Effective practices for the timely and accurate reporting of laboratory

Effective practices for the

timely and accurate reporting

of laboratory testing critical

values

Rapid and accurate communication of critical laboratory test

results is required by the Clinical Laboratory Improvement

Amendments (CLIA) regulations; included in laboratory

accreditation standards; noted as a National Patient Safety

Goal; featured in the World Health Organization's World

Alliance for Patient Safety; and codified in the International

Organization for Standardization standards for medical

laboratories. Improvement in critical value notification is

driven by the assumption that timely reporting will lead to

more timely clinical interventions with improved treatment

outcomes and prevention of co-morbidities. The studies

included in this review assessed the effectiveness of

automated notification systems and call centers to improve the timeliness of critical values reporting.

Summary of LMBP™ Findings and Recommendations

The evidence supporting the use of call centers shows substantial and consistent results in improving

the timeliness of critical value reporting in inpatient care settings, and the Laboratory Medicine Best

Practices Workgroup recommends call centers as an “evidence-based best practice” for improving the

timely reporting of critical values. The evidence, although suggestive, is not sufficient to make an LMBP

recommendation for or against using automated notification systems as a best practice to improve the

timeliness of critical value reporting in inpatient care settings.

About the Interventions and their Comparators

 Automated notification systems are automated alerting systems or computerized reminders

using mobile phones, pagers, email or other personal electronic devices to alert the responsible

healthcare provider(s) about laboratory test critical results. Upon receipt of an automated

notification, the responsible provider acknowledges the critical test result and confirms the

receipt of the alert. If the alert is not acknowledged within a specified timeframe, these systems

typically revert to a manual notification system of the responsible and alternate providers.

Through the Laboratory Medicine

Best Practices (LMBP) Initiative,

evidence-based evaluations are

conducted to identify effective

laboratory medicine practices

associated with improved

healthcare quality outcomes.

The LMBP Workgroup and Expert

Panels provide guidance and

subject matter expertise to the

Centers for Disease Control and

Prevention to complete these

reviews.

wwwn.cdc.gov/futurelabmedicine

o Studies have contrasted the timeliness of automated notification systems’ critical test

result reporting with manual (typically, laboratory personnel) notification systems.

 Call Centers use a centralized unit for the communication of critical laboratory test results via

telephone contact the responsible caregiver. If the responsible caregiver cannot be reached

within a specified timeframe, call centers will attempt to reach alternative caregivers. Twenty

percent of U.S. medical centers have reported using centralized call centers to communicate

laboratory test critical results.

o Studies have contrasted timeliness of call centers’ critical test result reporting with

manual (typically, laboratory personnel) notification systems.

Results from the Systematic Reviews

A total of nine studies met the review inclusion criteria. The estimated effects for both automated

notification systems and call centers consistently and substantially favor the tested practice. All studies

reported positive and statistically significant effects with the exception of one low-powered automated

notification study.

 Five studies assessed the improvement in timeliness of critical results communication associated

with call center systems (2 published and 3 unpublished).

o All call center studies were conducted in the United States

o Results from four of the five studies reporting improvement in timeliness from

implementing call centers could be standardized to a common metric. These results

were generally criterion referenced (e.g., percent of critical results reported within 30

minutes), therefore findings were standardized using odds ratios (mean odds ratio (OR =

22.1; 95% CI=17.1–28.6).

 Translating this result into a common language estimate, the time to report a

randomly selected critical results using a call center will be faster than a

randomly selected and manually reported critical results approximately 88.6%

of the time.

o The use of call centers may require additional communication with laboratory staff

when a responsible caregiver requires additional information that call center staff are

unable to provide. This situation may result in a delay of treatment while the

appropriate laboratory staff member is located.

 Four published studies assessed the improvement in timeliness of critical results communication

associated with automated notification systems.

o These studies were conducted in the USA, Canada, South Korea, Italy, and the Republic

of Singapore.

Valenstein PN, W.E., Stankovic AK, Walsh MK, Schneider F., Notification of critical results: a College of American

Pathologists Q-Probes study of 121 institutions. Arch Pathol Lab Med, 2008. 132(12): p. 1862-1867.

o Results from two of the four studies reporting improvement from implementing

automated notification report could be standardized to a common metric. Meta-

analysis of these results suggest that automated notification systems significantly

improve timeliness (standard difference in means (d) = 0.42; 95% CI=0.2–0.62).

 Translating this result into a common language estimate, the time to report a

randomly selected critical result using an automated notification system will be

faster than a randomly selected and manually reported critical value

approximately 61.8% of the time.

o The electronic audit trail captured by automated notification systems may improve

performance monitoring and evaluation. In addition, the development of automated

notification systems has been observed to lead to a re-examination of critical results

policies and thresholds.

o Automated notification systems may disrupt usual lines of communication, and may

provide too much or too frequent information. The risk of losing back-up contact

information must be properly anticipated. There are also risks for patient privacy

violations, with protected health information being misdirected and/or mobile

communication devices being accessible to unauthorized users.

o Automated notification systems require policies and procedures that mandate two-way

communication and acknowledgment/confirmation of receipt. Policies for routing and

escalation after unsuccessful notification attempts must be in place, and staff must

remain proficient in the use of manual procedures when a technology failure occurs or

escalation requires that laboratory staff revert to manual contacts.

These results are based on a systematic review of all available studies. This systematic review is

supported by contract CB-11-214 from the Centers for Disease Control and Prevention. Battelle

Memorial Institute provided administrative, research and technical support for this review along with

input from a panel of subject matter experts in laboratory medicine and systematic reviews.

Supporting Materials

 Supplementary Data: Evidence summary tables & included studies

 Search strategy

Publications

Liebow EB, Derzon JH, Fontanesi J, Favoretto AM, Baetz RA, Shaw C, Thompson P, Mass D,

Christenson R, Snyder SR, Epner P. Effectiveness of Automated Notification and Customer Service

Call Centers for Timely and Accurate Reporting of Critical Values: A Laboratory Medicine Best

Practices Systematic Review and Meta-Analysis. Clin Chem. 2012; 45(13-14):979-987.

Critical Values Clin Biochem 2012.

Disclaimer

The findings and conclusions are those of the authors and do not necessarily represent the official

position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease

Registry (CDC/ATSDR).

Sample Citation

The content of publications of Laboratory Medicine Best Practices is in the public domain. Citation as to

source, however, is appreciated. Sample citation: Laboratory Medicine Best Practices. Laboratory

Medicine Best Practices. Effective practices for the timely and accurate reporting of critical values

(abbreviated). http://wwwn.cdc.gov/futurelabmedicine/pdfs/CDC_ReportingCriticalValuesSummary.pdf.

Last updated: MM/DD/YYYY

Review completed: February 2012.