Laboratory Accreditation Program Research Articles

Which absorption coefficients are correct?

Each year absorptive material samples are sent to various accredited acoustic laboratories around the country by manufacturers who want to verify the performance of their products. Results are published as indisputable validation of the product absorption performance by the manufacturer. As no recent interlaboratory study results for ASTM C423—Standard Test Method for Sound Absorption and Sound Absorption Coefficients by the Reverberation Room Method are available, the Owens Corning Acoustic Research Center initiated a private interlaboratory study. A small set of accredited acoustical laboratories tested a set of the original National Voluntary Laboratory Accreditation Program reference panels. The resulting data and differences in the measured absorption coefficients will be reviewed.

Development of an accreditation process for analytical methods to measure microplastics in drinking water for regulatory monitoring

Development of a laboratory accreditation program to ensure competency of laboratories performing analytical measurements is a key step in adopting new analytical measurement methods for regulatory decision-making. Here, we describe California's three-part accreditation process for spectroscopically measuring microplastics in drinking water, and show how data from a multi-laboratory method comparison study informed development of accreditation programs for the resulting methods, which can inform analogous future work for other analytes. The first part is periodic performance evaluation (PE) samples, in which laboratories are provided blind samples of known composition to quantify within acceptable performance limits. The second is inspection, or audit, assessing whether the laboratory has the proper equipment to conduct the work and whether it is correctly employing proper procedures. The third is implementation of a quality management system providing documentation that protocols demonstrated during inspection are continuously maintained. These fell into three broad categories: instrument maintenance; laboratory cleanliness, especially important for microplastics and one that must be accompanied by a blanks measurement and correction process; and training so samples are being processed by qualified analysts. An intercomparison exercise among 22 laboratories was necessary to determine what parameter permutations were important for PE samples, and expected accuracy from competent laboratories. The recommended PE sample composition was two size categories (20-50um and 500um-1mm), two polymer types, and two morphologies (fibers and non-fibers). Discussions among intercomparison exercise participants were key in determining the factors that most contributed to laboratory variability, and the focus for both on-site inspections and quality management systems.

A high-throughput small volume matrix based calibration using isotope dilution liquid chromatography tandem mass spectrometry analysis for 42 per and polyfluoroalkyl substances in groundwater

A novel method for the determination of per- and polyfluoroalkyl substances (PFAS) in groundwater is presented using a subsample, matrix-matched calibrators, 96-well plate solid phase extraction (SPE), and ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Accuracy, precision, measurement of uncertainty (MOU), method detection limit (MDL), method quantitation limit (MQL), analytical measurement range, interferences/ion suppression, and analyte stability were determined as part of the in-house method validation. The method quantitates 42 PFAS compounds from nine different compound classes. Accuracy for the reference material (RM) and matrix spike (MS) ranged from 52.3 to 117.8 %, and precision for the MS and matrix spike duplicate (MSD) had a coefficient of variation (CV) from 2.0 % to 23.3 %. MDLs spanned from 0.07 to 1.97 ng L−1, with MQLs ranging from 0.20 to 5.90 ng L−1. Suppression studies determined that iron and manganese have effects on analytes that do not have paired isotopically labeled standards. The results from the in-house validation indicated that this Michigan Department of Health and Human Services laboratory developed test meets the necessary accuracy, precision, MDL, MQL and reporting limits requirement established by the laboratory's quality system essentials (QSEs) and select criteria from the Department of Defense (DoD) Quality Systems Manual for Environmental Laboratories and American Industrial Hygiene Association Laboratory Accreditation Program, LLC (AIHA LAP, LLC) accrediting International Standard Organization (ISO/IEC 17025:2017) check list.

A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests.

As next-generation sequencing (NGS) oncology tests vary by platform, application, and target of genes, specific methods for external quality assessment (EQA) have not been universally applied. Hence, we have attempted to implement on-site evaluation as EQA in the accreditation program under ISO 15189 for laboratories that perform NGS oncology tests. A total of 10 laboratories that performed NGS oncology tests were enrolled. Two types of EQA samples were prepared (Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA DNA samples), and the variant allele frequency of targeted genes was assigned. The samples were subjected to NGS oncology tests in participant laboratories according to their routine protocols. Based on the result reports, auditors visited the participant laboratories to perform on-site evaluations and provided feedback regarding possible laboratory process improvement. The participant laboratories identified the targeted variants in the Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA samples with a success rate of 31-100% and 9.5-100%, respectively, compared with reference information, depending on their sequencing systems, and reported a few lower-variant allele frequencies. Six of the eight evaluated laboratories failed to report at least three pathogenic variants due to errors in wet-lab and/or dry-lab processes. Based on the feedback reports and self-assessment, auditors and laboratory staff discussed potential improvements to processes during on-site evaluations for laboratory accreditations. On-site evaluation as EQA for NGS oncology tests in the laboratory accreditation program under ISO 15189 was successfully implemented and proved applicable to a broad spectrum of NGS tests.

Gamma Scientific Sets High Standards for Light Measurement

Gamma Scientific Sets High Standards for Light Measurement

Current State of Cytologic-Histologic Correlation Implementation for North American and International Laboratories: Results of the College of American Pathologists Cytopathology Committee Laboratory Practices in Gynecologic Cytology Survey.

The College of American Pathologists (CAP) updated the Laboratory Accreditation Program Cytopathology Checklist to assist laboratories in meeting and exceeding the Clinical Laboratory Improvement Amendments standards for gynecologic cytologic-histologic correlation (CHC). To survey the current CHC practices. Data were analyzed from a survey developed by the committee and distributed to participants in the CAP Gynecologic Cytopathology PAP Education Program mailing. Worldwide, CHC practice is nearly universally adopted, with an overall rate of 87.0% (568 of 653). CHC material was highly accessible. CHC was commonly performed real time/concurrently at the time the corresponding surgical pathology was reviewed. Investigation of CHC discordances varied with North American laboratories usually having a single pathologist review all discrepant histology and cytology slides to determine the reason for discordance, while international laboratories have a second pathologist review histology slides to determine the reason for discordance. The cause of CHC discordance was primarily sampling issues. The more common statistical metrics for CHC monitoring were the total percentage of cases that correlated with subsequent biopsies, screening error rate by cytotechnologist, and interpretative error rate by cytotechnologist. Many laboratories have adopted and implemented the CHC guidelines with identifiable differences in practices between North American and international laboratories. We identify the commonalities and differences between North American and international institutional practices including where CHC is performed, how CHC cases are identified and their accessibility, when CHC is performed, who investigates discordances, what discordances are identified, and how the findings affect quality improvement.

Laboratory Accreditation Improves Water Quality Data

Key TakeawaysAccreditation serves as a demonstration of competency and thus improves overall laboratory quality. To ensure traceable, reliable, defensible data, quality must be approached as a philosophy rather than a program.The Cypress Environmental Laboratory (CEL), built in 2008, has based its operations on a commitment to high data quality, responsibility, and transparency.The CEL adheres to a strict standard set by the National Environmental Laboratory Accreditation Program, following practices outlined in the standard for monitoring and maintaining data quality.

Preparing for Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) Inspections.

Clinical laboratories have many regulations to follow, requiring complete adherence to specific standards and regulations in order to be granted accreditation. As part of the accreditation process, a laboratory must be inspected. Whether it is an initial or biennial inspection, there are some standard tasks and duties a laboratory can do to prepare in advance to reduce stress, improve the inspection process, and reduce the risk of getting a deficiency. Good Clinical Laboratory Practice (GCLP) is an important part of preparing a clinical laboratory for Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) inspections. GCLP standards have been developed by CLIA and were developed with the goal of providing a sole source of requirements that clinical laboratories using human patient samples need to follow to ensure reproducible and reliable clinical laboratory results. The Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP) also has ongoing activities and guidelines for clinical laboratories to follow. Although this is a voluntary program, it is driven by peer review, education, and compliance to established performance standards. CAP is focused on laboratory improvement and views its inspections as collaborations between inspector and laboratory. The CAP checklists, based on their standards for good lab practice, are used by inspectors to ensure that each inspection is consistent and thorough and to enable CAP to determine if the laboratory meets the standards for accreditation. © 2021 Wiley Periodicals LLC.

Overview of the laboratory accreditation programme of the College of American Pathologists

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories (seven) remains low. Of these, five are accredited by the College of American Pathologists' Laboratory Accreditation Program (LAP)--the 'gold standard' of laboratory accreditation. It requires successful performance in the College of American Pathologists' proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists.

Participation in the College of American Pathologists Laboratory Accreditation Program Decreases Variability in B-Lymphoblastic Leukemia and Plasma Cell Myeloma Flow Cytometric Minimal Residual Disease Testing: A Follow-up Survey.

Minimal residual disease (MRD) testing by flow cytometry is ubiquitous in hematolymphoid neoplasm monitoring, especially B-lymphoblastic leukemia (B-ALL), for which it provides predictive information and guides management. Major heterogeneity was identified in 2014. Subsequently, new Flow Cytometry Checklist items required documentation of the sensitivity determination method and required lower level of detection (LLOD) inclusion in final reports. This study assesses Laboratory Accreditation Program (LAP) participation and new checklist items' impact on flow cytometry MRD testing. To survey flow cytometry laboratories about MRD testing for B-ALL and plasma cell myeloma. In particular, enumerate the laboratories performing MRD testing, the proportion performing assays with very low LLODs, and implementation of new checklist items. Supplemental questions were distributed in the 2017-A mailing to 548 flow cytometry laboratories subscribed to the College of American Pathologists FL3 Proficiency Testing Survey (Flow Cytometry-Immunophenotypic Characterization of Leukemia/Lymphoma). The percentage of laboratories performing MRD studies has significantly decreased since 2014. Wide ranges of LLOD and collection event numbers were reported for B-ALL and plasma cell myeloma. Most laboratories determine LLOD by using dilutional studies and include it in final reports; a higher proportion of LAP participants used these practices than nonparticipants. Several MRD testing aspects vary among laboratories receiving FL3 Proficiency Testing materials. After the survey in 2014, new checklist items were implemented. As compared to 2014, fewer laboratories are performing MRD studies. While LLOD remains heterogeneous, a high proportion of LAP subscribers follow the new checklist requirements and, overall, target LLOD recommendations from disease-specific working groups are met.

Use of Commercially Available Optically Stimulated Luminescence Dosimeter As Extremity Dose Estimator.

In 2009, Idaho National Laboratory (INL) transitioned to an external dosimetry program using optically stimulated luminescent (OSL) technology. This process led to the introduction of the Landauer, Inc., nanoDot dosimeter and MicroStar reader to INL's radiological control program. At the time, a small, self-contained, single chip OSL dosimeter that could be easily read in the field was recognized as having many potential applications for a radiological control program. The ability to achieve a realistic extremity-dose estimate in the field shortly following work where significant exposure is expected is a much sought-after capability at INL. It was proposed to employ the Landauer nanoDot dosimeter as a supplemental extremity monitor as an alternative to time-motion dose analyses based on direct radiation measurements, which had proven to be inaccurate and operationally inefficient. Additionally, this process does not involve the nanoDot in the US Department of Energy Laboratory Accreditation Program (DOELAP) process, which significantly reduces operational complexity. A dose conversion value for the nanoDot dosimeter was derived from direct comparisons with a DOELAP-accredited extremity dosimeter. The geometry or placement of the nanoDot relative to the accredited extremity dosimeter was kept as proximate as possible to best replicate the expected results from the accredited extremity dosimeter. Upon implementation, the nanoDot has proven to be effective in providing reasonable and timely extremity-dose estimates for operational control.

Korean Clinical Laboratory Accreditation Program Quality Standards for Laboratory Management: Identifying a Compliance Gap with World Health Organization Quality System Essentials

Korean Clinical Laboratory Accreditation Program Quality Standards for Laboratory Management: Identifying a Compliance Gap with World Health Organization Quality System Essentials

Preanalytics and Precision Pathology: Pathology Practices to Ensure Molecular Integrity of Cancer Patient Biospecimens for Precision Medicine.

Biospecimens acquired during routine medical practice are the primary sources of molecular information about patients and their diseases that underlies precision medicine and translational research. In cancer care, molecular analysis of biospecimens is especially common because it often determines treatment choices and may be used to monitor therapy in real time. However, patient specimens are collected, handled, and processed according to routine clinical procedures during which they are subjected to factors that may alter their molecular quality and composition. Such artefactual alteration may skew data from molecular analyses, render analysis data uninterpretable, or even preclude analysis altogether if the integrity of a specimen is severely compromised. As a result, patient care and safety may be affected, and medical research dependent on patient samples may be compromised. Despite these issues, there is currently no requirement to control or record preanalytical variables in clinical practice with the single exception of breast cancer tissue handled according to the guideline jointly developed by the American Society of Clinical Oncology and College of American Pathologists (CAP) and enforced through the CAP Laboratory Accreditation Program. Recognizing the importance of molecular data derived from patient specimens, the CAP Personalized Healthcare Committee established the Preanalytics for Precision Medicine Project Team to develop a basic set of evidence-based recommendations for key preanalytics for tissue and blood specimens. If used for biospecimens from patients, these preanalytical recommendations would ensure the fitness of those specimens for molecular analysis and help to assure the quality and reliability of the analysis data.

Development of Statistical Software for the Korean Laboratory Accreditation Program Using R Language: LaboStats.

BackgroundIn Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria).MethodsWe used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures.ResultsOur program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports.ConclusionsLaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.

Synoptic Reporting: Evidence-Based Review and Future Directions.

Synoptic reporting is a process for reporting specific data elements in a specific format in surgical pathology reports. Previously, surgical pathology reports were free text, highly narrative, and prone to omission of necessary data and inconsistencies in formatting.1 Synoptic reporting not only ensures that all reports contain all necessary data elements, but also is amenable to scalable data capture, interoperability, and exchange. Efforts are ongoing to create national2 and international3-7 health care meaningful use standards by using cancer registries and health information exchanges for storing and accessing data. Ideally, data will be fed dynamically and seamlessly into and out of these data exchanges by using lean and streamlined automated processes. In practice, the College of American Pathologists (CAP) has been promoting synoptic reporting for > 20 years,8 has published protocols with both required and optional data elements for at least a decade, and has required reporting of these elements for the past 2 years as part of its Laboratory Accreditation Program (LAP) checklist.9 The contents of the CAP protocols along with the contents of the American Joint Commission on Cancer (AJCC) TMN staging system, which the protocols use, are both copyright protected. The AJCC copyright includes all computable representations of its TNM staging system, which raises issues to be discussed later. Internationally, the Royal College of Pathology (United Kingdom), the Royal College of Pathology Australasia, the European Task Force for Structured Reporting, the American Society of Clinical Pathologists, the Canadian Association of Pathologists, and CAP have worked with the International Collaboration on Cancer Reporting to produce a standard data set for the international community.3-7 A detailed road map was outlined by those involved in the CAP effort, which went from free-text narrative reports (level 1), to synoptic reporting (level 3), toward fully structured reporting. The final product includes discrete data embedded in laboratory information systems (LISs) and structured messaging/data exchange standards (level 6).10,11 Synoptic reporting has many different connotations, which depend on the stakeholder. For practicing pathologists, synoptic reporting refers to specific elements in the cancer protocols and a specific format required by the CAP LAP checklist.9 For clinicians, synoptic reporting provides a checklist that ensures completeness of reported data elements. For registrars, researchers, and data scientists, synoptic reporting denotes a means to populate structured databases. Although substantial overlap exists, the requirements for these various stakeholders can differ. This review details the components of synoptic reporting that affect its utility for these stakeholders and the components of synoptic reporting from the perspective that synoptic reporting actually exist as two layers. These layers comprise a front-end presentation layer and a back-end computational data layer. This understanding becomes sharper as components of synoptic reporting are discussed in context throughout this review.

Budget Impact of the Accreditation Program for Clinical Laboratories on Colorectal Cancer Screening via Fecal Immunochemical Testing: Results from the National Cancer Screening Program in Korea.

BackgroundFalse-positive fecal immunochemical test (FIT) results in the National Cancer Screening Program (NCSP) for colorectal cancer may lead to unnecessary procedures, such as colonoscopies, increasing the medical costs. We estimated reductions in the cost of National Health Insurance according to the accreditation status of screening facilities participating in the NCSP for colorectal cancer.MethodsWe used data collected between 2007 and 2010 from NCSP and the Korea Central Cancer Registry to identify patients with colorectal cancer. We also ascertained the history of the accreditation of each facility by the Korean Laboratory Accreditation Program (KLAP). Budget impact was defined as a reduction in medical costs achieved when the false-positive rate of the non-accredited facilities decreased relative to that of the accredited facilities.ResultsA total of 3,285 screening facilities participated in the NCSP. Of these, 196 were accredited by the KLAP. The false-positive rate of the accredited facilities was 2.47%, and that of the non-accredited facilities was 6.83%. Medical costs were estimated to be reduced by approximately 19 million US dollars (USD), and the cost of detecting one case of colorectal cancer was estimated to decrease from 9,212 USD to 7,332 USD if the false-positive rate of non-accredited facilities were decreased to that of the accredited facilities. Clinics were estimated to have the largest associated cost reduction.ConclusionsQuality assurance in clinical laboratories could lower false-positive rates and prevent the use of unnecessary procedures, ensuring patient safety and increasing the cost-effectiveness of FIT screening in the NCSP for colorectal cancer.

The College of American Pathologists Biorepository Accreditation Program: Results from the First 5 Years.

The College of American Pathologists (CAP) developed the Biorepository Accreditation Program (BAP) in 2012. This program integrates best practices from the International Society for Biological and Environmental Biorepositories, the National Cancer Institute, the Organisation for Economic Cooperation and Development, the Center for Medicare and Medicaid Services, and the CAP Laboratory Accreditation Program. The goal of this elective program is to provide requirements for standardization in biorepository processes that will result in high-quality specimens that can be used to support research, drug discovery, and personalized medicine. CAP uses a peer inspection model to ensure the inspectors have proper expertise and to promote educational efforts through information sharing. Lead inspectors are comprised of pathologists, PhDs, and managers of biorepositories and they are often supported by CAP staff inspectors. Accreditation is a 3-year continuous cycle of quality with a peer inspection occurring at the start of year 1 and a self-inspection and CAP desk assessment at the start of year 2 and 3. At this time 53 biorepositories are fully CAP BAP accredited and 13 are in the process of obtaining accreditation. There are currently 273 established standards with requirement lists customized based on the scope of activities performed by a biorepository. A total of 90 inspections were completed between May 2012 and December 2016. Sixty-one were initial inspections and 29 were reinspections. A total of 527 deficiencies were identified in the areas of Equipment/Instrumentation (22%), Information Technology (18%), Specimen Handling and QC (15%), Quality Management (16%), Personnel (11%), Safety (10%), Facilities (6%), and Regulatory (2%). Assessment of common deficiencies identifies areas of focus for continuous improvement and educational opportunities. Overall success of the program is high based on the current enrollment of 66 biorepositories, anecdotal participant feedback and increasing national recognition of the BAP in federal documents.

International Organization for Standardization (ISO) 15189.

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.

Conventional Pap smear cervical cancer screening in 11 rural counties in Hainan Province, China: analysis of Bethesda system reporting rates for 218,195 women (predominantly ages 35-64 years) screened in China's National Cervical Cancer Screening Program in Rural Areas (NCCSPRA)

Recently the Chinese government has introduced support for cervical screening in rural areas. The College of American Pathologists (CAP)-certified Guangzhou Kingmed Diagnostics laboratory supported rural screening program in Hainan Providence utilizing low-cost conventional Papanicolaou smears (CPS). This was a retrospective study of CPS screening results from 2011 to 2014 in 11 rural counties in Hainan Province. Women, most previously unscreened, volunteered to attend free CPS screening. The targeted population was women aged 35-65 years. Among total 218,195 conventional Papanicolaou smears, the reported abnormal rate was 4.4% of all smears, with 0.5% for high-grade squamous intraepithelial lesion (HSIL), 0.9% for low-grade squamous intraepithelial lesion (LSIL), 2.6% for atypical squamous cells of undetermined significance, and 0.3% for atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion. Reporting rates for different TBS categories were generally within CAP benchmark ranges, except for low reporting rates for unsatisfactory smears and for atypical glandular cells. Abnormal cytology rates varied among counties. Comparing different age groups, the LSIL rate was significantly higher in women <50 years than in women ≥50 years (1.04% versus 0.64%). The HSIL rate was significantly higher in women ≥40 years than in women <40 years (5.3% versus 0.38%). A total of 2286 women with abnormal Papanicolaou smears had documented colposcopic and histopathologic follow-up. Cervical cancer was diagnosed in 23 of 2286 (1.01%) of screened and biopsied patients. Histopathologic HSIL results were confirmed in 80% of biopsied women with HSIL Papanicolaou tests. CPS offered a low cost method to introduce cervical screening in rural China. The international College of American Pathologists Laboratory Accreditation Program provided laboratory quality control standards not otherwise readily available. Educational training programs have been instituted to address areas identified for quality improvement.

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.

BackgroundMedical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests.MethodsWe analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP.ResultsCompared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different.ConclusionsThese results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing.