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Ethics and Safety In Medical Laboratory Faculty of Allied Health Sciences Department of Medical Laboratory Sciences MSC, Sajida F. Bataineh 2023 Role of medical laboratory services The Medical laboratory services play a pivotal role in the promotion, curative and...

Ethics and Safety In Medical Laboratory Faculty of Allied Health Sciences Department of Medical Laboratory Sciences MSC, Sajida F. Bataineh 2023 Role of medical laboratory services The Medical laboratory services play a pivotal role in the promotion, curative and preventive aspects of a nation’s health delivery system. The service gives a scientific foundation by providing accurate information to those with the responsibility for: Treating patients and monitoring their response to treatment Monitoring the development and spread of infectious and dangerous pathogens Deciding effective control measures against major prevalent disease Deciding health priorities and allocating resources. Without reliable laboratory services: 1. The source of a disease may not be identified correctly. 2 Patients are less likely to receive the best possible care. 3. Resistance to essential drugs may develop and continue to spread. 4. Epidemic diseases may not be identified on time and with confidence. ETHICS Character, custom, principles, or standards of human conduct, It is also referred to as moral What is medical laboratory ethics? The principles of doing "good" and not doing "harm" are the essence of every code of medical ethics. Medical ethics aim to protect patients from the abuse that can occur when one person is in a position of power. Medical Laboratory Professionals uphold the dignity and respect of the profession and maintain a reputation of honesty, integrity, competence, and reliability. Ethics examines the rational justification for our moral judgments; it studies what is morally right or wrong, just or unjust. In a broader sense, ethics reflects on human beings and their interaction with nature and with other humans, on freedom, on responsibility, and on justice.  Medical ethics are generally considered to be derived from the teachings of the Greek physician Hippocrates (460-377 BC), commonly known as the Father of Medicine.  In recent times, as an aid to decision-making in medicine and as a starting point for discussions on medical ethics, four principles have been generally agreed as fundamental. These are: Autonomy: The right of patients to make decisions on their own behalf. Beneficence: The duty or obligation to act in the best interests of the patient.  Non-maleficence: The duty or obligation to avoid harm to the patient. Justice: This embodies concepts of fairness and giving what is rightfully due. Ethical practice can be regarded as good technical practice accompanied by proper attitudes and behavior. In deciding what is proper, reference is often made to moral values voluntarily adhered to within the community and to standards espoused in various codes of professional practice.  General application of ethical principles Medical laboratories have responsibilities to others. There are three main groups to whom responsibility is owed: 1) Patient Medical laboratory professionals are accountable for the quality and integrity of the services they provide. This obligation includes maintaining individual competence and endeavoring to protect the patient from incompetence or illegal practices by others. 2) Colleagues and the profession Medical laboratory professionals should strive to uphold the dignity and respect of their professions and maintain a reputation for honesty, integrity, and reliability. They should aim to contribute to the advancement of the profession by improving the body of scientific knowledge, promoting high standards of education and practice, and collaborating with colleagues and other health professionals where practicable. 3) Society Professionals working in a medical laboratory also have a responsibility to contribute to the general well-being of society. This may be within their sphere of professional competence or simply as members of the community. Rules of medical laboratory A. Medical Laboratory request form Many different types of laboratory requests are received daily in a medical laboratory. The format of laboratory requisitions may vary from one health institution to the other. In many health institutions, the test request form serves as a test result report form. An efficient laboratory will be able to monitor the laboratory request and its requisition forms from the time the specimens arrive until the time that results are released.  The laboratory request form should be made in writing and provide the following information: The patient’s identification (full name, age, sex, address) Inpatient or outpatient identification number Specific test(s) required and date requested Type of specimen provided Name of the medical officer requesting the test and to whom the report should be sent Any other information relevant to the test requested. B. Keeping of laboratory records The laboratory must keep a record of all results and it should contain: Patient’s identification (name, age, sex, full address) Type of the specimen (s) Type of test(s) done Date and result(s) of the test (s). A record of test results must be kept by the laboratory as carbon copies, worksheets, or recording test results in registers. Whichever system is used, it must enable patients’ results to be found quickly. Records of tests and results are required in the laboratory to issue copies to patients who have lost their results. Moreover, they are also required when preparing duty reports and estimating the workload of the laboratory. C. Delivery of laboratory results Laboratory staff should provide as much relevant information as possible to assist those requesting tests. Standardization in the presentation of reports and use of units is important because it helps in the interpretation and comparison of results, contributes to the efficiency of laboratory service, and is of great value when patients are referred from one health unit or hospital to another. Reports should be clearly and neatly written, particularly figures. Therefore, to ensure the validity and accuracy of test results, the following points should be taken into consideration. 1. Experienced members of medical laboratory professionals must check all laboratory results before dispatching them to respective departments or units. 2. Any unexpected result should be investigated and repeated if necessary. 3. If possible, reference values (normal ranges) should be included in reports History of Ethics and ethical Federation in medical laboratory Lectures 2+3  In the current time, ethical concerns exist everywhere whether it is in the medical field or life science. Lab Medicine and biomedical research, both fields are interconnected by laboratory testing where new results, remaining patient’s blood samples, genetic testing, etc. are some of the major ethical issues that commonly exist. Ethical issues play a very crucial role in laboratory medicine. Therefore, it is required for laboratories to strictly follow ethical principles. The field of ethics involves a set of principles of right conduct and bioethics is well-defined as a branch of applied ethics that studies the philosophical, social, and legal issues arising in medicine and life sciences  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. IFCC International Federation of Clinical Chemistry is a global organization that promotes the fields of clinical chemistry and laboratory medicine. It was established in 1952. The organization aims to: 1) Transcend the boundaries of the field of clinical chemistry and laboratory medicine 2) To build the professionalism of members worldwide To disseminate information on ”best practice” at various levels of technology and economic development To provide a forum of standardization and traceability The IFCC membership comprises 95 national societies and is associated with 6 regional Federations, 55 corporate members and 21 affiliate members representing more than 45,000 laboratory medicine specialists worldwide.  Evolution of ethics Evolution of biologically-centered ethical guidelines in medical or biomedical research has upgraded the understanding of ethics over the years. Various guidelines and declarations evolved over the period, including international and national, are mentioned below:  1) Nuremberg Code, 1947: This code was the initiation of modern ethical morals. It introduced the discussion on rationale and explanation of research risks or benefits analysis. Initially there was no ethical conduct for the research involving biological subjects, the time before World War II. Nuremberg, during 1947, was the first to establish ethical principles for such researches which delineates: The necessity of competent and trained staff Participant’s consent Circumstances under which research should be discontinued  2) Declaration of Geneva, 1948: Declaration of Geneva, 1948: It comes into existence soon after Nuremberg code which emphasized guidelines for ethical issues related to clinical medicine. Soon after Nuremberg code, Declaration of Geneva was conscripted and accepted by World Medical Association (WMA) in 1948. It was actually a physician’s oath that was proposed as an amendment of Hippocratic Oath which was the assertion of physician’s commitment towards his duty for humanity in medicine. Its concept is applicable to clinical medicine unlike Nuremberg code  3) Declaration of Helsinki, 1964, Revised 1983, 1989, 1996, 2000, 2008, 2013: It is obliged to make individ investigators and research participant’s welfare as well. It was developed by World Medical Association (WMA) which includes the set of ethical moralities for conducting research involving humans for medical community. Ten principles of Nuremberg code and Declaration of Geneva were tied in a single document named as ‘Declaration of Helsinki 4) Belmont report, 1978–1979: 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. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects It is one of the key work concerning ethics and healthcare research and explains the ethical guidelines for experiments involving human participants. It three basic principles includes the respect for participants, justice and beneficence. In research these basic principles are obliged to consider. It also saves the rights of participants in clinical and experimental research. 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  5) CIOMS guidelines [Council for International organizations of Medical Sciences], 1992–1993, Revised 2002: International ethical guidelines were announced by CIOMS for epidemiological studies in 1991 and for research involving human participants were announced in 1993. It focuses on pharmacovigilance, reporting of adverse drug effects along with the protection of research participants  Principles of ethics The important three core ethical principles are discussed in all documents. These are as below  a) Respect for persons: We must respect patients and their self-respect. There is freedom of decision to the each participant of the study. It is an obligation to respect the decisions made by people concerning their own lives. This is respecting human dignity. We must not interfere with the decisions of competent adults, and also actively empower others for whom we are responsible.  b.Beneficence: best interests of the patient ‫واجباتنا في مصلحة املرضى أو املشاركني في البحث‬ It refers to our duties in the best interests of the patients or research participants. The goal is to maximize benefits and minimize harm. Everyone must be fair and correct in all their actions and must take positive steps to prevent harm  c) Justice: It is an obligation to provide all participants with whatever they deserve. ‫عامل جميع الناس على قدم املساواة والنزاهة والنزاهة‬ Basically, we have an obligation to treat all people equally, fairly, and impartially. All individuals should have an opportunity to participate in research unless contraindicated and we must not impose unfair burdens. All doubts of research participants should be cleared by the concerned staff. ‫يجب إزالة جميع شكوك املشاركني في البحث من قبل املوظفني املعنيني‬ We should make available all the safety concerns as demanded by research participants.  Various international ethical considerations Similar to other fields of medicine, laboratory medicine is obliged to adhere to high ethical standards. 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. Various policies and guidelines related to ethical issues are being developed time to time by several countries or related societies.  Ethical consideration in ISO 15189 The International Organization for Standardization (ISO) created ISO 15189:2012 “Medical laboratories-Requirements for quality and competence” in 2012. Its section 4.1.1.3 elaborated the ethical conduct required in laboratories. 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. Continue…. As per ISO 15189 standards, the core principles stated in the documents are: (i) There should not be participation in any activities that would diminish confidence in the laboratory’s competence, impartiality, judgment or operational integrity (ii) management and personnel are free from any undue commercial, financial, or other pressure and influences that may adversely affect the quality of work (iii) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements (vi) confidentiality of information is maintained Ethical issues in laboratory Lecture 4+5+6 Introduction The term ethics derives from the Ancient Greek word ethikos, meaning “habit” or “custom.” In clinical laboratories, ethical considerations involve a wide spectrum of laboratory activities, such as: Medical errors the use of biological material for research activity professional conduct  The general principle of patient well-being guides the ethics in healthcare services, this applies to laboratory services as well Medical laboratory professionals are presented with a lot of duties related to their conduct, these duties have been mostly presented as a moral theory concerned with duties and rights Here, we discuss how these ethics may be practically implemented in daily laboratory medicine practice in medical science. Sample collection The laboratory staff must treat all the patients equally. No special preference is given to a patient based on their acquaintances among the staff, their class, or caste Informed consent is taken from all the patients before sample collection, explaining the reason for performing the required tests in a language that he/she understands Information only relevant to the patient’s investigations is collected. No other personal details are collected The information received from each patient is confidential, and the patient should be aware of the reason for providing such information Continue… Special guidelines apply to certain infections, such as HIV, wherein the patient has to be given pre-and post-test counseling apart from taking informed consent. ✓Pretest counseling includes: providing information on HIV/AIDS, window period, routes of transmission, prevention, care, support and treatment services, explaining the benefits of HIV testing, and explaining that the individual has the right to stopt out of HIV testing and this will not affect their access to any other health-related services. ✓Informed consent has to be taken individually and in private and documented in a register ✓The result of the HIV test has to be kept strictly confidential  Post-test counseling involves explaining: the test result, risk education counseling, information about the window period, and retesting. Besides these, guidelines for counseling in a certain specific subgroup of patients should be available Sample preparation continue… Proper privacy has to be provided to the patient during sample collection, depending upon the site. Only authorized personnel and the donor may be present in the area where the collection takes place. An enclosed toilet must be available for individual privacy Standard guidelines for proper sample collection in local language should be displayed in the collection area and the toilet and the staff should be trained for sample collection Feedback should be taken from the patients regarding satisfaction toward clinical laboratory services after the sample collection procedure. A predesigned proforma may be made available at the collection center for the same. Performing test Tests should be performed as per established standard protocol derived from standard national/international guidelines The procedure for in-house testing must be standardized and validated. The standard protocol must include all documents related to the standardization Results The results of the investigations are always confidential unless disclosure of the same is required under special circumstances or by the law, for example: 1) When referring a patient to a different hospital 2) When a written requisition by the court or the police is given demanding the disclosure of the reports 3) Under the Insurance Act, when a patient gives up his rights on taking the insurance and the insurance company demands the reports of the patient 4) When required under workmen compensation and consumer protection laws 5) Disease registration of a notifiable disease 6) Investigations of communicable diseases 7) Vaccination studies 8) Reporting of adverse drug events 9) If a person is admitted to a government hospital during police or judicial custody, his health records should be disclosed.  Results continue…. Results may be used for statistical or epidemiological purposes anonymously (when the patient’s personal details are excluded and only the patient data are being used). Stored samples Collection and storage of human biological materials like tissue, blood samples, body fluids, and urine have become integral to disease diagnosis, and human research. Laboratory medical practice of retention of diagnostic samples for testing and retesting as per the integrity and stability of the samples may be viewed as a resource for research by the community Stored samples should not be used for performing tests other than for which informed consent has been taken from the patient. The samples may be stored for retesting in case of any fallacious results. If the stored sample has to be used for performing some higher tests in the interest of patient care, the patient must be informed Conscientiousness of the laboratory staff The laboratory staff must evaluate his/her conduct and maintain professional integrity The staff must take great care in performing the test procedure and recording the results The patient’s sample must be carefully stored by the staff No fabrication of the sample to be tested or the result should be done Great care has to be taken in delegating tasks to the staff, keeping in mind the importance of each patient’s sample No financial or personal interests should supersede patient’s interest Malpractice The laboratory should have transparent policies indicating the reason for performing the concerned tests. Unnecessary testing has to be avoided. Research ethics Patient samples being used for research involve research-related ethics, especially when dealing with vulnerable groups like children, pregnant women, old age people, and people with neurological disorders. No sample should be used by the researcher without taking informed consent from the patient The researcher should honestly report the data, materials, and methods used in the laboratory without fabricating any reports It is the responsibility of the researcher to maintain the confidentiality of the patient’s information obtained for the purpose of research. Ethical issues during an outbreak Medical laboratory professionals have an obligation to respond to public health crises like Influenza, Ebola, or Coronavirus infections. The risks of acquiring infection should not deter the professional from performing their duties. Despite the risk of acquiring the infection, it is better to go to work and take all necessary precautions to protect oneself from the epidemic. However, it is the responsibility of the hospital administration to ensure the safety of all the staff during such an epidemic or pandemic. The provision of personal protective equipment and vaccination of healthcare workers has to be assured by the administration  AN EPIDEMIC is a disease that affects a large number of people within a community, population, or region. A PANDEMIC is an epidemic that's spread over multiple countries or continents. ENDEMIC is something that belongs to a particular people or country Steps for implementation of ethical practices in a laboratory Standardization of all procedures Safe environment including proper wiring and maintenance of all electrical appliances and diagnostic equipment Ensuring the safety of the laboratory staff from healthcare hazards by the administration Automation including bar-coding that decreases manual error Different tiers of checking/monitoring system to detect the errors timely Repeated training of the laboratory staff  Standardized workflow of the laboratory (fixed protocol of work in different sections of the laboratory with the display of all instructions) Accountability of the technical staff and reporting doctors for safe and lawful practice Alleviating distracting elements like mobile phones to avoid negligence by the laboratory staff Ethical issues in laboratory There are several ethical issues in the laboratory. These issues have been divided into three phases according to the laboratory work distribution.  Pre-analytical phase issues are related to patient interaction, specimen collection, sample receiving, and transport. Analytical phase issues are usually related to quality control Post-analytical phase issues are related to reporting results, keeping and maintaining records Pre-analytical phase Clinicians ordering laboratory tests is also comes under the most important ethical obligations. The laboratory personnel are required to act every time to confirm whether the tests, which are referred by a clinician, are being met with the diseased person requesting the tests or not. However, it is commonly assumed that clinicians are referring laboratory tests so as to benefit the patient without any financial interests. In this phase, there is collective responsibility of many people including nurse, healthcare providers, researcher, or the technical staff collecting the samples. Their role includes: 1.Identification of a patient with respect to the tests ordered. 2.Proper collection, labelling, and handling of samples till the tests are performed  Three basic ethical principles in pre-analytical phase are: a. Respect for persons: Consent must be understood by the patient. It may be expressed if a participant is asked for a written agreement. The patient comfortably sits and allows his sample to be taken. Informed consent may lead to an ethical problem if the participant is incompetent owing to age, or mental status. The patient’s right to refuse to get tests done should be appreciated. Any information regarding patients’ demographics, their visit to the testing laboratory, the tests that were ordered, and the requirement for these tests, should be provided only to suitable personnel. At every step of sample handling, from sample collection to data entry, confidentiality should be maintained b. Beneficence: All tests performed/referred must benefit to the patient. Any adverse event during or after sample collection has to be managed by trained workers, with the help of standard operating procedures (SOPs). Collection of samples should be done as per universally recommended precautions so as to protect the patient and the healthcare worker. The additional samples should not be drawn from the patient without informing and getting the permission from Institutional ethics committee. The specimens should be well-labeled. Transportation of samples should be done to protect the integrity of the sample C. Justice: It provides access to several laboratory tests at a reasonable cost. The laboratory should evaluate the need to introduce new tests and the opportunities to discontinue older tests when better tests are available. No preference should be given to some patients in order to facilitate or accelerate the collection procedure at the cost of others Analytical phase The three principles in this phase are as follows: a. Respect for persons: After the collection and processing of samples, patients have the right to refuse to have their specimens examined. In such a case, confidentially should be appreciated and preserved. Special care must be taken to preserve confidentiality in point-of-care testing as much as possible.  b.Beneficence: The aim of the laboratory is to make available the best possible result to the patient. This is accomplished via good laboratory practices and maintaining high professional standards. Good laboratory practice should involve the establishment of a demanding quality assurance program including quality control analysis, proficiency testing, and accreditation of laboratory. In this regard “a wrong result is worse than no result” is a critical guiding principle. Good laboratory practice refuses to evaluate or account for 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. In this regard, Acceptability of “difficult to obtain” (such as cerebrospinal fluid) samples may be taken as a 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. C. Justice: There should be no discrimination in the examination of patient’s samples on the basis of gender, age or race; otherwise it would be an injustice. All samples should be treated likewise. It is recognized , that laboratories must develop some appropriate provision for STAT or priority testing. Laboratories should also state which tests are included and their expected turnaround times. It is anticipated that all specimens are being analyzed correctly in a timely routine. Post analytical phase a. Respect for persons: Patients reasonably expect that their specimens will not be used beyond the testing prescribed by a clinician and solely used for only prescribed testing for medical purposes. However, in the world substantial differences are there concerning the confidentiality of results. In many areas, the patient and referring clinician are the only authentic recipients of laboratory data. Exceptions are there in case if patients are not able to receive or understand the test reports. In other areas, the patient’s family is also considered to be genuine recipients of a patient’s test reports. Laboratories must develop a strategy for results dissemination so as to respect local customs. Reliable communication methods are to be used, and security should be protected in conveying the results regardless of the channel of communications including, hand deliveries by messengers. The local ethics committee or board should also have provision on any further testing in residual specimens (except for the samples used in validation processes), and patient consent may be obligator B. Beneficence: Results misinterpretation may harm the patients and it could be reduced only when skilled staff would interpret the reports; to minimize this harm. The reporting should be in proper time with correct and all necessary information so that the clinician gets the true interpretation. 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. As per laboratory conditions, turnaround time (TAT) should be minimum for any test but it should not compromise the legitimacy of the results. Timely access to test results is very essential for the welfare of patients, particularly in emergency conditions, and delaying the access to results in case of non-payment may harm the patient and ethically also not correct. Hence, delays in reporting should be avoided. 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 is required. C. Justice: Although reporting of test results must be consistent for all patients, speedy reporting may possibly be demanded for some results, including “critical” and “significant-risk” results. Instructions for quick reporting must apply irrespective of the source of sample as well as the patient’s financial capability and not disclosing the results just due to payment should also be avoided. 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. However, rules and practices differ among different regions and institutions Ethical issues in the laboratory/ Phases Lecture 6+7 Ethical issues in laboratory There are several ethical issues in the laboratory. These issues have been divided into three phases according to the laboratory work distribution.  Pre-analytical phase issues are related to patient interaction, specimen collection, sample receiving, and transport. Analytical phase issues are usually related to quality control Post-analytical phase issues are related to reporting results, keeping and maintaining records  Pre-analytical phase Clinicians ordering laboratory tests also come under the most important ethical obligations. The laboratory personnel are required to act every time to confirm whether the tests, which are referred by a clinician, are being met with the diseased person requesting the tests or not. However, it is commonly assumed that clinicians are referring laboratory tests to benefit the patient without any financial interest.  In this phase, there is the collective responsibility of many people including nurses, healthcare providers, researchers, or the technical staff collecting the samples. Their role includes: 1. Identification of a patient with respect to the tests ordered. 2. Proper collection, labeling, and handling of samples till the tests are performed 3. Appropriate identification and labeling of the sample so that the right tests are performed 4. Appropriate handling of the specimen until testing is performed A. Respect for persons: Consent must be understood by the patient and may be either expressed or implied. Expressed – The subject is asked for written or verbal agreement. Implied - When a patient provides a requisition and willingly sits in a collection chair and allows a sample to be taken The patient comfortably sits and allows his sample to be taken. Informed consent may lead to an ethical problem if the participant is incompetent owing to age, or mental status. The patient’s right to refuse to get tests done should be appreciated. Any information regarding patients’ demographics, their visit to the testing laboratory, the tests that were ordered, and the requirement for these tests, should be provided only to suitable personnel. At every step of sample handling, from sample collection to data entry, confidentiality should be maintained B. Beneficence: All tests performed/referred must benefit the patient. Any adverse event during or after sample collection must be managed by trained workers, with the help of standard operating procedures (SOPs). Collection of samples should be done as per universally recommended precautions to protect the patient and the healthcare worker. The additional samples should not be drawn from the patient without informing and getting the permission from Institutional ethics committee. The specimens should be well-labeled. Transportation of samples should be done to protect the integrity of the sample C. Justice: It provides access to several laboratory tests at a reasonable cost. The laboratory should evaluate the need to introduce new tests and the opportunities to discontinue older tests when better tests are available. No preference should be given to some patients in order to facilitate or accelerate the collection procedure at the cost of others Ethical issues in the analytical phase a. Respect for persons: After the collection and processing of samples, patients have the right to refuse to have their specimens examined. In such a case, confidentially should be appreciated and preserved. Special care must be taken to preserve confidentiality in point-of-care testing as much as possible. B. Beneficence: The aim of the laboratory is to make available the best possible result to the patient. This is accomplished via good laboratory practices and maintaining high professional standards. Good laboratory practice should involve the establishment of a demanding quality assurance program including quality control analysis, proficiency testing, and accreditation of laboratory. In this regard “a wrong result is worse than no result” is a critical guiding principle. Good laboratory practice refuses to evaluate or account for 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. In this regard, Acceptability of “difficult to obtain” (such as cerebrospinal fluid) samples may be taken as a 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. C. Justice: All patient samples are to be treated equally. There should not be any discrimination in the analysis of patient samples based on gender, age or racial origin is an injustice. Laboratories should develop appropriate operating procedures for STAT/priority testing, and state which tests are included and the expected turnaround times. It is expected that all specimens are analyzed accurately and in a timely manner. Ethical issues in post-analytical phase  Laboratories should have a policy for specimen storage that is analyte dependent. Archiving of results in either electronic or hard copy format is an important aspect of good laboratory practice. Archived documents may include: request forms raw analytical and quality control data results reports Policies on retention and destruction of medical records and specimen retention and discard should be put in place. Identification of authorized personnel allowed to access medical records such as doctors, patients, and laboratory staff should be documented in the policy manual. In addition, the patient should be allowed to give consent for access by others (such as family members) as required. Post analytical phase A. Respect for persons: (Confidentiality of results) Patients have a reasonable expectation that their samples will be used solely for the laboratory testing requested by the clinician. Individuals have the right to decide when and if their records or specimens shall be used outside the normal medical care to which they have consented. Any further testing of residual samples should be approved by a local ethics committee or board, and patient consent may be required. B. Beneficence: The reporting of results should be performed in a manner such that the patient’s clinician receives the right result within an appropriate time with inform that allows for the correct interpretation of the results. The reporting should be in proper time with correct and all necessary information so that the clinician get true interpretation. 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 remarki that the result is within or outside the reference interval. Timely access to test results is very essential for the welfare of patients, particularly in emergen conditions, and delaying the access to results in case of non-payment may harm the patient and ethically also not correct. Hence, delays in reporting should be avoided. Errors should be notified to clinicians immediately afte they came into notice and test results should be rectified or repeat tests should be done, whichever is requi C. Justice: Although reporting of test results must be consistent for all patients, speedy reporting may possibly be demanded for some results, including “critical” and “significant-risk” results. Instructions for quick reporting must apply irrespective of the source of sample as well as the patient’s financial capability and not disclosing the results just due to payment should also be avoided. 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. However, rules and practices differ among different regions and institutions Withholding of laboratory results because the patient has not paid should be avoided. Ethical issues in ISO-15189 Section 4.1.1.3 of the document summarizes the ethical conduct expected in laboratories. The document states that laboratories should have in place means to ensure that: There is no involvement in any activities that would diminish confidence in the laboratory’s competence, impartiality, judgment or operational integrity. Management and personnel are free from any undue commercial, financial, or other pressure and influences that may adversely affect the quality of work Where potential conflicts in competing interests exist, they shall be openly and appropriately declared. There are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements. Confidentiality of information is maintained  Summary Professional personnel of a medical laboratory are bound by the ethica codes of their respective profession. Laboratories shall not engage in practices restricted by law and should uphold the reputation of their profession. Always patient’s welfare is paramount. Laboratories should try to avoid situations that give rise to a conflict of interest Some unanswered questions Who owns patient specimens? Whether patients should share in profits if financial gains are derived from leftover samples? Legal or Ethical?