External Quality Assurance Program Research Articles

External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe

IntroductionCurrent external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). AimThe results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. MethodImprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. ResultsOf the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. ConclusionsResults obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients.

The European Gonococcal Antimicrobial Surveillance Programme (Euro-GASP)—a sentinel approach in the European Union (EU)/European Economic Area (EEA)

Antimicrobial resistance in Neisseria gonorrhoeae is monitored in the European Union/European Economic Area through the European Gonococcal Antimicrobial Surveillance Programme (Euro-GASP) coordinated by the European Centre for Disease Prevention and...

The implementation of an external quality assurance method for point- of- care tests for HIV and syphilis in Tanzania

BackgroundExternal quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs).MethodDBS samples were collected for retesting at a reference laboratory and the results compared to the POCT results obtained at the clinic. In total, 2341 DBS samples were collected from 10 rural health facilities over a period of nine months, of which 92.5% were correctly collected and spotted.ResultsThe EQA method was easily implemented by healthcare workers under routine conditions in Northern Tanzania. For HIV, 967 out of 972 samples (99.5%) were concordant between DBS and POCT results. For syphilis, the sensitivity of syphilis tests varied between clinics with a median of 96% (25th and 75th quartile; 95-98%). The specificity of syphilis POCT was consistent compared to laboratory based test using DBS, with a median of 96% (25th and 75th quartiles; 95-98%).ConclusionOverall, the quality of testing varied at clinics and EQA results can be used to identify clinics where healthcare workers require remedial training, suggesting the necessity for stringent quality assurance programmes for POC testing. As Tanzania embarks on scaling up HIV and syphilis testing, DBS can be a useful and robust tool to monitor the quality of testing performed by healthcare workers and trigger corrective action to ensure accuracy of test results.

External quality assessment of BRAF molecular analysis in melanoma

The availability of BRAF inhibitors has given metastatic melanoma patients an effective new treatment choice and molecular testing to determine the presence or absence of a BRAF codon 600 mutation...

Validation of 4% albumin as a diluent in the Bethesda Assay for FVIII inhibitors

External quality assurance programs show the Nijmegen Bethesda Assay for FVIII inhibitors improves test specificity compared to the Classic Bethesda Assay but its uptake has been slow possibly due to the cost of using FVIII deficient plasma as diluent. This study was conducted to determine if modifying the Nijmegen Bethesda assay by replacement of FVIII deficient plasma with 4% as a diluent would be suitable for for measuring FVIII inhibitors. The titres of 59 samples from 35 patients with FVIII inhibitors were determined in parallel tests by the Nijmegen Bethesda Assay and and the modified Nijmegen assay. Method reproducibility was assessed on inhibitor-containing samples from seven individuals covering a range of titres from 1-200 Bethesda units/mL. The all-sample geometric mean titre was 6.73 Bethesda units/mL for the Nijmegen Bethesda Assay and 7.54 Bethesda units/mL for the modified Nijmegen assay. No sample was found where a difference in measured titre between methods would have altered clinical management. Agreement was very close in samples with titres less than 2BU/mL. Both assays gave inhibitor titres in external quality assurance samples of close to consensus values. The average between-run coefficients of variation were 8.6% for the Nijmegen Bethesda Assay and 7.9% for the modified Nijmegen assay. The modified Nijmegen assay using 4% albumin as the sample diluent showed good overall comparability to our existing Nijmegen Bethesda Assay and is substantially more cost-effective, making it a reasonable alternative for measuring FVIII inhibitors.

External quality assurance with dried tube specimens (DTS) for point-of-care syphilis and HIV tests: experience in an indigenous populations screening programme in the Brazilian Amazon

ObjectivesThe availability of point-of-care (POC) tests for infectious diseases has revolutionised the provision of healthcare for remote rural populations without access to laboratories. However, quality assurance for POC tests has...

Use of CD157 in FLAER-based assays for high-sensitivity PNH granulocyte and PNH monocyte detection

Recent Flow Cytometric guidelines to detect Paroxysmal Nocturnal Hemoglobinuria (PNH) in white blood cells recommend using FLAER-based assays to detect granulocytes and monocytes lacking expression of GPI-linked structures. However national proficiency testing results continue to suggest a need for improved testing algorithms, including the need to optimize diagnostic analytes in PNH.CD157 is another GPI-linked structure expressed on both granulocytes and monocytes and here we assess its ability to replace CD24 and CD14 in predicate 4-color granulocyte and monocyte assays respectively. We also assess a single tube, 5-color combination of FLAER, CD157, CD64, CD15, and CD45 to simultaneously detect PNH clones in granulocyte and monocyte lineages.Delineation of PNH from normal phenotypes with 4- or 5-color CD157-based assays compared favorably with 4-color predicate methods and PNH clone size data were similar and highly correlated (R(2) >0.99) with predicate values over a range (0.06%-99.8%) of samples. Both CD157-based assays exhibited similar high levels of sensitivity and low background levels in normal samples.While CD157-based 4- and 5-color assays generated closely similar results to the predicate assays on a range of PNH and normal samples, the 5-color assay has significant advantages. Only a single 5-color WBC reagent cocktail is required to detect both PNH granulocytes and monocytes. Additionally, sample preparation and analysis time is reduced yielding significant efficiencies in technical resources and reagent costs. All 4- and 5-color reagent sets stained stabilized whole blood PNH preparations, used in external quality assurance programs.

P6.008 External Quality Assurance with Dried Tube Specimens (DTS) For Point of Care Syphilis and HIV Tests: Experience in an Indigenous Populations Screening Programme in the Brazilian Amazon

BackgroundThe availability of point of care(POC) tests for infectious diseases has revolutionised the provision of health care for remote rural populations without access to laboratories. However, little attention has been...

Use of CD157 in FLAER-based assays for high-sensitivity PNH granulocyte and PNH monocyte detection.

Background: Recent Flow Cytometric guidelines to detect Paroxysmal Nocturnal Hemoglobinuria (PNH) in white blood cells recommend using FLAER-based assays to detect granulocytes and monocytes lacking expression of GPI-linked structures. However national proficiency testing results continue to suggest a need for improved testing algorithms, including the need to optimize diagnostic analytes in PNH. Methods: CD157 is another GPI-linked structure expressed on both granulocytes and monocytes and here we assess its ability to replace CD24 and CD14 in predicate 4-color granulocyte and monocyte assays respectively. We also assess a single tube, 5-color combination of FLAER, CD157, CD64, CD15 and CD45 to simultaneously detect PNH clones in granulocyte and monocyte lineages. Results: Delineation of PNH from normal phenotypes with 4- or 5-color CD157-based assays compared favorably with 4-color predicate methods and PNH clone size data were similar and highly correlated (R2 >0.99) with predicate values over a range (0.06% - 99.8%) of samples. Both CD157-based assays exhibited similar high levels of sensitivity and low background levels in normal samples. Conclusion: While CD157-based 4- and 5-color assays generated closely similar results to the predicate assays on a range of PNH and normal samples, the 5-color assay has significant advantages. Only a single 5-color WBC reagent cocktail is required to detect both PNH granulocytes and monocytes. Additionally, sample preparation and analysis time is reduced yielding significant efficiencies in technical resources and reagent costs. All 4- and 5-color reagent sets stained stabilized whole blood PNH preparations, used in external quality assurance programs. © 2013 Clinical Cytometry Society.

Aplicación práctica de las especificaciones mínimas de la calidad analítica obtenidas por consenso

A working group was created to define and explain the minimum specifications for analytical quality obtained by consensus (MSC) by the four Spanish scientific societies that organise external quality assurance programs in laboratory medicine. The basis of these MSC were results obtained in the external programs of the 2005-2010 period, and were defined for 60 analytes. This paper gives guidelines on how the individual laboratory should use these specifications in its daily routine. It is concluded that laboratories should perform a cause analysis study and take the appropriate corrective action when a single result in an external program falls outside the MSC for an analyte. Fulfilling MSC is a necessary -but not sufficient- requirement in the laboratory quality system, but due to its condition of ‘minimum quality’ they should not be used as quality goals.

Measurement of Lupus Anticoagulants: An Update on Quality in Laboratory Testing

Lupus anticoagulants (LAs) are antiphospholipid antibodies that interfere with in vitro phospholipid-dependent clotting tests, but are associated in vivo with significant clinical manifestations such as recurrent pregnancy loss and venous and arterial thrombosis. Although their detection is important for the diagnosis of thrombotic disorders such as the antiphospholipid syndrome, laboratory identification has historically been fraught with many issues. These have included variability in the sensitivity of assays and reagents; high false-negative and false-positive detection rates; a lack of consensus for the use of mixing tests; and, to some extent, lack of compliance with guidelines published by the Lupus Anticoagulant/Antiphospholipid Antibody Scientific Standardization Committee of the International Society on Thrombosis and Haemostasis (ISTH). Since the most recently updated guidelines in 2009, external quality assurance (EQA) programs have conducted surveys to provide a "snapshot" of laboratory practices related to the investigation of LA and to identify problems and monitor improvements in testing for LA. This article will review the impact of the most recently updated ISTH guidelines for LA testing and discuss the findings of recent EQA surveys.

Evaluation of a Novel Commercial Assay for the Determination of Cyclosporine A, Tacrolimus, Sirolimus, and Everolimus by Liquid Chromatography–Tandem Mass Spectrometric Assay

The aim of this study was the evaluation of the first commercially available in-vitro diagnostic (IVD)- mass spectrometric immunosuppressant assay from Chromsystems (MassTox Immunosuppressants ONEMINUTE Test) and the comparison to a routinely used online solid phase extraction liquid chromatography-tandem mass spectrometric assay method for the measurement of cyclosporine A, everolimus, sirolimus, and tacrolimus in patient whole blood samples. An API 4000 [tandem mass spectrometer (AB SCIEX)] combined with a CTC Pal autosampler (CTC Analytics AG) and a Shimadzu ultra-fast liquid chromatography (UFLC) system were applied for the direct liquid chromatography-tandem mass spectrometric assay analysis using electrospray ionization in positive ion mode. Isotope-labeled internal standards were used for the commercial assay. Within- and between-day variation, accuracy, and limits of quantification were determined. Samples from external international proficiency testing schemes were measured to assess the accuracy of the commercial assay. About 100 patient samples were reanalyzed with the commercial test kit, and the results were compared with our in-house results. The limit of quantification for the commercial assay was 0.5 ng/mL for everolimus, sirolimus, and tacrolimus and 5 ng/mL for cyclosporine A. The coefficient of variation for all immunosuppressants was lower than 7% (within day) and 12% (between days) for all 5 concentration levels. Accuracy ranged between 82% and 111% for quality control samples and between 89% and 112% for samples from the external quality assurance program. Both methods showed a very good agreement (r > 0.91) in patient samples over the whole concentration range for all immunosuppressants. The commercial immunosuppressant assay from Chromsystems represents a standardized IVD-certified alternative to our in-house developed assay.

Are sperm counts declining? Or did we just change our spectacles?

The popular and scientific debates about a possible decline in semen quality over the past decades are largely based on retrospective analyses of semen analysis data performed in the past. This article will argue that the conclusions from such analyses are significantly weakened because the methods of laboratory andrology have changed considerably since the 1950s. In the last 20–30 years, there have been significant developments in training and competence, increased emphasis on Quality Assurance (QA) and Quality Control (QC) as well as a major attempt at standardisation of technique through five successive editions of the World Health Organization (WHO) laboratory manuals. Interestingly, the only large prospective study carried out to date shows no change in sperm concentration over 15 years, being consistent with the idea that when laboratory methods are adequately controlled, no secular change in sperm counts are observed. In 1954, a High Court judge in the Court of Appeal of England and Wales made a landmark ruling that has become an important legal principle in English Tort law. It related to a case brought against the Minister of Health by two men who, 7 years earlier, had suffered paraplegia as a consequence of being given anaesthetic by lumbar puncture before a surgical procedure. While the precise details of the case are not really relevant to the topic of this paper, it is important to know that, unbeknown to the anaesthetists, the vials of anaesthetic had been contaminated in a manner that had not previously occurred, and could not be detected, before it was administered. Following the incident, clinical practice was immediately changed to prevent further occurrences. But, perhaps understandably, the two men sued for negligence and the matter was resolved in the courts. In his judgement, the Judge Lord Denning dismissed the men's claim saying, ‘We must not look at the 1947 incident with 1954 spectacles'.1 In effect, he was pointing out that we could not always view things that happened in the past with modern eyes. While this is now an important principle for lawyers, this paper will argue why it is also an important principle for interpreting whether or not we can establish if semen quality has been declining in recent years. When Elizabeth Carlsen and colleagues2 published their review of data from 61 papers published between 1938 and 1991, their regression analysis relied on the assumption that, during the 53 years in question, andrology laboratory methods had been wholly comparable and had remained unchanged. While they understandably excluded papers where sperm counting had been performed by computer-assisted methods or by flow cytometry (these methods were not widely used and were introduced only in later years), they recognized the apparent imprecision of counting sperm by other methods. However, they concluded that ‘there is no reason to believe that this test in itself has been subject to secular trend' and in support of this argument, they cited that ‘the same types of counting chambers have been used for the past 50 years by haematologists, who have not reported a similar secular trend in blood cell counts.' The issue of how accurate haematological methods may or may not have been in the past will be dealt with later in this paper. But it is fair to conclude that these arguments did not completely resonate with many at the andrology lab coalface. Their concern was highlighted only weeks later in the British Medical Journal,3 where Carlsen et al. were urged to ‘establish that their comparison of historical data is free of methodological bias'. To this day, this is a criticism that remains unresolved, both for the Carlsen et al.'s paper2 and those which have followed it (see Fisch4 for review). This opinion paper will argue that even with today's relatively well-standardized laboratory methods to assess semen quality, with well-established training programmes for laboratory staff, increased emphasis on laboratory accreditation and comprehensive internal and external quality assurance programmes in place, we are still far from generating consistent error-free data for semen analysis. As a consequence, it is very hard to look back into the archives with any sense of confidence about the precision and reliability of measurements made in the past. In effect, we are wearing the wrong spectacles. To set the scene, there are three areas of current and historical laboratory practice that need to be examined before the main arguments can be set out: (i) the development of semen analysis methodology; (ii) the selection and implementation of laboratory tests; and (iii) Quality Assurance (QA) and Quality Control (QC). Each will now be discussed in turn.

Using relative survival measures for cross-sectional and longitudinal benchmarks of countries, states, and districts: the BenchRelSurv- and BenchRelSurvPlot-macros

BackgroundThe objective of screening programs is to discover life threatening diseases in as many patients as early as possible and to increase the chance of survival. To be able to compare aspects of health care quality, methods are needed for benchmarking that allow comparisons on various health care levels (regional, national, and international).ObjectivesApplications and extensions of algorithms can be used to link the information on disease phases with relative survival rates and to consolidate them in composite measures. The application of the developed SAS-macros will give results for benchmarking of health care quality. Data examples for breast cancer care are given.MethodsA reference scale (expected, E) must be defined at a time point at which all benchmark objects (observed, O) are measured. All indices are defined as O/E, whereby the extended standardized screening-index (eSSI), the standardized case-mix-index (SCI), the work-up-index (SWI), and the treatment-index (STI) address different health care aspects. The composite measures called overall-performance evaluation (OPE) and relative overall performance indices (ROPI) link the individual indices differently for cross-sectional or longitudinal analyses.ResultsAlgorithms allow a time point and a time interval associated comparison of the benchmark objects in the indices eSSI, SCI, SWI, STI, OPE, and ROPI. Comparisons between countries, states and districts are possible. Exemplarily comparisons between two countries are made. The success of early detection and screening programs as well as clinical health care quality for breast cancer can be demonstrated while the population’s background mortality is concerned.ConclusionsIf external quality assurance programs and benchmark objects are based on population-based and corresponding demographic data, information of disease phase and relative survival rates can be combined to indices which offer approaches for comparative analyses between benchmark objects. Conclusions on screening programs and health care quality are possible. The macros can be transferred to other diseases if a disease-specific phase scale of prognostic value (e.g. stage) exists.

Point of care (POCT) testing for human immunodeficiency virus (HIV) infection in Australia: in context

The laboratory diagnosis of HIV infection is most often made by the detection of antibodies to the virus. Conventional serologi-cal tests for detection HIV antibodies are usually referred to as ‘screening or standard’ tests (the initial test) or ‘confirmatory, supplemental or reference tests’. Screening tests identify samples that contain antibodies to HIV but are usually not used to provide a presumptive diagnosis for a patient whose sample is found to be initially reactive. Only after confirmatory or reference tests have been performed can an individual conclusively be identified as being seropositive and having established HIV infection. Screening and confirmatory tests are performed in a testing strategy which has been scientifically validated for a particular population demographic to provide the most sensitive and specific result for the individual tested. For many years, point of care (PoCT, rapid or short incubation) tests for HIV have been successfully used in many developed and developing countries. In 2012, the US Food and Drug Administration (FDA) announced the approval of a home test or over-the-counter HIV PoCT that would enable individuals to perform self-testing. In many countries the use of rapid tests has overcome resource constraints where laboratory infrastructure and sample transportation logistics are limited, in remote settings and in populations where the return rate for receiving a confirmed result is poor. Recent research suggests that much HIV transmission occurs from people who have themselves only recently have become infected. Many approaches have been tried to increase the demand for testing and improve rates of testing amongst people at risk of acquiring HIV. There is a strong case of for the introduction of PoCT for HIV in Australia including the desire to improve the rates of testing for populations at risk of infection. Reducing barriers around testing through improving access and consumer experiences suggests that more convenient testing could increase the rates of testing and stimulate the demand for HIV testing in target groups. In Australia, all in vitro diagnostic devices (IVD) are regulated according to a public health risk stratification. Currently all HIV and HCV screening tests are classified in the highest category (Class 4) and undergo a high degree of scrutiny before they are approved for registration on the Australian Register of Therapeutic Goods (ARTG) and approved for sale. This ensures that tests that are available in the Australian market are of a high standard. At the time this abstract was prepared there were two PoCT tests approved on the ARTG; however, one test was approved for use as a screening test and could only be used in laboratory settings. In 2011, the National HIV Testing Policy underwent significant review and established a framework for the introduction of PoCT in Australia proposing standards around training, settings and quality assurance. This presentation will outline the current situation of point of care tests for HIV in Australia and highlight some issues around their introduction and regulation in the broad non-laboratory based context. Data will be presented on the performance of participants in the Royal College of Pathologists of Australasia (RCPA) external quality assurance program (QAP) for HIV PoCT, highlighting issues with quality in regional laboratories where PoCT are widely used.

Current status of verification practices in clinical biochemistry in Spain

Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification. Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase). Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size. A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.

A pilot external quality assurance programme for line-probe assay detection of anti-tuberculosis drug resistance

Multidrug-resistant tuberculosis (MDR-TB; resistance to isoniazid and rifampicin) is difficult to detect and control. Line-probe assays (LiPA) are widely used for the rapid detection of MDR-TB. To ensure the quality of the test, a pilot external quality assurance (EQA) programme was initiated to assess the feasibility of running such a programme and the possibility of improving the proficiency of TB laboratories in performing the test. Prepared filter-paper-based Mycobacterium tuberculosis DNA samples were shipped to participant laboratories for LiPA EQA. The tests were performed blind, and the results were returned to the organising laboratory for comparison and analysis. A total of four rounds of EQA samples were dispatched to five laboratories in four countries. Overall inter- and intra-laboratory reproducibility was respectively 97% and 96%. The strengths and weaknesses of the participant laboratories in performing the test were discussed. A LiPA EQA programme can ensure quality and improve the performance of TB laboratories. This is a critical step during the initial stages at the time of setting up this method of testing.

Entwicklung von Verfahrensweisen und Instrumenten zur externen Qualitätssicherung in Einrichtungen der stationären Vorsorge und Rehabilitation für Mütter und Väter einschließlich Mutter-/Vater-Kind-Einrichtungen

There so far is no standardized program for external quality assurance in inpatient parent-child prevention and rehabilitation in Germany. Therefore, instruments and methods of external quality assurance were developed and evaluated on behalf of the federal-level health insurance institutions. On the level of structure quality, a modular questionnaire for assessing structural features of rehabilitation/prevention centers, basic and allocation criteria as well as a checklist for visitations were developed. Structural data were collected in a nationwide survey of parent-child prevention and rehabilitation centers. Process and outcome quality data were collected in n=38 centers. Process quality was assessed using multiple methods (process-related structural features, case-related routine documentation, and incident-related patient questionnaires). Outcome quality was measured via patient questionnaires (n=1 799 patients). We used a multi-level modelling approach by adjusting relevant confounders on institutional and patient levels. The methods, instruments and analyzing procedures developed for measuring quality on the level of structure, processes and outcomes were adjusted in cooperation with all relevant stakeholders. Results are exemplarily presented for all quality assurance tools. For most of the risk-adjusted outcome parameters, we found no significant differences between institutions. For the first time, a comprehensive, standardized and generally applicable set of methods and instruments for routine use in comparative quality measurement of inpatient parent-child prevention and rehabilitation is available. However, it should be considered that the very heterogeneous field of family-oriented measures can not be covered entirely by an external quality assurance program. Therefore, methods and instruments have to be adapted continuously to the specifics of this area of health care and to new developments.

The measurement of 25-hydroxy vitamin D – an analytical challenge

The measurement of 25-hydroxy vitamin D – an analytical challenge

Development of External Quality Assurance Programs for Biorepositories

Differences in biorepository methods and practices can result in sample variation that has the potential to impact research results derived from those samples. The establishment of common quality assurance (QA) and quality control (QC) tools has been difficult due to the wide variety of specimens and intended uses of the collections in biorepositories. The development and adoption of the ISBER Best Practices for Repositories (Best Practices), the latest edition of which was published in Biopreservation and Biobanking this past April, has been an important advancement in the field. Best Practices provides guidance on management practices and technical aspects, and addresses repository development, facilities and equipment, cost management, security, and training, while taking regulatory compliance and the ethical, legal, and social issues relevant to repositories into account. Although many biorepository institutions have adopted these Best Practices, dissemination of information on sample preparation methods and sample quality assessment practices across biorepositories remains a significant issue for the repository community. External quality assurance (EQA) programs are utilized throughout the world to control interlaboratory variation in the clinical diagnostic arena and are excellent models to apply for standardization of key quality assessment processes in the biorepository industry.