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

Introduction:

Medical ethics is a sub-discipline
of bioethics, which focuses on topics related to medical sciences, including the
consideration of societal value systems and religion-based concerns. Laboratories
performing clinical diagnostic tests should follow their own set of ethical
practice guidelines, ideally based on four fundamental areas outlined by the
World Health Organization (WHO), namely autonomy, beneficence, non-malfeasance,
and justice. These principals concern the right of patients to make decisions
on their own behalf, acting in the best interests of the patient, avoiding harm
to patients, and acting with fairness and respect ref. The main roles of these laboratories
are to assess and perform biological, biochemical, parasitological, and genetic
testing to help guide the diagnosis and treatment of health conditions.

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Due to the importance of the application of
ethical principles by clinical laboratory personnel, the World Health
Organization (WHO) and the International Organization for Standardization (ISO)
have produced guidelines to enhance patient care. These standards provide a
framework for performing and reporting diagnostic testing, with an emphasis on
patient satisfaction, confidentiality, and storage and retention of medical
records. Despite the important role that laboratory-based diagnostics play in
maintaining and promoting health, ethical issues related to diagnostic laboratories
have not been evaluated in detail.

One of the areas that has resulted in much
discussion is that of genetic testing.  Because
some genetic tests may not provide complete information, patients may be
required to make difficult decisions. As an example, cystic fibrosis carrier
testing can help identify couples who are both carriers of the cystic fibrosis
(CF) transmembrane conductance regulator (CFTR) gene mutation. When the CF
mutations are identified in the parents, prenatal testing can be performed to
determine whether a fetus has inherited a CF gene mutation from each parent.
Knowing that a fetus has inherited 2 CF mutations, however, does not predict
the severity of CF in the baby. For couples in this situation, the ethical
dilemma involves the decision to continue or to end a pregnancy without having
knowledge of the severity of the disorder.

Ethical issues can also arise when genetic
testing is able to identify a condition for which there is no treatment
available.  For example, a new type of
newborn screening technology called tandem mass spectrometry can detect more
than 20 different genetic conditions. At present, however, not all of the
conditions can be adequately treated. Although testing for these disorders can
help parents and clinicians avoid “diagnostic odysseys” with an ill child,
there remains no specific cure, and long-term prognosis for some patients is
uncertain. Therefore, the question becomes how to appropriately deal with the
repercussions of parents possessing this knowledge.

Certain genetic tests can also determine, with
limitations, if a person is at increased risk of developing specific conditions,
such as some forms of cancer, haemochromatosis, and some neurological
conditions such as early onset Alzheimer disease. However, testing cannot
determine whether the person will definitely develop the condition later in
life (if they live long enough). In the “classic” model of genetics
services, genetic counseling is provided by a specialized team of
professionals, including a clinical geneticist and genetic counselor. With
improved testing methods, genetic counseling is now being offered by primary care
providers, who may not have received specialized training in this area. Primary care practitioners are
also less likely to endorse an important principle of classical genetic
counseling—that is, autonomous patient decision making (Geller,
Tambor, Chase, & Holtzman, 1993)ref. The movement of genetics
services into primary care is likely to increase as the number of genetic tests
expands. Even if specialized genetics professionals are considered the best
providers of genetic counseling services, it is anticipated that there will be
too few genetics professionals to meet the growing demand for services.

Once genetic tests are considered to be for
routine use, primary care practitioners are likely to be the ones to offer such
testing and obtain informed consent. When risks are revealed, especially for
non-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 other
personnel to provide genetic testing and counseling services as part of their
professional activities.

Ethical
concerns related to access to patient information and samples also need to be
addressed since laboratory results might lead to discrimination or
stigmatization. This is especially important when dealing with conditions of a
sensitive nature, such as sexually transmitted diseases (STDs). The IFCC
(International Federation of Clinical Chemistry) has suggested assembling
international focus groups and conducting meetings to develop globally-accepted
protocols for various ethics topics in the laboratory. The objective of this
paper is to introduce general ethical issues that patients may encounter during
the performance and reporting of laboratory-based diagnostic testing.

 

Ethical responsibilities of
clinical laboratories

Clinical laboratories should be
updated for current rules and regulations implementation. Laboratories services
are required to present newest standards with respecting human rights and
munificence and paying attention to patients’ welfare and relaxation. The patient’s
benefits and respecting his/her legitimate demands, beliefs and culture should
be in priority in each laboratory. The laboratories personnel duty is appreciating
truthfulness, responsibility, job conscience, loyalty, equity, discipline,
benevolence, and maintaining patient’s privacy and paying attention to the
society considerations in case of conflict with personal benefits. It is
obvious that laboratories should recruit experienced that be justified about
professional ethics, good greetings with patients, seriousness on doing
assigned tasks, observing safety in all stages of dong test.