Specimen Mislabeling Research Articles

Utilization of Short Tandem Repeat Analysis to Resolve Specimen Mislabeling in the Anatomic Pathology Laboratory

Abstract Introduction/Objective A mislabeled specimen is an example of preanalytical error that can have significant consequences on patient care. These errors can be difficult to detect and resolve. One method to confirm genetic identity is short tandem repeat (STR) analysis, which is utilized in forensic investigations, paternity studies, and post- hematopoietic stem cell transplantation monitoring. Herein we present application of STR analysis to resolve a suspected specimen mislabeling prior to receipt in our anatomic pathology laboratory. Methods/Case Report DNA was extracted from paraffin embedded tissues. Chimerism testing was performed by STR analysis using the Globalfiler (ThermoFisher Scientific) and analyzed by Chimermarker (Softgenetics) automated chimerism software. Results (if a Case Study enter NA) Colon biopsies were received for a single patient (#1) with two requisition forms. Each specimen (A-F) was labeled with the patient’s name, with specimens A-D noted on first page of requisition and specimens E-F on the second requisition page. After the case was signed out, the lab was contacted looking for biopsy results on another patient (#2) who was seen on the same day as patient #1. Review of all the patients seen in the endoscopy suite on the given date raised suspicion that specimens E-F from the second page of the requisition actually pertained to patient #2. STR analysis performed on specimens confirmed that specimens E-F were genetically distinct from those labelled A-D. Tissue from a subsequent biopsy on patient #2 was analyzed by STR testing, which was identical to STR results performed on specimens E-F. Conclusion Here we utilized STR testing to resolve a suspected mislabeled specimen, allowing the appropriate diagnosis to be attributed to the correct patient. This is a unique application of a common method, which could be implemented in anatomic pathology laboratories to resolve cases of specimen mix-ups.

In the Eye of the BBHolder: A Look into Recent Trends in Blood Bank Hold Order Utilization

Abstract The transfusion service at a large academic institution provides transfusion support to the regional cancer center in inpatient and outpatient settings. This center has a large patient population many of whom require frequent blood count monitoring. To reduce the number of blood draws and port accesses, it is standard of care to collect a blood bank hold (BBHold) tube simultaneously with routine CBC samples. The BBHold tube is routed to the transfusion services lab and stored in case a type and crossmatch (TXM) is needed in preparation for transfusion; it is valid for 72 hours. While advantages to this system are eliminating the need for a secondary blood draw and ready access to a sample for transfusion testing, disadvantages include drawing an additional tube, increased cost and storage, and increased specimen mislabeling in the conversion of a BBHold to a TXM. Our objectives were to analyze trends in BBHold usage, make recommendations to reduce unnecessary utilization, and create an algorithm to predict which patients would need transfusion. We collected data from March 2016 to June 2019 including hemoglobin values, BBHold orders, and TXM orders, and used the statistical programming language R for data analysis. Approximately 1,000 BBHold samples were collected monthly, with 64.2% taking place in the outpatient setting. Our analysis focused on this outpatient population. A total of 31.1% of BBHold orders were unnecessary, as they were re-collected within the 72-hour window of sample viability. Of all the BBHold orders, including the previously mentioned unnecessary orders, only 32.7% were converted to a TXM, which was used as a surrogate marker for transfusion. Unexpectedly, 28.2% of the last hemoglobin values collected prior to a BBHold (either concurrently with the BBHold or up to 3 days prior) were ≥10 g/dL. Notably, only 44.6% of these hemoglobin orders occurred concurrently with a BBHold, indicating that over 55% of BBHold orders were placed after the hemoglobin order. Once a hemoglobin value is resulted, a BBHold has minimal use since the hemoglobin value would determine if a transfusion is indicated. If transfusion is indicated, a TXM order should be placed directly, rather than a BBHold. Next, the average hemoglobin values were compared between patients who did and did not receive a transfusion within 7 days, and these were 8.8 and 9.1 g/dL, respectively. In conclusion, the trends illustrated here indicate overutilization of BBHold orders and highlight potential areas for optimization. Hemoglobin values within 7 days of a BBHold may not be enough to design a robust algorithm to stratify patients based on need for transfusion. Recommendations moving forward may include improving the EHR interface to display the expiration date of the current BBHold sample or displaying the patient’s last hemoglobin if ≥10 g/dL.

Chemotyping and identification of protected Dalbergiatimber using gas chromatography quadrupole time of flight mass spectrometry

The international trade in illegally logged and environmentally endangered timber has spurred enforcement agencies to seek additional technical procedures for the identification of wood species. All Dalbergia species are listed under the Convention on International Trade in Endangered Species (CITES) which is the reason this genus was chosen for study. Multiple sources of the heartwood from different Dalbergia species were extracted and chromatographic profiles collected by gas chromatography with high resolution quadrupole Time of Flight mass spectrometry (GC/QToF). The collected data was mined to select peaks and mass ions representative of the investigated Dalbergia species, and used to develop a Microsoft Excel® template offering immediate graphical representation of the results. Using wood specimens sourced from different xylaria, this graphical fingerprint proved adept at definitive identification of Dalbergia species. The CITES Appendix I species, D. nigra, was easily distinguished from D. melanoxylon and look-alike species of other genera. Similarly, a number of other Dalbergia species were differentiated using this current approach. Kernel discrimination analysis (KDA) was applied to increase the confidence of the species identification. The mislabeling of specimens appears to be common, and the emerging technique of GC/QToF in combination with other techniques, offers improved confidence in identification. GC/QToF further provides automation, the dimension of chromatography to avoid interferences, and production of reproducible electron impact positive (EI+) spectra. The prospect of building an EI+ spectral database for future wood identification is an important feature considering the limited accessibility of authenticated wood species specimens.

Radio-Frequency Identification Specimen Tracking to Improve Quality in Anatomic Pathology

Preanalytic errors, including specimen labeling errors and specimen loss, occur frequently during specimen collection, transit, and accessioning. Radio-frequency identification tags can decrease specimen identification and tracking errors through continuous and automated tracking of specimens. To implement a specimen tracking infrastructure to reduce preanalytic errors (specimen mislabeling or loss) between specimen collection and laboratory accessioning. Specific goals were to decrease preanalytic errors by at least 70% and to simultaneously decrease employee effort dedicated to resolving preanalytic errors or investigating lost specimens. A radio-frequency identification specimen-tracking system was developed. Major features included integral radio-frequency identification labels (radio-frequency identification tags and traditional bar codes in a single printed label) printed by point-of-care printers in collection suites; dispersed radio-frequency identification readers at major transit points; and systems integration of the electronic health record, laboratory information system, and radio-frequency identification tracking system to allow for computerized physician order entry driven label generation, specimen transit time tracking, interval-based alarms, and automated accessioning. In the 6-month postimplementation period, 6 mislabeling events occurred in collection areas using the radio-frequency identification system, compared with 24 events in the 6-month preimplementation period (75% decrease; P = .001). In addition, the system led to the timely recovery of 3 lost specimens. Labeling expenses were decreased substantially in the transition from high-frequency to ultrahigh frequency radio-frequency identification tags. Radio-frequency identification specimen tracking prevented several potential specimen-loss events, decreased specimen recovery time, and decreased specimen labeling errors. Increases in labeling/tracking expenses for the system were more than offset by time savings and loss avoidance through error mitigation.

Understanding the Types and Effects of Clinical Interruptions and Distractions Recorded in a Multihospital Patient Safety Reporting System.

Interruptions and distractions have been shown to be a frequent occurrence across health care and have been linked to negative outcomes that create potential patient safety risks. Although observational studies have catalogued interruption frequency and source, the impact of an interruption is difficult to observe. We analyzed patient safety event (PSE) reports related to interruptions to identify clinical processes reported to be frequently interrupted and the reported outcomes of those interruptions. We retrospectively analyzed PSE reports entered by frontline staff between January 2013 and January 2016. Of 79,428 total PSEs entered, 220 reports were identified using keyword matching and subsequent manual review as being directly related to a clinical interruption. Categories were developed to identify the cause of the interruption, task being interrupted, and the result of the interruption. Percentages were calculated. Nurses were most often reported to be interrupted in the PSEs (50%). General distractions (43.2%) or high workload (18.6%) were most commonly noted to interrupt the individual's work. The interrupted activity was most often a medication task (50.9%), frequently in the administration phase (24.1%), or the ordering phase (16.8%). The most common medication error was wrong dose administration (14.4% of total medication-related errors). Laboratory processes were reported to be disturbed by interruptions in 22.7% of reports, and this frequently resulted in mislabeling of specimens (75% of laboratory-related errors). This retrospective review of PSE reports involving interruptions of clinical activities reveals that interruptions affect a variety of aspects of patient care and can help to guide future work on interruption management.

Blood Bank Specimen Mislabeling: A College of American Pathologists Q-Probes Study of 41 333 Blood Bank Specimens in 30 Institutions.

-Incorrectly labeled patient blood specimens create opportunities for laboratory testing personnel to mistake one patient's specimen for a specimen from a different patient. Transfusion of blood that is typed on specimens that are mislabeled can result in acute hemolytic transfusion reactions. -To assess the rates of blood bank ABO typing specimens that are mislabeled and/or contain blood belonging to another patient (so-called wrong blood in tube [WBIT]), and to compare these rates with those determined in a similar study performed in 2007. -Participants enrolled in this College of American Pathologists Q-Probes study for the first quarter of 2015 tallied the number of mislabeled and WBIT ABO blood typing specimens. Outcome measurements were the number of mislabeled and WBIT instances per 1000 specimens. We also evaluated the effects of various practice characteristics, in particular the use of bar coding, on the outcome measurements. -A total of 30 institutions submitting data on 41 333 ABO blood typing specimens recorded aggregate rates of 7.4 instances of mislabeling (306 specimens) and 0.43 instances of WBIT (10 of 23 234) per 1000 specimens submitted. Mislabeling rates were lower in institutions requiring that specimens be labeled with patients' birth dates than those that did not. The rates of specimen mislabeling and WBIT were otherwise unassociated with any of the other practice variables evaluated. -The rates of ABO blood typing specimen mislabeling and WBIT are not statistically different from those determined in a similar study performed in 2007 (P = .94 and P = .10). The use of bar coding was not associated with lower mislabeling (P = .80) or WBIT rates (P = .79).

Errors upstream and downstream to the Universal Protocol associated with wrong surgery events in the Veterans Health Administration

BackgroundThe Universal Protocol has been associated with the prevention of wrong surgery procedures; however, such events still occur.This article explores wrong surgery events, defined as those incorrect procedures (wrong site, wrong side, wrong procedure, wrong patient, wrong level, wrong implant) that would have occurred despite the Universal Protocol including the performance of a time-out by the surgical team. Understanding why some of these events are not caught by the steps of the Universal Protocol, culminating in the time-out, can help the field to add upstream and downstream safeguards to help prevent these never events. MethodsThe Veterans Health Administration database of root cause analyses was queried for all cases involving an incorrect surgical procedure between 2004 and 2013 to determine the relative frequency and characteristics of wrong surgery events because of errors upstream and downstream to the Universal Protocol. This subgroup of wrong surgery events was selected from among all the wrong surgery events by 2 clinicians with expertise in patient safety (Kappa = .91). ResultsForty-eight cases of wrong surgery events because of upstream/downstream errors were analyzed, representing 16% of the 308 root cause analyses for wrong surgery events reported during this period.Upstream errors included mislabeling of specimens, while downstream errors were associated with ineffective intraoperative process. Surgical procedures that were particularly vulnerable included wrong level spine operations, wrong patient prostatectomies, wrong implant cataract procedures, and wrong site skin lesion excisions. ConclusionsWrong surgery events can and do occur despite adherence to Universal Protocol including a time-out. The prevention of incorrect procedures requires complementary safety behaviors and technologies to address errors that occur upstream and downstream to the Universal Protocol and the time-out.

Conservation and historical biogeography: How did the mountain chicken frog get to the Caribbean?

Leptodactylus fallax, commonly known as the mountain chicken frog, is a large terrestrial frog currently found on two islands in the Caribbean. Habitat destruction, overhunting and disease outbreaks have contributed to declining population numbers. In order to identify appropriate conservation strategies, the historic geographic distribution of this frog must first be determined. Because no archeological evidence exists, this was accomplished by reviewing historical documents and inspecting museum collections. Inaccuracies in location and species names were identified in documents as well as in the mislabeling of museum specimens. Two means for natural immigration (dispersal and vicariance) and the artificial introduction by humans were considered. The authors concluded that the Amerindians transported L. fallax to eight islands throughout the Lesser Antilles as potential food resources as they colonized this area. The implication that 75% of the historical distribution is currently unoccupied by this species is considered in light of future reintroduction projects. Key words: Leptodactylus fallax, Amerindians, dispersal, vicariance.

Context Is Everything

Changes in breast tissue in female-to-male transsexuals following gender reassignment and androgen therapy can cause difficulties in interpreting breast core biopsies. Clinical history and awareness of histological changes in breast tissue associated with androgen treatment are important in such cases. Specimen mislabeling is a potential pitfall to be borne in mind while evaluating unusual presentations in breast core biopsies. We report a case of a 58-year-old male with a well-defined supra areolar lesion clinically thought to be a fibroadenoma.

Mislabeling of Cases, Specimens, Blocks, and Slides: A College of American Pathologists Study of 136 Institutions

Mislabeling of Cases, Specimens, Blocks, and Slides: A College of American Pathologists Study of 136 Institutions

Markers for Screening Lynch Syndrome Are Reliable and Useful for Identifying the Specimen Mislabeling

BackgroundDuring specimen processing in surgical pathology laboratories, specimen-related adverse events (SRAEs), such as mislabeling and specimen mixed-up might occur. In these situations, molecular techniques using short tandem repeat (STR) loci are required to identify the personal identity. Microsatellite instability (MSI) test is widely used for screening the hereditary non-polyposis colon cancer (Lynch syndrome) in surgical pathologies using polymorphic STR markers. We tried to evaluate the applicability of the MSI test for SRAEs.MethodsWe obtained 253 MSI test results to analyze the allele frequencies. After calibrating the estimated nucleotide lengths, we calculated the allele frequencies, a random match probability, and a likelihood ratio (LR) of three dinucleotide STR markers (D5S349, D17S250, and D2S123).ResultsThe distribution of LR was 136.38 to 5,606,213.10. There was no case of LR<100. In addition, there were 153 cases (60.5%) of LR ranging from 100 to 10,000 and 100 cases (39.5%) of LR>10,000. Furthermore, the combined probability of identity was 9.23×10-4 and the combined power of exclusion was 0.99908.ConclusionsUsing the three STR markers that are recommended for MSI test, all the cases were positively identified in 1% range and about one-third cases showed high LR (>10,000). These results showed that MSI tests are useful to screen the personal identity in case of SRAE in pathology laboratories.

Mislabeling of Cases, Specimens, Blocks, and Slides: A College of American Pathologists Study of 136 Institutions

Accurate specimen labeling is a major patient-safety initiative by the Joint Commission and the College of American Pathologists. Inadequate specimen labels have led to patient injury from wrong patient diagnosis, wrong side treatment, and delay in diagnosis. To quantify the rates of mislabeled cases, specimens, blocks, and slides and to identify the sources of error and the ways in which errors are detected. In this voluntary-subscription Q-Probes study, participants prospectively reviewed surgical pathology cases for 8 weeks or until 30 errors (mislabeled cases, specimens, blocks, and slides) were identified. Information collected on each labeling error included the work location where the defect occurred, what was mislabeled, the number of items affected, the point of detection, and the consequences of the mislabeling error, along with institutional demographics and practice. The rates of mislabeled cases, specimens, blocks, and slides were tested for association with institutional demographics and practice variables. Of the 136 institutions providing information on a total of 1811 mislabeling occurrences, the overall mislabeling rates per 1000 were 1.1 cases, 1.0 specimen, 1.7 blocks, and 1.1 slides. Of all mislabeling events, 27.1% were cases, 19.8% specimens, 25.5% blocks, and 27.7% slides. The work locations at which the errors occurred were 20.9% before accessioning, 12.4% at accessioning, 21.7% at block labeling, 10.2% during gross pathology, and 30.4% at tissue cutting. Errors were typically detected in the first or second steps immediately following the error. Lower mislabeled slide rates were associated with continuous individual case accessioning and use of formal checks at accessioning. Routinely including a statement in the gross description that the specimen is labeled with the patient's name and is properly identified was also associated with lower rates of specimen mislabeling. The errors were corrected before reports were issued 96.7% of the time; for 3.2% of errors, a corrected report was issued. In 1.3% of error occurrences, participants gauged that patient care was affected. This study quantified mislabeling rates across 136 institutions of cases (0.11%), specimens (0.1%), blocks (0.17%), and slides (0.11%). Errors in labeling appear nearly equally throughout the system of accessioning, gross pathology processing, and tissue cutting. Errors are typically detected in the immediate steps after the errors occurred, reinforcing the need for quality checks throughout the system.

Simulations of delta check rule performance to detect specimen mislabeling using historical laboratory data

Background Despite their widespread use, the performance of delta check rules is rarely evaluated because errors are rare and lack a gold standard for detection. In this study we used a simulation-based approach to compare strategies for empirically defining criteria for univariate delta checks, and assessed the performance of these rules for detecting mislabeled specimens in 2 inpatient populations. Methods We performed simulations using historical laboratory test results by randomly sampling pairs of specimens successively drawn from the same patient or two different patients. We evaluated the performance of delta check rules using a variety of thresholds, including those currently in use in our laboratory. Result Mean corpuscular volume had the highest positive predictive value for specimen mislabeling, and produced the fewest false positives. Conversely, rules using other laboratory tests had considerably poorer performance. Several of the “best guess” thresholds historically used in our laboratory, notably those for potassium and anion gap, were predicted to have extremely low yields. In addition, rule performance was not consistent between the two patient populations. Conclusions The low yield of delta checks based on any single analyte should prompt careful evaluation of their practical utility. Furthermore, our results indicate that it may not be possible to generalize delta rules across institutions.

Specimen Identity Testing Using Deoxyribonucleic Acid Analysis in Clinical and Surgical Pathology Setting

Identity testing using DNA, which has been developed and used most often in forensic medicine, has important applications in anatomic and clinical pathology laboratories. These include identification of mixed-up specimens and identification of “floaters” in paraffin blocks or on slides of surgical pathology specimens. Polymerase chain reaction-based identity testing now provides a tool to address these challenging issues of specimen mislabeling, misidentification, and tissue contamination. We examined a case from a 35-year-old man with a laryngeal biopsy specimen that showed a fragment of benign salivary gland tissue and a separate fragment of squamous cell carcinoma. Because the carcinoma diagnosis was unexpected, identity testing on the paraffin-embedded tissue block was performed at the molecular diagnostic laboratory along with testing of the patient's repeat biopsy specimen. The presumed “floater” showing squamous cell carcinoma, and the remaining benign tissue were microdissected using the Pinpoint Slide DNA Isolation System. DNA was extracted and the genetic pattern for each sample was determined using a forensics kit employing short tandem repeats and the amelogenin locus, using multiplex polymerase chain reaction and capillary electrophoresis. The genetic pattern from the squamous cell carcinoma did not match with the benign tissue or the rebiopsy. This result indicates that the fragment with squamous cell carcinoma most likely did not originate from this patient. Resolution of specimen mislabeling or sample mix-ups is essential to prevent serious clinical consequences. In this article, we examine the current status of clinical laboratory medicine identity testing as it applies to surgical pathology, including reviewing the techniques and approaches used, and provide a discussion of clinically relevant pitfalls related to identity testing of anatomic pathology samples.

Patient Misidentification in Laboratory Medicine: A Qualitative Analysis of 227 Root Cause Analysis Reports in the Veterans Health Administration

Mislabeled laboratory specimens are a common source of harm to patients, such as repeat phlebotomy; repeat diagnostic procedure, including tissue biopsy; delay in a necessary surgical procedure; and the execution of an unnecessary surgical procedure. Mislabeling has been estimated to occur at a rate of 0.1% of all laboratory and anatomic pathology specimens submitted. To identify system vulnerabilities in specimen collection, processing, analysis, and reporting associated with patient misidentification involving the clinical laboratory, anatomic pathology, and blood transfusion services. A qualitative analysis was performed on 227 root cause analysis reports from the Veterans Health Administration. Content analysis of case reports from March 9, 2000, to March 1, 2008, was facilitated by a Natural Language Processing program. Data were categorized by the 3 stages of the laboratory test cycle. Patient misidentification accounted for 182 of 253 adverse events, which occurred in all 3 stages of the test cycle. Of 132 misidentification events occurring in the preanalytic phase, events included wrist bands labeled for the wrong patient were applied on admission (n = 8), and laboratory tests were ordered for the wrong patient by selecting the wrong electronic medical record from a menu of similar names and Social Security numbers (n = 31). Specimen mislabeling during collection was associated with "batching" of specimens and printed labels (n = 35), misinformation from manual entry on laboratory forms (n = 14), failure of 2-source patient identification for clinical laboratory specimens (n = 24), and failure of 2-person verification of patient identity for blood bank specimens (n = 20). Of 37 events in the analytic phase, relabeling all specimens with accession numbers was associated with mislabeled specimen containers, tissue cassettes, and microscopic slides (n = 27). Misidentified microscopic slides were associated with a failure of 2-pathologist verification for cancer diagnosis (n = 4), and wrong patient transfusions were associated with mislabeled blood products (n = 3) and a failure of 2-person verification for blood products before release by the blood bank (n = 3). There were 13 events in the postanalytic phase in which results were reported into the wrong patient medical record (n = 8), and incompatible blood transfusions were associated with failed 2-person verification of blood products (n = 5). Patient misidentification in the clinical laboratory, anatomic pathology, and blood transfusion processes were due to a limited set of causal factors in all 3 phases of the test cycle. A focus on these factors will inform systemic mitigation and prevention strategies.

A Quality Initiative to Decrease Pathology Specimen–Labeling Errors Using Radiofrequency Identification in a High-Volume Endoscopy Center

Our institution has had problems with mislabeling of tissue specimens in our gastrointestinal and colorectal surgery endoscopy units. Most labeling errors have been due to either the wrong patient label or no label being affixed to a specimen bottle. As a result, an initiative was created to reduce the number of specimen-labeling errors. This initiative involved the application of radiofrequency identification (RFID) technology to specimen bottles, moving to a paperless pathology requisition system and confirmation of the correct site and correct patient by both the endoscopy nursing staff and the endoscopist for each specimen bottle. We reviewed the number of specimen-labeling errors from our endoscopy unit for the first 3 months of 2007, before the implementation of the initiative, and for the first 3 months of 2008, 6 months after the initiation of RFID specimen labeling with paperless requisition and two-provider confirmation of correct site, correct patient specimen labeling. The RFID system we used was an off-the-shelf 3M (St. Paul, MN) Library Sciences RFID system modified and installed for our purposes. Specimen-labeling errors were categorized as Class 1 (only typographical with no potential clinical consequences), Class 2 (minor error, unlikely to have clinical consequences) or Class 3 (significant error that has the potential to detrimentally impact patient care). The Fischer's exact test was used to compare the rate of specimen-bottle labeling errors before and after the initiation of this new system. In the first 3 months of 2007, our endoscopy unit sent 8,231 specimen bottles to our pathology laboratory for evaluation; 8,539 bottles were sent in the first 3 months of 2008. There were 646 (7.85%) Class 1 errors in the first quarter of 2007 and 35 (0.41%) in the first quarter of 2008 (P<0.001). There were 112 (1.36%) Class 2 errors in the first quarter of 2007 and 10 (0.12%) in the first quarter of 2008 (P<0.001). Finally, in the first quarter of 2007 there were seven (0.09%) Class 3 errors and in the first quarter of 2008, there were two (0.02%) Class 3 errors. However, with the new system in place, both Class 3 errors in the first quarter of 2008 were recognized and corrected before the processing of the specimens in the pathology laboratory (P=0.001). These data confirm that the initiation of a new specimen-labeling system that uses RFID technology, a paperless requisition process, and confirmation of the correct site and correct patient by two health-care providers significantly decreased specimen-labeling errors at every level in a high-volume endoscopy center.

A Quality Initiative to Decrease Pathology Specimen Labeling Errors Using Radiofrequency Identification in a High-Volume Endoscopy Center

Purpose: Our institution has had problems with mislabeling of tissue specimens in our gastrointestinal and colorectal surgery endoscopy units. Most labeling errors have been due to either the wrong patient label or no label being affixed to a specimen bottle. As a result, an initiative was created to reduce the number of specimen labeling errors. This initiative involved the application of radiofrequency identification (RFID) technology to specimen bottles, moving to a paperless pathology requisition system and confirmation of the correct site, correct patient by both the endoscopy nursing staff and the endoscopist on each specimen bottle. Methods: We reviewed the number of specimen labeling errors from our endoscopy unit for the first three months of 2007, prior to the implementation of the initiative and the first three months of 2008, 6 months after the initiation of RFID specimen labeling with paperless requisition and two provider confirmation of correct site, correct patient specimen labeling. Specimen labeling errors were categorized as Class 1 (only typographical with no potential clinical consequences), Class 2 (minor error, unlikely to have clinical consequences) and Class 3 (significant error that has the potential to detrimentally impact patient care). The Fischer's exact test was used to compare the rate of specimen bottle labeling errors before and after the initiation of this new system. Results: In the first three months of 2007, our endoscopy unit sent 8231 specimen bottles to our pathology laboratory for evaluation and 8539 bottles in the first three months of 2008. There were 646 (7.85%) Class 1 errors in the first quarter of 2007 and 35 (0.41%) in the first quarter of 2008 (P < 0.001). There were 112 (1.36%) Class 2 errors in the first quarter of 2007 and ten (0.12%) in the first quarter of 2008 (P < 0.001). Finally, in the first quarter of 2007 there were seven (0.09%) Class 3 errors and in the first quarter of 2008, there were two (0.02%) Class 3 errors. However, with the new system in place, both Class 3 errors in the first quarter of 2008 were recognized and corrected prior to the processing of the specimens in the pathology laboratory (P= .001). Conclusion: These data suggest that the initiation of a new specimen labeling system that uses RFID technology, a paperless requisition process and confirmation of the correct site correct patient by two health-care providers significantly decreased specimen labeling errors of every level in a high volume endoscopy center.

Quality Improvement to Decrease Specimen Mislabeling in Transfusion Medicine

Proper specimen identification and labeling is a critical preanalytic step in pretransfusion compatibility testing. To gather baseline data for specimen mislabeling, specifically targeting major mislabeling events, and to design and implement a plan of corrective action. All mislabeled specimens received by the transfusion service for a type and screen were recorded and classified into minor and major mislabeling categories. Major mislabeling events were tracked by origin of the specimen. Locations with a high proportion of major mislabeling were given timely feedback (within 1 week) of the events as they arose. A university hospital. The incidence of major mislabeling. The incidence of mislabeling in the transfusion service was 0.5% (243/49 955) during 21 months of data collection. Of these mislabeling events, 47% were classified as major events (unlabeled, mismatched specimen/ requisition, ABO/Rh result on current specimen not matching historical record on file). The emergency department accounted for a high proportion of these major mislabeling events. After the intervention of providing weekly feedback to emergency department staff, their contribution to major mislabeling fell from 47% in 1 year (23/49) to 14% (4/29) in the subsequent 3 quarters. Collecting and trending data on mislabeled samples with timely feedback to patient care areas can change phlebotomy practice and reduce specimen mislabeling.

Testing for parentage and kinship

Parentage analyses are of interest to workers in health care, law enforcement, immigration and other fields. This review describes recent applications, technical advances, and quality improvements. Mutations at short tandem repeat sequence loci confound interpretations of genetic data used to assess all blood relationships. Rates of the usual mutation type (change in repeat number) are probably related to specific alleles at each locus as well as to allele length, locus, and gender. Short tandem repeat sequences have relatively limited information content per locus. Intermediate tandem repeat sequence loci may be better. In immigration proceedings, probabilities can be calculated for excluding parentage in blood relatives who might impersonate the biologic parent. Unrelated immigrants from a subpopulation may appear to be related, but it is now possible to statistically determine the effect of population substructure on kinship determinations. In forensic analyses, sex chromosomal (X and Y) short tandem repeat sequences and mitochondrial DNA sequence variations have helped identify the parental lineages of human remains. Recent laboratory quality improvements include a way to estimate the frequency of common mother-child specimen mislabeling in routine paternity cases. In prenatal testing there are now methods for avoiding erroneous assignment of contaminant maternal alleles to the fetus. False paternity exclusions can be avoided by adhering to a standard of the American Association of Blood Banks requiring duplicate DNA isolation and retesting of excluded men. Laboratory technology and quality have advanced, but genetic tests with greater information content are needed. Better communication is highly desirable between persons requesting tests and parentage laboratories.

Accuracy of results obtained by performing a second ligase chain reaction assay and PCR analysis on urine samples with positive or near-cutoff results in the LCx test for Chlamydia trachomatis.

Nucleic acid amplification assays such as the ligase chain reaction and PCR have encountered reproducibility problems. The initial extract and a newly extracted aliquot of urine specimens (n = 120) which had signal-to-cutoff (S/CO) ratios above 0.80 by the LCx Chlamydia assay were retested. Nucleic acid was extracted from an additional urine sample for testing by the AMPLICOR PCR Chlamydia assay. Fifteen percent (18 of 120) of the urine specimens were negative by all repeat tests (initial mean S/CO ratio by the LCx Chlamydia assay, 0.93; S/CO ratio range, 0.80 to 3.30). Repeat testing of the 102 specimens with possible positive results by the LCx Chlamydia assay by use of the initially extracted aliquot confirmed the results for 95 (93.1%) of the specimens; repeat testing of a newly extracted aliquot confirmed the results for 87 (85.3%) of the specimens. Twenty specimens had discordant results by the two repeat LCx Chlamydia assays. A total of 78 of 102 (76.5%) of the specimens were positive by the AMPLICOR PCR, and the AMPLICOR PCR confirmed the results for 82.1% (78 of 95) and 89.6% (78 of 87) of the specimens positive by the two repeat LCx Chlamydia assays, respectively. Some of the discrepancies observed by multiple repeat tests may have been due to specimen mislabeling or contamination during performance of the procedure rather than to the LCx Chlamydia assay. Both assays suffered from a lack of reproducibility on repeat testing with a small proportion of specimens, probably due to the presence of low levels of DNA, the presence of variable amounts of amplification inhibitors, and the loss of DNA during extraction.