Quality Management System Chapter 1

Accuracy, reliability, and timeliness.

The 1% error can become substantial when numerous events, like multiple tests, occur, leading to significant consequences.

Unnecessary treatment and failure to provide the proper treatment.

<p>To coordinate activities that direct and control the organization with regard to quality.</p> Signup and view all the answers

<p>To achieve the highest level of accuracy and reliability in test results.</p> Signup and view all the answers

<p>International Organization for Standardization (ISO).</p> Signup and view all the answers

<p>It requires that many processes and procedures be performed properly to maintain quality.</p> Signup and view all the answers

<p>The organizational structure, processes, and procedures of the laboratory.</p> Signup and view all the answers

<p>The laboratory employee must verify whether the test ordered is covered by Medicare, based on the medical necessity and reason for the order.</p> Signup and view all the answers

<p>It is unlawful because it circumvents the responsibility of collectors to verify Medicare coverage and misleads patients about the necessity of the test.</p> Signup and view all the answers

<p>Medical necessity dictates which tests are considered essential for specific health conditions and how often they should be conducted.</p> Signup and view all the answers

<p>Quality management in laboratories involves ensuring that all components function correctly to achieve accurate and reliable results, akin to practices in manufacturing.</p> Signup and view all the answers

<p>Staying updated on changes in Medicare regulations is vital to avoid compliance issues and ensure that patients receive accurate information regarding test coverage.</p> Signup and view all the answers

<p>Pre-analytical, analytical, and post-analytical.</p> Signup and view all the answers

<p>It outlines the complete set of operations from patient interaction to reporting results, ensuring all processes are managed for quality.</p> Signup and view all the answers

<p>It may lead to unreliable test results that do not accurately reflect the patient's condition.</p> Signup and view all the answers

<p>The key components include the purpose and goal, identification of items/processes to be reviewed, timing and methods of review, and acceptable thresholds for each indicator.</p> Signup and view all the answers

<p>Original documents must be retained for compliance and to ensure a clear record of changes and revisions.</p> Signup and view all the answers

<p>To detect errors and implement corrective actions to enhance quality throughout laboratory operations.</p> Signup and view all the answers

<p>The three main phases are pre-analytic, analytic, and post-analytic.</p> Signup and view all the answers

<p>ISO 15189:2022 and ISO/IEC 17025:2005.</p> Signup and view all the answers

<p>CLSI develops consensus standards that guide laboratory practices, ensuring alignment with quality management requirements.</p> Signup and view all the answers

<p>The laboratory director is responsible for overseeing the quality assessment plan and can delegate responsibilities as needed.</p> Signup and view all the answers

<p>It can hinder traceability and accountability, leading to inaccurate or unreliable test results.</p> Signup and view all the answers

<p>One reason is to assign a diagnosis, especially when symptoms are vague or similar to other conditions.</p> Signup and view all the answers

<p>Steps include accessing appropriate documents, reviewing the documentation, documenting the review findings, and performing any corrective actions needed.</p> Signup and view all the answers

<p>Timeliness is crucial as it affects patient care decisions and overall treatment outcomes.</p> Signup and view all the answers

<p>Quality essentials refer to the necessary components and procedures that ensure accuracy, reliability, and timeliness in testing.</p> Signup and view all the answers

<p>Quality control ensures that testing processes are accurate, reliable, and meet regulatory standards.</p> Signup and view all the answers

<p>It facilitates the review of processes and outcomes, identifying areas for enhancement and efficiency.</p> Signup and view all the answers

<p>Documenting findings is crucial for tracking issues, ensuring accountability, and formulating corrective actions.</p> Signup and view all the answers

<p>Quality control procedures.</p> Signup and view all the answers

<p>An acceptable threshold refers to the predefined standard that defines whether the results of a quality indicator are acceptable.</p> Signup and view all the answers

<p>They may perform tests incorrectly, leading to inaccurate results and compromised patient safety.</p> Signup and view all the answers

<p>Proficiency testing verifies the accuracy of tests, while calibration ensures instruments produce reliable results.</p> Signup and view all the answers

<p>Documents must be stored in a designated location, either paper or electronic, to ensure compliance and easy retrieval.</p> Signup and view all the answers

<p>They provide guidance on achieving quality in manufacturing and service industries, applicable to various organizations.</p> Signup and view all the answers

<p>It encompasses all processes, procedures, and quality management practices across pre-analytical, analytical, and post-analytical phases.</p> Signup and view all the answers

<p>Corrective actions can include repeat testing, review and revision of documents, retraining staff, or further document reviews.</p> Signup and view all the answers

<p>Laboratory staff should be informed and included in the development and implementation of the quality assessment plan.</p> Signup and view all the answers

<p>Key factors include test reports, distribution of results, critical values, and turnaround times.</p> Signup and view all the answers

<p>A QMS comprises policies, processes, procedures, and forms.</p> Signup and view all the answers

<p>Quality assessment is pro-active and focuses on processes, while quality control is reactive and centers on products.</p> Signup and view all the answers

<p>A policy serves as a statement of intent outlining what is to be done.</p> Signup and view all the answers

<p>Procedures provide detailed, step-by-step instructions for completing processes.</p> Signup and view all the answers

<p>Forms are used to record data and provide documentation for specific activities.</p> Signup and view all the answers

<p>A process answers the question, 'How do we meet the requirement outlined in the policy?'</p> Signup and view all the answers

<p>Early screening allows for effective treatment, potentially keeping patients healthier longer.</p> Signup and view all the answers

<p>Key personnel like laboratory directors, managers, and supervisory staff are involved.</p> Signup and view all the answers

<p>Frequency is determined by the pathological condition and the patient's response to treatment.</p> Signup and view all the answers

<p>It conveys essential patient and diagnostic information required for laboratory testing.</p> Signup and view all the answers

<p>Quality control activities aim to verify the accuracy of specific methodologies used for analytic data.</p> Signup and view all the answers

<p>A quality policy outlines the intentions and approach for achieving quality operations and outcomes.</p> Signup and view all the answers

<p>The ICD-9 code is used for indicating the diagnosis or symptom for reimbursement purposes.</p> Signup and view all the answers

<p>Documentation provides essential references and protocols for all personnel involved in laboratory operations.</p> Signup and view all the answers

<p>It provides detailed information about test processing, storage, and requirements for analysis.</p> Signup and view all the answers

<p>It may lack details on specimen processing, storage, and minimum volume requirements.</p> Signup and view all the answers

<p>Completed documentation is labeled, stored, and retained as outlined in the QMS.</p> Signup and view all the answers

<p>Processes and procedures are often documented in a single document that describes the steps to be taken.</p> Signup and view all the answers

<p>Additional comments that may provide context or specific considerations for the tests.</p> Signup and view all the answers

<p>A checkpoint review is an inspection activity aimed at validating quality control measures.</p> Signup and view all the answers

<p>Laboratory directories can also be provided in a book format.</p> Signup and view all the answers

<p>CPT codes are necessary for reimbursement purposes related to each laboratory test.</p> Signup and view all the answers

<p>Incorporating regulatory requirements ensures compliance and maintains the integrity of laboratory operations.</p> Signup and view all the answers

<p>Labels link patient information on the requisition with the specific sample in the laboratory database.</p> Signup and view all the answers

<p>The primary goal is to ensure quality laboratory testing systems and quality test results.</p> Signup and view all the answers

<p>Quality assessment provides confidence that quality requirements are met, while quality control involves operational techniques to fulfill those requirements.</p> Signup and view all the answers

<p>Organization and Personnel.</p> Signup and view all the answers

<p>It refers to the processes for identifying and implementing opportunities for improvement.</p> Signup and view all the answers

<p>It ensures effective management of information generated and stored in laboratory recordkeeping systems.</p> Signup and view all the answers

<p>Personnel are responsible for performing work practices and managing laboratory activities according to quality standards.</p> Signup and view all the answers

<p>It involves processes for detecting and correcting nonconformances that may affect quality.</p> Signup and view all the answers

<p>The three phases are preexamination (preanalytical), examination (analytical), and postexamination (post-analytical).</p> Signup and view all the answers

<p>All lab employees must participate at an appropriate level and adhere to quality documentation relevant to their roles.</p> Signup and view all the answers

<p>Assessments are external and internal monitoring processes to verify that laboratory practices meet quality requirements.</p> Signup and view all the answers

<p>Customer focus ensures that the laboratory designs work to meet customer expectations and inputs.</p> Signup and view all the answers

<p>Failure to manage documents may lead to noncompliance, errors, and loss of critical information.</p> Signup and view all the answers

<p>A structured workflow ensures consistency, efficiency, and quality in laboratory testing processes.</p> Signup and view all the answers

<p>Process management refers to optimizing workflow processes to meet requirements and utilize resources efficiently.</p> Signup and view all the answers

<p>It involves arrangements for consistent provision of necessary supplies and services for the laboratory.</p> Signup and view all the answers

<p>Two unique identifiers for the patient must be documented.</p> Signup and view all the answers

<p>Reference ranges help determine the expected results for the general healthy population.</p> Signup and view all the answers

<p>Patients must sign an Advance Beneficiary Notice of Noncoverage (ABN).</p> Signup and view all the answers

<p>Age, race, gender, geographical location, and testing methods can all affect reference ranges.</p> Signup and view all the answers

<p>It ensures accountability and accuracy in patient data management.</p> Signup and view all the answers

<p>Coverage may be denied due to frequency of testing, diagnosis, or if the test is deemed experimental.</p> Signup and view all the answers

<p>Proper storage and transportation maintain the integrity of the specimen.</p> Signup and view all the answers

<p>The report must include the date and time of collection, patient identification, and report generation details.</p> Signup and view all the answers

<p>They must be reviewed promptly to facilitate appropriate medical actions.</p> Signup and view all the answers

<p>The collection process must ensure that the specific type of specimen, volume, and collection methods are followed.</p> Signup and view all the answers

<p>Verification ensures that the correct test is documented on the ABN form.</p> Signup and view all the answers

<p>They are transmitted back to the healthcare provider and become part of the patient’s health record.</p> Signup and view all the answers

<p>The employee ID (or initials), date, and time of collection need to be documented.</p> Signup and view all the answers

<p>To inform patients of their potential financial responsibility for the laboratory tests.</p> Signup and view all the answers