what is the analytical phase of laboratory testing

accuracy, precision, reliability, turn-around time etc. Instructions for quick reporting must apply irrespective of the source of sample as well as the patients financial capability and not disclosing the results just due to payment should also be avoided. Belmont report, 19781979: The Belmont Report was generated by the United States of America (USA) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978. The Three Phases of Medical Laboratory Testing - 24 Hours access EUR 36.00 GBP 32.00 USD $39.00 Rental. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. The organizations specially; International of federation of clinical chemistry (IFCC), American Association of Clinical Chemistry (AACC) and International Organization for Standardization (ISO) have defined ethical recommendations for clinical laboratories. Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation ( 2, 3 ). As per ISO 15189 standards, the core principles that stated in documents are: (i) there should not be participation in any activities that would diminish confidence in the laboratorys competence, impartiality, judgment or operational integrity; (ii) management and personnel are free from any undue commercial, financial, or others pressure and influences that may adversely affect the quality of work; (iii) where potential conflicts in competing interests exist, they shall be openly and appropriately declared; (iv) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements; (v) confidentiality of information is maintained. Get CDCs free global health newsletter each week! 1. The local ethics committee or board should also have provision on any further testing in residual specimen (except for the samples used in validation processes), and patient consent may be obligatory. trainings) have been developed and are being implemented. Laboratories must develop a strategy for results dissemination so as to respect local customs. Such processes include: specimen collection, storage of specimen, specimen packaging and transportation, completion of test forms, test ordering, test result collection and filing, and finally using and acting upon the results for patient management and decision making. Apart from laboratory staff, everyone who is involved on the way is equally responsible for maintaining laboratory ethical values. To address this issue, IFCC has recently constituted a task force on ethics (TF-E) to rationalize the documents and spread the education and training on ethics [12]. In this regard a wrong result is worse than no result is a critical guiding principle. Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2022 Proper collection, labelling, and handling of samples till the tests are performed. Federal government websites often end in .gov or .mil. In such a case, confidentially should be appreciated and preserved. By making research easy to access, and puts the academic needs of the researchers before the business interests of publishers. Advances in analytical techniques, laboratory instrumentation, and automation have improved analytical quality resulting in a significant decrease in error rates. These issues have divided into three phases according to the laboratory work distribution. 2004;42(7):868-73. doi: 10.1515/CCLM.2004.142.1. It also describes the approval of study by the Institutional ethical committee and ensures that participant should at least get nominal care for their medical condition [7]. Not processing a specimen properly prior to analysis or substances interfering with . At every step of sample handling, from sample collection to data entry, confidentiality should be maintained. Publishing on IntechOpen allows authors to earn citations and find new collaborators, meaning more people see your work not only from your own field of study, but from other related fields too. Biochem Med (Zagreb). There is freedom of decisions to the each participant of the study. Lippi G, Banfi G, Church S, Cornes M, De Carli G, Grankvist K, Kristensen GB, Ibarz M, Panteghini M, Plebani M, Nybo M, Smellie S, Zaninotto M, Simundic AM; European Federation for Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. The analytical phase involves the actual running of the test, while the post-analytical phase includes recording the results, interpreting the results, reporting the results to the ordering physician, and filing the report. All laboratories should maintain proper authorization as required by their country or region. Documents that can be archived include request forms, raw analytical as well as quality control data, results, and reports. The Symposium has the involvement and support of the National Department of Health (NDoH) and the National Health Laboratory Service (NHLS), as well as donors who are working to improve the CLI. official website and that any information you provide is encrypted The pre-analytical phase involves specimen collection, acquisition by the laboratory, labeling and coding, and preparation for analysis. This phase includes reporting and interpretation of tests results, storage of residual sample, and access to the data. The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. All laboratories should have a procedure for storage of a specimen that is analyte dependent. These are as below (Figure 1): Respect for persons: We must respect patient and their self-respect. With the advancement of medical science in the area of laboratory medicine, special ethical considerations should be taken in addition to the general ethical framework followed in biomedical research. In 2017, Indian Council of Medical Research introduced ethical guidelines for research on Human Participants. UNITED KINGDOM, Neerja Aggarwal, Pawan Kumar Kare and Sudip Kumar Datta, Various international ethical considerations. Before In addition, the assessments have revealed long turn-around times for some tests, high specimen rejection rates, and gaps in management and coordination of laboratory services in some districts. ISO 15189 is technically applicable for laboratory equipment, personnel, environmental conditions, consumables, pre- and post-examination processes, reporting and release of laboratory results, and lab information management. This will surely initiates and encourages the change of paradigm with the aim of increasing knowledge keeping in mind ethical principles in daily procedures. An official website of the United States government. Abstract. Pre-analytical phase issues are related to patients interaction, specimen collection, sample receiving and its transport. Various guidelines and declarations evolved over the period, including international and national, are mentioned as below: Nuremberg Code, 1947: This code was the initiation of modern ethical morals. The analytical phase involves the actual running of the test, while the post-analytical phase includes recording the results, interpreting the results, reporting the results to the ordering physician, and filing the report. Laboratories shall not engage in practices restricted by law and should uphold the reputation of their profession. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Disclaimer. Processing of results for transcription onto report forms 2. IFCC-task force has suggested that all the area of medicine to fulfill with ethical standards and guidelines and the field of lab medicine is no exemption. 8600 Rockville Pike Any adverse event during or after sample collection have to be managed by trained workers, with the help of standard operating procedures (SOPs). Special care must be taken to preserve confidentiality in point-of-care testing as much as possible. The CDC-funded Linking for Change: Strengthening Clinic Lab Interface (CLI) Systems Symposium, hosted by SEAD, is scheduled to take place at Emperors Palace, Johannesburg, on the 11th and 12th of August 2014. The three principles in this phase are as follows: Respect for persons: After collection and processing of samples, patients have the right to refuse to have their specimens examined. Assessment of the significance of results in the context of established reference values and decision for further tests. It ties together the analytical quality achieved, the context of the patient, the perceived ability of the physicians, to interpret and utilize the laboratory information. This phase begins with conducting direct Gram stains of the clinical material (e.g., pus, blood, etc. Clinicians ordering laboratory tests is also comes under the most important ethical obligations. Most errors are identified in pre-pre-analytic and post-post-analytic steps . London, SW7 2QJ, Finally, it has been observed that it is necessary to incorporate the core principles and guidelines of bioethics in the areas of laboratory medicine. Frank H. Wians HF. Laboratories should also state which tests are included and their expected turnaround times. The PIs shown in Figure 3 mainly correspond to the pre-analytical phase because we excluded articles solely focused on analytical quality and because most errors in the testing process occur in the pre-analytical phase. The https:// ensures that you are connecting to the Analysis of preanalytical errors in a clinical chemistry lab - LWW Quality indicators to detect pre-analytical errors in laboratory testing. Reports indicate that up to 70% of laboratory errors occur in this phase [ 10, 11 ]. Compliance with Ethical StandardsThe author declares that he/she has no competing interests. What are the 3 phases of laboratory testing? - Studybuff.com Int J Lab Hematol. Some of the errors particular to CLI include inappropriate test requests, misidentification of patient, inappropriate test tube, inadequate sample collection and transport, inadequate sample/anticoagulant volume ratio, insufficient sample, labelling errors, improper data entry etc. However, most attention developmental and strengthening efforts (e.g. All samples should be treated likewise. Focusing first on the analytical phase of laboratory testing, the analytical phase begins when the patient specimen is prepared in the laboratory for testing, and it ends when the test result is interpreted and verified by the technologist in the laboratory. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving . HHS Vulnerability Disclosure, Help There are several ethical issues in laboratory (Figure 2). Errors should be notified to clinicians immediately after they came into notice and test results should be rectified or repeat tests should be done, whichever required. Brief introduction to this section that descibes Open Access especially from an IntechOpen perspective, Want to get in touch? The preanalytic phase. An important component of laboratory medicine This task force (TF-E) has created a toolkit which serves as a repository of documents developed worldwide in the kingdom of laboratory ethics [13]. Challenges in Preanalytical Phase of Laboratory Medicine: Rate of Blood Findings from the assessments have shown concurrence in the weaknesses of CLI with other previous assessments conducted. Finally, incorrect results should be still accessible but marked as erroneous and corrected result should be mentioned on the report. Immediate scrutiny of urgent results with issue of provisional report and its delivery to the requesting clinician 3. When we talk about the laboratory system, staff comes at first as they are directly linked in interaction with patients and their care. Laboratory testing is an integral part of a cycle consisting of three phases: pre-analytic, analytic, and post-analytic phases. The major ethical challenges such as; consent, confidentiality, codes of conduct, conflict of interest, lab utilisation, proficiency, and direct access testing are some times more prevalent in resource-limited settings. Guidelines on retention or destruction of medical records along with remaining sample retention and its dispose of should be kept in place. It three basic principles includes the respect for participants, justice and beneficence. Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2022 Skip to main Products PRODUCT Notebook Inventory Dashboard Molecular biology FEATURE Consumables Live-editing Protocols Insights Solutions GENEMOD FOR Biopharma Startups Transportation of samples should be done to protect the integrity of the sample. Bookshelf accuracy, precision, reliability, turn-around time etc. Post-Analytical Phase - an overview | ScienceDirect Topics A lab testing process is divided into three stages: pre-analytical, analytical, and post-analytical. Bioethics in Medicine and Society, Submitted: July 9th, 2020 Reviewed: January 20th, 2021 Published: February 4th, 2021, Total Chapter Downloads on intechopen.com. The tests are heavily relied on for making accurate diagnosis, and monitoring of treatment and treatment outcomes. The preanalytical phase of the laboratory testing process includes all of the procedures prior to the start of sample analysis, and typically involves a variety of healthcare professionals. The .gov means its official. Epub 2022 Aug 5. Recognizing and Reducing Analytical Errors and Sources of Variation in Apart from the lab results, laboratory staff is another important aspect of the laboratory. Preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the laboratory professionals. However, implication of ethical standards and guidelines are vary between different cultures, geographies, and according to available resources. From: Accurate Results in the Clinical Laboratory (Second Edition), 2019 View all Topics Add to Mendeley About this page Jokic A, Rimac V, Vlasic Tanaskovic J, Podolar S, Honovic L, Lenicek Krleza J. Biochem Med (Zagreb). EJIFCC. Initially there was no ethical conduct for the research involving biological subjects, the time before World War II. It was developed by World Medical Association (WMA) which includes the set of ethical moralities for conducting research involving humans for medical community. Good laboratory practice should involve the establishment of demanding quality assurance program including quality control analysis, proficiency testing and accreditation of laboratory. Quality control is the component of the quality assurance system that recognizes and minimizes analytical errors. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. Henceforth, it is highly obligatory to evade any such activity that would downgrade the expertise, neutrality, outcomes, operational truthfulness or patients confidence in laboratory. Various assessments and reviews performed at healthcare facilities around the country have shown weaknesses in CLI. 2014 May 15;432:44-8. doi: 10.1016/j.cca.2013.07.033. However, it is commonly assumed that clinicians are referring laboratory tests so as to benefit the patient without any financial interests. Besides this, the patient should have the right to give consent to access by others (such as family members), if required. In this chapter, we have mentioned the ethical consideration of IFCC, AACC and ISO 15189:2012 with regard to laboratory medicine and also addressed the various ethical issues that arises day to day in laboratory medicine in the current scenario. Integrated Systems Analysis of Clinic-Laboratory Interface 2010. http://www.sead.co.za/downloads/clinic-part-a.pdf. Declaration of Helsinki, 1964, Revised 1983, 1989, 1996, 2000, 2008, 2013: It is obliged to make individual rights as informed decisions, duties of investigators and research participants welfare as well. Informed consent may lead to an ethical problem if participant is incompetent owing to age, mental status, or critical illness. *Address all correspondence to: pawankare4@gmail.com. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. Analytical Phase - an overview | ScienceDirect Topics It focusses on the pharmacovigilance, reporting of adverse drug effects along with protection of research participants [8]. Analytical phase: test analysis, quality . We should make available all the safety concerns as demanded by research participants. The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. CLIA regulations are now arranged to match the path a patient specimen takes as it moves through the laboratory; i.e., specimen receiving (pre-analytic), testing (analytic), and result reporting (post-analytic) phases. While the mechanisms of communication vary from verbal to digital, the end goal remains the same: provide accurate, timely, informative results to the physician. Quality Indicators to Detect Pre-Analytical Errors in Laboratory Testing The total testing process (TTP) The total testing process (or total testing cycle) is based on the original brain-to-brain loop concept described by Lundberg [ 1, 2 ]. Similar to other fields of medicine, laboratory medicine is obliged to adhere to high ethical standards. Based on these findings, various intervention plans and activities (e.g. SEAD. Policy manual should also mention the strategies on the identification of authorized personnel such as doctors, patients, and laboratory staff; that would be allowed to access medical records. In laboratories settings confidentiality, quality and competency are essential. It may be expressed if a participant is asked for written agreement. From: Molecular Diagnostics, 2010 View all Topics Add to Mendeley About this page Finally, the CDC South Africa Laboratory Program hopes that the CLI symposium will bring CLI activities and challenges to prominence and attract much needed attention and support of leaders, development agencies and partners, the wider community of implementing partners, healthcare workers, and managers at all levels of government for the strengthening of CLI and improving the quality of laboratory services. Post-analytical Issues in the Clinical Laboratory | SpringerLink CDC twenty four seven. Bethesda, MD 20894, Web Policies With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. In this regard, Acceptability of difficult to obtain (such as cerebrospinal fluid) samples may be taken as special case, and departmental facilities should develop some suitable policy on examination and records of such specimens where specimen integrity or identification is being compromised. Pre-analytical phase management: a review of the procedures from Analytical Phase - an overview | ScienceDirect Topics A critical review of laboratory performance indicators It is one of the key work concerning ethics and healthcare research and explains the ethical guidelines for experiments involving human participants. Therefore, ethics plays a significant role in laboratory medicine. The laboratory should evaluate the need to introduce new tests and the opportunities to discontinue older tests when better tests are available. What are the three phases of quality assurance? However, preanalytical activities, management of unsuitable specimens and reporting policies are not fully standardized, nor harmonized PPT Postanalytical Phase of Laboratory Testing - luc.edu The goal is to maximize benefits and minimize harms, the latter sometimes Latinate as non-maleficence. Pre-Analytical Phase - an overview | ScienceDirect Topics Good laboratory practice (GLP) refuses to evaluate or account a result in the presence of poor sample integrity, improper or poor labeling or any other insufficiency that may lead to compromise with the test result. Analytical Phase - an overview | ScienceDirect Topics The next stage of the diagnostic cycle is the analytical phase of laboratory testing. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory U.S. Department of Health & Human Services. The final part of the laboratory testing process is known as the "Post-Analytical Phase.". Keywords: 5 Princes Gate Court, Errors occur much less frequently in the analytic phase of laboratory testing than in either the preanalytic or postanalytic phases. Medical laboratory testing and reporting is a complex and arduous task,That seeks to provide answers to questions; which our clients and clinicians ask.Collecti . The analytical phase involves the actual running of the test, while the post-analytical phase includes recording the results, interpreting the results, reporting the results to the ordering physician, and . 2019 May;41 Suppl 1:170-176. doi: 10.1111/ijlh.13007. 2021 Oct 15;31(3):030704. doi: 10.11613/BM.2021.030704. It is anticipated that all specimens are being analyzed correctly in a timely routine. Lab Med. Abstract. There is much discussion in the literature about who owns patient specimens and whether patients should share in profits if financial gains are derived from leftover samples. Quality Assurance Flashcards | Quizlet The pre-pre-analytical phase, which is primarily composed of test order- ing, and the post-post-analytical phase, which is primarily composed of test result interpretation, can be. The International Federation of Biomedical Laboratory Science (IFBLS) suggests to maintain strict confidentiality of patient information and test results; safeguard the dignity and privacy of patients and above all be accountable for the quality and integrity of clinical laboratory services being provided [15]. 2022 Oct 1;32(3):030701. doi: 10.11613/BM.2022.030701. 2015 Feb;53(3):357-70. doi: 10.1515/cclm-2014-1051. 2012; 43(2):41-44. POST ANALYTICAL PHASE OF LABORATORY TESTING POST ANALYTICAL PHASE / POST ANALYTICAL QUALITY-The ultimate check on the consistency of pre-analytical and analytical quality.And it can be considered as the overall quality. What are the 3 phases of laboratory testing? Various policies and guidelines related to ethical issues are being developed time to time by several countries or related societies. Module 5 Postanalytical Phase of Laboratory Testing Once an accurate test result is obtained the lab must Report the result in a timely manner by: Using an electronic process allowing for acceptable results to be transmitted electronically via an 'interface' between the analyzer and lab information system(LIS) and then via another 'interface' between the LIS and the electronic medical . To date our community has made over 100 million downloads. These pre-analytical errors can result in sample rejection and can therefore require extra work in order to resolve them. Saving Lives, Protecting People. Books > The pre-analytical phase encompasses all the procedures before the start of laboratory testing. We must not interfere with the decisions of competent adults, and also actively empower others for whom we are responsible. However, rules and practices differ among different regions and institutions. What is pre-analytical phase in quality assurance? Beneficence: It refers to our duties in the best interests of the patients or research participants. However, while the pre-analytical phase is known to be error-prone, only recently have data been collected to demonstrate that the errors occurring are mainly related to procedures performed outside the laboratory walls, by healthcare personnel not under the direct control of the clinical laboratory. Epub 2013 Sep 5. The pre-analytic and post-analytic phases, which are also referred to as clinic-laboratory interface (CLI), have been largely neglected. Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications. It was actually a physicians oath that was proposed as an amendment of Hippocratic Oath which was the assertion of physicians commitment towards his duty for humanity in medicine. During this, confidentiality is almost a by-product of laboratory automation which uses automated code readers, automated analysis, as well as auto-verification and also names of patients are normally given a unique sequential number for processing. eCollection 2023. The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. In the remainder of this section, we describe the PIs . Review of Medical Errors in Laboratory Diagnostics and Where We Are The analytical phase commences when the sample arrives to the laboratory has been accessioned into lab computer system and and analytical testing is initiated (Smith, et al., 2013) . 2 The numbers don't lie: it's a significant problem Basically, we have an obligation to treat all people equally, fairly, and impartially. Pre- and postanalytical errors in haematology. Laboratory staffs behavior and etiquettes also comes in this category, thus, their actions should be in a professional way for example, wearing laboratory coat/apron, proper dressed-up, phones should be turned silent/OFF during the time of testing and not discussing any report with clients and others. Clin Chem Lab Med. Its section 4.1.1.3 elaborated the ethical conduct required in laboratories. MeSH This phase of the testing process is responsible for the majority of the laboratory errors, since the related procedures involve many sorts of non-laboratory professionals working outside the laboratory s Clin Chim Acta. Lab Medicine and biomedical research, both fields are interconnected by laboratory testing where new results, remaining patients blood sample, and genetic testing, etc. Epub 2020 Aug 5. Unable to load your collection due to an error, Unable to load your delegates due to an error. As per laboratory conditions, turnaround time (TAT) should be minimum for any test but it should not compromise the legitimacy of the results. 6.1 Pre-analytical phase. Furthermore, a complete report usually covers the name of the test executed, a suitable reference interval (which might be age or gender specific), units of measurement if needed, and a remarking that the result is within or outside the reference interval. In this phase, lab results are communicated to physicians. All doubts of research participants should be cleared by concerned staff. quality assurance system, new technology, maintenance etc.)