Ability Of Laboratories Research Articles

COVID-19 MOLECULAR-BASED TESTING CAPACITY IN FIVE CUSTOMARY AREAS OF PAPUA

Background: COVID-19 (Corona Virus Disease-19) is a disease that emerged at the end of December 2019 and was declared a world pandemic by the WHO (World Health Organization) in March 2020. The gold standard for testing for covid-19 until now is molecular-based virus detection with RT-PCR (Real Time-Polymerase Chain Reaction) and TCM (Molecular Rapid Test). In the early of this pandemic, Indonesia, especially Papua, still had difficulty examining COVID-19 due to limited laboratories that could carry out these tests. Aims: This study aimed to see the laboratory's ability from various regencies representing five customary Papuan areas Methods: This research was a descriptive study that uses primary data and secondary data collected from the Provincial and Regency Papua COVID-19 Response Acceleration Task Force and the representative hospitals of 5 customary Papuan areas (Saireri, Ha anim, Mee Pago, Lapago, Mamta) Results: There are several challenges and things that need to be considered by all stakeholders involved in examining COVID-19 in Papua so that the examination capacity can be maximally increased. Conclusion: Regency that only has GeneXpert are recommended to have qPCR so that the acceleration of COVID-19 testing in Papua Province can be carried out. The qPCR can be procured in several cities/regencies within one customary area so that sample delivery can be done more quickly without having to send samples to Jayapura City

"РИЗИК-ПРОФІЛЬ" ВИПРОБУВАЛЬНОЇ ЛАБОРАТОРІЇ

Goal of the study is to improve the laboratory management system. The substantiation of principles classification and assessment of risks are carried out. The mind-activity methodology is used. To achieve the goal it is necessary to determine the source of risk, assess a scale of selected risk impact, establish reference (control) points, assess the risk, develop and implement corrective actions. Research methods. The mind-activity methodology is the basic method for research. Application to the risk management process of testing laboratory activities. The results of the study. The levels of the hierarchy are determined by the level of consequences (low, high, medium) from the onset of a negative situation. The phases are determined by the type (category) of risk by the stage of its determination. Forecasted risks are determined by the method of forecasting for a certain future period of time (for example, the next calendar year). In fact, identified are risks that have been identified and are aimed at the short-term perspective of their emergence. Not detected - risks remain identified and arise from the implementation of inappropriate preventive measures. These risks are stipulated by the uncertainty of the input information in the analysis of risks and the inadequacy of measures to eliminate possible negative consequences. The proposed risk classification system makes it possible to compile a “risk profile” of the laboratory. The "Risk-Profile" of a laboratory is a conditional indicator that characterizes the laboratory's ability to possibly provide unreliable test results. Conclusions. The mind-activity methodology was used. Principles, classification and risk assessment method have been developed for the testing laboratory. This made it possible to establish the relationship between the level of risk, its source and the period of exposure, as well as to identify the most vulnerable elements of the management system at a given time and to find ways to improve and search for opportunities. The scientific value of the study lies in the substantiation of the principles classification and method of risk assessment of the testing laboratory. The practical value of the study lies in the possibility of forming a "risk profile" of the laboratory, provides objective information about the current state of the laboratory management system and indicates possible ways of improvement.

Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients.

Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers. We performed a prospective observational study on paired venous and fingerstick capillary blood samples from admitted patients undergoing vancomycin therapy. Paired specimens were analyzed for vancomycin and a basic metabolic panel (BMP: calcium, carbon dioxide, chloride, potassium, sodium, creatinine, glucose, serum urea nitrogen) on the core laboratory's automated chemistry and immunochemistry platforms. A total of 59 paired fingerstick and venous blood specimens from 56 unique inpatients were analyzed. Paired samples were comparable for all the analytes tested with the exception of bicarbonate and potassium, which were significantly different among the capillary sample group. Patients required multiple fingers be lanced in 15% of cases to obtain sufficient blood to carry out the testing. Capillary sample rejection rates due to insufficient volumes were as high as 30% in the initial 30 patients enrolled in the study. Vancomycin and the BMP, with the exception of potassium and bicarbonate, were determined to be analytically comparable. However, significant preanalytical issues should preclude laboratories and providers from more widespread adoption of fingerstick-derived capillary blood as an alternative sampling method except in the most extenuating of circumstances.

Variant Call Format–Diagnostic Annotation and Reporting Tool: A Customizable Analysis Pipeline for Identification of Clinically Relevant Genetic Variants in Next-Generation Sequencing Data

In this article, we introduce the variant call format-diagnostic annotation and reporting tool (VCF-DART), a customized analysis pipeline tool for the rapid annotation of variants from exome or genome sequencing and the generation of reports for genetic diagnostics. VCF-DART uses custom gene lists to categorize variants into specific analysis tiers and to subcategorize them on the basis of standard parameters to facilitate the rapid interrogation of potentially pathogenic variants by human operators. The tool uses publicly available databases to identify a range of data to assist with variant classification and curation processes and includes robust logging of parameters and database versions to allow comparison of analyses performed at different times. VCF-DART-an online analysis pipeline for next-generation sequencing data-is a platform agnostic tool that leverages the use of publicly available databases to improve a laboratory's calling ability and reduce analysis times long-term. It also runs highly efficiently and scales from desk and laptop machines to servers. Overall, VCF-DART provides a simple, customizable, and entirely open-source method to identify genetic variants that may be of clinical importance in a variety of genetically important conditions.

Preanalytical Variables in Coagulation Testing: Setting the Stage for Accurate Results.

Many preanalytical variables may affect the results of routine coagulation assays. While advances in laboratory instrumentation have partially addressed the laboratory's ability to recognize some of these variables, there remains an increased reliance on laboratory personnel to recognize the three potential areas where coagulation testing preanalytical issues may arise: (1) specimen collection (including patient selection), (2) specimen transportation and stability, and (3) specimen processing and storage. The purpose of this article is to identify the preanalytical variables associated with coagulation-related testing and provide laboratory practice recommendations in an effort to improve the quality of coagulation testing and accuracy of result reporting.

Implementation and Validation of an Automated Flow Cytometry Analysis Pipeline for Human Immune Profiling.

Automated reagent preparation, sample processing, and data acquisition have increased the rate at which flow cytometry data can be generated. Furthermore, advances in technology and flow cytometry instrumentation continually increase the complexity and dimensionality of this data. Together, this leads to increased pressure on manual data analysis, which has inherent limitations including subjectivity of the analyst and the length of time needed for data processing. These issues can create bottlenecks in the data processing workflow and potentially compromise data quality. To address these issues, as well as the challenges associated with manual gating in a high-volume human immune profiling laboratory, we sought to implement an automated analysis pipeline. In this report, we discuss considerations for selecting an automated analysis method, the process of implementing an automated pipeline, and detail our successful incorporation of an automated gating strategy with flowDensity into our analysis workflow. This validated pipeline augments our laboratory's ability to provide rapid high-throughput immune profiling for patients participating in cancer immunotherapy clinical trials. © International Society for Advancement of Cytometry.

CPHLN recommendations for the laboratory detection of Shiga toxin-producing Escherichia coli (O157 and non-O157).

Shiga toxin-producing Escherichia coli (STEC) are important enteric pathogens responsible for sporadic cases and outbreaks of gastroenteritis. E.coli O157:H7/NM (STEC O157) are the most commonly known STEC serotypes but it is now increasingly apparent that non-O157 STEC serotypes have been underreported in the past because they were not part of routine screening in many front-line laboratories. The Canadian Public Health Laboratory Network (CPHLN) has identified the need for improved detection and surveillance of non-O157 STEC and has developed the following recommendations to assist in the decision-making process for clinical and reference microbiology laboratories. These recommendations should be followed to the best of a laboratory's abilities based on the availability of technology and resources. The CPHLN recommends that when screening for the agents of bacterial gastroenteritis from a stool sample, front-line laboratories use either a chromogenic agar culture or a culture-independent diagnostic test (CIDT). CIDT options include nucleic acid amplification tests (NAATs) to detect Shiga toxin genes or enzyme immunoassays (EIAs) to detect Shiga toxins. If either CIDT method is positive for possible STEC, laboratories must have a mechanism to culture and isolate STEC in order to support both provincial and national surveillance as well as outbreak investigations and response. These CPHLN recommendations should result in improved detection of STEC in patients presenting with diarrhea, especially when due to the non-O157 serotypes. These measures should enhance the overall quality of healthcare and food safety, and provide better protection of the public via improved surveillance and outbreak detection and response.

Investigation and Implementation of Commercially Available Optically Stimulated Luminescence Dosimeters for Use in Fixed Nuclear Accident Dosimeter Systems.

Idaho National Laboratory transitioned from an external dosimetry system reliant on thermoluminescent dosimeters to one that uses optically stimulated luminescence dosimeters in 2010. This change not only affected the dosimeters worn by personnel, but those found in the nuclear-accident dosimeters used across Idaho National Laboratory. The elimination of on-site use and processing of thermoluminescent dosimeters impacted Idaho National Laboratory's ability to process nuclear-accident dosimeters in a timely manner. This change in processes drove Idaho National Laboratory to develop an alternative method for fixed nuclear-accident dosimeter gamma-dose analyses. This new method was driven by the need to establish a simple, cost-effective, and rapid-turnaround alternative to the thermoluminescent-dosimeter-based fixed nuclear-accident dosimeter system. An adaptation of existing technologies proved to be the most efficient path to this end. The purpose of this article is to delineate the technical basis for replacing the thermoluminescent dosimeter contained within the Idaho National Laboratory fixed nuclear-accident dosimeter system with optically stimulated luminescence-based Landauer, Inc., nanoDot dosimeters.

Identification of Friend or Foe: The Laboratory Challenge of Differentiating M-Proteins from Monoclonal Antibody Therapies.

Since the first monoclonal antibody (mAb) therapy hit the market in 1996, the number of disorders treated with this class of therapeutics has seen tremendous growth, with over 50 antibody-based therapeutics currently approved for use in the US and Europe. This class of therapeutics recently made profound progress in the treatment of refractory multiple myeloma (MM). Treating MM with the mAbs will challenge the laboratory's ability to differentiate exogenous mAbs being used to treat patients from endogenous mAbs associated with disease. An overview of the therapeutic mAbs (t-mAbs) developed for the treatment of MM is provided. The anticipated impact of these therapies on patient care, laboratory testing, and clinical research is discussed. Efforts underway to develop strategies and technologies to help laboratories address the growing challenge of mAb interferences are reviewed. Laboratories can implement risk mitigation strategies at the preanalytical and postanalytical phase of testing to reduce the likelihood of reporting false-positive M-protein results in patients receiving t-mAbs. However, at the analytical phase of testing, current laboratory methods are ill-suited to differentiate between residual disease and residual drugs. Mass spectrometry-based methods might be best positioned to aid laboratories with the rapidly evolving landscape of MM treatment.

Safe Reduction of Blood Volume in the Blood Gas Laboratory.

Phlebotomy is a significant cause of iatrogenic anemia in the critical care environment. It is estimated that one-third of all transfusions of packed red blood cells in intensive care units (ICU) result from phlebotomy. The aims of this study were to determine if utilizing the 1mL blood gas syringe for an adult population would impact the rate at which specimens were acceptable for testing and result reporting based on lab specimen rejection criteria; and to compare blood utilization between the 2 different syringes. This study was conducted in 1 of the adult ICUs at the University of Utah Hospital. Over a baseline period a standard adult 3 mL blood gas syringe was utilized. Subsequently the standard adult syringe was replaced by a 1 mL syringe produced by the same manufacturer with the same heparin concentration. The change to the 1 mL syringe had no effect on specimen integrity in regards to laboratory's ability to process the specimen. With use of the 1 mL syringe there was a 60% reduction in the volume of blood drawn compared with the baseline period. Standardizing the 1 mL syringe for Blood Gas Laboratory tests will reduce patient blood loss without appreciably affecting specimen rejection relative to current rates.

Process Optimization to Improve Immunosuppressant Drug Testing Turnaround Time.

Timely reporting of immunosuppressant (ISP) drug level results is needed for transplant patient management. This study characterized the local ISP testing process, identified bottlenecks and implemented process improvements to meet turnaround time requirements. Laboratory information time stamps, direct observation and discussion with staff were used to construct a value stream map of the ISP testing process to identify process bottlenecks. Improvements were implemented to attain the required turnaround time. Baseline performance of the existing ISP process (seven weeks, n = 272 samples) indicated that only 28% of samples were reported by 2:00 pm Major bottlenecks were identified to be the analytical run schedule, instrument delays, difficulty identifying ISP samples at intake, and difficulty collecting specimens. Process changes resulted in a median of 76% samples reported by 2:00 pm : Adjusting ISP collection and analysis processes improved the laboratory's ability to meet physician requested result reporting time of 2:00 pm.

Air quality in the assisted reproduction laboratory: a mini-review

Quality of air in the clinical embryology laboratory is considered critical for high in vitro fertilization (IVF) success rates, yet evidence for best practices is lacking. Predominantly anecdotal reports on relationships between air quality and IVF success rates have resulted in minimal authentic clinical laboratory guidelines or in recommendations that are based on industrial cleanroom particulate standards with little attention to chemical air filtration. As a result, a nascent industry of costly, specialized air handling equipment for IVF laboratories has emerged to provide air quality solutions that have not been clearly assessed or verified. Clinics are embracing such technology because their embryology laboratories have become epicenters of assisted reproductive technology as the practice of IVF has moved to blastocyst transfers and utilization of trophectoderm biopsy for preimplantation genetic testing (PGT). Thus, a laboratory's ability to culture, biopsy, and freeze blastocysts is a rate-limiting step that depends on technical proficiency and a supportive and stable culture environment based on a foundation of high-quality ambient air. This review aims to describe how evidence for the importance of air quality, in particular the role of volatile organic compounds (VOC), has resulted in an evolution of clinical practice that has arguably contributed to improved outcomes.

First experience of a multicenter external quality assessment of molecular 16S rRNA gene detection in bone and joint infections.

The objective of this study was to assess the performance of seven French laboratories for 16S rRNA gene detection by real-time PCR in the diagnosis of bone and joint infection (BJI) to validate a large multicenter study. External quality control (QC) was required owing to the differences in extraction procedures and the molecular equipment used in the different laboratories. Three proficiency sets were organized, including four bacterial DNA extracts and four bead mill-pretreated osteoarticular specimens. Extraction volumes, 16S rRNA gene primers, and sequencing interpretation rules were standardized. In order to assess each laboratory's ability to achieve the best results, scores were assigned, and each QC series was classified as optimal, acceptable, or to be improved. A total of 168 QCs were sent, and 160 responses were analyzed. The expected results were obtained for 93.8%, with the same proportion for extracts (75/80) and clinical specimens (75/80). For the specimens, there was no significant difference between manual and automated extraction. This QC demonstrated the ability to achieve good and homogeneous results using the same 16S rRNA gene PCR with different equipment and validates the possibility of high-quality multicenter studies using molecular diagnosis for BJI.

Laborartory Medicine Resource Management in Times of Austerity: An Opportunity to Rationalize Services Using Vitamin B12 and Folate Testing As an Example

Abstract 4229 Introduction:Laboratory medicine services are critical to delivering high quality patient care. They operate to internationally recognized standards to ensure the quality and accuracy of their test results. Their responsibilities are wide ranging including enabling the clinician to confirm or exclude the presence of significant diseases, monitoring the progress of chronic conditions, providing expert advice in the management of patients with complex conditions, supporting research and development into new laboratory tests, systems and processes and supporting undergraduate teaching, postgraduate teaching and professional development. In the current economic climate, resources are diminishing in accordance with government austerity measures. At the same time, patients have increasing knowledge and therefore often have increasingly complex demands. To optimize primary care services, it is crucial that primary care physicians have appropriate access to tests. But a balance needs to be struck between a primary care physician's access and a laboratory's ability to limit access so that limited resources can be used to the maximum benefit of patients. Evidence based guidelines are critical. Laboratory tests can broadly be split into two categories: frequently ordered, inexpensive tests such as blood counts and infrequently ordered, expensive tests such as hereditary thrombophillia screens. In our institution, we chose to review vitamin B12 and folate testing as they are frequently requested, relatively inexpensive but time consuming assays.The aims of our study were to review the number of vitamin B12 and folate tests ordered by primary care physicians, to find out why the tests were being ordered and to see if they were being ordered appropriately. Methods:We reviewed our laboratory records to ascertain the number of vitamin B12 and folate assays carried out between 2004 and 2011. To find out why the tests was being ordered, the primary care physicians that use the laboratory in University Hospital Galway were sent out a questionnaire. To review whether or not clinical data was provided, 200 random request forms form March 2012 were reviewed. The literature was then reviewed to look at international guidelines. Results:The number of B12 and folate requests have risen year on year between 2004 and 2011, numbering 33,872 in 2004 and 96,544 in 2011. 69 of 172 primary health care centers responded to the survey. The main reasons given for ordering the test were unexplained neurological symptoms, macrocytosis, anemia and fatigue. 200 random request forms that the laboratory had received from primary care physicians were reviewed. 50% had clinical details. The reasons given for ordering the test were very varied, the most common being rountine screening and fatigue. 50 % had no clinical details provided. If the patient had had a recent full blood count in our laboratory, this was reviewed to see if any indication for the test could be ascertained. The majority (81%) had normal full blood counts. Discussion:According to the central statistics office, the population of our catchment area increased by 17% between 2002 and 2011. This did not account for the 185% increase in testing between 2004 and 2011. As vitamin B12 and folate were invariably requested in association with a ferritin level, this equates to €376,522 per year in assay cost alone. These tests are time consuming (around 40 minutes per batch) and labor intensive, which is increasingly a major factor as the main method for reducing laboratory costs to date has been to reduce the workforce. While the majority of primary care physicians knew the appropriate indications for B12 and folate testing when asked, this was not reflected in their practice. It was also worrying that many seemed unaware of important indications for testing such as unexplained cytopenias.On reviewing the literature, it is clear that there is no current guideline for vitamin B12 and folate testing. The most recent British committee for standards in hematology (BCSH) guideline was published in 1994 and is archived. Conclusion:In the current economic crisis, it is imperative that services are optimized so that patients do not suffer in the setting of decreased resources. This is best achieved when secondary and tertiary care institutions collaborate with primary care to deliver evidenced based health care. Disclosures:No relevant conflicts of interest to declare.

Identification and elimination of ion suppression in the quantitative analysis of sirolimus in human blood by LC/ESI-MS/MS

Ion suppression can negatively affect the performance characteristics of LC/ESI-MS/MS based methods, and we wished to identify sources of ion suppression in an assay for quantitating sirolimus in human whole blood. We first compared the peak areas of sirolimus and ascomycin added to human blood samples treated with and without extraction using octadecyl silyl (ODS)-silica gel after protein precipitation, and we found that water-soluble compounds cause the ion suppression for both drugs. Post-column infusion studies indicated that compounds retained in the sample after ODS extraction and protein precipitation caused ion suppression. MS analysis of these compounds suggested they were hydroxyl group-possessing phosphocholines, and this was confirmed using purified lysophosphatidylcholine variants. Therefore, we included a HybridSPE treatment step after the ODS extraction into the preanalytical workflow to remove phosphocholines, and this successfully eliminated the observed ion suppression for determining sirolimus concentration in human whole blood by LC/ESI-MS/MS. Sirolimus is a highly lipophilic molecule, and this study demonstrates the impact that preanalytical extraction and purification steps can have on a laboratory's ability to accurately detect and quantitate this and other lipophilic drugs.

Final report on CCQM-K63.a,b: Non-peptide hormones in serum: cortisol and progesterone

Hormones are chemical messengers that regulate many life functions. Deviations from normal hormone levels can have serious health consequences. Accurate measurement of hormone levels in serum can be beneficial in diagnosing, monitoring, and treating a number of diseases. Two steroid hormones, cortisol and progesterone, were selected by the Organic Analysis Working Group (OAWG) to evaluate its member Institutes' measurement capabilities for this important class of measurand.Serum concentrations of cortisol range from 30 ng/mL to 230 ng/mL. Serum concentrations of progesterone in adult females range from 0.15 ng/mL to 25 ng/mL but can rise to ≈230 ng/mL during pregnancy. The ability to measure cortisol is indicative of a laboratory's ability to measure steroid hormones at concentration levels similar to cortisol. The ability to measure progesterone is indicative of a laboratory's ability to measure steroid hormones with similar functional groups and concentration levels, such as testosterone.Pilot studies CCQM-P77.a and CCQM-P77.b on the determination of cortisol and progesterone in human serum were completed in 2006. There was good agreement among the results reported by participants who used isotope dilution/mass spectrometry (ID/MS) with either gas chromatography (GC) or liquid chromatography (LC). In 2007 the OAWG decided to proceed with key comparison (KC) CCQM-K63.a, cortisol in human serum, and CCQM-K63.b, progesterone in human serum. Thus, following established OAWG procedure, only results from participants that (1) used an ID/MS-based method, (2) participated in the relevant pilot study, and (3) used a metrologically traceable primary standard were to be eligible for use in calculating the key comparison reference value (KCRV) for each measurand.Six laboratories participated in CCQM-K63.a and eight laboratories participated in CCQM-K63.b. The same pooled frozen female serum material was used in both of the KCs. The mean value for the six ID/MS-based cortisol results is 100.4 ng/g with a relative standard deviation (%RSD) of 1.1%. The mean value for the seven ID/MS-based progesterone originally reported results is 2.83 with a %RSD of 1.8%. While a number of the reported results were not eligible to be used in establishing the KCRVs, the KCRVs as estimated from just the eligible results agree very well with these means. The excellent among-participant agreement indicates that ID/MS-based measurement procedures can provide precise and true results for steroid hormones at levels greater than about 1 ng/g. The progesterone result reported by a laboratory using a non-isotopically labelled internal standard was about 11% larger than the KCRV.Main text.To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/.The final report has been peer-reviewed and approved for publication by the CCQM, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

Final report on CCQM-K62: Nutrients in infant/adult formula—Vitamins

Key comparison CCQM-K62 was designed to enable demonstration of the equivalence in capabilities for measurement of vitamins in a food matrix. A milk-based fortified human infant/adult formula was selected as the matrix based upon material availability and relevance. Because vitamins were added to the CCQM-K62 study material in a single form and at levels significantly higher than those that would be naturally occurring in the milk base, the ability of a laboratory to measure the study vitamins is only indicative of a laboratory's ability to measure vitamins in fortified foods. Target analytes were selected for study because of the ready availability of suitable standard materials and the range of their chemical properties: folic acid (vitamin B9) is a single water-soluble molecular entity that typically occurs at low levels and can be unstable, niacin (vitamin B3) is a single stable molecular entity and is typically present at higher concentrations than the other water-soluble vitamins, vitamin A has multiple molecular forms (including retinol and retinyl palmitate), is fat-soluble and typically occurs at relatively high levels. Results for participants measuring only folic acid or niacin are only indicative of their ability to make that measurement; results for participants measuring both folic acid and niacin are indicative of a laboratory's ability to measure folic acid, thiamine, niacin, and riboflavin in fortified foods but not vitamin C or other water-soluble vitamins. The ability to measure vitamin A (reported as retinol equivalents) in this material is also indicative of the participant's ability to measure vitamin E (as alpha-tocopherol and alpha-tocopheryl acetate) but is not indicative of the ability to measure vitamins D and K, which typically occur at much lower concentrations. The relative degrees of equivalence of the reported measurements for all three analytes in CCQM-K62 were within 10%; however, since only two results were submitted for niacin and vitamin A and one of the three results for folic acid was withdrawn, no strong conclusions as to the expected comparability of higher-order vitamin measurements can be established.Main text.To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/.The final report has been peer-reviewed and approved for publication by the CCQM, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

Experimental Validation of Peptide Immunohistochemistry Controls

Peptide immunohistochemistry (IHC) controls are a new quality control format for verifying proper IHC assay performance, offering advantages in high throughput automated manufacture and standardization. We previously demonstrated that formalin-fixed peptide epitopes, covalently attached to glass microscope slides, behaved (immunochemically) in a similar fashion to the native protein in tissue sections. To convert this promising idea into a practical clinical laboratory quality control tool, we tested the hypothesis that the quality assurance information provided by peptide IHC controls accurately reflects IHC staining performance among a diverse group of clinical laboratories. To test the hypothesis, we first designed and built an instrument for reproducibly printing the controls on microscope slides and a simple software program to measure the color intensity of stained controls. Automated printing of peptide spots was reproducible, with coefficients of variation of 4% to 8%. Moreover, the peptide controls were stable at <or=4 degrees C for at least 7 months, the longest time duration we tested. A national study of 109 participating clinical laboratories demonstrated a good correlation between a laboratory's ability to properly stain formalin-fixed peptide controls to their ability in properly staining a 3+ HER-2 formalin-fixed tissue section mounted on the same slide (r=0.87). Therefore, peptide IHC controls accurately reflect the analytical component of an IHC stain, including antigen retrieval. Besides its use in proficiency survey testing, we also demonstrate the feasibility of applying peptide IHC controls for verifying intralaboratory IHC staining consistency, using Levy-Jennings charting.

Patient Safety and Error Reduction in Surgical Pathology

National patient safety goals and error reduction efforts should be addressed by each surgical pathology laboratory. To review issues relevant to patient safety and error reduction in surgical pathology in the context of continuous quality improvement. The literature is reviewed. Patient safety goals can and should be addressed within the context of a quality improvement plan. Multiple factors that contribute to errors in surgical pathology are discussed. The current literature defines the extent of these problems within specific segments of the test cycle (preanalytic, analytic, and postanalytic). Potential solutions are presented that may reduce or avoid errors. In addition, general principles are outlined that enhance the laboratory's ability to successfully and continuously address patient safety and error reduction.

Patient safety and error reduction in surgical pathology.

Abstract Context.—National patient safety goals and error reduction efforts should be addressed by each surgical pathology laboratory. Objective.—To review issues relevant to patient safety and error reduction in surgical pathology in the context of continuous quality improvement. Data Sources.—The literature is reviewed. Conclusions.—Patient safety goals can and should be addressed within the context of a quality improvement plan. Multiple factors that contribute to errors in surgical pathology are discussed. The current literature defines the extent of these problems within specific segments of the test cycle (preanalytic, analytic, and postanalytic). Potential solutions are presented that may reduce or avoid errors. In addition, general principles are outlined that enhance the laboratory's ability to successfully and continuously address patient safety and error reduction.