**6.1 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:


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 written agreement. It may be implied

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data entry, confidentiality should be maintained.

protect the integrity of the sample.

procedure at the cost of others.

**6.2 Analytical phase**

are as follows:

when patient is comfortably sits and allows his sample to be taken. Informed consent may lead to an ethical problem if participant is incompetent owing to age, mental status, or critical illness. The patient's right to refuse to get tests done should be appreciated. In special cases, healthcare professionals should be obliged to consult the institutional guidelines. Any information regarding patient's 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

b.**Beneficence:** All tests performed/referred must benefit to patient. Any adverse event during or after sample collection have 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 with minimum two unique identifiers. Transportation of samples should be done to

c.**Justice:** It provides access to several laboratory tests at 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

In laboratories settings confidentiality, quality and competency are essential. 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. Maintaining confidentiality is more challenging during the analytical phase in small laboratories as compared to larger ones, as smaller laboratories perform manual testing. However, it is most important to maintain ethical standards by each laboratory in conducting patient's testing. The three principles in this phase

a.**Respect for persons**: After 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 patient. This is accomplished via good laboratory practices (GLP) and maintaining high professional standards. Good laboratory practice should involve the establishment of 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 (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. 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

*DOI: http://dx.doi.org/10.5772/intechopen.96122*

*Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues DOI: http://dx.doi.org/10.5772/intechopen.96122*

when patient is comfortably sits and allows his sample to be taken. Informed consent may lead to an ethical problem if participant is incompetent owing to age, mental status, or critical illness. The patient's right to refuse to get tests done should be appreciated. In special cases, healthcare professionals should be obliged to consult the institutional guidelines. Any information regarding patient's 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.


#### **6.2 Analytical phase**

*Bioethics in Medicine and Society*

Pre-analytical phase issues are related to patient's interaction, specimen collection, sample receiving and its transport. Analytical phase issues are usually related to quality control, whereas, post-analytical phase issues are related to reporting of

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

1.Identification of a patient with respect to the tests ordered.

Three basic ethical principles in pre-analytical phase are:

2.Proper collection, labelling, and handling of samples till the tests are

a.**Respect for persons:** Consent must be understood by the patient. It may be expressed if a participant is asked for written agreement. It may be implied

results, keeping and maintaining records [16].

**6.1 Pre-analytical phase**

*Ethical issues in laboratory phases.*

**Figure 2.**

the samples. Their role includes:

performed.

**110**

In laboratories settings confidentiality, quality and competency are essential. 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. Maintaining confidentiality is more challenging during the analytical phase in small laboratories as compared to larger ones, as smaller laboratories perform manual testing. However, it is most important to maintain ethical standards by each laboratory in conducting patient's testing. The three principles in this phase are as follows:


suitable policy on examination and records of such specimens where specimen integrity or identification is being compromised. All laboratories should maintain proper authorization as required by their country or region. Only qualified, properly skilled and regularly re-accredited employees should be authorized to execute point-of-care testing (POCT).

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.

## **6.3 Post analytical phase**

This phase includes reporting and interpretation of tests results, storage of residual sample, and access to the data. All laboratories should have a procedure for storage of a specimen that is analyte dependent. An essential part of good laboratory practice is to archive the results either in electronic and/or hard copy format. Documents that can be archived include request forms, raw analytical as well as quality control data, results, and reports. Guidelines on retention or destruction of medical records along with remaining sample retention and its dispose of should be kept in place. 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. Besides this, the patient should have the right to give consent to access by others (such as family members), if required. Applying the basic ethical principles in post analytical phase as follows:


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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, delaying 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 required. Finally, incorrect results should be still accessible but marked as erroneous and corrected result should

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. Remaining patient's samples should not be used further without patient's knowledge which is very common these days. 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

Finally, it has been observed that it is necessary to incorporate the core principles

and guidelines of bioethics in the areas of laboratory medicine. Any laboratory involving human participants should follow international standards and practices of ethics. Laboratories shall not engage in practices restricted by law and should uphold the reputation of their profession. It is required to develop an ethics policy and add it to the laboratory's quality assurance manual. Development and implementation of an ethics training program for laboratory staff should be done in such a way that it would promote the development of the professional life of laboratory staff, highlighting human values and responsibility, honesty in their work. This will surely initiates and encourages the change of paradigm with the aim of increasing

knowledge keeping in mind ethical principles in daily procedures.

The authors declare no conflict of interest.

*DOI: http://dx.doi.org/10.5772/intechopen.96122*

be mentioned on the report.

among different regions and institutions.

**7. Conclusion**

**Conflict of interest**

*Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues DOI: http://dx.doi.org/10.5772/intechopen.96122*

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, delaying 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 required. Finally, incorrect results should be still accessible but marked as erroneous and corrected result should be mentioned on the report.

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. Remaining patient's samples should not be used further without patient's knowledge which is very common these days. 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.
