LM Unit 4
LM Unit 4
Immediate corrective
Systematic improvements based on
Action actions if out-of-range
feedback from external agencies
results
Validation Process
1.Defining Validation Parameters: Labs first decide what parameters (e.g., accuracy,
precision, linearity, sensitivity) will be tested during validation. These parameters are based on
the clinical use of the instrument.
2.Test Protocol Development: Detailed test protocols outline the number of tests, sample types,
and analysis methods that will be used in the validation process.
3.Initial Validation: The instrument is put through a series of tests using actual samples. These
tests verify whether it meets predefined performance specifications under different conditions.
4.Data Analysis: The results are analyzed to check for accuracy, precision, linearity, and other
metrics. Data analysis confirms whether the instrument performs as expected.
5.Performance Monitoring: Even after validation, ongoing performance checks (e.g., quality
control, proficiency testing) are required to ensure that the instrument continues to perform well
over time.
6.Documentation: Detailed records of the validation tests and results are maintained as part of
the lab's quality management system (QMS).
4. Challenges and Best Practices in Calibration and Validation
Challenges
•Instrument Drift: Over time, instrument sensors may wear out, causing the readings to drift
from their true values. This requires more frequent recalibration.
•Environmental Factors: Instruments are sensitive to external conditions like temperature,
humidity, and air pressure, which can affect their accuracy.
•Complexity of Equipment: Advanced instruments, such as automated immunoassay analyzers,
require complex calibration and validation protocols due to their highly sophisticated design.
•Cost: Calibration standards, validation reagents, and skilled personnel are expensive.
Laboratories must budget for these costs while still ensuring high-quality patient care.
Best Practices
•Scheduled Calibration and Validation: Labs should maintain a regular schedule for calibration
and validation to ensure consistent instrument performance.
•Use of Quality Control Samples: Implementing regular use of internal and external quality
control samples can provide ongoing assurance of instrument performance.
Training and Competency: All laboratory personnel should be properly trained in calibration and
validation procedures to ensure that these tasks are performed accurately.
•Documentation and Record-Keeping: Maintaining detailed records of calibration and
validation activities ensures that the lab can demonstrate compliance during audits or
inspections. It also supports continuous quality improvement by allowing for data-driven
decision-making.
2. Beneficence:
Beneficence refers to the principle of acting in the patient's best interest. Medical laboratory
professionals must perform all tasks with the aim of benefiting the patient by ensuring accurate
and timely test results that will support appropriate clinical decision-making.
This also means avoiding unnecessary tests and ensuring that all procedures are carried out with
the highest standard of care to promote positive health outcomes.
3. Non-maleficence:
This principle is closely related to the concept of "do no harm." In medical laboratory ethics, it
focuses on ensuring that no unnecessary harm is caused to patients, either through incorrect
testing, improper sample handling, or inaccurate reporting.
Unethical practices that could harm the patient, such as using outdated equipment, skipping
validation processes, or mishandling samples, would violate this principle.
4.Justice:
Justice in medical ethics refers to fairness and equality in healthcare delivery. In a laboratory
setting, this translates to providing services equitably, ensuring that no patient is discriminated
against based on race, gender, socioeconomic status, or any other factors.
Ethical practice requires that all patients receive the same standard of care and attention,
regardless of their background or personal circumstances.
5.Confidentiality:
Confidentiality is the ethical principle that obligates professionals to protect the privacy of
patient information. In a medical laboratory, this is particularly important because the results of
tests often involve sensitive medical data.
Breaching confidentiality can result in loss of trust, legal consequences, and damage to the
professional reputation of the laboratory and its staff.
Ethics in Relation to Pre-Examination Procedures
Pre-examination procedures are critically important because errors or unethical behavior at this
stage can invalidate the entire diagnostic process. This phase includes patient identification,
sample collection, transportation, storage, and all activities before the actual test is performed.
1. Informed Consent:
Detailed Exploration: Informed consent is a fundamental ethical requirement in healthcare. It
ensures that patients are fully informed about the nature, purpose, and potential risks of medical
tests and procedures, and that they voluntarily agree to undergo them.
Application in Medical Laboratories: Before a sample is collected (e.g., blood, tissue, urine),
patients must understand why the test is being done, what the test entails, and any potential
risks associated with it. This is particularly important in invasive procedures (e.g., biopsy). For
example, a patient should be informed of the possibility of minor pain during a blood draw or the
implications of a genetic test.
Challenges: Often, laboratory staff may assume that physicians have already obtained consent,
but it remains the laboratory's ethical responsibility to ensure that the patient is informed,
especially when new tests are added during sample collection or later stages.
5. Avoiding Coercion:
Detailed Exploration: Coercion refers to pressuring
patients to undergo tests or procedures against their will. In an ethical medical laboratory,
patients must always retain the right to refuse testing.
Application in Medical Laboratories: For example, in genetic testing, where results can have
significant implications for the patient and their family, it is essential that patients are not forced
or unduly influenced into consenting to tests.
Challenges: Ethical lapses may occur if healthcare providers indirectly pressure patients by
overstating the necessity or urgency of tests, particularly when the tests are not immediately
essential.
2. Professional Competence:
Detailed Exploration: Professional competence is a key ethical consideration, ensuring that only
qualified and trained personnel handle complex diagnostic procedures.
Application in Medical Laboratories: Laboratory technicians must have the necessary education,
certifications, and ongoing training to stay current with advancements in technology and
methodology. Performing advanced tests, such as molecular diagnostics, without proper training
violates ethical standards.
Challenges: In some cases, untrained staff may perform tasks outside their competence due to
staffing shortages or pressure to reduce costs. Such unethical practices can lead to significant
diagnostic errors.
5. Non-Discrimination:
Detailed Exploration: Ethical practice in the medical
laboratory demands non-discriminatory treatment of all patients, ensuring equal care for
individuals regardless of personal characteristics.
Application in Medical Laboratories: Laboratory staff must avoid biases in test prioritization,
sample handling, or the level of care based on the patient's gender, race, religion, or social status.
Challenges: Discrimination can occur unconsciously or systematically within organizations,
particularly in underfunded systems. Ethical oversight ensures that all patients receive equal and
fair treatment.
Reporting of Results
Ethical Considerations in Reporting:
Accurate and timely reporting of laboratory results is one of the most critical ethical
responsibilities of a medical laboratory. Errors or delays in reporting can have serious
consequences for patient care, potentially leading to incorrect diagnoses, delayed treatments, or
even harm.
Confidentiality:
• While reporting results, laboratory staff must ensure that reports are only shared with
authorized individuals (e.g., attending physicians or healthcare providers involved in the patient's
care). Unauthorized disclosure of results is a breach of patient confidentiality.
Ethical guidelines demand that all communication channels used for reporting (whether digital or
paper-based) are secure to protect patient privacy.
Reporting Errors:
If errors are identified after the results have been reported, ethical protocols dictate that the
healthcare provider be immediately informed of the mistake, and corrected results should be
issued without delay.
Laboratories must implement systems to track, audit, and address reporting errors to avoid
recurrence.
Secure Storage:
• Medical records must be stored in a manner that prevents unauthorized access, modification,
or loss. This includes both physical (e.g., paper records) and digital formats (e.g., electronic
health records). Secure storage solutions, such as encryption for digital records and locked,
restricted access for physical records, are vital to preserving confidentiality and data integrity.
• Ethical laboratories must implement and follow best practices in data security to prevent
breaches or accidental data loss.
Data Integrity:
• Records must be protected from tampering or unauthorized alterations. Ethical practices
involve using systems that maintain an audit trail of any modifications made to the records. This
ensures that the integrity of the data is maintained throughout its lifecycle.
• For digital records, integrity can be ensured by using secure, tamper-proof electronic medical
record (EMR) systems, where changes are logged, and access is restricted based on roles and
permissions.
Destruction of Records:
• When medical records have reached the end of their retention period and are no longer
required, ethical guidelines dictate that they be destroyed securely to protect patient
confidentiality.
• Simply discarding records can result in unauthorized access or misuse of patient information.
Ethical laboratories employ methods such as shredding for physical records and secure deletion
for digital data, ensuring that confidential information is irretrievable.
3. Access to Medical Laboratory Records
Ethical Considerations in Accessing Records:
Access to medical laboratory records must be carefully managed to balance patient
confidentiality with the need for healthcare providers and authorized parties to have access to
relevant data. Ethical issues arise when considering who can access the records, under what
conditions, and how privacy is maintained.
Third-Party Access:
• Access to medical laboratory records by third parties (e.g., insurance companies, employers, or
researchers) requires explicit patient consent. Without such consent, providing access to these
entities would constitute an ethical and legal violation.
• Even with consent, the extent of access should be limited to the information necessary for the
specific purpose. For example, an insurance company may need access to test results related to a
specific claim but does not need to view the patient's entire medical history.
Confidentiality and Privacy:
• Access to medical laboratory records must always adhere to strict confidentiality protocols.
Laboratory staff are ethically bound to ensure that records are only accessed by authorized
individuals and that there is no unauthorized sharing of patient information.
Digital systems that store medical records must be designed to prevent unauthorized access
through strong authentication mechanisms (e.g., passwords, biometric access). For physical
records, access should be restricted to trained personnel, and logs should be maintained to track
who has accessed the records and when.
Emergency Access:
• In certain circumstances, such as medical emergencies, laboratory records may need to be
accessed quickly without the usual formalities to save a patient's life or prevent significant harm.
Ethical guidelines typically allow for such access but require that it be documented and justified.
• Following the emergency, an audit should be conducted to ensure that only the necessary
information was accessed and that appropriate use of the records occurred.