical values for a given assay on the same patient (but subsequent specimen).Genzen and Tormey / Critical Values outpatient setting during “off” hours to a hospital emergency department (ED) or triage center. For example. Approximately 70% of surveyed laboratories have a policy on repeat critical values. Repeat Critical Values Escalation Policies What should a laboratory do when a technologist is not able to reach a responsible clinician with the critical value? In these circumstances. We ultimately advocate for active involvement of a pathology resident.31 For example. (3) Call critical values once per interval of time. © American Society for Clinical Pathology . Results would still need to be conveyed to the responsible clinician for long-term management. 45. ❚Table 3❚ Examples of Possible Critical Diagnoses in Anatomic Pathology35-39.42. customized protocols for handling critical diagnoses.35 This concept of critical diagnoses in surgical pathology and cytology (analogous to critical values in the clinical laboratory) has received significant attention in recent years. This change not only enhanced the quality of the laboratory’s performance but also eased the burden of unnecessary critical value calls.14.35-37 In fact. and permitting physician opt-out runs counter to the overall patient care objective of the notification process.44 Finally. and protocols. and they are a great starting point for quality improvement initiatives. tissue slicing. Tables including pediatrics critical value limits are available. there is no consensus on how to actually report these diagnoses nor on the appropriate time frame for communication.10 Analysis can reveal differences in critical value patterns by patient location (eg.44 Even though these conditions were suggested as being important for immediate communication. one program identified a specimen transport issue that led to falsely elevated K+ results in some patients.and/or location-specific critical value lists are another issue of controversy. falling hematocrit values on surgical services vs low K+ values on medical services).12 Critical Diagnoses in Anatomic Pathology Anatomic pathologists evaluate organs.135:505-513 511 DOI: 10. Critical value lists often include unique limits for neonates. For example.3 The laboratory has a clear mandate to convey critical values. staining. clinicians at a dialysis clinic may be concerned about a different range of electrolyte results than clinicians at an orthopedics rehabilitation unit. fine-needle aspiration. the diagnosis suggests that “immediate treatment or prompt evaluation of the patient” may be indicated. but these values are easily incorporated onto a single laboratory-wide critical value list and would not be maintained separately.”38. The concept of critical diagnoses. Physician. with the caveat that any such list “needs to be customized to each individual hospital based on specific requests from clinicians and institutional factors such as the scope of services provided. however.1309/AJCP9IZT7BMBCJRS 511 511 .35-39. Preanalytic and analytic processes (eg. the authors found an overall lack of consensus from participants on what might actually be included on such lists.38. case mix.27 Changing the transport requirements decreased the number of critical high K+ results. include some populationspecific critical values. © American Society for Clinical Pathology Am J Clin Pathol 2011.35-43 For example.and/or locationspecific lists are not in widespread use. tissues. and cellular specimens and provide diagnoses when abnormal findings are observed. several retrospective reviews and multiinstitutional surveys led to the creation of a list of possible critical diagnoses in anatomic pathology and cytology ❚Table 3❚. it will remain necessary for institutions to establish local. for example. in the evaluation of new point-of-care programs. In certain circumstances.Pathology Consultation / Special Article Critical Value Audits The importance of using critical value data to better understand laboratory process and preanalytic error cannot be overemphasized.30 This information could be used. Many laboratories.40.42. however. acuity level. there are no specific national guidelines as to what types of diagnoses in surgical pathology should qualify as critical. Analysis of critical value limits can also be used to estimate the impact on call frequency that would result from changing threshold requirements. and a generic list of possible diagnoses was published in 2006 based on the aforementioned studies. has been endorsed by the Association of Directors of Anatomic and Surgical Pathology. For example. Maintaining multiple. and immunohistochemical analysis) often mean that hours to days may pass before a diagnosis can be made.16 and one study on interlaboratory variability in pediatric critical values was recently published. gross examination. Others have used critical values analysis in studies of adverse events and clinical activity at discrete hospital locations. separate lists in the laboratory can be challenging (if not impossible) at most institutions and would be prone to technologist error in underreporting and overreporting of critical results.2.44 Surgical pathology Crescents in >50% of glomeruli in a kidney biopsy specimen Vasculitis Bacteria in a heart or bone marrow specimen Select organisms in immunocompromised patients Uterine contents without villi or trophoblast Fat in an endometrial curettage Mesothelial cells in a cardiac biopsy specimen Fat in colonic endoscopic polypectomy specimens Transplant rejection Malignancy in superior vena cava syndrome Neoplasms causing paralysis Significant disagreement between frozen section and final diagnoses Cytology Unexpected malignancy Malignancy in critical places that can cause spinal cord injury Disagreement between immediate and final interpretations of FNA specimens Fungi in an FNA specimen from an immunocompromised patient The finding of certain microorganisms in any patient FNA.46 In the absence of specific guidelines.34 Critical value audits provide tremendous information on laboratory processes. Physician.42.14 Opt-out is also strongly discouraged in the CAP checklist. Opt-Out and Specific Lists Physician “opt-out” of critical value notifications (or “no call hours”) were prohibited by more than 80% of programs surveyed in one study. Evaluation of effectiveness of a computerized notification system for reporting critical values. Emancipator K. Friedberg RC. The telephone (and pager) directory was updated for all physicians at this clinic. 4th ed. Technological advancements will certainly alter the way in which critical value notifications are made. 20. Kaiser AB. Rensburg MA.117:890-896. they are responsible for ensuring compliance with TJC. Table of critical limits. 1990. et al. et al. 15.126:663-669. cutoffs. Med Lab Obs.108:247-253. Medicaid. Clin Biochem. Implementation of a closed-loop reporting system for critical values and clinical communication in compliance with goals of the Joint Commission. Barenfanger J. Clin Chem. Coakley AB. Laboratory critical values policies and procedures: a college of American Pathologists Q-Probes study in 623 institutions. MLO Med Lab Obs. Kost GJ. Parl FF. New Haven. Adeli K. a strong commitment to the critical value notification process can enhance overall patient care and should be a focus of ongoing quality improvement. 1997. They are involved in establishing and updating the critical value lists and policies (in consultation with clinicians and institutional medical boards).121:801-803. Pediatrics. Critical limits for urgent clinician notification at US medical centers. Lusky K. Cornell University. Analysis of laboratory critical value reporting at a large academic medical center. Wagar EA. 2009. New York. Am J Clin Pathol.org/. Kost GJ. References 1. Medicare. 2006. 2003. Burtis C.56:417-423.iso. 13.7. The resident had access to the outpatient EMR and noticed that a cardiology fellow (and not the patient’s primary attending physician) wrote the clinic notes. et al. CT. Am J Clin Pathol. the laboratory technologist paged the on-call pathology resident. 2004. When to panic over an abnormal value. eds. Improving patient safety by repeating (read-back) telephone reports of critical information. and the Pathology and Laboratory Medicine Service. 11. She accepted the critical results. Lang DL.and CAP-required documentation. A national survey on pediatric critical values used in clinical laboratories across Canada. ISO 15189:2007: medical laboratories: particular requirements for quality and competence [items 5. College of American Pathologists. Sciacovelli L. Gong Y. 1993. Ashwood E. it was determined that a new member of the outpatient office staff did not know how to set the telephone system appropriately to forward calls to the answering service. A recent CAP Today Q&A discussion on critical value notification concluded by stating that “a focus on building a patient-centric system requires strong pathologist leadership to ensure a safe and reliable system. 5. 17. GEN. Codified at 42 CFR §493.88:597-603. 6. Arch Pathol Lab Med. The resident called back the laboratory technologist and provided necessary information for documentation of the critical value notification.125:758-764. VA Connecticut Healthcare System. The significance of ionized calcium in cardiac and critical care: availability and critical limits at US medical centers and children’s hospitals. The Joint Commission. 9. 5. http://www. On investigation the next day. NY. NY 10065.01).1309/AJCP9IZT7BMBCJRS 2.41320.42:1610-1615. 21.41330. Sautter RL. Accessed August 7. New York. but these will not change the overall responsibility of pathologists and laboratory directors for ensuring compliance with critical value notification requirements.4:47-54.33:12-13.org. Rao A. 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