Introduction: (CFTR) gene mutation. When the CF mutations are

Introduction:Medical ethics is a sub-disciplineof bioethics, which focuses on topics related to medical sciences, including theconsideration of societal value systems and religion-based concerns.

Laboratoriesperforming clinical diagnostic tests should follow their own set of ethicalpractice guidelines, ideally based on four fundamental areas outlined by theWorld Health Organization (WHO), namely autonomy, beneficence, non-malfeasance,and justice. These principals concern the right of patients to make decisionson their own behalf, acting in the best interests of the patient, avoiding harmto patients, and acting with fairness and respect ref. The main roles of these laboratoriesare to assess and perform biological, biochemical, parasitological, and genetictesting to help guide the diagnosis and treatment of health conditions. Due to the importance of the application ofethical principles by clinical laboratory personnel, the World HealthOrganization (WHO) and the International Organization for Standardization (ISO)have produced guidelines to enhance patient care. These standards provide aframework for performing and reporting diagnostic testing, with an emphasis onpatient satisfaction, confidentiality, and storage and retention of medicalrecords.

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Despite the important role that laboratory-based diagnostics play inmaintaining and promoting health, ethical issues related to diagnostic laboratorieshave not been evaluated in detail. One of the areas that has resulted in muchdiscussion is that of genetic testing.  Becausesome genetic tests may not provide complete information, patients may berequired to make difficult decisions. As an example, cystic fibrosis carriertesting can help identify couples who are both carriers of the cystic fibrosis(CF) transmembrane conductance regulator (CFTR) gene mutation. When the CFmutations are identified in the parents, prenatal testing can be performed todetermine whether a fetus has inherited a CF gene mutation from each parent.Knowing that a fetus has inherited 2 CF mutations, however, does not predictthe severity of CF in the baby. For couples in this situation, the ethicaldilemma involves the decision to continue or to end a pregnancy without havingknowledge of the severity of the disorder.Ethical issues can also arise when genetictesting is able to identify a condition for which there is no treatmentavailable.

  For example, a new type ofnewborn screening technology called tandem mass spectrometry can detect morethan 20 different genetic conditions. At present, however, not all of theconditions can be adequately treated. Although testing for these disorders canhelp parents and clinicians avoid “diagnostic odysseys” with an ill child,there remains no specific cure, and long-term prognosis for some patients isuncertain. Therefore, the question becomes how to appropriately deal with therepercussions of parents possessing this knowledge. Certain genetic tests can also determine, withlimitations, if a person is at increased risk of developing specific conditions,such as some forms of cancer, haemochromatosis, and some neurologicalconditions such as early onset Alzheimer disease.

However, testing cannotdetermine whether the person will definitely develop the condition later inlife (if they live long enough). In the “classic” model of geneticsservices, genetic counseling is provided by a specialized team ofprofessionals, including a clinical geneticist and genetic counselor. Withimproved testing methods, genetic counseling is now being offered by primary careproviders, who may not have received specialized training in this area. Primary care practitioners arealso less likely to endorse an important principle of classical geneticcounseling—that is, autonomous patient decision making (Geller,Tambor, Chase, & Holtzman, 1993)ref.

The movement of geneticsservices into primary care is likely to increase as the number of genetic testsexpands. Even if specialized genetics professionals are considered the bestproviders of genetic counseling services, it is anticipated that there will betoo few genetics professionals to meet the growing demand for services. Once genetic tests are considered to be forroutine use, primary care practitioners are likely to be the ones to offer suchtesting and obtain informed consent. When risks are revealed, especially fornon-treatable disorders and conditions associated with a carrier status,referral to specialized genetic counselors will most likely be desirable.Specialized genetics professionals will also increasingly need to train otherpersonnel to provide genetic testing and counseling services as part of theirprofessional activities.

Ethicalconcerns related to access to patient information and samples also need to beaddressed since laboratory results might lead to discrimination orstigmatization. This is especially important when dealing with conditions of asensitive nature, such as sexually transmitted diseases (STDs). The IFCC(International Federation of Clinical Chemistry) has suggested assemblinginternational focus groups and conducting meetings to develop globally-acceptedprotocols for various ethics topics in the laboratory.

The objective of thispaper is to introduce general ethical issues that patients may encounter duringthe performance and reporting of laboratory-based diagnostic testing.  Ethical responsibilities ofclinical laboratoriesClinical laboratories should beupdated for current rules and regulations implementation. Laboratories servicesare required to present newest standards with respecting human rights andmunificence and paying attention to patients’ welfare and relaxation. The patient’sbenefits and respecting his/her legitimate demands, beliefs and culture shouldbe in priority in each laboratory.

The laboratories personnel duty is appreciatingtruthfulness, responsibility, job conscience, loyalty, equity, discipline,benevolence, and maintaining patient’s privacy and paying attention to thesociety considerations in case of conflict with personal benefits. It isobvious that laboratories should recruit experienced that be justified aboutprofessional ethics, good greetings with patients, seriousness on doingassigned tasks, observing safety in all stages of dong test.