Module 4-Val/Ver, LDTs, IQCP, QC Reference Range Establishment, Quality Assessment of Personnel PDF

Module 4: Val/Ver, LDTs,IQCP, QC Reference Range Establishment, Quality Assessment of Personnel Professor: Brittany Teeter M.S CLS, MLS(ASCP)cm Validation / Verification Validation Validation and verification are essential components of quality assurance in clinical laboratory testing. They...

Module 4: Val/Ver, LDTs,IQCP, QC Reference Range Establishment, Quality Assessment of Personnel Professor: Brittany Teeter M.S CLS, MLS(ASCP)cm Validation / Verification Validation Validation and verification are essential components of quality assurance in clinical laboratory testing. They refer to distinct processes that ensure the accuracy, reliability, and fitness for purpose of laboratory methods, instruments, and systems. Validation vs. Verification Validation: Validation is the process of establishing documented evidence, through a combination of experiments, that a particular laboratory method, instrument, or system consistently produces results that meet predefined acceptance criteria. It involves evaluating the performance characteristics of the method or system to ensure its suitability for the intended use. Validation is typically conducted during the development or implementation of a new method or instrument, or when significant changes are made to an existing method or system. Verification: Verification is the process of confirming that a laboratory method, instrument, or system is performing as intended within the established and validated specifications. It involves assessing the method or system's performance using a set of predefined criteria or standards. Verification is usually performed on an ongoing basis to ensure that the method or system remains accurate and reliable. Validation Parameters Accuracy: Determines the closeness of results to the true value or a known reference value. Precision: Measures the consistency and reproducibility of results when the same sample is tested repeatedly. Analytical Sensitivity: Evaluates the method's ability to detect and measure low concentrations of analytes. Analytical Specificity: Assesses the method's ability to accurately measure the target analyte without interference from other substances. Validation Parameters Linearity: Examines the method's ability to provide results that are directly proportional to the analyte concentration across a specified range. Limit of Detection (LOD): Determines the lowest concentration of analyte that can be reliably detected. Limit of Quantification (LOQ): Establishes the lowest concentration of analyte that can be accurately quantified. Reference Range: Establishes the range of values for a particular analyte in a healthy population, providing a basis for interpreting results. Verification Parameters Precision: Assess the repeatability and reproducibility of the method or instrument within the laboratory setting. Accuracy: Verifies the method's agreement with known or expected values for samples with known concentrations. If the results for these samples fall within the manufacturers stated acceptable limits, accuracy is verified. Reportable Range: Establishes the range of values for a particular analyte in a healthy population, providing a basis for interpreting results. To verify choose samples with abnormal high and abnormal low values, qc materials, or calibration materials with known high and low values. This allows for the verification of the highest and lowest levels. Reference interval/range (normal values): Perform analysis and determine the laboratories normal range for the patient population. Does the reference range provided by the test system’s manufacturer fit your laboratory patient population? Verification of Performance Specifications 1988 Congress passed the Clinical Laboratory Improvement Amendments establishing authority to promulgate standards for certain laboratory testing to ensure the accuracy, reliability and timelines of test results regardless of where or by whom the test was performed. Verification of performance specification is required for the following instances: ○ prior to reporting patient test results for unmodified, FDA-cleared or approved non-waived testing. ○ When a test system or analyte is first introduced to the lab ○ Multiple instruments are used to perform the same test Verification of Performance Specifications The Technical Consultant , Technical Supervisor, or Laboratory Director are responsible for the following: ○ Ensuring the procedure used for verifying performance specifications is adequate. ○ Evaluation of results generated during verification process are within established allowable error limits. ○ Establishing the laboratories test performance characteristics, including precision and accuracy of each test and test system Laboratory Director Responsibilities: ○ Approve the verification procedure Recommended Quantity of Testing Outline Form Quantitative, Semi-Quantitative and Qualitative Methods Qualitative Methods: ○ The laboratory must verify that a method will identify the presence or absence of the analyte. ( i.e positive or negative) ○ Sensitivity and Specificity diagnostically important. Quantitative Methods: ○ The laboratory verifies that the method will detect a specific numerical value typically within 2sd of the mean for a given analyte. The interpretation of the numerical result guides clinical decision making. Semi-Quantitative Methods: ○ The laboratory verifies that quantitative cut-off value produces the correct qualitative result. This method evaluation is commonly used drug screen testing where the quantitative cut-off value produces a qualitative positive or negative result. Laboratory Developed Tests (LDTs) Laboratory Developed Tests (LDTs) LDT stands for Laboratory Developed Tests. These tests are diagnostic tests that are developed, validated, and performed by a specific laboratory for in-house use. LDTs are typically designed to detect, diagnose, or monitor specific diseases or conditions. Unlike commercial tests that are manufactured and distributed by diagnostic companies, LDTs are created and used within a single laboratory. Laboratory Developed Tests (LDTs) The regulatory oversight of LDTs varies depending on the country or region. In the United States, the oversight of LDTs is primarily carried out by the Food and Drug Administration (FDA). Historically, the FDA has exercised enforcement discretion and allowed laboratories to develop and use LDTs without pre-market approval. However, in recent years, the FDA has taken steps to increase regulatory oversight of LDTs, particularly for high-risk tests. Laboratory Developed Tests (LDTs) Validation and verification are crucial steps in ensuring the accuracy and reliability of LDTs. Validation involves demonstrating that the test performs as intended within the laboratory's specific setting. This includes evaluating the test's analytical performance characteristics, such as sensitivity, specificity, precision, and accuracy. Verification, on the other hand, is the process of confirming that the test works as expected in a specific laboratory, using the laboratory's instruments, reagents, and personnel. Laboratory Developed Tests (LDTs) Implementing robust quality control procedures is essential for ensuring the accuracy and reliability of LDTs. Quality control measures involve monitoring the performance of the test system to detect and correct any potential errors or deviations. This includes regular calibration of instruments, monitoring reagent stability, establishing appropriate control limits, and performing routine quality control testing using control materials with known values. Quality control procedures help identify and address any issues that may affect the accuracy and reliability of LDT results. Individualized Quality Control Plan Individualized Quality Control Plan The Individualized Quality Control Plan (IQCP) is a Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) procedure that offers an alternative QC option as permitted by 42CFR493.1250. The guidance and principles behind IQCP represent and consolidate the various practices laboratories already employ to guarantee accurate test results. IQCP enables laboratories to tailor their QC plan to match the specific test method and usage, environment, and personnel competency, while ensuring equivalent quality testing. In cases where the manufacturer's' instructions do not cover quality control or if those instructions are not as strict as the regulatory control procedures for Analytic Systems, the laboratory must either adhere to the regulatory requirements or create an IQCP. Laboratories have the freedom to either strictly adhere to all regulatory requirements or tailor their control procedures by utilizing the IQCP procedure. However, regardless of the chosen option, laboratories are prohibited from establishing quality control procedures that are less rigorous than those specified by the test system manufacturer. Individualized Quality Control Plan The following must be included in an IQCP: ○ Risk Assessment,Quality Control Plan, and Quality Assessment Risk Assessment: Is the identification and evaluation of potential failures and sources of errors during the testing process. This assessment must encompass the entire testing process and include at minimum the full evaluation of the specimen, test system(s), reagent, environment, and testing personnel. The Quality Control Plan (QCP): is a written document outlining the practices, resources, and procedures implemented to ensure the quality of a testing process. It is designed to continuously monitor the accuracy and precision of test performance, considering any potential impact from system changes over time. The QCP should specify the quantity, type, and frequency of testing, as well as establish criteria for determining acceptable quality control results. Quality Assessment: The laboratory must establish and follow written policies and procedures for ongoing monitoring of the effectiveness of their IQCP. Monitoring should include but are not limited to QC review, proficiency testing records, patient result review, specimen rejection logs, turnaround times, environment and testing personnel. Quality Control Reference Range Establishment QC Reference Range The Quality Control Reference Range, also known as the reference interval or reference range, is a range of values used to assess the performance and accuracy of laboratory test results. It represents the expected range of values for a particular analyte or measurement in a healthy population or a specific subgroup. The reference range serves as a benchmark against which individual test results can be compared to determine if they fall within normal limits. QC Reference Range Healthy Volunteer Sampling: In this method, a sample of apparently healthy individuals is recruited, and their analyte levels are measured. Statistical analysis is then performed to determine the range of values that represent the central 95% or 99% of the healthy population. Method Comparison: This method compares the results obtained from a new or modified laboratory assay to those obtained from a well-established reference method. The data obtained is used to establish the reference range for the new assay. QC Reference Range Establishment You will need to collect and calculate your own control limits that apply to your laboratory. Values and limits found on assay sheets often describe performance observed by a specific method in multiple laboratories which means the values can vary between laboratories. If control limits are too wide you won’t be able to detect problems in your own lab. QC Reference Range and CLIA CLIA requires that the lab determine its own mean and SD for calibration or control materials for each lot of calibration material and each lot of control material through repetitive testing. QC Limit Calculation Example You have a QC material for Cholesterol ❏ Mean = 200 mg/dL , SD = 4 mg/dL ❏ 2SD control limits = 192 mg/dL and 208 mg/dL ❏ 3SD control limits = 188 mg/dL and 212 mg/dL Assessment of Personnel & Delegated Duties Assessment of Personnel Education and Credentials: Clinical laboratory personnel are typically required to have specific educational qualifications and certifications. This may include but is not limited to a bachelor's degree in medical laboratory science or a related field, along with certifications such as the Medical Laboratory Scientist (MLS) or Medical Laboratory Technician (MLT) certification. Assessing the educational background and verifying the credentials of potential candidates is an essential step in the compliance assessment process. Assessment of Personnel Delegation of Duties In CLIA-regulated laboratories, delegation of duties generally refers to the assignment of specific responsibilities and authorities to qualified personnel within their respective roles. The laboratory director has overall responsibility for the operation and administration of the laboratory, ensuring compliance with CLIA regulations and maintaining the quality and accuracy of test results. The laboratory director may delegate certain responsibilities to other qualified individuals within the laboratory, such as the technical supervisor or general supervisor, while maintaining overall accountability. Assessment of Personnel-Delegations Delegation Complexity Requirements Technical Consultant Moderate MD, DO, or DPM with a current medical license1 with at least 1 year of training and/or experience in Complexity nonwaived testing in the designated specialty/subspecialty area; OR 2. Doctoral or Masters degree in a chemical, physical, biological or clinical laboratory science with at least 1 year of training and/or experience in nonwaived testing in the designated specialty/subspecialty area; Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology with at least 2 years of experience in nonwaived testing in the designated specialty/subspecialty area Technical Supervisor High Complexity MD or DO with a current medical license and 1 year training and experience in high-complexity testing in the respective specialty; OR Doctoral degree in clinical laboratory science, chemical, physical or biological science with 1 year training and experience in the respective specialty; OR Master's degree in medical technology, clinical laboratory science, or chemical, physical or biological science and 2 years training and experience in high-complexity testing in the respective specialty; OR Bachelor's degree in medical technology, clinical laboratory science, or chemical, physical or biological science and 4 years training and experience in high-complexity testing in the respective specialty. General Supervisor High Complexity Qualified as a Director for high-complexity testing; OR 2. Qualified as a Technical Supervisor for high complexity testing; OR3. Doctoral degree in clinical laboratory science or chemical, physical or biological science with 1 year training and experience in high-complexity testing; OR 4. Master's degree in clinical laboratory science, medical technology or chemical, physical or biological science and 1 year training and experience in high-complexity testing; OR 5. Bachelor's degree in clinical laboratory science, medical technology or chemical, physical or biological science and 1 year training and experience in high-complexity testing. Duties that cannot be Delegated: It is the Laboratory Director’s responsibility to ensure that your laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results. Duties that cannot be Delegated: The testing systems implemented in the laboratory ensure the delivery of high-quality services across all stages of test performance, including the preanalytic, analytic, and post analytical phases of testing. These systems are carefully selected to be suitable and effective for the specific patient population being served. Ensure that the physical and environmental conditions of the laboratory are sufficient and suitable for the specific testing conducted. Duties that cannot be Delegated: The laboratory maintains a safe environment for its employees, free from physical, chemical, and biological hazards. Stringent adherence to safety and biohazard requirements is prioritized. A general supervisor specializing in high complexity testing is present to offer daily supervision for all testing personnel, ensuring accurate reporting of test results. Additionally, the general supervisor provides on-site supervision specifically for minimally qualified testing personnel when they are conducting high complexity testing. Duties that cannot be Delegated: The laboratory employs an adequate number of personnel who possess the necessary education, experience, and training to provide appropriate consultation, supervise effectively, and perform tests accurately. These personnel diligently adhere to the written duties and responsibilities specified by you, ensuring accurate reporting of test results. The laboratory conducts a comprehensive review of new test procedures, incorporating them into the procedure manual. These procedures are then diligently followed by the laboratory personnel. Additionally, each employee's responsibilities and duties are clearly documented in written form. Why is Assessment of Personnel important… Ensuring Quality Assurance: Personnel assessment plays a vital role in maintaining quality assurance in laboratory testing. By evaluating the knowledge, skills, and competence of individuals, it ensures that testing is conducted accurately, reliably, and according to established protocols. Qualified personnel are better equipped to perform tests with precision, reducing the risk of errors and ensuring the reliability of test results. Upholding Patient Safety: Patient safety is of paramount importance in the clinical laboratory. Assessing personnel helps identify individuals who possess the necessary qualifications and proficiency to handle patient specimens, operate laboratory equipment, and perform testing procedures. Competent personnel help minimize the risk of mishandling samples, misinterpreting results, or compromising patient safety in any way. Meeting Regulatory Compliance: Clinical laboratories must comply with various regulatory requirements, including those set forth by organizations like CLIA. Personnel assessment ensures that the laboratory meets these regulatory standards by employing individuals who meet the educational, training, and certification requirements for their specific roles. Compliance with personnel qualification standards is vital for maintaining the laboratory accreditation, licensure, and overall credibility. Conclusion The clinical laboratory landscape is shaped by various critical factors that directly impact the quality and compliance of laboratory operations. Laboratory developed tests (LDTs) play a significant role in providing innovative and tailored diagnostic solutions. However, the validation and verification of laboratory results for LDTs are crucial to ensure their accuracy, reliability, and clinical relevance. Thorough validation processes, including analytical and clinical validations, are vital for establishing the performance characteristics of these tests and validating their utility in patient care. Conclusion Having qualified individuals who meet the educational, training, and certification requirements for their roles ensures the competence and expertise necessary for accurate and reliable testing. Personnel qualifications encompass not only their technical proficiency but also their understanding of quality assurance principles, adherence to regulatory guidelines, and commitment to patient safety. Robust personnel qualifications and competency assessments contribute significantly to maintaining high-quality standards and reducing the risk of errors in laboratory testing. Conclusion The concept of delegated duties within the laboratory, such as technical supervisor, technical consultant, and general supervisor, also plays a vital role in ensuring quality and compliance. Clearly defined qualifications for delegated duties help in assigning responsibilities to qualified personnel who possess the necessary knowledge and experience to oversee testing processes, maintain regulatory compliance, and ensure the accuracy of test results. Delegation within the laboratory is essential for effective management, supervision, and coordination of personnel, ultimately enhancing the overall quality and efficiency of laboratory operations. Conclusion Collectively, the validation/verification of laboratory results, testing personnel qualifications, and qualifications for delegated duties serve as pillars for maintaining quality and compliance within the laboratory setting. These factors not only contribute to accurate and reliable testing but also ensure patient safety and satisfaction. By upholding stringent standards and adhering to regulatory requirements, laboratories can foster confidence among healthcare providers and patients, enhance the overall quality of healthcare delivery, and ultimately improve patient outcomes.