Qc&Qa

• Bachelor of Medical Laboratory Science AY 2023 - 2024 – 2nd Semester MT 208 – MOLECULAR BIOLOGY AND DIAGNOSTICS (Laboratory) is taught by Dyan Jumamoy.
• Molecular analysis is a wide range of techniques and methods used to study biomolecules such as DNA, RNA, proteins, nucleic acids and other protein molecules.
• The main purpose of molecular analysis is for diagnostic or investigative purposes.
• Specific application of molecular analysis techniques is to define a treatment strategy for individual patients.
• Molecular testing should be made appropriately and should be offered in a timely manner to achieve accurate and effective results.
• The goal of the molecular diagnosis procedure is to select the right test for each patient, generating accurate, clinically relevant results.
• Evaluation, selection, and implementation of appropriate diagnostic tests for the clinical setting is part of the process of molecular diagnosis.
• Incorporation of guidance for health care providers regarding the use of testing for appropriate patients is a crucial aspect of the molecular diagnosis process.
• Timely sample collection, transport, and processing, and timely reporting of results are essential elements of the molecular diagnosis process.
• Preanalytical process in molecular testing includes patient preparation, sample collection, transportation and specimen handling.
• Decontamination of the lab area is necessary to avoid biological hazards.
• Accession books/electronic records contain the date of receipt, laboratory identifier, and pertinent information associated with the accession.
• Aliquotting helps avoid handling volumated samples when only small amount is needed, preserve the original sample's integrity, reproduce multiple tests, and have back up samples when it is lost or contaminated.
• If a specimen is unacceptable, the disposal/retention of the specimen is recorded.
• Special collection tubes include Plasma Preparation Tube (PPT) used for WBC separation upon configuration and also used for HIV, HCV analysis, and tubes designed to stabilize RNA.
• Standard precautions, designed by the Center for Disease Control and Prevention (CDC), are a set of infection precaution practices to protect the transmission of infectious diseases, including hand hygiene, PPE, and safe handling of sharps.
• Contact precautions are designed for direct patient care where there is the potential for direct exposure to infectious agents on or from the patient.
• Proper ID labeling and handling of the specimen to avoid preanalytical errors is a crucial aspect of the preanalytical process in molecular testing.
• Decontamination agents include disinfectants, sterilants, and antiseptics.
• Biological hazards include samples (body fluid, tissues, and supplies/materials containing pathogen, genetic material or recombinant DNA), ingestion, inoculation, contaminated needles, aerosol inhalation, HBV, HIV, HCV, tuberculosis.
• Testing specimens with minimal content such as buccal cell suspension and CSF requires aliquoting, which is the division of a larger sample into smaller representative samples for analysis, testing or storage.
• Avoid potential biological hazards by not mouth pipetting, consuming food, smoking, applying cosmetics, and potential needlestick situations.
• Transmission precautions prevent airborne or contact-transmissible agents.
• Providers should be notified the results in real time.
• Analytic Specific Reagents (ASRs) detect a specific target.
• Providers should understand the test results.
• Class 1 Analytic Specific Reagents (ASRs) are used in molecular laboratories.
• After a test result is discovered and interpreted properly, prompt & appropriate clinical action must be taken to adopt the suitable care optimally.
• The NFPA/National Fire Protection Assn has developed a series of warning labels for universal use on all chemical containers.
• Solid tissue samples (fresh/frozen) are generally preferred over fixed paraffin embedded tissues for molecular testing due to the higher quality of DNA and RNA.
• Class 3 In vitro Diagnostic Devices/Reagents are used in laboratories with the highest risk.
• Purity determination involves assessing the presence of contaminants (proteins or organic compounds) in nucleic acid samples.
• Reagents for laboratory procedures should have instructions for preparation and quantities for each assay in the written laboratory protocol.
• Radioactive chemicals are handled with absorbent papers, drip trays, or other protective container.
• Speci men storage is a process in molecular biology and diagnostics that involves storing biological samples for future use.
• In vitro Diagnostic Devices/Reagents are used in the diagnosis of disease, products that may be used to collect, prepare and examine specimens.
• Chemical hazards in molecular biology and diagnostics involve the use of chemicals for DNA/RNA extraction, purification and analysis.
• Class 2 In vitro Diagnostic Devices/Reagents are used in laboratories with moderate risk.
• A Molecular Diagnostic Report should include Patient ID (name, age, sex, DOB, ordering physician), reporting style & content, test performed and any limitations of the test, name of the individual taking responsibility for the test, and interpretation.
• Secondary/reinforced containers for chemicals include phenol, concentrated acids.