Quality Assurance and Standardization in Immunohistochemistry. A Proposal for the Annual Meeting of the Biological Stain Commission, June, 1991

Quality assurance, quality control, proficiency testing, reagent documentation and validation are standard parts of everyday practice in clinical laboratories throughout the United States. Immunohistochemical stains employ reagents and principles in common with immunoenzyme methods utilized in the clinical laboratory. However, immunohistochemistry has not routinely been subjected to similar standardization and quality assurance procedures that manufacturers and pathologists alike have applied to essentially the same techniques in the clinical laboratory environment. The current proposal was invited by the Biological Stain Commission with the charge of incorporating the findings of previous workshops on quality control in immunohistochemistry into a practical design for implementation. The status of quality assurance, quality control and standardization in immunohistochemistry is reviewed and a phased strategy for implementation is proposed.     

Quality assessed nonculture techniques for detection and typing of meningococci

PCR protocols are increasingly used in laboratories worldwide for the diagnosis and confirmation of invasive meningococcal infection. Protocols are now available for the identification of Neisseria meningitidis, for genogrouping, susceptibility to antibiotics and genotyping of the corresponding isolates. The implementation of quality assurance (QA) schemes and standardization of protocols are required. Diagnostic and confirmatory PCRs should perform consistently in clinical and reference microbiology laboratories. General QA schemes address the issues of sample preparation, PCR laboratory environment, equipment and validation of protocols. Moreover, external QA interlaboratory studies are essential. The European Monitoring Group on Meningococci has provided a good forum to conduct such studies through the development and distribution of samples and protocols for nonculture detection and typing of N. meningitidis.     

A 3-year experience of quality control and quality assurance in the multisite delivery of a lymphocyte-based cellular therapy for renal cell carcinoma

Autolymphocyte therapy (ALT) is outpatient-based adoptive immunotherapy using ex vivo-activated memory T-cells. To support the safe and reproducible delivery of ALT at three cell processing facilities (Boston, MA; Atlanta, GA; Orange, CA) we created a comprehensive quality assurance/quality control program compliant with recent FDA guidance relevant to activated lymphocytes and somatic cell therapies. Each facility performed extensive QC testing to ensure sterility, viability, and proper cell yield. Additonally, several QC tests were performed at Cellocr's centralized reference laboratory to monitor cell potency and identity of the ex vivo-processed lymphocytes. We report here the successful implementation of this QA/QC program for ALT which has resulted in the safe preparation and delivery of cell infusion products amounting to over 3600 treatments at seven clinical sites nationwide. We believe this program will serve as a model for other cellular therapies.     

Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban,South Africa

In South Africa, various point-of-care hemoglobin meters are used. However, the regulatory framework for approval, implementation and oversight of use of point-of-care hemoglobin meters is suboptimal. We assessed the diagnostic accuracy of the HemoCue Hb 301, STAT-Site M^Hgb and URIT-12 point-of-care hemoglobin meters, compared to a central laboratory based reference assay, in a central laboratory and a community based clinic in Durban, South Africa. Differences in performance of the point-of-care assays, compared to the reference assay, were more pronounced in the community based clinic. Results were reasonable for the HemoCue Hb 301, but poor for the STAT-Site M^Hgb and the URIT-12. Poor test performance of point-of-care hemoglobin meters, and inadequate evaluations and oversight in South Africa, leads to suboptimal clinical care and clinical research, and increased costs. There is a need for proper evaluation and quality assurance of point-of-care tests, the results of which should be made widely available to key stakeholders.     

Quality assurance activities of the College of American Pathologists

Since its inception, the College of American Pathologists (CAP) has played a fundamental and pivotal role in the development and execution of quality assurance programs for laboratories. Within the realm of anatomic pathology, operational programs include those in surgical pathology, immunohistochemistry and cytopathology. The emphasis of prior cytopathology programs on cervical cytology has now been expanded to include body fluids and fine needle aspiration material. CAP's role in the expansion of quality assurance programs in cytology may be enhanced in the future by intersociety cooperation with established cytology organizations and will also be influenced by and closely linked to the expansion of its quality assurance programs in surgical pathology. As for the Papanicolaou smear, it can no longer be regarded as the "Cinderella of cytology"; it is in fact the present-day cynosure in the laboratory. In recognition of this, CAP has undertaken efforts to help heighten public awareness about the value of Papanicolaou smear testing and is encouraging women to become more informed about the process involved in the examination of their smears.     

Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA(1c) testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services.THE QUALITY ASSURANCE PROGRAM COMPRISED FOUR ELEMENTS: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA(1c) testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA(1c). The short and long term performance of each service's DCA 2000 was reviewed monthly and at the end of each six month testing cycle.The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA(1c) testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA(1c) testing has ensured the program's sustainability.Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA(1c) testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments.     

Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.     

Analytical strategies for the discovery and validation of quality-markers of traditional Chinese medicine

BackgroundQuality control of traditional Chinese medicine (TCM) is the basis of clinical efficacy. Due to the complexity of TCM, it is difficult to unify the quality control, and hinders the further implementation of the quality standardization of TCM. As a new concept, quality-marker (Q-marker) plays a powerful role in promoting the standardization of quality control system of TCM.Hypothesis/PurposeThe present review aims to provide reference and scientific basis for further development of Q-marker and assist standardization of quality control of TCM.MethodsExtensive search of various documents and electronic databases such as Pubmed, Royal Society of Chemistry, Science Direct, Springer, Web of Science, and Wiley, etc., were used to search scientific contributions. Other online academic libraries, e.g. Google Scholars, Scopus and national pharmacology literature were also been employed to learn more relevant information about Q-marker.ResultsQ-markers play vital role in promoting the standardization of quality control of TCM. The factors that affect the quality of TCM, the advantages and disadvantages of the analytical techniques commonly used in Q-marker research were reviewed, as well as the systematic research strategies, which were verified by practices.ConclusionThe proposal of Q-marker not only provided a new perspective to break through the bottleneck of current quality control, but also can be used in the evaluation of pharmacological efficiency, therapeutic discovery, toxicology, etc. In addition, the Q-marker analysis strategies summarized in this paper is helpful to standardize the quality control of TCM and promote the internationalization of TCM.     

Validation and Quality Control of Protein Microarray-based Analytical Methods

Protein microarray technology is used mainly in the research laboratory and it is being used to uncover important diagnostic and prognostic markers that may one day emerge as routine clinical laboratory tests. It is important that these methods are subject to control procedures, in order to ensure that data of the highest quality are obtained. If quality is not controlled, the assay may yield erroneous results that would mask or confound meaningful diagnostic or prognostic associations. This chapter surveys the range of strategies designed to assure the analytical quality of protein microarray methods and it also highlights some of the potential pitfalls when moving these arrays into routine clinical practice. With the development of appropriate quality control and assurance measures, we anticipate protein microarray-based assays will be of substantial benefit in the future practice of laboratory medicine.     

关于实验动物设施安全检查、研发实验动物行业通用安全检查表的讨论

实验动物设施的安全运行和环境条件标准化控制是实验动物繁育生产质量和进行动物实验的条件保证。本人运用安全系统工程、安全科学管理理论,结合我国实验动物安全工作发展,就实验动物环境设施的安全运行管理、检查、发现、分析和消除实验动物环境设施运行中潜在的危险和危害因素,做一阐述。总结性地提出了实验动物环境设施安全检查的程序、内容、实施步骤的闭环式安全检查模型。利用安全检查表,科学有效地开展实验动物环境设施安全检查工作,把事故消灭在萌芽状态。     

Guideline for the collection and preparation of non-transfusion autologous platelet concentrate or platelet-rich plasma from patients in hospitals

Non-transfusion autologous platelet concentrate (PC), also known as platelet-rich plasma (PRP), has become a widely used blood-based product in the field of sports medicine, rehabilitation medicine, and clinical medicine. Currently, autologous PC or PRP operation procedures (personnel qualification, equipment, methods, environment and tracking, protocols, preparations, techniques and product quality control) lack unified specifications and standards, which lead to inconsistencies in the quality of PC or PRP products made by medical institutions, affecting treatment efficiency. In blood collection and supply organizations, the collection of blood components has a series of standard operating procedures (SOP) and quality assurance which can be referenced by medical institutions to standardize the preparation and usage of patient autologous PC or PRP products. According to Technical Standards for Preparation of Platelet Concentrate for Blood Stations, we compiled this guideline for medical staff to prepare high quality and reliable PC or PRP products in order to promote the standardization of PC or PRP in clinical application.     

Basic aspects of and recent developments in telepathology in Europe, with specific emphasis on quality assurance

Telepathology is the diagnostic work of a pathologist from a distance and includes all specific fields of diagnostic pathology, such as frozen section services, expert consultation, cytometric and histometric measurement, and continuous education. For about 15 years experience has been collected at several universities in the United States and Europe based upon analog telephone lines (9.2 kbaud), digitized lines (ISDN, 64 kbaud), broad band connections (1.5 Mbaud) and the World Wide Web (28 kbaud). Potential use can be expected in the application of telepresentation, remote slide preparation, remote central diagnostics and telediscussion. The transfer of still images is well developed; that of live images is used in only a few institutions for frozen section services. The image quality and spatial resolution as well as the transfer speed are sufficient for expert consultations, morphometric measurements, quality assurance and education. All applications focus on discontinuous work flow. Although the European Community focuses on user needs and standardization aspects of telepathology by sponsoring a widespread telepathology project (Europath), implementation of telepathology into routine application in the continuous work flow has still to be developed. The technical equipment has still to be adjusted to the labor flow charts in routine pathologic diagnostic procedures. Telepathology seems to be the appropriate technique to offer both improvement in diagnostic quality and inclusion of the "control institution" into diagnostic responsibility.     

与医科学生谈实验动物标准化

实验动物标准化由实验动物生产条件的标准化、实验动物质量标准化、动物实验条件的标准化以及与之相适应的饲养管理规范化和动物实验规范化几个部分组成。实验动物法制化管理是实验动物标准化的保证。动物实验是医学生物学必需的是实验手段之一,用标准的实验动物进行标准的动物实验是科研实验的基本要求。     

Quantitation of viral load using real-time amplification techniques

Real-time PCR amplification techniques are currently used to determine the viral load in clinical samples for an increasing number of targets. Real-time PCR reduces the time necessary to generate results after amplification. In-house developed PCR and nucleic acid sequence-based amplification (NASBA)-based systems combined with several detection strategies are being employed in a clinical diagnostic setting. The importance of these assays in disease management is still in an exploration phase. Although these technologies have the implicit capability of accurately measuring DNA and RNA in clinical samples, issues related to standardization and quality control must be resolved to enable routine implementation of these technologies in molecular diagnostics.     

Cervical cancer screening from the public health perspective

Many state health departments have a significant role in cervical cancer screening. Given that role, a group of public health personnel from eight southeastern states drafted a set of questions and quality assurance issues to be discussed with a laboratory under consideration as a contract provider of cytology services. The major points of concern included: (1) quality of laboratory services (accreditation, personnel, facilities and operational and quality control procedures); (2) quality of sampling (including techniques used and the training and monitoring of sample takers); (3) terminology for cytology reporting; and (4) protocols used for diagnostic evaluation of abnormal Papanicolaou smears.     

Ethical problems in cytology

Great advances in medical science have raised a number of ethical issues, many of which affect cytopathology. Some of the main issues addressed in this paper relate to the organization of a cytology laboratory: internal and external quality control, adequate staffing levels and staff education, cytopathology reporting format and contents, confidentiality issues, relationship with the clinicians and involvement of cytopathologists in clinical management teams. Quality control has to be provided within cytology departments but external quality assurance is also essential, with national monitoring. New technologies should be used according to the best scientific methods, following cytological analysis. Scientific work in cytology has to respect the general principles of scientific ethics. The patient's interest has to be the main reason for such work.     

实验用鱼遗传质量控制及标准化

在遗传学及其他生命科学研究领域, 实验用鱼已成为一类应用越来越广的实验动物, 但是尚缺少标准化的质量控制标准和监管。在我国, 实验动物实行严格的许可证制度和质量监督制度。实验用鱼遗传质量控制标准是实验用鱼质量控制的基础。为了规范实验用鱼的遗传质量, 避免实验用鱼种质退化、遗传漂移, 导致实验结果误差, 开展了本标准的研究。依据《实验动物管理条例》, 参考国内外实验用鱼遗传学相关的研究成果, 结合我国实验用鱼生产和使用的实际情况, 在全面收集、分析实验数据和广泛征询专家意见的基础上, 以实验用斑马鱼和剑尾鱼遗传质量控制为规范对象, 研究制定了实验用鱼遗传质量控制标准, 供科研工作者参考、讨论。本标准对实验用斑马鱼和剑尾鱼的遗传分类及命名原则、实验用鱼的繁殖方法、近交系和封闭群的遗传质量监测进行了规范。新标准将为实验用鱼的使用和管理提供理论支撑。     

Development and Challenge of HIV/AIDS Testing Laboratory Network and Quality Assurance System in China

This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Reference Laboratory,HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities,and each class of laboratories take charge of their function strictly according to the "National Management of HIV/AIDS Detection (2006)". A complete quality assurance and quality control system for HIV/AIDS testing has been developed,which includes technical training,strict laboratory monitoring and approval,examination or proficiency testing on HIV/AIDS detection,and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test,more and more laboratories began to conduct other tests,such as CD4 T lymphocyte cell counting,HIV viral load,HIV DNA PCR,genotyping,drug resistance,and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example,the provincial PT program is inefficient,the internal quality control is conducted perfunctorily,personnel training can not met the needs of the workplace,which need to be improved.     

HUPO Plasma Proteome Project specimen collection and handling: towards the standardization of parameters for plasma proteome samples

There is a substantial list of pre-analytical variables that can alter the analysis of blood-derived samples. We have undertaken studies on some of these issues including choice of sample type, stability during storage, use of protease inhibitors, and clinical standardization. As there is a wide range of sample variables and a broad spectrum of analytical techniques in the HUPO PPP effort, it is not possible to define a single list of pre-analytical standards for samples or their processing. We present here a compendium of observations, drawing on actual results and sound clinical theories and practices. Based on our data, we find that (1) platelet-depleted plasma is preferable to serum for certain peptidomic studies; (2) samples should be aliquoted and stored preferably in liquid nitrogen; (3) the addition of protease inhibitors is recommended, but should be incorporated early and used judiciously, as some form non specific protein adducts and others interfere with peptide studies. Further, (4) the diligent tracking of pre-analytical variables and (5) the use of reference materials for quality control and quality assurance, are recommended. These findings help provide guidance on sample handling issues, with the overall suggestion being to be conscious of all possible pre-analytical variables as a prerequisite of any proteomic study.     

European guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories.

The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based.