Quality Management System Chapter 1

Laboratory quality is defined as the accuracy, reliability, and timeliness of the reported test results.

Negative consequences include unnecessary treatment, complications from treatment, failure to provide proper treatment, and delays in diagnosis.

While 99% accuracy may seem acceptable, the 1% error can lead to significant inaccuracies due to the volume of tests conducted.

<p>A quality management system is crucial for addressing all aspects of laboratory operations to assure quality and reliability.</p> Signup and view all the answers

<p>It is defined as coordinated activities to direct and control an organization with regard to quality.</p> Signup and view all the answers

<p>ISO and CLSI are internationally recognized organizations that set laboratory standards and guidelines.</p> Signup and view all the answers

<p>All aspects including the organizational structure, processes, and procedures must be addressed.</p> Signup and view all the answers

<p>Laboratories can minimize errors by performing all processes and procedures to the highest possible standards.</p> Signup and view all the answers

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

<p>Accuracy.</p> Signup and view all the answers

<p>It outlines the complete set of operations in testing from patient to results interpretation.</p> Signup and view all the answers

<p>Errors in laboratory operations.</p> Signup and view all the answers

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

<p>CLSI develops standards through a consensus process involving multiple stakeholders.</p> Signup and view all the answers

<p>Timely reporting of all results.</p> Signup and view all the answers

<p>Quality in manufacturing and service industries.</p> Signup and view all the answers

<p>They ensure proper execution of testing processes.</p> Signup and view all the answers

<p>It may produce inaccurate or unreliable laboratory results.</p> Signup and view all the answers

<p>To manage and oversee the total quality operation.</p> Signup and view all the answers

<p>It can result in unreliable test results.</p> Signup and view all the answers

<p>They are foundational elements for developing quality operations in the laboratory.</p> Signup and view all the answers

<p>A poor laboratory environment may compromise test conditions and results.</p> Signup and view all the answers

<p>To ensure quality laboratory testing systems and reliable test results.</p> Signup and view all the answers

<p>Quality assessment involves planned activities to ensure that a product or service meets quality requirements.</p> Signup and view all the answers

<p>Quality control encompasses operational techniques to fulfill quality requirements.</p> Signup and view all the answers

<p>Quality Assessment (QA) and Quality Control (QC).</p> Signup and view all the answers

<p>They are intended to structure any quality management system program.</p> Signup and view all the answers

<p>It involves designing work to meet the expectations of laboratory customers.</p> Signup and view all the answers

<p>It refers to establishing and retaining sufficient qualified staff for laboratory operations.</p> Signup and view all the answers

<p>Preexamination, Examination, and Postexamination.</p> Signup and view all the answers

<p>Documentation outlines necessary information for quality essentials and job responsibilities.</p> Signup and view all the answers

<p>Each employee contributes at an appropriate level and completes required documentation.</p> Signup and view all the answers

<p>Quality assessment ensures defined quality requirements are fulfilled, while quality control implements techniques to meet those requirements.</p> Signup and view all the answers

<p>Identifying, documenting, classifying, and correcting nonconformances.</p> Signup and view all the answers

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

<p>It identifies opportunities for improvement and develops strategies to sustain those improvements.</p> Signup and view all the answers

<p>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 concentrates on testing products.</p> Signup and view all the answers

<p>A policy outlines quality operations and answers the question 'What is to be done?'</p> Signup and view all the answers

<p>A process consists of activities required to implement specific policies.</p> Signup and view all the answers

<p>Forms document specific activities and record data related to fulfilling requirements.</p> Signup and view all the answers

<p>They are key team members in establishing and compiling the quality manual.</p> Signup and view all the answers

<p>Reactive quality control focuses on locating quality failures.</p> Signup and view all the answers

<p>Training ensures that laboratory personnel understand quality operations and their roles.</p> Signup and view all the answers

<p>Documents specifying policies, procedures, processes, and forms.</p> Signup and view all the answers

<p>Policies define what is to be done, while processes describe how to meet those requirements.</p> Signup and view all the answers

<p>A quality manual compiles all policies, processes, and procedures for the laboratory.</p> Signup and view all the answers

<p>Documentation must be accessible to all staff and regulatory agencies for compliance.</p> Signup and view all the answers

<p>Checkpoint review is an activity that evaluates quality at specific stages.</p> Signup and view all the answers

<p>Procedures should provide step-by-step instructions on how to complete processes.</p> Signup and view all the answers

<p>To ensure all aspects of laboratory testing are evaluated and maintained for compliance.</p> Signup and view all the answers

<p>What items/processes will be reviewed?</p> Signup and view all the answers

<p>To maintain compliance and provide a reference for audit and review processes.</p> Signup and view all the answers

<p>To oversee the implementation of the quality assessment plan.</p> Signup and view all the answers

<p>On a regular schedule as outlined in the quality assessment plan.</p> Signup and view all the answers

<p>They refer to how the process performs when properly completed.</p> Signup and view all the answers

<p>They must be retained in a designated storage location.</p> Signup and view all the answers

<p>To provide critical information for appropriate patient treatment.</p> Signup and view all the answers

<p>They can confirm clinical diagnoses and differentiate between similar symptoms.</p> Signup and view all the answers

<p>It ensures accountability and informs any necessary corrective actions.</p> Signup and view all the answers

<p>Laboratory employees can verify Medicare coverage by using a computer database.</p> Signup and view all the answers

<p>It is unlawful to have every Medicare patient fill out an ABN 'just in case'.</p> Signup and view all the answers

<p>Access documents, review required documentation, submit findings, and take corrective action.</p> Signup and view all the answers

<p>They may be retired as per regulatory guidelines.</p> Signup and view all the answers

<p>Medicare's decision on coverage is based on 'medical necessity' rules.</p> Signup and view all the answers

<p>It is essential for establishing an appropriate treatment plan for infections.</p> Signup and view all the answers

<p>Start with changes that can be easily accomplished and have the biggest impact.</p> Signup and view all the answers

<p>Preanalytic, analytic, and post-analytic phases.</p> Signup and view all the answers

<p>Quality management has grown from the good works of innovators over a span of 80 years.</p> Signup and view all the answers

<p>Early screening allows for effective treatment and management of chronic health conditions before significant symptoms develop.</p> Signup and view all the answers

<p>Tests can include blood tests for therapeutic drug levels, hepatic profiles, or hemoglobin tests.</p> Signup and view all the answers

<p>The requisition form collects essential patient information and specifies the tests to be performed.</p> Signup and view all the answers

<p>An ICD-9 code indicates the diagnosis or symptom associated with a laboratory test.</p> Signup and view all the answers

<p>Requisitions are organized by general types of tests such as hematology, serology, or chemistry.</p> Signup and view all the answers

<p>A CPT code is a five-digit procedure code necessary for reimbursement of laboratory tests.</p> Signup and view all the answers

<p>A laboratory directory provides detailed information about specimen processing, storage, and test performance frequency.</p> Signup and view all the answers

<p>It includes patient demographics, date and time of collection, and documentation of test results communication.</p> Signup and view all the answers

<p>Labels link patient information on requisitions to the specific specimen, ensuring correct identification.</p> Signup and view all the answers

<p>Results can be relayed via documented communication specified on the requisition form.</p> Signup and view all the answers

<p>The internal test number is used to enter the test order into the laboratory's database.</p> Signup and view all the answers

<p>Reference ranges indicate the expected results for healthy individuals, helping healthcare providers interpret test outcomes.</p> Signup and view all the answers

<p>Two unique identifiers for the patient, the employee ID or initials, the date, and the time of collection are documented.</p> Signup and view all the answers

<p>The ABN informs Medicare patients that a specific test may not be covered, allowing them to decide on financial responsibility.</p> Signup and view all the answers

<p>Storage instructions can include conditions like room temperature, frozen, or refrigerated.</p> Signup and view all the answers

<p>It includes notations for results outside the reference range, signaling possible health concerns.</p> Signup and view all the answers

<p>Demographic information is critical as it affects the reference ranges used for test results interpretation.</p> Signup and view all the answers

<p>Denials can occur due to testing frequency, diagnostic reasons, or if the test is experimental.</p> Signup and view all the answers

<p>It ensures accurate tracking of when the specimen was taken and affects result validity.</p> Signup and view all the answers

<p>Reports may be hand-delivered, faxed, mailed, or sent electronically.</p> Signup and view all the answers

<p>The report can include patient identifiers, specimen source, and laboratory identification details.</p> Signup and view all the answers

<p>The patient will be billed for the full cost of the test if they proceed.</p> Signup and view all the answers

<p>The directory specifies both requested specimen volume and minimum acceptable specimen volume.</p> Signup and view all the answers

<p>Differences can arise due to variations in population demographics and testing methods.</p> Signup and view all the answers