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I. Laboratory Fundamentals & Concepts:
Laboratory Tests
Diagnostic Medicine
Value of Laboratory Tests
Laboratories Perspective
Precision & Accuracy
Normal Curve & Gaussian Curve
Biological Reference Range
Internal Quality Control (IQC)
External Quality Assurance (EQA)
II. Laboratory Operations & Procedures:
Locations of BCMCH Laboratory Services
Phlebotomy Services
Inpatient Collections
Vacutainer System & Tube Selection
Sample Mixing
Tests Requiring Specific Tubes (Gel vs. Non-Gel)
Urine Sample Collection
III. Hospital Information & Forms:
Architecture of the Laboratory
Test Request Form (Filling out & EMR)
Test Profiles & Costs
Turnaround Time (TAT, STAT, CRITICAL)
HIS/LIS (Hospital Information System / Laboratory Information System)
IV. Clinical Tests & Diagnostics:
Human Blood Composition
Median Cubital Vein (Phlebotomy Site)
Outsourced Tests (List of various specific assays)
Overview: This module provides a foundation for understanding the role, function, and underlying principles of a clinical laboratory. It emphasizes quality control, data interpretation, and the critical impact of laboratory results on patient care.
Definition: Laboratory tests are procedures performed on biological specimens (e.g., blood, urine, tissue) to obtain information about a patient's health status.
Purpose:
Diagnosis: Identifying the presence and nature of disease.
Screening: Detecting potential health problems in asymptomatic individuals.
Monitoring: Tracking the progress of a disease or the effectiveness of treatment.
Prognosis: Estimating the likely outcome of a disease.
Guiding Treatment: Selecting and adjusting therapies based on test results.
Types of Tests:
Hematology: Blood cell counts, coagulation studies.
Clinical Chemistry: Analysis of blood and urine for various chemical constituents (e.g., glucose, electrolytes, enzymes).
Microbiology: Identification of infectious agents (bacteria, viruses, fungi).
Immunology: Detection of antibodies, antigens, and immune system components.
Molecular Diagnostics: Analysis of DNA, RNA, and other genetic material.
Anatomic Pathology: Examination of tissues and cells for disease.
Pre-analytical, Analytical, and Post-analytical Phases: Understanding the processes to minimize errors during each step of testing.
Key Considerations: Understanding which test to select and why. The impact the results will have on patient care.
Ethical Considerations: Maintaining patient confidentiality, obtaining informed consent where necessary, and avoiding conflicts of interest.
Definition: The branch of medicine concerned with identifying and diagnosing diseases.
The Role of Laboratory Tests: Laboratory tests are integral to diagnostic medicine, providing objective data that complements clinical findings.
"70% Rule": Historically, studies suggested that approximately 70% of medical decisions are based on laboratory information. While this specific number can be debated, the key takeaway is the significant impact of lab results.
Integrated Diagnostics: The concept of combining laboratory results with imaging studies, patient history, and clinical examination for a more comprehensive diagnosis.
Point-of-Care Testing (POCT): Bringing testing closer to the patient (e.g., at the bedside or in a clinic) for faster results and improved patient management. Considerations for proper POCT implementation and quality.
3. Value of Laboratory Tests:
When Tests are Used Correctly:
Aid in early diagnosis and treatment.
Reduce unnecessary procedures or hospitalizations.
Improve patient outcomes and quality of life.
Provide objective data for clinical decision-making.
Help to monitor treatment and prevent complications.
When Tests are Used Incorrectly (Leading to Lost Value):
Inappropriate test ordering: Leads to unnecessary costs, potential for false positives, and patient anxiety.
Failure to order necessary tests: Delays diagnosis and potentially worsens patient outcomes.
Misinterpretation of results: Can lead to incorrect diagnoses or treatment plans.
Delayed or missed results: Results in delayed treatment.
Incorrect or Inaccurate Results: Leads to misdiagnosis and potentially harmful medical procedures.
Over-utilization & Under-utilization: Balancing cost-effectiveness with patient needs.
Laboratories as Information Providers: Emphasizing the role of the lab in generating high-quality data that is crucial for patient care.
Quality Management Systems (QMS): Understanding the importance of a comprehensive QMS in ensuring accurate and reliable results. This includes documentation, training, equipment maintenance, and proficiency testing.
Continuous Improvement: A commitment to constantly seeking ways to improve laboratory processes and reduce errors.
Accreditation & Regulatory Compliance: Understanding the requirements for accreditation (e.g., ISO 15189, NABL) and compliance with relevant regulations.
Patient-Centered Care: Recognizing the lab's contribution to overall patient well-being.
Definitions:
Accuracy: How close a measurement is to the true value.
Precision: How repeatable a measurement is (how close repeated measurements are to each other).
Visual Representation: Use the bullseye diagram to illustrate the difference:
High Precision, High Accuracy: Grouped tightly around the center.
High Precision, Low Accuracy: Grouped tightly, but far from the center.
Low Precision, High Accuracy: Scattered, but the average is close to the center.
Low Precision, Low Accuracy: Scattered, and the average is far from the center.
Sources of Error:
Systematic Error: Consistent deviation from the true value (e.g., calibration errors, reagent contamination).
Random Error: Unpredictable variations in measurements (e.g., pipetting errors, instrument fluctuations).
Importance of Precision & Accuracy: Ensuring the reliability and validity of laboratory results.
Quantifying Precision & Accuracy: Using statistical measures such as standard deviation (SD), coefficient of variation (CV), and bias.
Concept: A bell-shaped distribution that represents the typical pattern of variation for many biological measurements.
Key Features:
Symmetrical: The curve is symmetrical around the mean.
Mean, Median, and Mode: They are all equal and located at the center of the curve.
Standard Deviation (SD): A measure of the spread or dispersion of the data.
Area Under the Curve: Represents the total probability (equal to 1 or 100%).
Empirical Rule (68-95-99.7 Rule):
Approximately 68% of the data falls within 1 SD of the mean.
Approximately 95% of the data falls within 2 SDs of the mean.
Approximately 99.7% of the data falls within 3 SDs of the mean.
Significance in Laboratory Medicine:
Defining reference intervals (normal ranges).
Evaluating quality control data.
Determining the statistical significance of differences between groups.
Definition: The range of values for a laboratory test that is considered normal or healthy for a particular population.
Factors Influencing Reference Ranges: Age, sex, ethnicity, diet, lifestyle, and geographical location.
Establishing Reference Ranges: Typically, based on measuring test values in a large group of healthy individuals. Often defined as the range encompassing the central 95% of the data.
Using Reference Ranges: Interpreting laboratory results and determining whether they fall within or outside the expected range.
Limitations: Reference ranges are population-based and may not be applicable to all individuals. False negatives and false positives can occur.
Critical Values/Panic Values: Results outside the reference range that represent an immediate health risk to the patient. Protocols for reporting and acting on critical values.
Definition: Procedures performed within the laboratory to monitor the quality of analytical testing processes on a daily basis.
Purpose:
Detecting errors and biases in the analytical system.
Ensuring that results are accurate and reliable.
Identifying trends and shifts in performance.
Preventing the release of erroneous results.
Control Materials: Substances with known values that are analyzed along with patient samples to assess the performance of the analytical system.
Westgard Rules: A set of statistical rules used to evaluate control data and determine whether the analytical system is in control.
Levey-Jennings Charts: Graphical representation of control data over time, used to identify trends and shifts.
Corrective Actions: Steps taken to correct problems identified by IQC procedures.
Definition: A program in which a laboratory analyzes samples sent by an external organization and compares its results to those of other laboratories.
Purpose:
Evaluating the laboratory's performance against a peer group.
Identifying areas for improvement.
Maintaining accreditation and regulatory compliance.
Ensuring comparability of results across different laboratories.
Participation: Laboratories must actively participate in EQA programs for the tests they perform.
Data Analysis: EQA providers send reports comparing a lab's result to the mean and standard deviation of all participants.
Corrective Actions: If a laboratory's results are outside acceptable limits, it must investigate the cause and implement corrective actions.
Module I establishes a crucial framework for understanding the clinical laboratory. A strong grasp of these fundamental concepts is essential for anyone working in or interacting with the clinical laboratory, from medical technologists to physicians. It provides a strong foundation for future learning and enables informed decision-making in patient care.
Overview: This module delves into the practical aspects of laboratory operations, covering sample collection, handling, and specific considerations for different tests and patient populations.
Importance: Knowing the specific locations of laboratory services is crucial for efficient workflow, timely sample delivery, and effective communication.
Primary Facility (Ground Floor near Chapel):
Hours of Operation: 6:30 AM to 7:00 PM (Monday-Saturday).
Services Provided: General phlebotomy for outpatient and inpatient requests.
Billing Information: Billing counter available during 7:00 AM - 4:30 PM. After hours and Sundays, IP cash billing is utilized.
Staff Contact: Identify key personnel (supervisor, lead phlebotomist).
Central Laboratory (Second Floor):
Hours of Operation: 24/7, including Sundays.
Services Provided: Receiving, processing, and analyzing samples.
Billing Information: Primarily accepts billed requests/cashless payments; no dedicated billing counter.
Staff Contact: Identify key personnel (supervisor, lead technologist).
Additional Facility at 6th Floor (Hemato/Onco OPD):
Hours of Operation: Morning hours as required (check daily schedules).
Services Provided: Dedicated phlebotomy for hematology/oncology patients.
Billing Information: Billing at the OPD GR station.
Staff Contact: Identify key personnel (nurse in charge, phlebotomist).
Additional Facility at Ground Floor Priority:
Hours of Operation: Morning hours as required (check daily schedules).
Services Provided: Priority test such as ABG
Billing Information: Billing at the GR station.
COVID/Influenza Swab Collection Area (ED Reception):
Hours of Operation: As needed; coordinated by the ED.
Services Provided: Collection of nasopharyngeal swabs for COVID-19 and influenza testing.
Billing Information: Follow ED billing procedures.
Staff Contact: Identify key ED personnel.
Definition: The process of collecting blood specimens from patients.
Safety Precautions:
Universal Precautions: Treating all blood and body fluids as potentially infectious.
Personal Protective Equipment (PPE): Gloves, lab coats, face shields/masks.
Sharps Safety: Proper handling and disposal of needles and lancets using sharps containers.
Hand Hygiene: Frequent hand washing or use of alcohol-based hand sanitizers.
Latex Allergy Awareness: Using non-latex gloves for patients and staff with latex allergies.
Patient Identification: Verifying the patient's identity using two identifiers (e.g., name, date of birth, medical record number) and comparing them with the test request form.
Patient Preparation: Explaining the procedure to the patient, addressing any concerns, and ensuring that the patient is in a comfortable position.
Site Selection:
Median Cubital Vein: Often the first choice due to its size and accessibility.
Cephalic Vein: A good alternative if the median cubital vein is not suitable.
Basilic Vein: Use with caution due to its proximity to nerves and arteries.
Avoiding Problem Areas: Areas with hematomas, scars, burns, or edema; arms with IV lines or dialysis shunts.
Venipuncture Technique:
Applying a tourniquet to distend the veins.
Cleaning the venipuncture site with an antiseptic (e.g., 70% isopropyl alcohol).
Anchoring the vein with your non-dominant hand.
Inserting the needle at a 15-30 degree angle.
Collecting the blood in the appropriate tubes in the correct order of draw.
Releasing the tourniquet.
Applying pressure to the venipuncture site with gauze.
Bandaging the site.
Observing the patient for any adverse reactions.
Capillary Puncture (Finger Stick):
Used primarily for infants and small children, or when venipuncture is not possible.
Warming the site to increase blood flow.
Using a sterile lancet to puncture the skin.
Collecting the blood in microcollection tubes.
Coordination: Working closely with nurses and other healthcare providers to coordinate sample collections.
Timed Collections: Understanding the importance of collecting samples at specific times for certain tests (e.g., therapeutic drug monitoring, hormone levels).
Labeling: Accurately labeling all samples with the patient's name, date of birth, medical record number, date and time of collection, and collector's initials.
Delivery: Transporting samples to the laboratory promptly, following established protocols.
Specific Considerations for COVID-19 Sample Collections:
Strict adherence to infection control guidelines.
Use of appropriate PPE.
Proper specimen collection technique.
Designated collection areas.
Special handling and transport procedures.
Collection is managed by the laboratory for non emergency collection.
Pre request required from admitted areas.
Collections initiated at timed intervals starting from 5 AM till 6 PM.
All Critical areas samples to be collected by Nurses/Area
Components: Needle, tube holder, evacuated tubes.
Evacuated Tubes:
Description: Glass or plastic tubes with a pre-determined vacuum and a color-coded stopper.
Purpose: To automatically draw a specific volume of blood.
Tube Additives: Different tubes contain different additives that serve specific purposes.
Anticoagulants: Prevent blood from clotting (e.g., EDTA, heparin, citrate).
Clot Activators: Promote clot formation (e.g., silica particles).
Separation Gels: Create a physical barrier between serum/plasma and blood cells.
Order of Draw: Following the correct order of draw is crucial to prevent cross-contamination of additives between tubes:
Blood Culture Tubes
Citrate Tubes (Light Blue)
Serum Tubes (Red, Gold, Tiger Top)
Heparin Tubes (Green)
EDTA Tubes (Lavender, Pink)
Fluoride Tubes (Gray)
Proper Tube Filling: Ensuring that tubes are filled to the correct volume to maintain the proper additive-to-blood ratio.
Visual Inspection: Examining tubes for any signs of damage or expiration before use.
Purpose: Gently inverting tubes to mix the blood with the additive.
Inversion Technique: Turning the tube upside down and back to the upright position without shaking.
Number of Inversions: Following the manufacturer's recommendations for the number of inversions required for each tube type.
Importance of Gentle Mixing: Avoid vigorous shaking, which can cause hemolysis (rupture of red blood cells) and affect test results.
Gel Separator Tubes (SST or Gold Top): Contain a gel that forms a barrier between serum and blood cells after centrifugation. Used for many routine chemistry tests.
Non-Gel Tubes (Red Top): Used for tests that require serum without any additives, such as blood bank testing.
Crucial Information:
Gel separator tubes should not be used for therapeutic drug monitoring (TDM) in emergency situations or for other specialized tests that require accurate measurement of drug levels or immediate analysis.
Refer to laboratory guidelines for a complete list of tests requiring specific tube types.
Importance of Following Guidelines: Using the correct tube type ensures the integrity of the sample and the accuracy of the test results.
This module equips personnel with the essential knowledge and skills for performing their duties safely and efficiently while maintaining the highest standards of accuracy. By mastering these practices, lab personnel contribute significantly to the quality of patient care. It's important for staff to stay updated on any changes to protocols and always consult with supervisors or senior staff for clarification when needed.
Overview: This module focuses on the administrative and informational aspects of the laboratory workflow, including the laboratory's structure, request forms, understanding test-related information, and interpreting laboratory results.
Importance: Understanding the physical layout and functional areas of the laboratory is crucial for efficient workflow, sample routing, and communication.
Central Laboratory (Second Floor):
Reception Area: Where samples are received, logged in, and sorted. Key role in accurate sample identification and order verification.
Sample Separation/Distribution Area: Centrifugation, aliquotting, and distribution of samples to different testing sections. Proper handling and labeling are critical.
Biochemistry (Routine Chemistry & Immunology): Glucose, electrolytes, liver function tests, thyroid hormones, tumor markers, etc.
Hematology, Clinical Pathology, & Pathology (Histo & Cyto) @ MC: Complete blood counts, coagulation studies, urine analysis, microscopy, tissue processing, staining, and microscopic examination of tissues and cells.
Microbiology (Bacteriology, Serology, Mycology, Parasitology, TB, Virology): Culture and identification of microorganisms, serological testing for antibodies, fungal identification, parasite detection, and viral assays.
CRL Molecular Laboratory @ Medical College: COVID-19 testing, PCR, other molecular assays (if applicable).
Analytical Chemistry Lab, Cytogenetics & ARL @ Medical College: (Details depend on the specific services provided).
Understanding Sample Flow: Mapping the journey of a sample from collection to reporting results.
Staff Roles & Responsibilities: Recognizing the roles and responsibilities of different laboratory personnel.
Purpose: The test request form is a legal document that authorizes the laboratory to perform testing on a patient's sample. Accurate and complete information is essential for proper test selection, result reporting, and billing.
Manual Form Completion (if applicable):
Required Information: Patient name, date of birth, medical record number (UHID), hospital unit/ward, doctor's name, clinical history/diagnosis, specific tests requested, date and time of collection, and collector's initials.
Clarity and Legibility: Writing clearly and legibly to avoid errors.
Proper Test Selection: Choosing the correct tests based on the patient's clinical presentation and the doctor's orders.
Appropriate Markings: Marking the test or tests desired.
Clinical Information: Provide pertinent clinical information relevant to the testing being requested
Electronic Medical Record (EMR) Request (Preferred Method):
Benefits: Reduces errors, improves efficiency, and facilitates data integration.
Navigating the EMR: Locating the laboratory test ordering module, searching for specific tests or panels, and entering required patient information.
Ensuring Accuracy: Double-checking all information before submitting the request.
Order Commenting: Using the comment section to provide any additional information or special instructions to the laboratory.
Understanding Test Profiles: A "profile" or "panel" is a group of related tests that are commonly ordered together. Examples: Liver Function Panel, Renal Function Panel, Lipid Profile, Thyroid Function Tests, etc.
Benefits of Using Test Profiles: Streamlines the ordering process, ensures that all necessary tests are performed, and may be more cost-effective than ordering individual tests.
Commonly Ordered Profiles at BCMCH: Provide a list of the most frequently ordered profiles, including the tests included in each profile.
Interpreting Cost Information: Provide general overview of costs and the different costs dependent on the class the patient in (OP, General Ward, MDCCU2, ICU).
Navigating the Test Menu (if applicable): Learning how to access the laboratory's online test menu to search for specific tests and view information about test requirements, turnaround times, and costs.
Cost-Effective Test Ordering: Choosing the most appropriate tests based on the patient's clinical needs and avoiding unnecessary testing.
Consultation with Laboratory Staff: Contacting the laboratory for guidance on test selection or for clarification on test costs.
Definition: The time it takes for the laboratory to complete a test and report the results, starting from when the sample is received in the laboratory.
Importance: Understanding TATs is crucial for clinical decision-making and patient management.
Routine TAT: The standard TAT for most laboratory tests. Typically provided in hours (e.g., "Routine results reported within 2 hours of acceptance").
STAT Tests: Tests that are required urgently and are performed with a shorter TAT. "STAT" means "immediately."
Critical Values (Panic Values): Results that are significantly outside the normal range and represent an immediate threat to the patient's health. Critical values require immediate notification of the ordering physician or responsible caregiver.
Factors Affecting TAT: Sample volume, complexity of the test, instrument availability, and staffing levels.
TAT Goals at BCMCH:
Routine: Reported in 2 Hours from acknowledge at laboratory
Emergency/ED: All emergency tests from ED reported within 1 hour from acknowledge at laboratory.
All critical Values are relayed to requested clinician.
Expediting Results: Understanding the process for requesting expedited results in urgent situations.
Communicating Delays: Informing the ordering physician if there are any delays in TAT.
Accessing Results: Understanding how to access laboratory results through the EMR or other designated systems.
Module III ensures that laboratory personnel and other hospital staff are adept at navigating the informational and administrative aspects of the laboratory. Accurate test ordering, cost-conscious practices, and awareness of turnaround times are all critical for optimal patient care. Clear communication and collaboration between the laboratory and clinical staff are essential for efficient and effective utilization of laboratory services. This module's skills are integral to providing a patient-centered and efficient healthcare experience.
Overview: This module provides an overview of blood composition, the ideal site for phlebotomy (median cubital vein), and an introduction to outsourced tests.
Importance: Understanding the composition of blood is crucial for understanding how different laboratory tests are performed and interpreting the results.
Components of Blood:
Whole Blood: Approximately 8% of the body weight.
Other fluids & tissues: Approximately 92% of the body weight.
Plasma (55% of Blood Volume): The liquid component of blood, containing water, proteins, electrolytes, nutrients, and waste products.
Water (91% of Plasma): Solvent for carrying other components.
Proteins (7% of Plasma):
Albumins (57% of Plasma Proteins): Maintain osmotic pressure, transport lipids and hormones.
Globulins (38% of Plasma Proteins): Antibodies, transport proteins.
Fibrinogen (4% of Plasma Proteins): Involved in blood clotting.
Prothrombin (1% of Plasma Proteins): Involved in blood clotting.
Other Solutes (2% of Plasma): Electrolytes (Na+, K+, Cl-), nutrients (glucose, amino acids), waste products (urea, creatinine), gases (O2, CO2), and regulatory substances (hormones).
Formed Elements (45% of Blood Volume): The cellular components of blood.
Erythrocytes (Red Blood Cells, >99% of Formed Elements): Transport oxygen.
Leukocytes (White Blood Cells, <1% of Formed Elements): Immune defense.
Neutrophils (60-70% of Leukocytes): Phagocytosis of bacteria.
Lymphocytes (20-25% of Leukocytes): Adaptive immunity (T cells, B cells).
Monocytes (3-8% of Leukocytes): Phagocytosis, antigen presentation.
Eosinophils (2-4% of Leukocytes): Allergic reactions, parasitic infections.
Basophils (0.5-1% of Leukocytes): Release histamine, inflammation.
Platelets (Thrombocytes, <1% of Formed Elements): Blood clotting.
Buffy Coat: A thin layer between the plasma and red blood cells, containing leukocytes and platelets.
Understanding Blood Collection Tubes: Different additives in tubes are designed to preserve specific blood components for analysis.
Implications for Laboratory Testing: Knowing the composition of blood helps understand which tests use whole blood, plasma, or serum.
Common abnormalities in blood counts:
Anemia
*Leukocytosis
*Thrombocytopenia
Importance: Selecting the correct phlebotomy site minimizes patient discomfort and reduces the risk of complications.
The Median Cubital Vein:
Location: Located in the antecubital fossa (the bend of the elbow).
Why it's the First Choice:
Center: Relatively centered in the antecubital area.
Larger: Usually larger than other veins in the area.
Closer: Closer to the surface of the skin.
Better Anchored: More stationary than other veins, making it easier to stick.
Easier and Less Painful: Generally, easier to puncture and less painful.
Less Bruising: Less likely to bruise than other veins.
Alternative Veins (in order of preference): Cephalic and Basilic.
Contraindications: Avoid sites with hematomas, scars, burns, edema, IV lines, or dialysis shunts.
Procedure:
Apply a tourniquet to distend the veins.
Palpate the veins to assess their size and depth.
Clean the venipuncture site with an antiseptic.
Anchor the vein with your non-dominant hand.
Insert the needle at a 15-30 degree angle.
Collect the blood in the appropriate tubes.
Release the tourniquet and apply pressure to the site.
Definition: Laboratory tests that are sent to an external reference laboratory for analysis.
Reasons for Outsourcing:
Low Volume: Some tests are not performed frequently enough to justify the cost of equipment and reagents.
Specialized Expertise: Some tests require specialized expertise or equipment that is not available in-house.
Cost-Effectiveness: It may be more cost-effective to outsource certain tests.
Common Outsourced Tests at BCMCH: (Provide a detailed list of specific tests and general categories).
Immunology: Specific autoantibodies, allergy testing.
Molecular Diagnostics: Specific PCR tests, genetic testing.
Endocrinology: Specialized hormone assays.
Specialized Chemistry: Trace metals, vitamins.
Etc. (Specific examples: Beta-2 Microglobulin, QUANTIFERON TB GOLD, Anti Neutrophil Cytoplasmic Ab -p -(p-ANCA) Serum, Anti Mullerian Hormone(AMH), Mumps Ab (IgG),etc.)
Key Considerations for Outsourced Tests:
Turnaround time can be longer than in-house tests.
Follow specific collection and handling requirements (contact the lab for details).
Ensure accurate patient information and test requests are submitted.
Procedures for Handling Outsourced Tests:
Properly labeling the samples.
Completing the necessary paperwork.
Packaging and shipping the samples according to the reference laboratory's instructions.
Tracking the status of the tests.
Reporting results in the EMR.
Contacting the Reference Laboratory: Knowing how to contact the reference laboratory for questions about test requirements or results.
Module IV provides valuable insight into blood composition, best practices for phlebotomy site selection, and awareness of the BCMCH's outsourced test menu. A strong understanding of these components are necessary for accurate and efficient laboratory processes.