What is a Specimen Error?
A Specimen Error is any defect that occurs during the entire testing process, from ordering tests to reporting results, and in any way influences the quality/safety of laboratory services. Tracking specimen errors to identify problems in the process is critical to patient safety as they can lead to injuries, misdiagnoses and delayed or unnecessary treatments.
American Data Network Patient Safety Organization (ADNPSO) analyzed 4 years of data and found specimen events consistently ranked among its highest reported errors with 73.7% of the incidents deemed preventable. This led ADNPSO to develop and launch a 9-month Specimen Focused Study aimed at better understanding why these events happen and how to reduce errors across all stages of the Specimen Process (Pre-analytical, Analytical and Post-analytical). ADNPSO collaborated with Patient Safety and Laboratory experts to create a specimen data collection form and recruited PSO members to join the study. In partnership with the 15 acute care participants, ADNPSO performed aggregate analytics, hosted learning sessions to discuss findings, guided Rapid Cycle PDSAs, and developed detailed Process/Cause Mappings to galvanize improvement activities. Among other successes, ADNPSO participants realized a 147% increase in specimen event reporting during the study and potentially estimated avoidable costs of $420K - $1.04M in just 9 months.
Healthcare literature supported ADNPSO’s internal findings of specimen error prevalence and verified the complexity and risks associated with laboratory processes. Further affirmation for this focused study include:
- Estimations that 60% - 70% of medical decisions are based on laboratory results
- The majority of errors occur in the Pre-analytical Phase
- Post-analytical errors most often result in major patient harm
- Redraws and recollections contribute to financial waste and patient dissatisfaction
- The majority of these errors are preventable
A large percentage of medical decisions, if not most, are based on laboratory results. These decisions are dependent on the normals, abnormals, and critical values. This requires collaboration, coordination and communication across multiple disciplines to ensure specimens are correctly ordered, collected, tested and interpreted, resulted, and acted upon in a timely manner.
The goal of the study was to establish baseline performance and quantify the opportunity to decrease high-volume/high-risk specimen errors. To accomplish this goal, ADNPSO was committed to:
- Better understand the causation of specimen errors through data collection and analysis occurring in Pre-analytical, Analytical and Post-analytical Phases.
- Promote collaboration among participants via learning sessions with federal protections.
- Develop recommendations for best-practice patient safety activities.
As a first step, ADNPSO adopted the following literature-based definition of specimen errors: “Any defect that occurs during the entire testing process, from ordering tests to reporting results, and in any way influences the quality/safety of laboratory services” (Goldschmidt 1995).
In July 2018, ADNPSO successfully recruited 15 acute care facilities across Arkansas by capitalizing on its successful 2017 Good Catch Campaign partnerships. ADNPSO also collaborated with lab directors to develop a Specimen Collection Form. Participating hospitals were encouraged to provide internal education on the new Specimen Form to prepare for the November 1, 2018, start date.
ADNPSO hosted a Kickoff Webinar in September 2018, which outlined the goals and objectives of the study. ADNPSO provided tools and held Working and Outcome Learning Sessions in March and September 2019. The study was structured around two data analytic phases. While data collection occurred for a full nine months, ADNPSO used the first 90 days to establish a baseline (Nov 2018 - Jan 2019). Then, ADNPSO performed baseline data analysis and brought clients together to discuss and identify improvement opportunities. The next 90 days focused on problem identification and initiation of Rapid Cycle PDSA (Plan-Do-Study-Act). Participants returned to their facilities, engaged subject matter experts and strengthened the internal plans. The final 90 days were used to collect post-implementation data and measure the effectiveness of the corrective actions.
ADNPSO Specimen Study Deep Dive
The graph below shows the study timeframe and associated volumes. The reporting process was stable across the study, with an average of 264 specimen events reported each month during the nine months of data collection.
The graph below shows the patient age distribution within the study. While Adults 18-64 years old represent almost half (47.26%) of the specimen events reported, it is followed by Older Adults > 65 years old at 38.95%. This was noteworthy as this population is more vulnerable and may incur more serious outcomes following specimen errors, such as delayed results and/or inappropriate treatments.
Another vulnerable population is Neonates 0-28 days old, which account for 11.38% of all specimen events reported during the study timeframe. A comprehensive review of these revealed the majority of the errors were associated with the mother’s label affixed to the neonate’s specimen. Strict adherence to best-practice labeling techniques at the crib side is crucial to mitigating the risk for neonatal harm.
ADNPSO’s collection form was designed to capture the Specimen Source. Data revealed 65.7% of all reported errors involved Venous Blood, followed by Urine at 11.56%, and Other at 10.97%. Examples categorized as Other included: Cord Blood, Various Swab Samples, and Surgical/Procedural Aspirations.
The specimen error data was also stratified by Collector Discipline, revealing Nursing as the primary collector at 60.11%, followed by Phlebotomists at 24.13% and Unknown at 8.07%. Of note, ADNPSO delved deeper into Unknown Collectors and found the missing information resulted from incomplete specimen labels.
In reviewing the data by Specimen Stages, ADNPSO found that the vast majority of events (89.99%) occurred within the Pre-analytical Phase or before ever reaching the Laboratory. Analytical Phase events accounted for 4.29% and the Post-analytical Phase for 4.04%. Note, the Specimen Stage was reported as Unknown for 1.68% of events.
Preventability & Known Contributing Factors
In ADN’s patient safety event reporting system, one or more subject matter experts completes a follow-up investigation form that addresses incident preventability. The graph below presents data for Specimen Incident Preventability by Study Phase.
While analyzing baseline data early in the study, ADNPSO noted that 44.72% of subject matter experts were answering Unknown for Specimen Incident Preventability. ADNPSO brought this to the attention of participating hospitals during the Baseline Analytic Learning Session in March 2019 and encouraged internal education on appropriate categorizations to help curb Unknown responses. As seen in the graph above, this was effective as there was a major decrease in Unknown when comparing across study phases. More specifically, Unknown responses decreased from 44.72% to 7.49% by the end of the study. This indicates increased accountability among investigators who are responsible for assessing preventability.
ADN’s follow-up investigation form additionally garners input from subject matter experts on known factors contributing to the event, and captures recommended actions to prevent recurrence. Topping the list of Known Contributing Factors are Inattention at 30.77%, Communication at 14.14% and Training at 12.13%. The highest-ranking Recommended Actions for aggregate data include Education/Training at 40.97%, No Action Recommended at 37.02% and Other at 20.72%. Of interest, ADNPSO found baseline data reflected No Action Recommended for over half of the specimen events reported, which conflicted with the Incident Preventability findings for the same timeframe. The March 2019 Learning Session provided an opportunity to discuss this incongruence with participants. Upon study completion, ADNPSO stratified the No Action Recommended responses by study phase and revealed a marked decline when comparing the Baseline and Post-implementation Phases. This is another desired outcome as investigators are acknowledging the need to advocate for stronger interventions to prevent event recurrence.
Putting the Data Into Practice
Throughout the study, ADNPSO analyzed the submitted specimen events to identify trends and opportunities for improvement. ADNPSO hosted two face-to-face Learning Sessions, held in March 2019 and September 2019. The first Learning Session presented aggregate baseline data findings to the participating hospitals. Each attendee was equipped with their hospital-specific data and PSO comparisons to identify priority areas of focus. ADNPSO used Process Mapping to guide participants in designing and implementing action plans through the remainder of the study.
Specimen Process & Risk for Errors
Lab Results—every patient needs them and every clinician wants them. Consider the number of steps and the number of hands involved between the Ordering and Resulting stages of the specimen process.
When examining any process, it is vital to identify and engage the disciplines involved, along with defining their roles and responsibilities. ADNPSO used Swimlane Mappings by Discipline and by Specimen Stages to help define ownership. In the Swimlane Diagram below, it is important to acknowledge the orange Laboratory Information System (LIS) bar that overarches all the swimlanes. The LIS plays an extensive role in all stages of the specimen process, impacting chain of custody, test requests, label generation, clinical worklists, test results, and report generation. The importance of the LIS is a recurring theme that is further explored in the Process and Cause Maps sections of this article.
Note that ADNPSO created swimlanes around the Specimen Stages and any involved disciplines. Then, the aggregated specimen data was applied to the corresponding swimlanes to visually link the relationships between the roles, stages and fractured process steps. The highest percentage errors are highlighted for attention and underscored the Collection Stage as a clear priority, and more specifically honed the focus on Hemolysis/Clotting at 71.64%. Because hemolysis happens while obtaining the specimen, the corrective actions can be targeted to the Nursing and Phlebotomy collectors.
When putting swimlane mappings into practice, organizations are encouraged to overlay their internal disciplines, stages and error data. Sharing this visual structure can act as a catalyst by increasing interdisciplinary awareness of the affected specimen process steps. Coupling this powerful data with a clear rationale for introducing change is key to propelling improvements.
A System Approach to Mapping the Specimen Process
ADNPSO collaborated with Patient Safety and Laboratory experts and referred to national standards to create Specimen Process Maps for each of the six stages: Ordering, Labeling, Collection, Transportation & Storage, Testing & Result Interpretation, and Result Communication. ADNPSO worked directly with cross-discipline teams from all participants to define the basic steps and desired outcomes for each stage. It is important to note when applying the Specimen Process Maps internally, each organization should engage involved disciplines, compare their internal workflows and tailor the maps as needed.
As seen in the images above, ADNPSO overlaid the aggregate data on the Specimen Process Maps to reveal and highlight the widespread system fractures. The next step was to examine the individual maps by Specimen Stage to pinpoint process vulnerabilities that require deeper investigation. Organizations using ADNPSO’s process maps are encouraged to overlay their specimen data in order to highlight error-prone steps for further analysis and advanced cause mapping.
Advanced Cause Mapping
With priority areas of focus identified using the Swimlane Mappings and Process Maps, ADNPSO used the Cause Mapping Method to further analyze and document the specimen errors. The template below served as a visual aid and tool for uncovering why errors occurred and better informing the subsequent corrective action plans.
To demonstrate the power of these tools collectively, review the example below for the Specimen Labeling Stage, which affected 32.91% of all reported errors during the study. The 3 images below illustrate ADNPSO’s approach to dissecting the aggregate data and associated process steps to identify cause-and-effect relationships.
This approach also guided ADNPSO’s study participants, who followed our recommendations and enlisted internal subject matter experts when defining cause-and-effect relationships. Each participating organization submitted their cause maps and corrective action plans to ADNPSO on or before May 1, 2019 so that the impact could be measured during the study’s Post-Implementation Phase. In the next section, ADNPSO shares some of the successes realized by study participants employing rapid-cycle improvement strategies.
Rapid Cycle PDSA: Real-World Improvements
Outcome 1: LIS Change Improves Workflow for Now Order Draws
At one participating organization, a physician reported a specimen event that resulted in a delay in treatment after a Troponin “Now” order was not drawn or resulted in the Emergency Department (ED). Investigation revealed that “Now” orders were not programmed by the LIS/EHR mainframe to show in the ED nursing worklist. Instead, “Now” orders were only displayed in the Patient Management Transfer Module on the receiving unit to be carried out on transfer. The multidisciplinary team mapped the error below, and the solution involved an LIS programming change to allow “Now” orders to appear on the current location, including ED nursing worklists. This is a perfect example of how a single event investigation can result in a system-wide improvement.
Outcome 2: Lab Policy Change Permits Critical Values to Post in EHR
One of the smaller, rural participants noticed events involving critical results for point-of-care (POC) blood glucose testing. By organizational policy, critical values for POC glucose required verification by laboratory staff prior to posting in the EHR. However, laboratory oversight was only available Monday through Friday, from 5 AM to 5 PM. This meant critical values were not available to providers via EHR during laboratory off-hours, leaving potential gaps in the information needed to guide care. The organization engaged key stakeholders who took prompt action. As seen below, the error was multi-pronged. The immediate solution was to change the verification policy/procedures and allow the LIS to post critical results in the EHR when the lab is closed.
Outcome 3: Hemolysis Prevention Program Leads to New Nursing School Curriculum
Another participant, a large urban hospital system, analyzed its Collection and Labeling errors to uncover a trend involving hemolyzed samples. The organization recognized that hemolysis occurs when obtaining the specimens, which are primarily collected by Nursing Staff in their hospitals. A knowledge assessment was performed, which confirmed that the majority of the nurses were never formally trained in phlebotomy practices. As a result, the Education and Laboratory Departments collaboratively developed and piloted a formal training program with nurses in specialty care areas. Post-training competencies were validated, so the program was expanded to all in-house Nursing Staff. The participant astutely recognized an opportunity to achieve even greater success by partnering with their School of Nursing. The phlebotomy training was adapted and is now part of the school’s curriculum effective July 2019. This will not only positively impact their system of hospitals, but graduates from the School of Nursing will take the phlebotomy skills with them to future positions and employers.
Outcomes & Reflections
In addition to examining process steps and error causations, ADNPSO analyzed outcome data. The Specimen Form captures patient outcomes resulting from incidents. Per ADNPSO’s aggregate data, the most commonly reported Patient Outcome was Blood Redraws at 44.59%, followed by Delay in Treatment at 28.15%. Both directly impact the quality and safety of patient care, and also have financial and patient satisfaction implications.
In conjunction with Patient Outcomes, ADNPSO evaluated the Final Harm of all submitted specimen incidents. Note, Risk Managers assign Final Harm upon event closure using AHRQ’s Harm Scale. As seen in the graph below, specimen incidents most often resulted in No Harm (72.79%) or Mild Harm (27.11%). Given that approximately 73% of specimen incidents led to Redraws and Delays in Treatment, ADNPSO reviewed the AHRQ definition of Mild Harm: “Bodily or psychological injury resulting in minimal symptoms or loss of function, or injury limited to additional treatment, monitoring, and/or increased length of stay.” With this in mind, ADNPSO challenged study participants to consider the definition and the associated patient outcomes when designating Final Harm. Subsequently, a slight increase in Mild Harm was noted in the Pre-and-Post Implementation Phases of the study when compared to Baseline.
Calculating Avoidable Costs
Assessing the financial impact of specimen errors proved challenging. Research showed that most calculations relied on the physical costs associated with rework, recollection and retesting of specimens. Examples of physical costs include Labor (time spent per discipline), Materials (tubes, butterfly, bio bags) and Lab Testing Supplies (reagents).
However, there are also soft costs associated with adverse specimen events that can negatively affect patient satisfaction and length of stay, as well as result in injuries, misdiagnoses and delayed or unnecessary treatments. The financial ramifications of these costs are far more difficult to quantify.
With this in mind, ADNPSO used existing studies focused on physical costs to frame our calculations. A literature review estimated specimen error costs can range between $289 to $712 each.3,4 ADNPSO applied these cost ranges to all Specimen Redraws and Recollections reported during the nine-month study and calculated the total Potentially Avoidable Costs as $420K to $1.04M. Organizations can utilize these ranges to approximate their avoidable costs, or work with their Finance Department to identify and calculate actual costs.
Specimen Study ResultsThe study was contingent on strong engagement from participating hospitals.
ADNPSO was pleased that 100% of participants submitted data during the study and shared their internal corrective action plans and results.
To further quantify study successes and identify areas for improvement, ADNPSO developed a Self-Assessment Survey. It was issued to all participants prior to the study in order to establish baseline perspectives and repeated upon study completion to evaluate organizational impact. ADNPSO received feedback from 100% of participants for both surveys. Results revealed 100% of post-survey respondents categorized their organization’s culture of safety as Engaged (89%) or Empowered (11%), indicating a strong and prepared environment for addressing fractured systems and processes. Significant increases were seen in understanding specimen events and routinely discussing them in patient safety meetings. And finally, the Overall Study Satisfaction was rated 4.33 on 5 point Likert Scale and 100% of respondents plan to participate in future ADNPSO studies.
Increased Reporting: ADNPSO compared the aggregate number of specimen events entered 9 months prior to the study to those submitted during the 9-month study timeframe and noted a 147% increase.
Positive Cultural Impacts: Following the study, participants reported increased leadership support and interest in the hospital’s ROI, increased collaboration among quality, lab, and frontline staff, and an enhanced empowerment and ownership of solutions. Physician engagement in specimen reporting and improvement efforts were also noted by participants.
“Learning to Report & Reporting to Learn”: Participants experienced how ADNPSO’s mantra becomes imperative to maintaining and improving patient safety. Post-Survey responses showed education on how to report specimen events and education emphasizing the value and purpose of specimen event reporting both increased 67% over Pre-Survey responses.
Facility Size Doesn’t Matter: While it is often assumed that larger organizations have bigger budgets and more resources to ensure success, all hospitals have the potential to promote a staff that is engaged and empowered to place improvements into action.
Varying Levels of Engagement: While 100% of the facilities engaged during the study, some were more proactive and responsive than others. ADNPSO sought feedback and found the reasons for lower levels of engagement included competing priorities, limited resources, multiple roles and the lack of a program champion.
Events Tracked Outside ADN’s Event Reporting Application: Some specimen-related issues were tracked via internal laboratory logs or other systems. For those who continued to track separately, this may have impacted their ability to accurately quantify and dissect data, resulting in missed opportunities.
OFIs for Data Collection Form: Analysis revealed a need to capture additional details related to causation, thus minimizing the need for manual review of free-text fields. The Specimen Form will be modified to include new questions and more answer value options to curb the use of narrative and Other responses.
Lack of Near Miss Reporting: Near miss reporting provides opportunities to learn about and repair fractured processes before reaching or harming patients. While analyzing submitted data, ADNPSO found a limited number of Near Miss Reports. An intentional Good Catch Campaign can help with this.
Difficult to Quantify Financial Impact: Soft costs associated with misdiagnoses and patient satisfaction, for example, are more difficult to quantify. ADNPSO is interested in taking on this challenge and working closely with willing participants.
- Specimen process awareness is key to propelling improvements.
- Redesign process steps to minimize risk for errors and distractions.
- A single event investigation can result in system-wide improvements.
- IT partnership and LIS optimization are essential.
- Successful education is designed to:
- Target roles/responsibilities specific to the staff levels involved.
- Provide rationale for standardized process steps.
- Include examples of how workarounds lead to negative outcomes in subsequent stages.
- Engineer change with persistence and reinforcement to create a new normal.
About American Data Network
For more than 25 years, American Data Network (ADN), which is also the parent company to its Patient Safety Organization (ADNPSO), has worked with large data sets from various sources, aggregating and mining data to identify patterns, trends and priorities within the clinical, financial, quality and patient safety arenas.3 ADN developed the Quality Assurance Communication (QAC) application, with which hospitals, clinics, rehabs, and other providers record and manage patient safety events. By entering events into ADN’s QAC application and submitting them to the PSO, information is federally protected and thereby privileged and confidential. These protections provide a safe harbor to learn from mistakes and improve patient safety.
- Specimen Errors: Examining the Quality, Patient Safety & Financial Impacts
Phyllis Ragland, Stephanie Iorio, Meredith Chappell
- Green, S. F. (2013). The cost of poor blood specimen quality and errors in pre-analytical processes. Chemical Biochemistry, 46, 1175-1179.
- Kahn S, Jarosz C, Webster K, et al. Improving process quality and reducing total expense associated with specimen mislabeling in an academic medical center. Poster. 2005 Institute for Quality in Laboratory Medicine Conference: Recognizing Excellence in Practice. April 28, 2005. acutecaretesting.org/en/articles/specimen-mislabeling-a-significant-and-costly-cause-of-potentially-serious-medical-errors
- Latino RJ. Case Study 3: Specimen Integrity Opportunity Analysis. Patient safety: the PROACT root cause analysis approach. Boca Raton, FL: CRC Press; 2009. P. 183-87. alraziuni.edu.ye/book1/nursing/PATIENT%20SAFETY,%20The%20PROACT%C2%AE%20Root%20Cause%20Analysis%20Approach%20(2009).pdf