Pennsylvania Patient Safety Advisory Safe Patient Outcomes Occur with Timely, Standardized Communication of Critical Values ABSTRACT need to establish a critical test list and a critical values A critical value is defined as an imminent life-threat- list, also known as critical results. Critical tests are ening laboratory result requiring immediate physician tests that always require immediate communication notification. The concept was first introduced in 1972 of the results, even if the results are normal.1 Critical and has been widely adopted as a standard of good values are test results that are significantly outside laboratory practice. Regulatory agencies and federal the normal range and may represent life-threatening legislation require that hospitals and laboratories values.1 The concept of critical values was first establish a list of critical tests and values and have introduced by Lundberg in 1972. A critical value procedures in place for promptly conveying critical is a pathophysiological state at such variance with results to the responsible practitioner. Yet, despite normal as to be life-threatening unless something is the importance of critical values in patient care and done promptly and for which some corrective action requirements to identify and promptly communicate must be taken.2,3,4 It is a life-threatening situation critical results to healthcare providers, there is little requiring immediate intervention.2,3,5 In 1988, Con- standardization of procedures. Communication of gress enacted the Clinical Laboratory Improvement critical values has potential for failure, as illustrated Act (CLIA), requiring laboratories to follow written in reports submitted to the Pennsylvania Patient Safety procedures for reporting critical values.4 The Col- Authority and demonstrated in the medical literature. lege of American Pathologists (CAP) and the Joint Standardization of processes related to critical tests, Commission are accrediting agencies that survey labo- results, and values can positively affect quality of ratories to assure CLIA compliance, which includes care and patient safety. First, facilities must develop establishing a list of critical values and results. More- a critical test list and identify critical values or results. over, laboratories must have procedures in place for Next, implementation of processes that identify criti- promptly passing on critical results to the responsible cal values and mechanisms to quickly document and practitioner.2,6 communicate critical values to healthcare providers caring for the patient may reduce harm to patients. The critical values concept extends beyond laboratory (Pa Patient Saf Advis 2009 Sep;6[3]:93-7.) tests, encompassing radiologic and other diagnostic tests and studies. The prompt communication of critical, life-threatening test results is crucial to reduce harm to patients. This article focuses on strategies From June 2004 through February 2009, the Pennsyl- to improve processes related to laboratory critical vania Patient Safety Authority received nearly 1,000 values. The same principles may be applied to radiol- reports involving critical tests and values. Failure of ogy and other diagnostic departments. Specifically, laboratory staff to communicate critical values to development of a standardized list of critical radiology the responsible provider and failure to match results tests and results and methods to document and com- to the correct patient are the most common issues municate the critical results promptly to healthcare identified in the reports. Approximately 3% of these providers may reduce harm to patients. The scope of reports were identified as Serious Events that required this article will focus on laboratory tests. additional interventions such as prolonged hospi- talizations or increased lengths of stay in intensive Poor Communication Leads to Delays care units (ICUs). Of the Serious Events, five patient in Treatment deaths were reported. Almost 50% of the total reports were generated from the laboratory, with the remain- Although most clinical laboratory results have ing reports dispersed throughout care areas. therapeutic implications that do not require urgent physician attention, some test results may indicate a The issues associated with the critical values reports potentially life-threatening situation. These critical were poor communication, delays in treatment, and results require immediate notification and action by documentation issues. Analysis of current processes the responsible licensed healthcare provider. This at a facility can determine what strategies (i.e., to multifaceted process has potential for failure, as identify, document, and communicate critical values) illustrated in reports submitted to the Authority. The may be necessary to improve patient safety and qual- most common errors identified are poor communica- ity of care, including strategies compliant with the tion and delays in treatment related to critical values, Joint Commission 2009 National Patient Safety Goal which are consistent with themes in the literature (NPSG) related to critical values. of communication breakdown in reporting critical results. Specifically, 33% of reports related to critical Background lab values identified a failure of laboratory staff to The Joint Commission recognizes an explicit differ- report critical results to the responsible provider or a ence between critical tests and critical values. Facilities delay in reporting. In particular, the reports described Vol. 6, No. 3—September 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 93 Pennsylvania Patient Safety Advisory healthcare providers who did not receive notification Barriers to Communication about critical results and discovered the critical results Effective communication is defined by the Joint Com- by calling the laboratory or referring to the medi- mission as timely, accurate, complete, unambiguous, cal record. In the majority of cases, the laboratory and understood by the recipient.7 Standardization of totally failed to report the result and in other reports communication and documentation of critical results there was a significant delay in communicating the by the responsible provider may improve patient safety result directly to the healthcare provider. In the latter and quality of care. In 2003, the Joint Commission cases of delay in communication, several issues were implemented NPSG 2C to improve the effective- identified, including the laboratory calling the wrong ness of communication among caregivers.7 The goal physician or the wrong number or the physician not includes implementation of a read-back process for responding in a timely manner. Additionally, some taking verbal orders and standardization of abbrevia- reports indicated failure by the recipient of the criti- tions throughout the organization. Read-back helps to cal value to verify correct patient and correct result ensure that a message sent by a sender is understood by means of the read-back process. The following by the receiver in the manner the sender intended. Authority reports illustrate how such errors can result The sender sends a message, the receiver fully repeats in patient harm: the message as understood, and the sender acknowl- The patient had blood drawn the day prior to the edges the message has been understood correctly.6,8 patient going to the cardiac catheterization labora- Some facilities require the recipient of the critical tory. The catheterization laboratory nurse checked the value perform a read-back of the value. Laboratory patient’s lab work prior to patient arriving to the [car- staff document the patient name, critical value, date diac catheterization] lab, but the laboratory results and time communicated to the provider, and the reviewed were from a previous blood draw. According provider’s name who received the critical value and to the supervisor, there was a delay in lab work being confirmation of the read-back process. In 2009, the sent to laboratory. While the patient was on the Joint Commission expanded NPSG 2 to include [cardiac catheterization] table, the patient became defining critical tests, critical results, and values as unresponsive, pulseless, and stopped breathing. Car- described previously. In addition, Joint Commission diopulmonary resuscitation (CPR) was initiated. The included a requirement for organizations to identify nurse checked the computer for lab work again. The and communicate critical tests and values in a timely critical result had been called to the nursing unit but manner and to measure, assess, and if needed, take had not been passed on to the catheterization staff. action to improve the timeliness of reporting and The potassium level was 6.8. the timeliness of receipt of critical tests and critical test results and values by the responsible licensed The critical hematocrit [laboratory value] was called caregiver. Data from the Joint Commission, which to the wrong physician. An order for blood was includes surveys conducted from 2003 through the obtained by the nurse. Blood transfusion started on third quarter of 2007, indicates that NPSG 2C has patient who developed a reaction. The blood was the lowest compliance rate (36%) compared to the stopped and the nurse called the physician, who at other NPSGs.9 this point realized this was not his patient. Delays and inaccuracies in reporting critical values Blood work was drawn in the morning. There was a place patients at risk of harm due to treatment delays, critical ammonia level of 352. Laboratory did not omissions, and errors. The following Authority notify the nursing unit about the result. The critical reports illustrate the range of communication prob- value was available via computer in the afternoon lems resulting in errors: but was not noted by the nurse until the night shift. Patient labs were drawn in the morning; critical blood The patient was unresponsive and pulseless. CPR sugar of 18 was not reported until five hours later. was initiated, and the patient was transferred to the ICU. Patient was admitted with fatigue. A laboratory test for a CBC [complete blood count] was drawn. [The Despite the importance of critical values in patient results included] a white count of 0.7. This was not care and various regulatory agency requirements to effectively communicated to the physician and went identify and promptly communicate critical results unnoticed until days later, at which point the patient to healthcare providers, there is little standardization was transferred to the hematology unit. of the process and procedures in organizations.2 The development of a list of critical tests and results is A patient [with] CHF [congestive heart failure] established at individual organizations after discus- had blood work drawn [on admission]. No results sion with representative groups of ordering providers. were obtained until the next day [when] a critical Establishment of communication processes is critical. potassium result of 6.4 was noted. Patient had been For example, facilities may assign laboratory person- receiving potassium daily. No call was received on nel to be responsible to communicate critical results. admission [for this critical result] and no printed lab Likewise, facilities may determine the appropriate report [was received] until the next day. fixed time frame and the method of communicating The unit clerk reported to the nurse and physician the critical test result to the provider. [a critical potassium level] of 2.2. The physician Page 94 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, No. 3—September 2009 Pennsylvania Patient Safety Advisory wrote orders for potassium bolus and PO KCL [potas- ■ Customize the critical list as directed by the sium chloride by mouth]. Both were given [promptly]. laboratory medical director, who has primary An hour later, the written lab results were received responsibility for the laboratory specimens list.4 and the potassium was high and the phosphorus [level was] critically low at 2.1. ■ Consider the needs of special programs in the facility, such as cardiac surgery, bone marrow trans- The report from the nurse included that the heparin plant, or high-risk obstetrics.4 4,000 was titrated based on what was believed to be a partial thromboplastin time (PTT) [level of] ■ Post the critical laboratory test list in all areas of 15. The patient was [given an intravenous] bolus of the laboratory. heparin and the heparin [drip] was increased. This titration was completed at [the end of the shift]. ■ Review and revise the critical values list and related During report, we received a call from the lab with policies annually to maintain compliance with a critical high PTT of 180. The previous nurse had regulatory agencies.4 misread the PT (prothrombin time) as the PTT value. [The nurse] notified the on-call physician of the error ■ Educate laboratory staff on the critical values list and held the heparin [drip]. annually.4 Patient evaluated with history of [cardiac and renal Recognize and Notify of Critical Values disease]. A critical potassium result of 8.5 was verbally Next, develop and implement methods to guarantee communicated from nurse to the emergency depart- that critical results from the approved list are recog- ment physician. Physician states he interpreted result nized and communicated to the responsible provider as 5.8. [The lab reported the] specimen was slightly and documented in the laboratory. Standardization hemolyzed. No treatment was initiated. A repeat of the process may promote the appropriate, prompt potassium level was 8.5. Treatment was ordered. treatment of patients. Identification of Critical Tests, Critical Results, Recognition and notification of critical results begins and Values in the laboratory. Laboratory staff should identify There is little consensus or benchmark data about a critical value by strict semantic interpretation of critical values in the clinical laboratory.3 The defini- the critical limits. For example, the upper limit for a tion of a critical value remains unspecified in the potassium level is 5. If the result is 5.1, it is a critical minds of many clinicians and laboratory profes- value, but staff may not interpret one tenth of one sionals. For example, data from 623 institutions point above as abnormal. Additionally, laboratory participating in a CAP Q-Probe study indicated that staff verifies that the sample of a critical lab value is critical value lists vary widely for routine chemistry satisfactory.4 Laboratories should set clear, realistic and hematology laboratory tests.5 Facilities must time frames to initiate and complete a critical value establish a list of critical laboratory test values relevant notification to enhance patient care.4 Healthcare facil- to their daily operations and patient population. ities should implement processes of notification based Ultimately, the medical director has the primary on resources, technology, and personnel available. responsibility to establish a list that meets the needs of the organization it serves.4 Some facilities communicate critical results to the nurse caring for the patient, while others communi- Establish a List of Critical Tests, Critical Results, cate critical results directly to medical staff by means and Values of alphanumeric pagers.4 If available, laboratory First, identify critical tests, critical results, and val- information system (LIS) software can identify criti- ues that warrant prompt notification to a licensed cal values and be integrated with telecommunication healthcare professional at the facility level. Establish systems to deliver critical values directly to the physi- a multidisciplinary committee to develop the critical cian’s pager.4 Additionally, two-way pagers provide a values test list.4 The Massachusetts Coalition for the method for physicians to acknowledge receipt of the Prevention of Medical Errors has created a starter critical value.4 An automated system provides high set of critical results.7 According to Hanna, this list reliability of critical value notification.4 The use of may stimulate discussion during the development of LIS software may limit communication breakdowns facility-specific lists.7 The CAP Q-Probes Committee such as those illustrated in Authority reports (e.g., does not endorse a national standard critical values unsuccessful attempts to notify responsible provider). list.4 However, improved safety and quality of care is enhanced with individualized lists. Consider the Furthermore, methods that identify a backup health- following components when establishing a facility- care provider to be notified may improve notification specific critical value list: of critical results.4 Identification of failure modes and implementation of strategies to prevent communica- ■ Ensure committee representation from various tion breakdown is essential. Establishing a process for departments, including the medical staff, labora- the communication of critical values to the respon- tory staff, and nursing staff.4 sible provider improves timely treatment to patients.10 Vol. 6, No. 3—September 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 95 Pennsylvania Patient Safety Advisory Additionally, implement policies and procedures that Verify Critical Results and Patient Treatment include the following strategies: ■ Verification of the critical result is the next step in ■ Identify and assign staff to report critical results.4 the process. Actions taken by the recipient of the critical result and subsequent steps taken to ensure ■ Establish a method for communicating the critical timely intervention is the key focus. Ideally, the result. (The telephone and alphanumeric pager are primary physician receives the critical result and reported to be the most effective methods to report determines the need for treatment. If treatment is critical values.)4 needed, the physician promptly instructs the nurse ■ Establish read-back policies appropriate to the or other care provider to treat the critical value. communication method that require laboratory The care provider or nurse provides the treatment, staff to ask and document the following elements and the process is complete. However, difficulty from the recipient of the critical value: recipient contacting the responsible physician directly has first and last name, critical test and value, date and resulted in facilities adopting a policy that permits time, sender first and last name, and completion of the laboratory to convey the critical result to the read-back. registered nurse caring for the patient.12 In this ■ Maintain an up-to-date directory of all relevant situation, the nurse must communicate the result telephone and pager numbers in the laboratory.4 accurately and promptly to the primary care physi- cian. Research and experience indicates that each ■ Develop and implement backup systems to report handoff communication increases the chance for critical test results for inpatients when the ordering error and miscommunication.12 Implementation provider is unavailable.6,11 of the following strategies may enhance commu- ■ Establish procedures to implement when an nication of critical results and improve timeliness attempt to report a critical value to the ordering of patient treatments. Identify and assign staff provider or backup provider fails. Follow the chain to receive critical results. The Joint Commission of command.4 requires that critical results be reported promptly to a licensed provider or the practitioner who ■ Document all critical value notifications. The ordered the test.8 documentation includes patient identification, laboratory test and result, date and time of notifica- ■ Confirm correct patient name and critical test tion, identity of reporter, and the recipient of the result by means of a read-back.6 critical value.4 ■ Use a standardized form (part of the medical ■ Require recipients of critical results to read back record) to document all communications and the message for affirmation.6 interventions related to the critical value and criti- ■ Identify methods for improving processes in report- cal result that includes patient identification, test ing critical values.6 result, date and time of notification, identity of reporter, and the recipient of the critical value.4,13 ■ Analyze and collect data to determine efficacy of notification to healthcare providers.6 ■ Also include in documentation the date and time the result was reported to the primary physi- Establish Time Frames for Reporting Critical Results cian and time the patient received treatment, if Not every critical test result needs to be reported with indicated.6,13 the same urgency.10 The Massachusetts Coalition for the Prevention of Medical Errors developed three cat- ■ Establish procedures to implement when an egories (i.e., red, orange, yellow) with different time attempt to report a critical value fails to reach the targets for communicating the result to the licensed primary licensed provider.4 healthcare worker. The goal is to ensure that results ■ Initiate treatment promptly, if ordered, and reach the provider and that treatment is initiated document the time that the patient received the within an established appropriate time frame.10 The intervention.13 definitions of the categories are as follows:10 ■ Assess patient response to the intervention, and ■ Red signifies all test results that represent a clinical document in the medical record. emergency that places a patient in imminent dan- ger of death, or a significant adverse event unless The process is complete when the patient receives treatment is initiated immediately. Notification treatment for the critical test result. However, main- within an hour is an appropriate time frame. tain attentiveness and continue to monitor and assess the patient’s response to treatment and subsequent ■ Orange represents test results that require immedi- laboratory testing related to the intervention. ate notification to the physician and may occur during change of shift within six to eight hours. Conclusion ■ Yellow represents test results with significant abnor- Identification and notification of critical tests, values, malities but do not pose an immediate threat to and results is a complex process with potential for life. Notification of the result within three days is communication breakdown at every step. Implemen- an appropriate time frame. tation of the protocols presented here may improve Page 96 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, No. 3—September 2009 Pennsylvania Patient Safety Advisory patient care and reduce harm. Ongoing evaluation 6. Barenfanger J, Sautter RL, Lang DL, et al. Improv- and improvements in identifying and reporting ing patient safety by repeating (read-back) telephone critical tests, values, and results will lead to accurate reports of critical information. Am J Clin Pathol 2004 notification from laboratory staff to the licensed pro- Jun;121(6):801-3. fessionals resulting in prompt treatment, if necessary, 7. Hanna D. Communicating critical test results. Jt Comm to patients. Perspect Patient Saf 2006 Jan;6(1):5-6. Notes 8. The Joint Commission. Accreditation program: hos- 1. The Joint Commission. National Patient Safety Goals. pital national patient safety goals [online]. 2009 [cited NPSG2 Communication among caregivers. 2009 stan- 2009 March 20]. Available from Internet: http://www. dards FAQs [online]. 2009 [cited 2009 Jul 18]. Available jointcommission.org/NR/rdonlyres/31666E86-E7F4- from Internet: http://www.jointcommission.org/Accred- 423E-9BE8-F05BD1CB0AA8/0/HAP_NPSG.pdf. itationPrograms/LongTermCare/Standards/09_FAQs/ NPSG/Communication/NPSG.02.03.01/ 9. Dayton E, Henriksen K. Communication failure: basic Critical_tests_results_values.htm. components, contributing factors, and the call for struc- ture. Jt Comm J Qual Patient Saf 2007 Jan;33(1):34-40. 2. Lum G. Critical limits (alert values) for physician noti- fication: universal or medical center specific limits? Ann 10. Top standards compliance issues for full-year 2007. Jt Clin Lab Sci 1998 Sep-Oct;28(5):261-71. Comm Perspect 2008 Sep;28(9):9-13. 3. Wagar EA, Stankovic AK, Wilkinson DS, et al. Assess- 11. Creating a backup system: ensuring timely reporting of ment monitoring of laboratory critical values: A College critical test results and values. Jt Comm Perspect Patient Saf of American Pathologists Q-Tracks study of 180 institu- 2008 Jun;8(6):6-8. tions. Arch Pathol Lab Med 2007 Jan;131(1):44-9. 4. Emancipator K. Critical values ASCP practice param- 12. Kuperman GJ, Boyle D, Jha A, et al. How promptly are eter. Am J Clin Pathol 1997 Sep;108(3):247-53. inpatients treated for critical laboratory results? J Am Med Inform Assoc 1998 Jan-Feb; 5(1):112-9. 5. Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures : a college of American 13. HCPro. Get in gear: Six road-tested ways to com- Pathologists Q-Probes Study in 623 institutions. Arch municate critical test results. Brief Patient Saf 2004 Pathol Lab Med 2002 Jun;126(6):663-9. Nov;5(11):5-7. Vol. 6, No. 3—September 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 97 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 6, No. 3—September 2009. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2009 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web An Independent Agency of the Commonwealth of Pennsylvania site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. 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