Specimen Labeling Research Articles

Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses.

- Surgical specimen adverse events can lead to delays in treatment or diagnosis, misdiagnosis, reoperation, inappropriate treatment, and anxiety or serious patient harm. - To describe the types and frequency of event reports associated with the management of surgical specimens, the contributing factors, and the level of harm associated with these events. - A retrospective review was undertaken of surgical specimen adverse events and near misses voluntarily reported in the University HealthSystem Consortium Safety Intelligence Patient Safety Organization database by more than 50 health care facilities during a 3-year period (2011-2013). Event reports that involved surgical specimen management were reviewed for patients undergoing surgery during which tissue or fluid was sent to the pathology department. - Six hundred forty-eight surgical specimen events were reported in all stages of the specimen management process, with the most common events reported during the prelaboratory phase and, specifically, with specimen labeling, collection/preservation, and transport. The most common contributing factors were failures in handoff communication, staff inattention, knowledge deficit, and environmental issues. Eight percent of the events (52 of 648) resulted in either the need for additional treatment or temporary or permanent harm to the patient. - All phases of specimen handling and processing are vulnerable to errors. These results provide a starting point for health care organizations to conduct proactive risk analyses of specimen handling procedures and to design safer processes. Particular attention should be paid to effective communication and handoffs, consistent processes across care areas, and staff training. In addition, organizations should consider the use of technology-based identification and tracking systems.

Process Improvements to Reduce Cardiac Troponin Turnaround Time in the Emergency Department

An efficient testing process is a key to a timely diagnosis of acute myocardial infarction in the emergency department (ED). This includes a rapid evaluation cardiac biomarkers. We conducted a quality and process improvement project to reduce troponin-T turnaround time (TAT) in the central laboratory at our facility. An interdisciplinary team, including front-line staff members, reviewed each step of troponin-T processing in both the ED and the central laboratory. A series of improvements were implemented during 2013, including changes to specimen labeling, elimination of duplicate test ordering, and efficiencies within the laboratory. Data from January 2013 to December 2014 on 31,496 patients with troponin tests were included in the analysis. Over the 2-year period of the projects, median troponin-T TAT decreased from 74 minutes to consistently less than 60 minutes. With an interdisciplinary team of health care professionals, we successfully reduced troponin-T TAT for possible acute coronary syndrome patients in our ED by 19%, consistently achieving laboratory results in less than 60 minutes.

Reduction in Hospital-Wide Clinical Laboratory Specimen Identification Errors following Process Interventions: A 10-Year Retrospective Observational Study.

BackgroundAccurate patient identification and specimen labeling at the time of collection are crucial steps in the prevention of medical errors, thereby improving patient safety.MethodsAll patient specimen identification errors that occurred in the outpatient department (OPD), emergency department (ED), and inpatient department (IPD) of a 3,800-bed academic medical center in Taiwan were documented and analyzed retrospectively from 2005 to 2014. To reduce such errors, the following series of strategies were implemented: a restrictive specimen acceptance policy for the ED and IPD in 2006; a computer-assisted barcode positive patient identification system for the ED and IPD in 2007 and 2010, and automated sample labeling combined with electronic identification systems introduced to the OPD in 2009.ResultsOf the 2000345 specimens collected in 2005, 1023 (0.0511%) were identified as having patient identification errors, compared with 58 errors (0.0015%) among 3761238 specimens collected in 2014, after serial interventions; this represents a 97% relative reduction. The total number (rate) of institutional identification errors contributed from the ED, IPD, and OPD over a 10-year period were 423 (0.1058%), 556 (0.0587%), and 44 (0.0067%) errors before the interventions, and 3 (0.0007%), 52 (0.0045%) and 3 (0.0001%) after interventions, representing relative 99%, 92% and 98% reductions, respectively.ConclusionsAccurate patient identification is a challenge of patient safety in different health settings. The data collected in our study indicate that a restrictive specimen acceptance policy, computer-generated positive identification systems, and interdisciplinary cooperation can significantly reduce patient identification errors.

Getting It Right for Patient Safety: Specimen Collection Process Improvement From Operating Room to Pathology.

Specimen labeling defects within the perioperative environment are a known patient safety risk that carries the potential for adverse outcomes. These outcomes are a result of errors that occur when unsuspecting providers operate within poorly designed processes with little control over the specimen collection context. Many costly outcomes resulting from labeling errors may include patient harm, inappropriate treatments, lengthy investigations, corrective actions, and, at times, legal action. This improvement initiative to identify and reduce the risk of specimen labeling defects includes the application of a disciplined Lean problem-solving approach with the engagement of employees who actually perform the work. By listening to the voice of our internal customers, we collectively redesigned the workflow by collaboratively linking work teams of the operating room and Pathology Department of Henry Ford Hospital, Detroit, over a 2-year period. We illustrate successful interventions achieved by Lean process management by streamlining, standardizing, and mistake proofing the processes and eliminating waste and inefficiency through systematic problem solving.

4:12 PMAbstract No. 324 - Application of plan-do-study-act (PDSA) principles to improve patient safety and specimen labeling errors in interventional radiology (IR)

To improve patient safety through the reduction of specimen labeling errors in Interventional Radiology (IR). Baseline data collected by the pathology department included: number of labeling errors, types of errors (non-labeled, incompletely labeled, incorrectly labeled), and type of procedures associated with errors. These data were analyzed using a Pareto chart. Factors in IR contributing to these errors were analyzed through the development of process map, a fishbone diagram created by a multi-professional focus group (MD, RT, and RN), and a prioritization matrix. The PSDA methodology was employed with the goal to reduce specimen labeling errors. A statistical control chart was used to determine significance of these interventions to reduce specimen error rates. Baseline data demonstrated an overall specimen error rate of 4.2%, ranging from 16.7% to 0%. The Pareto chart showed that incomplete requisitions accounted for more than 80% of these errors. The process map demonstrated variation in ways referring providers requested specimens, how specimens were labeled, and who was responsible for specimen labeling. Using QI tools, the focus group developed 3 interventions: (1) creation of an order entry system which allows referring providers to choose which specific labs/specimens they want sent, (2) development of a standardized double-check process through which an RN or RT confirms the specimen labels with the operator at the end of the procedure, and (3) use of a label printer rather than hand-written labels for slides and specimen vials. Post-intervention showed a lower and more consistent error rate ranging from 2.1% to 0.2%, with an average error rate of 1.0%. Through the use of classic process improvement tools, we decreased the variability and overall frequency of specimen labeling errors in IR to 1%. Our next goal is to decrease our error rate to 0%, since these errors threaten patient safety and are entirely avoidable.

OR Specimen Labeling

Mislabeled surgical specimens jeopardize patient safety and quality care. The purpose of this project was to determine whether labeling surgical specimens with two patient identifiers would result in an 80% reduction in specimen labeling errors within six months and a 100% reduction in errors within 12 months. Our failure mode effects analysis found that the lack of two patient identifiers per label was the most unsafe step in our specimen handling process. We piloted and implemented a new process in the OR using the Plan-Do-Check-Act conceptual framework. The audit process included collecting data and making direct observations to determine the sustainability of the process change; however, the leadership team halted the direct observation audit after four months. The total number of surgical specimen labeling errors was reduced by only 60% within six months and 62% within 12 months; therefore, the goal of the project was not met. However, OR specimen labeling errors were reduced.

Quality Measures in Pre-Analytical Phase of Tissue Processing: Understanding Its Value in Histopathology.

Quality monitoring in histopathology unit is categorized into three phases, pre-analytical, analytical and post-analytical, to cover various steps in the entire test cycle. Review of literature on quality evaluation studies pertaining to histopathology revealed that earlier reports were mainly focused on analytical aspects with limited studies on assessment of pre-analytical phase. Pre-analytical phase encompasses several processing steps and handling of specimen/sample by multiple individuals, thus allowing enough scope for errors. Due to its critical nature and limited studies in the past to assess quality in pre-analytical phase, it deserves more attention. This study was undertaken to analyse and assess the quality parameters in pre-analytical phase in a histopathology laboratory. This was a retrospective study done on pre-analytical parameters in histopathology laboratory of a tertiary care centre on 18,626 tissue specimens received in 34 months. Registers and records were checked for efficiency and errors for pre-analytical quality variables: specimen identification, specimen in appropriate fixatives, lost specimens, daily internal quality control performance on staining, performance in inter-laboratory quality assessment program {External quality assurance program (EQAS)} and evaluation of internal non-conformities (NC) for other errors. The study revealed incorrect specimen labelling in 0.04%, 0.01% and 0.01% in 2007, 2008 and 2009 respectively. About 0.04%, 0.07% and 0.18% specimens were not sent in fixatives in 2007, 2008 and 2009 respectively. There was no incidence of specimen lost. A total of 113 non-conformities were identified out of which 92.9% belonged to the pre-analytical phase. The predominant NC (any deviation from normal standard which may generate an error and result in compromising with quality standards) identified was wrong labelling of slides. Performance in EQAS for pre-analytical phase was satisfactory in 6 of 9 cycles. A low incidence of errors in pre-analytical phase implies that a satisfactory level of quality standards was being practiced with still scope for improvement.

Scientific death-knell against databases? Errors induced by database manipulations and its consequences

References to Terebratulina caputserpentis attributing its authorship to Zbyszewski, 1957, not to Linnaeus, 1767, have been found in three recent publications, in the collections of the Museum National d'Histoire naturelle de Paris and in several online databases. The use in these databases seems to have arisen from WoRMS (World Register of Marine Species), specifically from WBD (World Brachiopoda Database) of which the three authors of this paper are the editors (authors). The page concerning T. caputserpentis (Linnaeus, 1767) has been modified by WoRMS staff without the knowledge of these editors (authors). The decrease of the specialists in systematics and their replacement by IT specialists question the scientific reliability of the online databases as well as the specimen labelling in museums. The absence of scientific rigour becomes their Achilles' heel. Several other cases of errors are quoted and developed. In spite of applications to the staff of databases in biodiversity, the situation continued degrading so much so that today these bases are reached by the Peter principle and can no longer be used for scientific requirements, except if verifying all the desired data.

Improving the pathologic evaluation of lung cancer resection specimens.

Accurate post-operative prognostication and management heavily depend on pathologic nodal stage. Patients with nodal metastasis benefit from post-operative adjuvant chemotherapy, those with mediastinal nodal involvement may also benefit from adjuvant radiation therapy. However, the quality of pathologic nodal staging varies significantly, with major survival implications in large populations of patients. We describe the quality gap in pathologic nodal staging, and provide evidence of its potential reversibility by targeted corrective interventions. One intervention, designed to improve the surgical lymphadenectomy, specimen labeling, and secure transfer between the operating theatre and the pathology laboratory, involves use of pre-labeled specimen collection kits. Another intervention involves application of an improved method of gross dissection of lung resection specimens, to reduce the inadvertent loss of intrapulmonary lymph nodes to histologic examination for metastasis. These corrective interventions are the subject of a regional dissemination and implementation project in diverse healthcare systems in a tri-state region of the United States with some of the highest lung cancer incidence and mortality rates. We discuss the potential of these interventions to significantly improve the accuracy of pathologic nodal staging, risk stratification, and the quality of specimens available for development of stage-independent prognostic markers in lung cancer.

Error Avoidance in Dermatologic Surgery

Surgical errors pose a significant source of morbidity, mortality, and expense within the health care system. While rates of errors within dermatologic surgery are low, there are certain areas of dermatologic surgery that are more prone to errors than others. These include site identification, specimen labeling, triage, lidocaine toxicity, needle sticks, electrosurgery, and laser surgery. Within these areas, continued research is being done to identify the source of the errors and establish protocols to minimize the risk.

Sample PREanalytical Code for labeling of biospecimens: an analysis of specimen labeling protocols

Sample PREanalytical Code for labeling of biospecimens: an analysis of specimen labeling protocols Silvia Riondino,1* Umberto Nanni,2* Fay Betsou,3 Luisa Rossetti,2 Corrado Campisi,4 Riccardo Fiorentino,1 Raffaele Palmirotta,1 Patrizia Ferroni,1 Mario Roselli,5 Fiorella Guadagni1 1BioBIM-Interinstitutional Multidisciplinary BioBank, IRCCS San Raffaele Pisana – Research Center, Rome, Italy; 2Department of Computer, Control and Management Engineering "Antonio Ruberti", "Sapienza" University, Rome, Italy; 3Integrated Biobank of Luxembourg, Luxembourg City, Luxembourg; 4LC Campisi Laboratory Ltd, Avola (SR), Italy; 5Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy *These authors contributed equally to this work Abstract: The suitability of samples for a given research depends on many variables, among which, the best preanalytical conditions for the type of test that should be carried out. Thus, standardization and harmonization of processing conditions for samples entering a particular study should be highly pursued to facilitate research collaborations among different institutions and biological banks, allowing specimen comparison both for sample sharing and for the development of large-scale clinical trials. In this study, we review some issues and scenarios related to the adoption of the Sample PREanalytical Code, which deserve attention for a proper management of the samples and, ultimately, for maximizing the efficiency of the consistent investments required to set up biobanking resources. Keywords: biobanking, preanalytical variables, sample labeling

Can a barcode scanner for blood collection improve patient identification integrity in the emergency department? A prospective before-and-after study.

To describe the effect of interventions designed to improve patient identification (PI) during pathology collection in the ED. A prospective before-and-after intervention study was conducted between June 2009 and June 2010 in a regional ED in Queensland, Australia. Interventions aimed to improve PI and specimen labelling, and consisted of: (i) education alone; and (ii) education plus an armband scanner that voice-prompted collector behaviour. Main outcomes measured included: frequency of correct key behaviours (KBs) during specimen collection, pathology integrity errors and cost of interventions. Data from 282 ED pathology collections were analysed (before: n = 115, after with education: n = 95, after with education plus armband scanner: n = 72). KBs for PI and labelling improved significantly following education plus armband scanner use. Application of armbands before sample collection increased (36% vs 90%, P < 0.001), as did asking the patient to state their name (25% vs 93%, P < 0.001) and date of birth (22% vs 93%, P < 0.001). These results were similar, albeit less pronounced, when the effect of education only was assessed. No primary patient misidentification was detected in this small study. The annual costs for a hospital to adopt the education programme with and without the armband scanner were $104,045 and $5330 respectively. ED staff had poor behaviours for identifying patients and labelling pathology specimens before intervention. These safety behaviours were considered an assumed skill. Education alone improved critical KBs markedly that was further augmented by the armband scanner. The cost to adopt education alone is relatively low compared to the addition of armband scanner technology.

Handling of radioactive seed localisation breast specimens in the histopathology laboratory: the Western Australian experience

Radio-guided occult lesion localisation using iodine-125 seeds (ROLLIS) is a novel method of localisation for impalpable in situ and invasive carcinomas that has been the subject of a recent pilot study and pilot study extension in Western Australia. Robust protocols for radiation safety, specimen labelling, specimen tracking, seed retrieval and seed disposal were developed at two Western Australian laboratories to minimise the risk of seed loss. The processes are safe and effective with no significant radiation exposure to pathologists and with acquisition of all seeds intact and undamaged. The success can be attributed to developing specific seed retrieval techniques, suited to local preferences at each institution, with input from surgeons, radiologists and medical physics personnel. These techniques are now routine and will continue in the randomised control phase of the ROLLIS study.

Utilization of Simulation for the Introduction of New Software Technology to the Clinical Setting

ProVation Medical documentation software was introduced in our Department of Gastroenterology (GI). We evaluated the use of a simulation module to improve the introduction of new documentation software into a tertiary care center GI department. Train-the-trainer education was provided by the vendor of the new documentation module. A simulation module was developed to simulate the preparatory, intraprocedural, and postprocedure phase of active utilization of the software. A standardized patient (SP)/medical actor was used for provision of data to be entered in to the ProVation Medical preprocedure module. A procedural suite was configured to allow for staff to assume their roles during endoscopic cases. A checklist of key activities was used by observers during the training. A postscenario evaluation document was collected for perceptions of training. Twenty-one GI nurses and technicians spent 3 hours in groups of 7 over a 3-day period completing activities commensurate with these procedural phases. Nineteen of 21 learners felt the simulation was nonthreatening, and the same number gave the course an overall 5/5 rating. There were no specimen labeling errors, patient identification errors, or sentinel events related to the software rollout. All learners felt that physician involvement in the simulation would have been beneficial. Simulation can be used to improve the rollout of new software in a tertiary care center. Staff satisfaction associated with this type of learning activity was high, and a communicated level of comfort was achieved as a result of the simulation-based experiential learning.

Monitoring Specimen Labeling Errors in Cytopathology: An Important Measure of Patient Safety

Monitoring Specimen Labeling Errors in Cytopathology: An Important Measure of Patient Safety

Three-dimensional high resolution X-ray imaging and quantification of lithium ion battery mesocarbon microbead anodes

In order to improve lithium ion batteries it is important to characterise real electrode geometries and understand how their 3D structure may affect performance. In this study, high resolution synchrotron nano-CT was used to acquire 3D tomography datasets of mesocarbon microbead (MCMB) based anodes down to a 16 nm voxel size. A specimen labelling methodology was used to produce anodes that enhance the achievable image contrast, and image processing routines were utilised to successfully segment features of interest from a challenging dataset. The 3D MCMB based anode structure was analysed revealing a heterogeneous and bi-modally distributed microstructure. The microstructure was quantified through calculations of surface area, volume, connectivity and tortuosity factors. In doing so, two different methods, random walk and diffusion based, were used to determine tortuosity factors of both MCMB and pore/electrolyte microstructures. The tortuosity factors (2–7) confirmed the heterogeneity of the anode microstructure for this field of view and demonstrated small MCMB particles interspersed between large MCMB particles cause an increase in tortuosity factors. The anode microstructure was highly connected, which was also caused by the presence of small MCMB particles. The complexity in microstructure suggests inhomogeneous local lithium ion distribution would occur within the anode during operation.

An empirical assessment of the consistency of taxonomic identifications

Plankton counting and analysis is essential in ecological study, yet scant literature exists as to the reliability of those counts and the consistency of the experts who make the counts. To assess how variable expert taxonomic identifications are, a set of six archived mesozooplankton samples from a series of Longhurst Hardy Plankton Recorder net hauls were counted by expert zooplankton analysts located at six marine laboratories. Sample identifications were repeated on two separate days with over 700 target specimens counted and identified on each day across the samples. Twenty percent of the analysts returned counts that varied by more than 10%. Thirty-three percent of analysts exhibited low identification consistencies, returning Intraclass Correlation Coefficient scores of less than 0.80. Statistical analyses of these data suggest that over 83% of the observed categorical count variance can be attributed to inconsistencies within analysts. We suggest this is the root cause of variation in expert specimen labelling consistency.

Preanalytical considerations in blood gas analysis

Blood gas testing is a commonly ordered test in hospital settings, where the results almost always have the potential to dictate an immediate or urgent response. The preanalytical steps in testing, from choosing the correct tests to ensuring the specimen is introduced into the instrument correctly, must be perfectly coordinated to ensure that the patient receives appropriate and timely therapy in response to the analytical results. While many of the preanalytical steps in blood gas testing are common to all laboratory tests, such as accurate specimen labeling, some are unique to this testing because of the physicochemical properties of the analytes being measured. The common sources of preanalytical variation in blood gas testing are reviewed here.

National survey of breast cancer specimen orientation marking systems

BackgroundNHS Breast Screening Programme (NHSBSP) guidelines recommend using a protocol to orientate excised specimens, thus allowing accurate reexcision of positive margins. Variation between units, and surgeons, in protocols may cause confusion, labelling errors and specimen misorientation. We investigated variation of, and satisfaction with, specimen labelling protocols in breast surgery units. MethodsQuestionnaires were sent to the lead pathologist of all English breast units, addressing method (clips/staples/ink) and system (eg long suture = lateral) of orientation, and pathologist's satisfaction with the consistency and method used. ResultsOf 141 units, 117 responded: 82 screening and 35 non-screening units. 92 use a standardised orientation protocol. Eleven screening and 15 non-screening units report no protocol.Of responding units, 33 use sutures, 9 use clips, 67 use clips + sutures, 3 use coloured ink and 5 suture the specimen to paper/foam/marginmap®. The commonest protocol is suture: short-superior, medium–medial, long-lateral, by 50 units. However eleven labelling systems for sutures and 14 for clips were reported. Twenty-six pathologists reported no standardised method, with labelling technique either written on the specimen card (n = 15) or presumed, based on the surgeon-in-charge's usual practice.Thirty-four pathologists are satisfied with a locally established protocol, however 56 want a nationally standardised marking system. ConclusionDespite NHSBSP guidelines, nearly one quarter of breast units have no specimen orientation protocol. Specimen marking protocols vary widely – a concern in view of the transient nature of locum and trainee doctors. There is a clear wish by pathologists for specimen marking standardisation, whether this is nationally or locally defined.

Handling of Radioactive Seed Localization Breast Specimens in the Pathology Laboratory

Radioactive seed localization (RSL) is an increasingly utilized and effective approach to surgical excision of radiographically identified lesions in the breast. This approach has been reported to be at least as convenient to the patient, radiologist, and surgeon as the standard wire localized approach but with the considerable added benefit of a lower positive margin rate in some studies. To date, there is little information in the published medical literature concerning the optimal handling of these specimens in the pathology laboratory. The US Nuclear Regulatory Commission and its Agreement States oversee the use of radioactive materials in clinical practice and provide guidelines for the performance of RSL procedures, including the safe handling of radioactive seeds. The RSL procedure involves multiple departments, and a robust process should be in place to ensure appropriate accountability, seed tracking, and minimal radiation exposure to staff. This article describes how to properly and safely handle RSL breast specimens, including regulation requirements, specimen labeling and receipt, specimen dissection, protective wear, and seed retrieval, transport, and disposal.