R E V I E W S & A N A LY S E S Reducing Errors in Blood Specimen Labeling: A Multihospital Initiative ABSTRACT INTRODUCTION Patient blood specimen identification is Background critical for quality patient care. Misiden- Accurate patient identification and correct specimen labeling are critical patient safety tified specimens can result in delayed issues in healthcare. Inaccurately identified specimens can lead to delayed or wrong diagnosis, additional laboratory testing, diagnoses, missed or incorrect treatments, blood transfusion errors, and additional treatment of the wrong patient for the laboratory testing. The Joint Commission has implemented two hospital National wrong disease, and severe transfusion Patient Safety Goals related to patient identification: (1) use at least two patient identi- reactions. Specimen identification errors fiers when identifying patients, and (2) label containers used for blood in the presence have been reported to occur at rates of the patient.1 The College of American Pathologists includes patient and sample of 0.1% to 6.5%. From August 2009 identification as one of its five top patient safety goals.2 Literature reviews have identi- through October 2010, the Pennsylvania fied specimen labeling error rates of 0.1% to 6.5%.3-6 Patient Safety Authority sponsored a multihospital blood specimen labeling In 2010, the Centers for Disease Control and Prevention’s Laboratory Medicine Best collaborative. The Authority worked Practices Team published the third phase of an ongoing effort by the Division of Labo- with the hospitals to measure blood ratory Science and Standards to develop new systematic evidence review and evaluation specimen labeling error rates, document methods for identifying pre- and postanalytic laboratory medicine practices that are hospital-specific interventions to reduce effective at improving healthcare quality.7 A key objective of this initiative was to exam- the labeling error rate, and measure ine the utility and feasibility of including unpublished assessments or studies as part of the outcome of the interventions. At the the systematic evidence reviews of laboratory medicine practices. There was enough evi- end of the collaborative, there was a dence from published and unpublished sources to support the following best practices 37% aggregate statistically significant for patient specimen identification: the use of barcoding systems versus no barcoding decrease in specimen labeling errors. (eight studies, log odds ratio = 2.45; 95% CI 1.6–3.3) and the use of point-of-care- This study discusses the collaborative’s testing barcoding systems (five studies, odds ratio 6.55; 95% CI 3.1–14.0). objectives, methods, and outcomes. However, solutions to the specimen identification problem are not easily accessible to (Pa Patient Saf Advis 2011 Jun;8[2]:47-52.) hospitals. Not all healthcare facilities can afford barcode systems, and even in those facilities that have one, many blood draws and labeling activities are performed in units that do not have access to this technology. For example, in a blood specimen labeling collaborative sponsored by the Pennsylvania Patient Safety Authority, several participating facilities used barcode systems, but staff performing venipunctures in the emergency departments (ED) or neonatal intensive care units did not always have access to the systems. The challenge, then, was to discover if other interventions could improve the specimen labeling error rates within the Authority-sponsored collaborative. Blood Specimen Labeling Collaborative Objectives The goal of the collaborative was a 50% reduction in blood specimen labeling errors over 18 months. The Authority identified the following scope of activities: — Educate participants (i.e., reliable design, Just CultureTM, human factors engineering, event investigations) — Provide participants with data collection and event investigation tools — Provide ongoing aggregate data analysis for participants — Be available for participant mentoring and coaching — Facilitate interhospital communication and collaboration to reduce blood specimen labeling errors MATERIALS AND METHODS Participants Hospital representatives in the northeast region of Pennsylvania were invited to partici- pate in the Authority collaborative. Inclusion criteria were reporting blood specimen Vol. 8, No. 2—June 2011 Pennsylvania Patient Safety Advisory Page 47 ©2011 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S labeling errors through the Authority’s acceptance. Types of mislabeling included Authority were those related to technol- Pennsylvania Patient Safety Reporting wrong, missing, incomplete, or illegible ogy, communication, education, staffing, System (PA-PSRS), submitting monthly labels. Samples that were properly labeled workflow, and leadership. laboratory reports to an Authority analyst, but not accepted for processing for other reasons (i.e., insufficient blood in tube, In September 2009, the Authority devel- and investigating mislabeling events using presence of hemolysis) were not included. oped and distributed a standard event a standardized event investigation tool (see the tool at http://patientsafetyauthority. Point-of-care testing was not included. investigation tool, which guided collab- org/EducationalTools/PatientSafetyTools/ Hospitals could report denominator data orative participants through the event Pages/home.aspx). Eight acute care hos- as any of three variables, depending on investigation process and asked investiga- pitals and one rehabilitation hospital the availability of data at each facility: tors to identify contributing factors for participated in the collaborative. Each (1) number of venipunctures, (2) number each error. Many collaborative participants hospital assembled a team to participate of accessions, or (3) number of tests. For were not clinical personnel familiar with in the collaborative, and team members the statistical analysis, denominator data included laboratory directors, phlebotomy was combined to represent total number supervisors, patient safety officers, and of error opportunities. PARTICIPATING HOSPITALS risk management, quality and perfor- Blood specimen labeling error data was AND COLLABORATIVE mance improvement, and regulatory collected monthly from August 2009 LEADERS compliance personnel. Hospitals selected through October 2010. Baseline error Allied Services Rehabilitation Center collaborative participants based on a vari- rates were calculated as the number of Viewmont Medical Laboratories ety of factors, such as care areas studied, blood specimen labeling errors per 1,000 Gene Mushak, Patient Safety Officer leadership support of the project, and opportunities for error after 3 months of Berwick Hospital Center resources available for the time and effort Joseph V. Bazzarri, MBA, MT (ASCP) data collection. Education was provided commitment. Because of hospital diver- from August 2009 through May 2010. Easton Hospital sity, the Authority allowed each hospital Various process improvements were imple- Georgiann Gerlach, RN, BSN, Risk to select the care areas for study. Hospital mented at each facility from April through Manager/Patient Safety Officer collaborative participants decided whether July 2010. Endpoint error rates were cal- Shelly Williams, Laboratory Support to engage the whole hospital or only cer- Service Coordinator tain areas, according to their perception culated for August through October 2010 of the greatest problems in blood speci- and compared to baseline error rates at the Geisinger Medical Center, Danville facility level and in the aggregate. Exclusion- Janine Alexis, MS, MT (ASCP) men labeling. Five hospitals engaged the entire facility in the collaborative, and the ary criteria included failure to implement Geisinger Wyoming Valley Medical remaining hospitals chose specific areas: improvement interventions, failure to Center ED, ED and intensive care area, progres- report mislabeled specimens through Barbara Booth, MT (ASCP), sive intensive care unit, and medical PA-PSRS, and failure to submit laboratory Laboratory Service Improvement data to the Authority; three facilities were Coordinator intensive care unit. Authority representa- tives included the director of educational excluded from the data analysis. Lehigh Valley Health Network programs, the regional patient safety liai- Kristy Lowery, BS, RN, CPHQ, CPHRM son, and a patient safety analyst. Lori Izzo, BSN, RN, Patient Safety Education Coordinator In September and October 2009, the Data Sources Authority provided educational sessions Sacred Heart Hospital Diane Guerrero, MT (ASCP), Director Authority and collaborative members about reliable design, Just CultureTM, and of Laboratory Services specified numerator data as the number human factors engineering. Subsequently, of blood specimen tubes not accepted for Pocono Health Systems each hospital team mapped its blood speci- Joanne Reinitz, Manager Regulatory testing because of labeling issues. Collab- men labeling process, assessed the process Compliance orative participants entered case data (i.e., for compliance through direct observa- Amy Yoblonski, MT (ASCP), events) into PA-PSRS on a continual basis as errors were identified, and the Author- tion, and presented an overview of the Laboratory Supervisor ity analyst validated the monthly totals for processes to the rest of the collaborative Lois Wahrmann, Outpatient/Client participants. This was an opportunity for Services Supervisor each facility against quality assurance data generated by the hospitals’ phlebotomy the collaborative participants to identify Wyoming Valley Health Systems laboratories. Mislabeled blood specimen barriers to labeling compliance that Joan DeRocco, MS, RN, CPHRM, samples were defined as those not meet- transcended specific care areas and orga- CAN, Director, Patient Safety Services ing the same local standards for sample nizations. Common barriers noted by the Page 48 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority root-cause analysis; therefore, the Author- Table 1. Event Investigations Contributing Factor Data ity held an additional training session DOMAIN FACTOR NUMBER regarding event investigation in January Organizational Procedures not followed 256 2010. This training session included clini- No dedicated phlebotomy 3 cal scenarios and role-playing that allowed collaborative participants to gain familiar- Lack of policies/procedures 2 ity with techniques related to respectful Unclear policies/procedures 2 investigation of errors, including gaining Other 1 trust of staff, allowing for gracious space Total 264 during an interview, refraining from the Work Environment Distraction/interruptions 70 use of individual blame, and using active Equipment malfunction 7 listening skills. Inadequate equipment availability 6 Authority representatives analyzed the Limited access to patient information 4 data monthly and reconciled any discrep- High noise 3 ancies found between PA-PSRS reports Poor lighting 2 and laboratory data. Quarterly analysis Other 9 was provided to each facility. Addition- Total 101 ally, the Authority organized biweekly Task Factors Emergency situation 22 conference calls, tapering to monthly, Inexperienced staff 15 in which interventions, successes, barri- ers to success, and mutual support and Training issues 9 encouragement were exchanged. Several Inadequate resident supervision 7 guest speakers were invited to partici- Cardiac/respiratory arrest 5 pate in these calls, including laboratory Order entry problem 4 directors and phlebotomy supervisors Other 4 with direct experience in specimen label- Total 66 ing projects. Authority representatives Team Factors Unplanned workload increase 32 were available by means of e-mail and Communication 15 telephone consultation for coaching or Shift change 3 mentoring throughout the duration of Cross-coverage 2 the collaborative. An additional goal of the collaborative was to develop capable Change of service 1 and confident mentors within the par- Other 1 ticipating hospitals who could become Total 54 resource personnel for other Pennsylvania Staff Factors Issue related to proficiency 6 healthcare facilities that may also want to Agency staff 5 address blood specimen labeling errors. Float staff 5 Insufficient staff 5 Event Investigation Data Issue related to impairment 4 By October 2010, the Authority had col- Inadequate system for covering 3 lected and analyzed 485 investigations. patient care Facilities reported 520 different contribut- Scheduling issues 1 ing factors associated with the mislabeling Total 29 errors (see Table 1). Patient Characteristics Lack of understanding 3 The top three contributing factors were Language barrier 1 (1) procedures not followed (n = 256), Lack of family cooperation 1 (2) distractions and interruptions (n = 70), Other 1 and (3) unplanned workload increase Total 6 (continued on page 51) Grand Total 520 Vol. 8, No. 2—June 2011 Pennsylvania Patient Safety Advisory Page 49 ©2011 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Table 2. Summary of Blood Specimen Labeling Collaborative Barriers and Interventions DOMAIN BARRIERS INTERVENTIONS Technology Technology issues with label printing Changed to new laboratory IT system Lack of strong wireless signal throughout Installed laboratory printers for labels in care areas facility Implemented “hold” labels with patient identification Collection technology used only by versus patient chart labels phlebotomy staff but nursing staff also collect Investigated label printing option to add blanks between blood specimens in some locations patient label sets Lack of financial resources for information Standardized location of all labels technology (IT) equipment updates Created a bidirectional interface between multiple IT Inability to print blank labels between patient systems label sets Communication Communication issues between nursing and Held monthly meetings with laboratory and nursing staff laboratory staff Addressed staff printing multiple sets of labels at once Lack of teamwork and cooperation across Shared case studies with staff responsible for laboratory service lines blood specimen draws and labeling Facilitated transferring labels with patients transferred to another department; ensured all labels followed patient to next care setting Implemented a patient-specific binder system for labels Education Lack of knowledge regarding phlebotomy Implemented mandatory competency testing for policies/procedures specimen labeling process Physicians ordering all labs STAT to get timely Updated laboratory handbook; provided electronic results version to all employees Educated staff regarding proper patient identification procedures Addressed printing of multiple label sets at same time Educated physicians regarding STAT orders Staffing High turnover in laboratory staff Leveled work loads Short-staffed; phlebotomists performing 45 to Implemented new processes for student phlebotomists 50 morning draws from a normal high of 25 Permitted nursing home phlebotomists to work overtime morning draws in mornings to assist with blood specimen collection Float pool staff not always aware of proper specimen labeling procedures Workflow Lack of care area specific procedures that Developed mini emergency department (ED) registration expedited workflow to make labels available at time of blood draw in ED Created patient folders to hold labels; patients to give labels to person drawing blood Added third printer to ED to facilitate label printing Began immediate bedside labeling of peripherally inserted central catheter line draws Started hourly batch printing of labels to smooth workflow Leadership Lack of management support Created dashboard/scorecard for collaborative team Lost momentum for collaborative work; other Used dashboard for laboratory draws to focus staff initiatives with higher priority attention on labeling issues Loss of clinical leadership; difficult to sustain Increased awareness via Pennsylvania Patient Safety compliance with improved procedures Authority-sponsored posters and pins Page 50 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority (continued from page 49) within these domains to improve speci- change in pre- and postintervention blood men labeling accuracy. specimen labeling error rates (see Table 3). (n = 32). This data indicates that the development of strategies to monitor At the facility level, the decrease in blood RESULTS specimen labeling errors ranged from compliance with existing labeling proce- dures, as well as strategies to maintain 57% to 84%. However, one hospital expe- Error Data rienced a 67% increase in errors. compliance in the face of interruptions Of participating hospitals, six acute care and distractions, may be a worthwhile From January through March 2010 (see hospitals submitted data about more endeavor for hospitals. Figure), the aggregate number of error than 1.3 million opportunities for error reports peaked. Thereafter, a steady (i.e., number of venipunctures, the Barriers and Interventions decline in the aggregate number of error number of accessions, and the number The collaborative participants imple- reports continued through June 2010, of tests). Three hospitals were excluded mented more than 20 interventions followed by another slight peak in July from data analysis because interventions between April and July 2010. They also and August 2010, ending with a mean to reduce blood specimen labeling errors identified barriers to improvement that decrease in error rates of 37%. were not implemented. Baseline error they felt affected their hospitals’ blood rates for the hospitals ranged from 0.1 to Overall, there was a 37% statistically specimen labeling error rates (see Table 2). 4.1 mislabeling errors per 1,000 oppor- significant decrease in blood specimen There were six major categories of barriers tunities for error. Postintervention error labeling errors in the collaborative over to blood specimen labeling accuracy: (1) rates ranged from 0.0 to 1.3 mislabeling the 18-month period (95% CI; p < 0.04). technology, (2) communication, (3) educa- errors per 1,000 opportunities for error. A A sensitivity analysis was performed by tion, (4) staffing, (5) workflow, and (6) test of two proportions (z-test) was run to removing data from each of two facilities leadership. The collaborative participants determine the statistical significance of the with the largest denominator data to test implemented a number of interventions whether the significant decrease observed Table 3. Reduction in Facility-Specific and Program-Wide Error Rates POSTINTERVENTION BASELINE ERROR RATES ERROR RATES (August through (August through HOSPITAL-SPECIFIC FACILITY October 2009) October 2010) CHANGE CHARACTERISTICS Rate per Rate per 1,000 LCL UCL 1,000 LCL UCL A 4.1 1.8 6.4 0.8 0.0 1.7 -81%* One care area of focus; adequate leadership support; targeted interventions B 0.6 0.4 0.9 0.3 0.1 0.4 -57% Multiple care areas of focus; adequate leadership support; targeted interventions C 0.1 0.0 0.2 0.0 0.0 0.0 -84%* Multiple care areas of focus; adequate leadership support; targeted interventions D 2.5 1.6 3.3 0.7 0.4 1.1 -71%* Multiple care areas of focus; adequate leadership support; targeted interventions E 3.2 1.5 4.9 1.3 0.2 2.4 -61% One care area of focus; adequate leadership support; targeted interventions F 0.3 0.2 0.4 0.5 0.3 0.7 67% One care area of focus; inadequate leadership support; targeted interventions Pooled 0.44 0.36 0.52 0.28 0.21 0.34 -37%* Mean *p < 0.05. Test of two proportions (z-test). Vol. 8, No. 2—June 2011 Pennsylvania Patient Safety Advisory Page 51 ©2011 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Figure. Collaborative Aggregate Specimen Labeling Error Rate efficacy of sustained attention and imple- mentation of interventions is sound, the 0.8 ERROR RATE PER 1,000 ERROR OPPORTUNITIIES 0.73 effectiveness of this approach cannot be 0.7 0.64 determined through this study. 0.6 Lack of standardization of the interven- 0.50 0.5 tions could be viewed as a limitation 0.51 0.44 0.40 0.39 0.41 0.38 of the study. However, the Authority 0.4 0.42 recognized that each of the participating 0.3 hospitals had unique problems in par- 0.32 0.21 0.2 ticular care areas with different patient 0.23 0.1 0.17 0.19 populations and had varying amounts of resources available for improvement. 0.0 The hospitals with statistically significant AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT decreases in error rates had in common 2009 2010 a sustained focus on the labeling prob- MS11140 lem and adequate administrative and MONTHS leadership support. The single hospital that experienced an increase in labeling in the aggregate was overly influenced by (October 2010), the decline would be even errors underwent a change in leadership the observations at these larger hospitals. more significant (i.e., greater than the in its care area of focus. According to the The aggregate results remained statistically original goal of a 50% decrease in errors). hospital leader for the collaborative, this significant in these two scenarios: 36% Additionally, the statistical significance of resulted in a lack of follow-through with decrease in errors (95% CI; p < 0.01) and the collaborative decline (37%) remained planned interventions, which may have 61% decrease in errors (95% CI; p < 0.01). even after removing data from the two contributed to the increased error rate. facilities with the largest denominators, DISCUSSION individually, from the aggregate pool. CONCLUSION The peak blood specimen labeling error These positive results apply only to the Specimen identification error analysis rates occurred in January 2010 (month 6). hospitals that continued to participate in combined with interventions to reduce This peak likely correlated with increased the collaborative and were able to imple- specimen labeling errors can decrease rates facilitywide focus and attention to blood ment some interventions to decrease the of specimen identification error and con- specimen labeling issues (shortly after edu- blood specimen labeling error rate. tribute to improvements in patient safety. cation by the Authority, when surveillance Compared to the hospitals included Leadership support, sustained attention and reporting efforts were likely to be in the study, those hospitals that were to the labeling issue, and implementation at their highest). If the decrease in error excluded experienced a 20% increase in of interventions to reduce error rates are rates was recognized from the peak (Janu- error rates (not statistically significant) critical components of a specimen labeling ary 2010) to the end of the collaborative (95% CI; p > 0.05). Therefore, while the error reduction program. NOTES 1. Joint Commission. National patient analysis of 147 clinical laboratories. Arch study of quality issues in transfusion safety goals hospital program [online]. Pathol Lab Med 2008 Oct;132(10):1617-22. practice. Arch Pathol Lab Med 1993 Jun; [cited 2011 Jan 18]. Available from Inter- 4. Valenstein PN, Sirota RL. Identi- 117(6):573-7. net: http://www.jointcommission.org/ fication errors in pathology and 7. Snyder S, Liebow E, Shaw C, et al. assets/1/6/2011_NPSGs_HAP.pdf. laboratory medicine. Clin Lab Med 2004 Centers for Disease Control and Preven- 2. College of American Pathologists Labo- Dec;24(4):979-96, vii. tion. Laboratory medicine best practices: ratory Accreditation Program. Patient 5. Howanitz PJ. Errors in laboratory developing systematic evidence review and safety and the library [online]. 2008 May medicine: practical lessons to improve evaluation methods for quality improve- 21 [cited 2011 Jan 18]. Available from patient safety. Arch Pathol Lab Med 2005 ment [phase 3 final technical report Internet: http://www.cap.org/apps/docs/ Oct;129(10):1252-61. online]. 2010 May [cited 2011 Jan 18]. education/lapaudio/pdf/052108_ Available from Internet: https://www. 6. Renner SW. Wristband identification presentation.pdf. futurelabmedicine.org/pdfs/LMBP%20 error reporting in 712 hospitals. A Col- 3. Wagar EA, Stankovic AK, Raab S, Executive%20Summary%20%20YR%20 lege of American Pathologists’ q-probes et al. Specimen labeling errors; a q-probes 3%20Final%20Report.pdf. Page 52 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 8, No. 2—June 2011. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2011 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 http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website 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 An Independent Agency of the Commonwealth of Pennsylvania website 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. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.