Survey of Critical Value Reporting and Reduction of False-Positive Critical Value Results

Anand S. Dighe, MD, PhD; Jay B. Jones, PhD; Sue Parham, BS; Kent B. Lewandrowski, MD

Context.Reporting of laboratory critical values has become an issue of national attention because of important regulatory, medicolegal, and clinical concerns. Objective.To survey aspects of the laboratory criticalvalue reporting process at a broad range of institutions. Design.A survey was developed regarding the operational and information-technology aspects of critical value reporting. Results.More than 730 responses were obtained from a broad distribution of hospitals. In addition, we analyzed more than 700 written responses from survey participants. ritical value reporting was originally highlighted by Lundberg,1 who dened critical value as a result suggesting that the patient was in imminent danger unless appropriate therapy was promptly initiated. In the 30 years since Lundbergs observations, critical value reporting has been addressed in the Clinical Laboratory Improvement Amendments of 1988, and its recommendations were subsequently widely adopted by laboratory-accrediting agencies, such as the Joint Commission and the College of American Pathologists (CAP).2,3 Consequently, critical values are used in virtually all US clinical laboratories and are a frequent source of operational issues. The recent national focus on patient safety has brought increased attention to the issue of laboratory critical value reporting. The Joint Commission and the CAP require health care organizations to track and improve the timeliness of reporting and receipt of critical test results by the responsible, licensed clinician. Moreover, the Joint Commission has dened critical values as not only laboratory tests but also imaging studies, electrocardiograms, anatomic pathology, and other diagnostic studies. Therefore, the process of critical value reporting is of interest across the health care organization. Despite the nearly ubiquitous use of critical value reporting systems, the literature describing how critical value policies have been applied in practice is limited. The
Accepted for publication March 17, 2008. From the Department of Pathology, Massachusetts General Hospital, Boston (Drs Dighe and Lewandrowski); the Geisinger Medical Laboratories, Danville, Pa (Dr Jones); and the American Association for Clinical Chemistry, Washington, DC (Ms Parham). The authors have no relevant nancial interest in the products or companies described in this article. Reprints: Kent B. Lewandrowski, MD, Department of Pathology, Massachusetts General Hospital, Bigelow 510, 55 Fruit St, Boston, MA 02114 (e-mail: klewandrowski@partners.org). 1666 Arch Pathol Lab MedVol 132, October 2008

Conclusions.The survey results provide insight into the standard of practice and level of compliance with current Joint Commission and College of American Pathologists requirements for critical values, demonstrate considerable heterogeneity, and suggest areas for improvement. A common issue raised during the survey and follow-up teleconference was the incidence of outpatient false-positive critical values. In this report, we also demonstrate that attention to preanalytic transport and processing issues can assist in minimizing this issue. (Arch Pathol Lab Med. 2008;132:16661671) last comprehensive assessment of overall laboratory performance with critical values, to our knowledge, was a survey published in 2002 as a part of the CAP Q-Probes program (a voluntary quality improvement program).4 This survey of 623 institutions demonstrated that the critical value systems in place at various institutions were highly variable and costly in terms of time and labor expended. In the 5 years since the publication of the Q-Probes survey, critical value reporting has received increased attention. The Joint Commission has mandated the improvement of critical value reporting as part of national patient safety goal 2 for the years 2005 through 2008, and the CAP has raised the prole of critical value reporting with inclusion of new critical valuerelated items in the CAP checklists. Herein, we provide the results of a survey assessing the current state of operational, technologic, and compliance issues involving critical value reporting. In the current survey, problems with outpatient critical value reporting were reported by the majority of respondents as their most difcult obstacle to success. Here, we discuss strategies and procedures that can improve this problematic issue. In addition to procedural and operational strategies, another important consideration is the unique preanalytic variables inherent in outpatient laboratory testing, particularly for potassium and glucose values. We demonstrate that improvements in the packaging and transport of specimens can have a tangible effect on the number of critically elevated plasma potassium values. MATERIALS AND METHODS Survey Construction
Using the SurveyMonkey (SurveyMonkey.com, Portland, Ore) online survey-generation tool, an online survey consisting of questions relating to the practice of reporting critical values was developed by the authors. Questions were chosen from lists of questions submitted to the American Association for Clinical Chemistry (AACC) by the faculty that presented the June 5, 2007,
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Table 1.

Critical Values Survey: Policies and Procedures

Response, Response, No. % (N 731)

Question and Answer Options

1. What nomenclature does your laboratory use to describe critical test results? Panic values Critical test results (or critical values) Other (please specify) 2. Are critical value ags used in your computer system identical to those that are reported to caregivers? Yes No 3. For each test on your critical value list, have you compared your critical values to national norms? Yes No 4. Do you have a policy on how to manage repeat critical values? Yes No

14.2 78.1 7.6

104 571 56

92.1 7.9

673 58

77.4 22.6

566 165

70.2 29.8

513 218

audio conference entitled Improving the Reporting of Critical Test Results. At the end of the survey, participants were asked to voluntarily provide their e-mail addresses. The survey was supported by an educational grant from Siemens Medical Solutions Diagnostics (Tarrytown, NY). A list of current Clinical Laboratory News subscribers, who had provided e-mail addresses to AACC and had not opted out of receiving e-mail from the organization, was generated from the AACC database. On May 17, 2007, an email requesting participation in the survey was sent to 19 132 Clinical Laboratory News subscribers. Survey participants were given 8 working days to complete the survey. No follow-up emails were sent. The AACC received 731 survey responses, for a response rate of 3.82%. Of these 731 respondents, 677 (92.6%) provided unique e-mail addresses, and 92.9% (629/677) of these e-mail addresses could be used to identify the location and the hospital system of the participant. Thus, despite the low overall response rate (3.82%), we were able determine that the survey responses represented more than 350 different hospitals and hospital systems, including representation from all regions of the country and from 10 of the top 20 hospitals listed in US News and World Report.5 Just 5% of e-mail addresses were for generic Internet service providers (eg, AOL, Yahoo) and could not be used to identify the individual hospital, 2.5% of e-mail addresses were from reference laboratories, and 1% of e-mail addresses were from other corporations (eg, regulatory agencies). All of the responses were included in the survey results presented here.

light of the recent Joint Commission distinction between critical tests (those tests always requiring rapid communication of results) and critical values, we believe that the best term is critical values (rather than critical test results) because it is unlikely to be confused with critical tests. In addition, with the increasing proliferation of electronic medical record formats, it is important that those result ags that are reported in the clinical information systems retain the laboratorys critical value designation. Doing so reinforces the concept of critical values and permits those life-threatening values to attract the attention they require in the clinical information system. Thus, a critically high potassium value of 7.5 should reect that this result is a critical value and be agged as such in the clinical information system. Of the survey respondents, 92.1% indicated that critical value ags used in their laboratory computer system are identical to those that are reported to caregivers. The validation of critical value lists, by comparison with national norms, is an important component of a critical value program.4,6,7 Moreover, meeting the standard of care for critical value reporting is important in medicolegal proceedings involving critical values.8 In the current survey, 22.6% of respondents indicated that they had not compared their critical value lists with national norms. In a recent Q-Tracks study,9 it was reported that the practice of mandatory notication to caregivers of repeat inpatient critical values was associated with improved overall performance in critical value reporting as compared with those institutions that had a policy not to call back repeat critical values. The authors9 suggested that this may reect the increased vigilance that may be inherent in the approach of calling back all critical values, even repeat critical values. In the present survey, 70.2% of respondents had policies in place to prevent the callback of repeat critical values. These laboratories will need to assess whether their policy is appropriate given the Q-Track data that suggest this policy may result in worse performance. It is also difcult to determine whether clinicians appreciate the subtlety of such policies. Clinicians may not fully understand why certain values are not called, and that can lead to adverse consequences if treatment is delayed. There may be value in the rapid communication of repeat critical values because the laboratory does not have the clinical details and cannot know whether the repeated result is expected or unexpected. In addition, operationally, it is simpler in practice to call back all life-threatening critical values. Critical Value Reporting: Reporting Survey responses pertaining to operational aspects of critical value reporting are presented in Table 2. Respondents indicated that the predominant personnel involved in making the phone call to the responsible caregiver are the laboratory technologists (91.2%). Although callback has traditionally been performed by the technologist performing the test,4 the increased prole and operational considerations of critical callback has led some laboratories to form call centers to centralize critical value callback. In the present survey, 17.8% of laboratories reported that they used a call center to handle critical callbacks. It is apparent from the survey responses that many of these call centers are staffed, in part, with laboratory technologists. The ability to contact the responsible, licensed clinician
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Data Collection and Analysis

All data were obtained from reports generated from SurveyMonkey. The data were exported to Access/Excel (Microsoft, Redmond, Wash) for analysis.

RESULTS Critical Value Reporting: Policies and Procedures The results of survey questions regarding specic policy and procedure issues are presented in Table 1. The nomenclature for critical values has changed during the past 30 years from the original classication as panic values. The panic value label is still reportedly used in 14.2% of respondent laboratories. The term critical values or critical test results was reportedly used by 78.1% of respondents. In
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Table 2.

Critical Values Survey: Reporting

Response, Response, No. % (N 731)

Table 3. Critical Values Survey: Documentation/Monitoring

Question and Answer Options Response, Response, No. % (N 731)

Question and Answer Options

1. When a critical value is recognized, who makes the call to the appropriate caregiver? (check all that apply) Laboratory technicians/technologists Call center Lab manager/laboratory director Other (please specify) 2. Who receives the call when your laboratory reports out a critical value? (check all that apply) The patients physician The hospital oor/clinic where the patient is located A dedicated nurse or nurse manager Other (please specify) 3. Does the laboratory track down patient phone numbers to assist physicians in relaying calls to patients? Yes No 4. Do you use any wireless technologies to report out critical values? Yes No 5. When do you report the critical values that are found during shift 2 or 3? (check all that apply) During the shift in which the critical value is found Later that night The next day Other (please specify)

91.2 17.8 7.5 6.6

667 130 55 48

1. Do you document the read-back of critical value result information? Yes No Answered question, n Skipped question, n 2. Do you measure the time from result availability to the time that the responsible caregiver is notied? Yes No

90.7 9.3

661 68 729 2

75.4 57.7 62.4 21.3

551 422 456 156

76.2 23.8

557 174

Table 4.
42.5 57.5 311 420

Greatest Obstacle Faced by Laboratory

Obstacle Responses % of Total

8.6 91.4

63 668

Providers not returning calls or pages Getting person to accept result Reporting to covering physicians Incorrect provider contact information Caregivers unwilling to read back Placed on hold awaiting caregiver Too long a list of critical values Reporting interrupts technology work ow Discharged patients Total

365 27 24 23 21 18 5 4 2 489

74.6 5.5 4.9 4.7 4.3 3.7 1.0 0.8 0.4 100

92.9 1.0 9.7 13.0

679 7 71 95

is an essential aspect of the critical value reporting process. Reponses to the survey indicated that most sites used a combination of calling the ordering location (57.7%), calling the patients physician (75.4%), and calling the nurse or nurse manager (62.4%). In addition, 42.5% of laboratories indicated that they provide patient phone-contact information to the responsible caregivers to assist the caregivers in contacting the patient. The use of wireless (pager) technology to report critical values has shown promise in improving the process of critical value reporting.1012 In the present survey, 8.6% of respondents indicated that they used wireless technologies to assist in the reporting of critical values. Critical values that occur on the evening or night shift of a laboratory may be challenging to communicate because of laboratory stafng and provider availability. Of the respondents, 92.9% indicated that critical values occurring during shift 2 or 3 are reported during the shift in which the critical value is found, in the same manner as a day shift critical value. Of the respondents, 9.7% indicated that some or all outpatient critical values are reported the following day. Critical Value Reporting: Documentation and Monitoring Survey responses regarding documentation and monitoring of critical values are presented in Table 3. The readback of critical values (having the caregiver write down and read back the critical value information) has been ad1668 Arch Pathol Lab MedVol 132, October 2008

vocated as a potential means of improving patient safety,13 and is part of the accreditation requirements for both the Joint Commission and the CAP.2,3 In the present survey, 90.7% of respondents indicated that they documented the read-back of the critical value. Another important component of critical value monitoring is measuring the time from critical result availability to the time the responsible clinician is notied. In the present survey, 23.8% of respondents indicated that they did not measure this key time period. The lack of measurement and monitoring of this essential aspect of critical values prevents documentation of compliance and is an impediment to performance improvement. Critical Value Reporting: Obstacles to Success Survey respondents were asked to provide their biggest obstacle to critical value reporting success. These responses are summarized in Table 4. Outpatient providers not returning laboratory calls or pages was the most commonly cited obstacle, with 74.6% of respondents indicating this issue. Other issues included getting a person to accept the results (5.5%), reporting the results to cross-covering physicians (4.9%), incorrect provider contact information (4.7%), caregivers unwillingness to read back the critical value information (4.3%), and being placed on hold awaiting the caregiver (3.7%). The responses clearly indicated that the reporting of outpatient critical values is the major obstacle to success for most centers. An essential component to any critical value approach is, therefore, improving the availability and responsiveness of outpatient physician groups. A complementary approach that can be carried
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Outpatient potassium values before and after changes to specimen transport and packaging. The percentage of potassium values greater than 5.0 mEq/L (left axis) and the percentage of potassium values greater than 6.0 mEq/L (right axis) are plotted versus time. On March 1, 2006, changes were implemented to eliminate the send-on-ice requirement for hemoglobin A1c testing.

out concurrently is to ensure that false-positive outpatient critical values are reduced as much as possible. Reducing False-Positive Outpatient Critical Values One of the most common outpatient critical values is plasma potassium. At our institution, potassium critical values account for nearly one third of all outpatient critical values.14 In late 2005 and early 2006, the chemistry laboratory became aware of complaints from outpatient providers regarding what the clinicians believed to be falsely elevated potassium. These patients all had blood drawn at outpatient locations. Following notication of the physician, many patients had blood redrawn, and the potassium levels were found to be within the reference range. The laboratory investigated individual cases, and in many instances, there was no apparent issue that could be identied (eg, hemolysis, order of draw, delayed transport). Upon further investigation, the laboratory noted that many of the high potassium ndings also had a co-ordered hemoglobin A1c (HbA1c). The HbA1c test was specied to be drawn in a potassium-EDTA purple-top tube and transported on ice to the laboratory. An order-of-draw error (from the purple-top contaminating the green-top tube) was effectively ruled out by investigating several instances and demonstrating that the plasma calcium level in the green top was in the expected range. In prior cases of order-of-draw errors, divalent cations in the green-top tube, such as calcium, were precipitously lowered because of the presence of the chelator
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EDTA. The laboratory noted that tubes for each patient were packaged together in the same Ziploc bag, such that the ice surrounding the purple-top tube was adjacent to the green-top tube. Transport times for these outpatient clinics were 2 to 3 hours, such that the green-top tube was exposed to cold during the entire transport period. The laboratory suspected that the tube from which the potassium was assayed (the green-top tube containing lithium heparin) was effectively being iced during transport because of its proximity to the ice that was sent along with the purple-topped, HbA1c tube. Icing an unspun lithiumheparin plasma blood-collection tube has been demonstrated to raise the plasma potassium level.15,16 This may be caused by cold inhibition of glycolysis, which provides the energy for the transport of potassium into the red blood cells. Passive potassium leakage out of red blood cells is then unchecked and raises the plasma potassium level. We then reevaluated the send-on-ice requirement for HbA1c and determined there was no difference in the HbA1c levels for an iced sample versus a noniced specimen (data not shown). The laboratory eliminated the send-onice requirement for HbA1c specimens and communicated this to all outpatient phlebotomy locations. As shown in the Figure, within several weeks, we observed a sustained 20% to 40% drop in the number of outpatient potassium critical values ( 6.0 mEq/L) and elevated potassium ( 5.0 mEq/L). To validate this observation, we serially measured paired, unspun, whole blood samples (in lithium-heparin collection tubes) and measured the potassium
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levels when stored at either 4 C or room temperature. Within 1 to 2 hours, we noted an approximately 0.6 mEq/ L increase in the 4 C sample as compared with the roomtemperature sample (data not shown). COMMENT In this report, we surveyed the current practices for critical value reporting in the United States. We demonstrate considerable heterogeneity in laboratory compliance with procedures, monitoring, and documentation. The heterogeneity of responses likely reects the adjustment to the relatively new set of regulatory guidance in this area. Increasing workload in the clinical laboratory makes it important to achieve efcient use of laboratory resources to maximize clinical benets. Critical value reporting extends throughout the entire hospital system. Processes need to be systematic and to generate monitoring data that serve as the substrate for further process improvements. One trend apparent in the survey is the formation of customer service centers that centralize laboratory functions, such as critical callbacks. In the current survey, 17.8% of centers used customer service centers for critical value callback. In the 2002 Q-Probes survey,4 call centers were not identied as being used for critical callback. In that survey, 93.6% of institutions reported that critical callbacks were handled by the person performing the test or the section supervisor. Centralizing callback removes the burden of distracting phone calls from the multitasking laboratory technologists performing testing. In our view, this is the preferred arrangement for large laboratories because it permits simplied tracking and documentation of critical values and allows the performing technologist to focus on accurate and rapid production of test results. The stafng of the customer service center should include technologists or other well-trained staff. Critical value calls often generate questions from nursing staff and physicians, and the technologist is in the best position to answer those queries effectively. Call center staff must have access to appropriate computer applications and information sources (clinical information systems, scheduling, call lists, provider directories) to optimally complete their task. A further advantage of the call center approach is that written policies for making critical value calls (including turnaround times, locations, escalation, documentation) can be more easily developed and maintained. At most centers, critical value callbacks will not consume all of staff members available time. For this reason, it is important to build up a critical mass of activities for the nascent call center. This may include items such as outreach client services, faxing reports, and courier dispatch. One strong recommendation would be to use callback modules that are present in most laboratory information systems; 23.8% of survey respondents are not currently monitoring the time from result availability to communication of the result to the responsible clinician. This suggests that these centers may not be using a laboratory information system (LIS) callback module because such modules generally automate the production of reports, facilitating monitoring. In addition, aggregating the data in the LIS permits the laboratory to use its reporting tools to create custom management reports to ensure that critical value outliers are followed up appropriately. When implementing an LIS callback module approach, it is important to standardize LIS test codes and critical value ranges across the enterprise to ensure consistent handling of crit1670 Arch Pathol Lab MedVol 132, October 2008

ical values and to simplify maintenance of the underlying rules that must be built into the LIS. Use of an LIS callback module is an important step in setting up a customer service center because the module can serve as the foundation for the call center by providing standardization and centralization of critical callback functions. The survey identied outpatient critical values as the major obstacle to success in critical value reporting, with more than 70% of respondents specically identifying difculties in outpatient critical value communication as the major obstacle to success. Improving the reporting of outpatient critical values needs to be a priority of all centers. If the proper denition of critical values is being used (with the patient being in imminent danger if they do not receive treatment), then the risk for an outpatient is amplied considerably because they are not necessarily available to contact or within reach of medical care. We have used our online safety reporting system to document and ensure responses to gaps in coverage and to improve the responsiveness of our outpatient providers. Each delayed outpatient critical value should be viewed as an opportunity for process improvement. In addition to improving the operational aspects of outpatient critical value reporting, laboratories need to assess preanalytic steps that may be leading to false-positive critical values. In our case, attention to these critical values led to an examination of the packaging and transport system and pointed out a simple solution that eliminated a major outpatient care issue with numerous falsely elevated potassium. Given the complexity of outpatient care, it is essential to analyze critical values that arise in the outpatient areas. Efforts to minimize these false critical values are highly rewarding because the time to locate the provider (and potentially the patient) to report the value is a signicantly greater task than for inpatients. An essential requirement for success in critical value reporting is engaging the outpatient providers in the program. Integral in the Joint Commission critical value statement is that the laboratory is responsible for ensuring not only that someone is contacted but also that the appropriate, responsible, licensed caregiver is contacted. The Joint Commission has recently claried this reporting requirement to indicate that the reporting of a critical result does not need to be directly to the licensed caregiver. The reporting of a critical value result to an authorized agent of the responsible licensed caregiver will meet the requirement only if the organization demonstrates that this action introduces no signicant additional delays in getting the test result to the responsible, licensed caregiver. The documentation of communication at the practice is an important component in closing the loop for outpatient critical values. The potential for technological solutions, including pagers and other wireless devices, to improve the process of critical value reporting is evident in several reports.1012,17 An important component in any such system is the ability of the automatic reporting system to reliably determine the identity of the responsible provider for a given result. At larger medical centers, this can be a challenging task because of multiple cross-coverage lists, tests ordered by consultants, and patient transfers to different locations or to different care teams. Poor communication is at the root of many serious medical errors. An electronic reporting system could potentially create dangerous delays in communication if not properly implemented. With many peoCritical Value ReportingDighe et al

ple collaborating on a single patients care, it is imperative for an organization to be able to determine rapidly which member of the team should be contacted with urgent ndings, such as critical values. The infrastructure and policies to create such roles must take place at the hospital organizational level because at most institutions there is a large and diverse group of physicians who collaborate on an individual patients care. Many institutions are starting to dene specic roles within the health care team, including the responding clinician, the physician member of the team who is available and responsible for critical values and other urgent situations. Denition of these roles for inpatient and outpatient care is an important task for each health care organization.
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5. RTI International. Americas best hospitals 2006 and top cancer hospitals US News & World Report. July 17, 2006. 6. Kost GJ. Critical limits for urgent clinician notication at US medical centers. JAMA. 1990;263:704707. 7. Kost GJ. Table of critical limits. MLO Med Lab Obs. 2004;36:67. 8. Dighe AS, Makar RS, Lewandrowski KB. Medicolegal liability in laboratory medicine. Semin Diagn Pathol. 2007;24:98107. 9. Wagar EA, Stankovic AK, Wilkinson DS, Walsh M, Souers RJ. Assessment monitoring of laboratory critical values: a College of American Pathologists QTracks study of 180 institutions. Arch Pathol Lab Med. 2007;131:4449. 10. Kuperman GJ, Teich JM, Tanasijevic MJ, et al. Improving response to critical laboratory results with automation: results of a randomized controlled trial. J Am Med Inform Assoc. 1999;6:512522. 11. Poon EG, Kuperman GJ, Fiskio J, Bates DW. Real-time notication of laboratory data requested by users through alphanumeric pagers. J Am Med Inform Assoc. 2002;9:217222. 12. Tate KE, Gardner RM, Weaver LK. A computerized laboratory alerting system. MD Comput. 1990;7:296301. 13. Barenfanger J, Sautter RL, Lang DL, Collins SM, Hacek DM, Peterson LR. Improving patient safety by repeating (read-back) telephone reports of critical information. Am J Clin Pathol. 2004;121:801803. 14. Dighe AS, Rao A, Coakley AB, Lewandrowski KB. Analysis of laboratory critical value reporting at a large academic medical center. Am J Clin Pathol. 2006;125:758764. 15. Seamark D, Backhouse S, Barber P, Hichens J, Salzmann M, Powell R. Transport and temperature effects on measurement of serum and plasma potassium. J R Soc Med. 1999;92:339341. 16. Sinclair D, Briston P, Young R, Pepin N. Seasonal pseudohyperkalaemia. J Clin Pathol. 2003;56:385388. 17. Bates DW, Pappius E, Kuperman GJ, et al. Using information systems to measure and improve quality. Int J Med Inform. 1999;53:115124.

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