Need For Accreditation and Ethics in Laboratory Medicine

Representational Pic
Representational Pic


A diagnostic test result should enable a decision to be made, which leads to an excision to be made which leads to an action being taken, yielding an improved outcome for the patient - Price and Christenson.

There are no mandatory laws yet to control laboratory services in many of the developing countries. We in India are waiting for initiation of implementation of laws to regulate laboratory medicine with many hospitals and laboratories choosing to be part of National accrediting standards with NABH and NABL. Certainly with time, many patients will choose to be treated and investigated at hospitals which maintain the standards in healthcare. With the progress of time, many health insurance agencies recommend the hospitals with accreditation, legalized by their countries meeting the national and International standards.

WHY ACCREDITATION OF LABORATORY MEDICINE: Many of the developed countries have concluded that laboratory reports are as good as therapeutic prescription which influences the progress of disease, and the area of interest and the challenge remain coordination between laboratory reports and clinical care.

THE PURPOSES AND NATURE OF LABORATORY ACCREDITATION: It is in the interests of patients, of society, and of governments that clinical laboratories operate at high standards of professional and technical competence, to give the optimal care. There exists much conflict of interests in many developed countries, especially worrisome at a time when most of the population is already facing a financial crunch. To pay for many laboratory investigations done with or without purpose related to the existing illness or just improving the academics or research, as happening with teaching institutes.

Patients, and to a lesser extent clinicians, may have no choice about the laboratory to be used as Laboratory testing can be expensive and the patients, insurance organizations, or governments who pay for testing expect the laboratory to provide valid information. It has led to much discussion on what tests to choose and which is an accredited laboratory and thus leads to more importance of accreditation and ethics.

FORMULATING A POLICY - It is in the interest of competent laboratories that their competence is verified through a process of inspection, comparison against appropriate standards, and public affirmation of their good standing. Accreditation is an external audit of the ability of a laboratory to provide a high-quality service.

This requires a laboratory to submit information demonstrating:

• Conformity with published accreditation standards

• The existence of a management system addressing internal and external measures of quality, outlined in a quality management manual

• A qualified expert appraisal by an accreditation body.

QUALITY POLICY: There must be documentation of policies and procedures, and of laboratory methods. Internal and external quality assurance procedures and systems evaluation must cover the preanalytical, analytical and post analytical phases of sample analysis or examination.

INCORPORATION OF ETHICS IN LABORATORY STANDARDS: Adherence to high standards, such as those related to timeliness of test results, laboratory accuracy and precision, the clinical relevance of the tests performed, qualifications and training of personnel, and prevention of errors, is an ethical responsibility of all clinical laboratory staff. Inspection and accreditation of clinical laboratories should also ensure that the owners, managers, and staff comply with ethical standards, such as:

• Maintenance of confidentiality of patient information

• Adherence to appropriate technical and professional standards regardless of cost pressures

• Avoidance of personal, financial and organizational conflicts of interest

• Non-discrimination against patients or staff based on race, gender, political or religious beliefs, or economic circumstances

DEFINING JOB RESPONSIBILITIES: Written job descriptions and contracts enable staff to know their duties, responsibilities, and rights.

1. Laboratory management shall ensure that all staff shall have job descriptions that include: a) a job title b) The location within the organization c) accountability d) the main purpose of the job e) the main duties and responsibilities f) a requirement for participation in staff annual joint review.

2. All staff shall have contracts of employment that provide clear terms and conditions of service

It is the responsibility of the employer to invest in training the staff in optimal methods to practice laboratory medicine. Increase engagement of laboratory professionals in quality improvement research and data collection. Encourage recognition of laboratory professionals as partners in healthcare policy and decision-making.

Dr Javeed Kakroo is a Microbiologist and infection control auditor at Kidney Hospital Srinagar.

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