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In the United States, the Centers for Medicare and Medicaid Services (CMS) regulates all human clinical laboratory testing as mandated by federal legislation entitled the Clinical Laboratory Improvement Amendments (CLIA). Other countries have similar regulations. In contrast, veterinary medicine is not uniformly governmentally regulated, and to our (contributors) knowledge, instruments marketed for veterinary testing are not required to have independent analysis or approval prior to sale. Although there is not a current global consensus for human medicine on standards of laboratory performance, there are various supporting consensus and/or accrediting organizations that provide standards and guidelines. Examples include, but are not limited to: Clinical Laboratory Standards Institute (CLSI, formerly NCCLS), International Organization for Standardization (ISO), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), International Laboratory Accreditation Cooperation (ILAC), International Council for Standardization of Haematology (ICSH), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), American Association for Laboratory Accreditation (A2LA), American Association for Clinical Chemistry (AACC), College of American Pathologists (CAP), World Organization for Animal Health (OIE), and Joint Committee for Guides in Metrology (JCGM). Failure of human laboratories to correct issues of non-compliance to federal legislation (CLIA or non-U.S. equivalent) results in lack of accreditation and termination of laboratory function. Limited government regulation exists for some aspects of clinical veterinary laboratory medicine in the U.S., mainly in place for reportable diseases. Laboratory accreditation is offered by the American Association of Veterinary Laboratory Diagnosticians (AAVLD) and is optional (per their website, this accreditation is "designed for state and national institutions or organizations such as colleges, departments or laboratories, and government agencies"a). ISO certification exists for veterinary laboratories but is also voluntary and is not prescriptive (ie, the certification is a commitment statement from the laboratory, not a top-down assurance of the standards which are provided in the guideline ISO:15189). The American Animal Hospital Association (AAHA) and the Royal College of Veterinary Surgeons (in the United Kingdom) have a laboratory quality section as a component of their overall veterinary hospital accreditation programs. The imperative for quality control and continuous quality improvement in veterinary clinical diagnostic laboratories and research organizations is self-evident. Inaccurate data that inform diagnostic/treatment modalities, scholarly research, and pharmaceutical development result in poor outcomes for individual patients and larger target populations, with corresponding ethical, financial, professional, and legal ramifications. Lack of understanding of causes of the statistical uncertainties that are inherent in all biologic measurements can/does lead to misdiagnosis. This guideline is aimed at advancing the ethos of continuous quality improvement in the veterinary laboratory setting, by raising awareness of potential sources of laboratory error, by providing recommendations for evaluation of current practices/identification of potential areas of improvement, and by providing actionable goals and tools for launching and refining systems of total quality management. The ultimate objective is maximizing the quality of laboratory output and thus value to clients/users and patients. The sections of this guideline are not intended to be all-inclusive. Rather, they provide a minimum standard for quality assurance in veterinary laboratories. They may augment, but should not substitute for, any applicable licensing/accreditation or good laboratory practice (GLP) standards, which are typically more specific per federal/state governing body requirements. This guideline does not distinguish quality assurance information and recommendations in relation to larger reference laboratories/academic institutions vs. the private practice setting. For more information on in-clinic laboratory quality assurance, please see the ASVCP Guideline: Quality assurance for point-of-care testing in veterinary medicine. This guideline is a revision of the previous (finalized 2009) document of the same name, American Society for Veterinary Clinical Pathology's Principles of Quality Assurance and Standards for Veterinary Clinical Pathology, developed by the Quality Assurance and Laboratory Standards (QALS) committee (and colloquially known as the "general guideline"), archived on the ASVCP website (www.asvcp.org/page/QALS_Guidelines), on a newly established Wiley freeware page (https://onlinelibrary.wiley.com/page/journal/1939165x/homepage/Qals) as published in Veterinary Clinical Pathology in three sectional special reports.1-3 This guideline's intended audiences are professional veterinary laboratorians (pathologists, technologists/technicians, research scientists, and pathology residents), operators/users of in-clinic instruments/in-clinic laboratories, and more broadly, all producers and consumers of clinical veterinary laboratory data, namely the veterinarians/training veterinarians who have the responsibility of ordering appropriate tests and properly interpreting results that inform further diagnostic and treatment decisions. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html CLIA summary https://wwwn.cdc.gov/clia CLIA website www.clsi.org Clinical Laboratory Standards Institute www.agriculture.gov.au/animal/health/system/lab-network#standards-and-accreditation and www.nata.com.au Information on Australia's accreditation system for veterinary laboratories www.iso.org International Organization for Standardization https://www.iso.org/standard/56115.html ISO's international standard 15189: Medical laboratories — Requirements for quality and competence www.ifcc.org International Federation of Clinical Chemistry and Laboratory Medicine www.ilac.org International Laboratory Accreditation Cooperation www.icsh.org International Council for Standardization in Haematology www.eflm.eu European Federation of Clinical Chemistry and Laboratory Medicine www.a2la.org American Association for Laboratory Accreditation www.aacc.org American Association for Clinical Chemistry; also found here is DACC, Division of Animal Clinical Chemistry www.cap.org College of American Pathologists www.oie.int World Organization for Animal Health www.sqa.org Society of Quality Assurance www.isacp.org International Society for Animal Clinical Pathology www.asvcp.org American Society of Veterinary Clinical Pathology www.acvp.org American College of Veterinary Pathology www.esvcp.com European College/Society of Veterinary Clinical Pathology www.acutecaretesting.org freeware regarding daily issues of acute care testing; content is provided by healthcare professionals around the world, including external experts, laboratory managers, point-of-care coordinators, physicians and nurses https://www.bipm.org/utils/common/documents/jcgm/JCGM_100_2008_E.pdf Guide to the expression of uncertainty in measurement; evaluation of measurement data published by working group of the Joint Committee for Guides in Metrology (JCGM) awww.aavld.org Association of American Veterinary Laboratory Diagnosticians www.dropbox.com/s/x6itiuw1cqbymj8/AAVLD%20Requirements%20for%20an%20Accredited%20Veterinary%20Medical%20Diagnostic%20Laboratory%20AC1%20v%202018-07.final.pdf?dl=0 AAVLD's requirements for an accredited veterinary medical diagnostic laboratory https://www.aaha.org/professional/membership/standards.aspx American Animal Hospital Association (AAHA) accreditation program https://www.rcvs.org.uk/setting-standards/practice-standards-scheme/apply-for-accreditation/ Royal College of Veterinary Surgeons accreditation program https://onlinelibrary.wiley.com/doi/full/10.1111/vcp.12099 ASVCP guideline: Quality assurance for point-of-care testing in veterinary medicine It is useful to think of the veterinary laboratory as operating within a framework of formalized, planned Total Quality Management, which operates as a systematic cycle/loop of components (described below) for continuous improvement (quality improvement models were originally adapted from industry/precision mass production)1, 2 (Figure 1). Designing a system of comprehensive quality management reflects a long-term commitment, with participation at all levels of the laboratory organization, and with accountability by upper management ("top-down" approach).3 Having a comprehensive, actionable, and revisable plan for total quality management is a prerequisite for quality assurance, which is the outcome of the system and not merely a component.4 The following elements act in a feedback loop of continuous quality improvement. Quality goals represent the requirements that must be achieved to satisfy the needs of customers/users and that ensure patient safety. This is the most important and time-consuming step of the TQMS. Goals should be regularly reviewed. For preanalytical and postanalytical quality, the requirement defines ensuring/maximizing sample stability/quality prior to analysis and accuracy in reporting test results and interpretive support, respectively (please also see Sections 3 and 12). For analytical quality, the requirement is to provide test results that are correct within stated limits. Prior definition of analytical quality goals is preferred; some goals may be revised based on state-of-the-art performance, but such revisions should be considered when interpreting results. Challenges in defining quality requirements arise due to the inherent complexity of biologic systems/lability of samples and due to options of several schema that may characterize quality goals and criteria for acceptable performance (such as biologic variation, six-sigma, clinical decision limits, total allowable error (TEa), and measurement uncertainty).5-8 Concepts and terms in the literature can be overlapping and confusing. A comprehensive explanation of these quality goal/requirement schema is beyond the scope of this document (further discussion of total allowable error and sigma metrics can be found in section 4, general analytical factors important in veterinary clinical pathology), and the reader is referred to the ASVCP quality assurance guidelines Allowable total error biochemistry and Allowable total error hematology,9, 10 and to the lists of resources/references. A systematic method of achieving, maintaining, and refining quality goals should be explicitly outlined (accomplished via the other components of the TQMS loop described below). Quality planning is the execution of quality goals, concerned with establishing, validating, and eliminating sources of error by implementing new and better ways of meeting customer needs, including selection/evaluation of new methods and instruments and selection/design of routine quality control procedures, using the feedback loop informed by quality improvement/QI (see 2.6 below and section 4 on general analytical quality). All spheres of laboratory function should be addressed. Aside from the procedural aspects of testing/examination processes (i.e., preanalytical, analytical, and postanalytical), planning should address: laboratory organization; processing and flow of specimens through the laboratory; personnel duties, training, and management; premises/environment; equipment; information systems; materials; document control; and, mechanisms of personnel/process evaluation. As a thorough discussion of these non-procedural arenas of laboratory function are outside the scope of this document, the reader is referred to comprehensive laboratory operation guidelines developed for human healthcare laboratories.11, 12 Appreciating that all laboratory personnel are members of the quality team, it is recommended that laboratories designate a quality manager and per laboratory size/need, a dedicated quality management team. The members of this team should have their duties and responsibilities outlined as a complete or partial job description, which may overlap, but should be treated independently of, other organizational duties (for example that of the laboratory director). This person(s) should have adequate training to undertake the role(s) and have the responsibility and authority to implement and maintain all aspects of the TQMS. They are accountable to upper management (as applicable per organization size) and users of the laboratory regarding TQMS functioning/effectiveness and should continually coordinate the needs/requirements of the laboratory users into the TQMS. The total quality management system should be outlined in a written policy statement referred to as the "quality policy" or "quality manual." This document should outline the laboratory organization/personnel responsibilities and interrelationships, laboratory philosophy, and overall approach to quality (i.e., description of the TQMS), with a stated intention of highest standard of services to meet the requirements of users. The policy should pronounce a commitment to: set quality goals (section 2.1), achieve continual quality improvement, conduct regularly scheduled staff training/CE and management reviews (section 2.2.3), assure the health/safety of workers, and comply with relevant safety, environmental, and accreditation legislation as applicable. The policy should describe the laboratory environment/facilities, list the clientele and scope of provided services, and outline working practices such as the management of resources, equipment, client communications, and data/document control/disposal.12 The quality policy is not a convenient place to list the names/numbers of all laboratory standard operating procedures (SOPs; see section 2.3) due to frequency of changes made to the latter (SOPs can be catalogued in a separate procedural manual). Writing and editing of the policy should be performed by the quality manager(s). The format/length of the policy will vary with the size and needs of the facility. Accrediting organizations may have specific requirements. The quality policy/manual will be signed, communicated/readily available to all personnel, implemented throughout the laboratory, and reviewed by management regularly (at least annually) for appropriate updates. The document should be incorporated into personnel training/onboarding. Management reviews are strongly recommended to synthesize/spur quality planning and to reinforce the "top-down" requirement of an effective TQMS. These should occur annually or more frequently depending on need, size of laboratory, regulatory requirements, etc. Reviews should be comprehensive evaluations of the TQMS in effectively executing of the needs and requirements of users, and should incorporate all mechanisms of feedback and quality improvement indicators/schema (section 2.6), including but not limited to: The findings of management reviews should be recorded and shared with personnel. New action items should be discharged in an appropriate and agreed-upon time frame. Quality laboratory processes refer to the policies, procedures, personnel standards, and physical resources that determine how work is done in the laboratory, directly informed by QG and QP. Integral to this arena is the existence of a cohort of current standard operating procedures (SOPs) for all laboratory tests and related procedures. Creation and editing of laboratory documents should be performed by an identified individual(s), recorded in the document. SOPs should cover preanalytical and postanalytical processes, the operation of necessary routine quality controls for the test/instrument (either embedded within test SOPs or outlined in an independent SOP), sample storage/disposal, data storage/disposal, and send-out procedures. SOPs should be compiled, stored together in a written or electronic procedures manual (distinct from the quality policy), and easily accessible to all personnel. Upon completion of training new personnel, there should be documented confirmation of observed competency in assay/procedure performance in alignment with all relevant SOPs and their related procedures. This official authorization to perform testing should become part of the individual's training record.1 When documents are revised (review of all documents by quality manager/management team every 1-2 years is recommended if no intermittent changes have ensued), updates should be systematically reviewed with applicable personnel in a timely fashion, and there should be a system of document control in place whereby only updated copies are used and obsolete versions are destroyed or permanently archived without availability for inadvertent use or circulation. A recommended template for elements to be included in SOPs is provided in Appendix 1. Quality control refers to procedures for monitoring the day-to-day work processes, detecting problems, and making corrections prior to test reporting. Statistical quality control is commonly employed in monitoring the analytical performance of laboratory methods, to include method validation/verification, selection of control materials, control rules, and number/timing of control runs necessary to efficiently detect unstable performance (please refer to section 4, general analytical factors, for further discussion). QC may include monitoring of key quality indicator tests2 (see Table 2 and section 12, postanalytical quality, for further information on quality indicators), evaluation of control data for trends or shifts that may indicate developing problems, and review of patient data. In the analytical phase, non-conformities identified in control or patient results should result in suspension of result reporting, corrective action(s) taken, and clients contacted as necessary. Non-conformities or other identified problems are documented and reviewed at regularly specified intervals by the quality manager(s) to determine and initiate corrective and preventive actions. Quality assessment refers to the broader monitoring of other dimensions (aside from statistical QC for the analytic phase) or characteristics of quality. Along with quality control, it is the measure of how well laboratory work is being done (example elements in Tables 1 and 2). Pre/postanalytical factors and turnaround time are monitored through QA activities (please see section 3 and section 12, respectively, for more information on preanalytical and postanalytical testing phases). Internal audits/training/continuing education and external quality assessment (EQA)/proficiency testing (PT) are important components. Internal audits should be scheduled and conducted using agreed-upon criteria, with recommendations and a suitable time frame for any preventive and corrective actions in response to non-conformities/deficiencies (in turn, these actions must be documented, reviewed, and further acted upon as applicable in an agreed-upon period). EQA/PT provides an external measure of analytical performance. The EQA program should be relevant to laboratory test services and ideally encompass preanalytical, analytical, and postanalytical phases. More information on EQA can be found in the ASVCP guideline: External quality assessment and comparative testing for reference and in-clinic laboratories. As for internal audits, these reports should be recorded, communicated to staff, reviewed, and acted upon, with action steps re-evaluated in turn. Quality improvement is aimed at determining the root causes/sources of problems/non-conformities identified by any means, with direct feedback into further quality planning (QP) for any necessary corrective and preventive actions. There should be a defined responsibility chain and time frame for change implementation. When considering the schema of total quality management/continuous quality improvement, it is important to recognize that non-conformities can occur in all different aspects of the laboratory environment.17 These can be identified in several different ways, to include: The percentage of errors/non-conformities in tracked key quality indicators should be tabulated monthly and annually and compared with predetermined quality goals for these indicators (examples from pre- and postanalytical phases, respectively, may include the percentage of hemolyzed samples and percentage of amended reports; admittedly many preanalytical errors are beyond the laboratory's control, but the laboratory should advise its clients on best practices). These information sources should be incorporated into annual management reviews (section 2.2.1). Preventive and corrective actions are to be recorded, made available to all staff, and evaluated/re-evaluated at determined time points for effectiveness, with further action steps as deemed appropriate. The results of the QI program should be incorporated into the training/continuing education of staff members. User/client evaluations should be encouraged by periodic dissemination of surveys or other instruments to a laboratory's clients and staff. These should encourage identification of positives and negatives and section(s) for open-ended comments. The results of these evaluations should be available to all laboratory staff and used to identify suitable prevention and corrective actions. To ensure full transparency, the results of internal and external audits should be available to laboratory clients. https://www.westgard.com/lesson50.htm. Westgard QC website. Basic Planning for Quality, lesson QP2: Assuring Quality through Total Quality Management (partial lesson/book excerpt from: Westgard, JO. Basic Planning for Quality. Madison, WI: Westgard QC, Inc.; 2000).4 https://www.westgard.com/essay35.htm Essay on Six Sigma Quality (note: many of the Westgard QC website materials require a no-cost registration). Westgard QC website. Basic Planning for Quality, lesson Designing a (partial lesson/book excerpt available on Westgard QC website. Basic Planning for Quality, lesson https://www.iso.org/standard/56115.html International Standardization Organization for quality and competence in medical laboratories, published The of these is to guideline and may be further in standard operating procedures The in the to the section in the to the of the in human laboratory the of any laboratory test result of identification (at several reporting, and 2 The preanalytical and postanalytical (please also see section 12, general postanalytical can be more to for quality assurance the analytical phase, the responsibility laboratory and clinical of preanalytical factors is to ensure that biologic samples are for and to that may result from lack of in and have the preanalytical as the highest to of all laboratory error, and of, this 4 referred to as the this is the of test selection by the that is based on and value of the diagnostic Clinical from other as should be directly available to clients/users by and for regarding testing based on vs. to include patient clinical resources, potential for diagnostic and of useful clinical decision points for any further and/or based on current test results. For all the laboratory should provide information to clients in written materials (such as a laboratory services special information or and/or by the is should be recorded in the laboratory information guidelines should also complete laboratory of services, of the tests which are to a laboratory of these laboratories provided upon time for test and a list of key factors known to test to include such as or should also be included in test SOPs and reports; see section Appendix 1 and section should be to standard is for testing in to may have of appropriate including and The specimens should be and to the laboratory in a timely appropriate for the of sample and its and important are any necessary personnel for applicable and/or issues (as to include and specific of specimens with potential that may sample quality or personnel should be recorded and to the laboratory and by the laboratory to the The patient and of mass should be written on the of or directly on with is recommended care not to around the of which can with on the in a is as may become from their should be identified on the with information as determined by the laboratory, including but not limited to: and if should be written on the and the should be should not be by the by the reference laboratory and as such with laboratory laboratory personnel must the client to any information on the should be and as well as into the laboratory information The should be on the as well as identification of any The laboratory should a for test or test The of into the laboratory, and tests should be into the laboratory information system please see section below). and to the appropriate section within the laboratory or several departments should be problems with sample quality which may analysis but not limited to of the should be recorded and to the the with sample quality is to be testing should not be performed on the quality is the client should be contacted and a new if a sample is deemed reportable if the client the test be of the of quality on test results should be communicated to the client in the laboratory (note: sections also to the postanalytical phase, and these areas should be outlined in the laboratory's quality policy per section laboratory personnel and clients should be timely and regarding preanalytical factors laboratory test results test for the clinical sample or sample poor sample quality, from clients to the laboratory should be encouraged to a team approach to preanalytical quality These procedures should be outlined in a to client The laboratory should meet standard requirements necessary for and effective performance. for adequate and of personnel through the laboratory limited