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Questions And Answers
Provider-Performed Microscopy (PPM) Personnel: - correct answer ✅-Director: Must possess a state license as a lab director if licensing is required -Must meet these requirements: -Be a physician -Be a state-authorized midlevel practitioner -Be a dentist -Responsibilities: -Direct no more than 5 labs -Ensure that any PPM procedure is personally performed by an individual who meets the qualification requirements and is performed in accordance with applicable requirements -Testing Personnel: Must possess a state license if the licensing is required -Must meet these requirements: -Be a physician -Be a state-authorized midlevel practitioner -Be a dentist -Responsibilities: -Personally performed by a physician, a midlevel practitioner, or a dentist
Questions And Answers
-Perform testing during a patient's visit on a specimen obtained from the patient -Performed using a bright field microscope Clinical Laboratory Improvement Amendments of 1988 (CLIA) - correct answer ✅-Established quality standards for all lab testing to ensure accuracy, reliability, and timeliness of patient test results -Regulations were finalized by the CDC and Centers for Medicare and Medicaid Services (CMS) -Requires all lab facilities to perform any testing on specimens collected from people to meet certain federal requirements and must obtain a certificate from a CLIA program that corresponds to the complexity of tests performed Certificate of Waiver - correct answer ✅Issued to a lab that performs only waived tests Certificate for Provider Performed Microscopy (PPM) - correct answer ✅Issued to a lab in which a physician, midlevel practitioner, or a dentist performs a specific microscopy procedure during a patient's visit (Usually moderate complexity)
Questions And Answers
-Examinations, procedures, and methodologies -Training required to operate the instruments for particular methodology Levels of Testing - correct answer ✅-Waived: -Cleared by the FDA for home use -Employs simple and accurate methodologies that pose no risk of harm to the patient -Moderate Complexity: -Knowledge -Training and experience -Reagents and materials preparation -Characteristics of operational steps -Calibration, quality control, and proficiency testing materials -Test system troubleshooting and equipment maintenance -Interpretation and judgement -Provider Performed Microscopy (PPM): -Personally performed by either a physician, midlevel practitioner, or a dentist
Questions And Answers
-Must be moderately complex -Primary instrument is a microscope (brightfield or phase-contrast) -Specimen is labile. Delays in testing could compromise accuracy of result -No control materials to monitor testing -Limited specimen handling or processing is required -High Complexity: -Any modified FDA-cleared or approved test -Any lab-developed test (LDT) -Cytology Inspections - correct answer ✅-Department of Health and Human Services (HHS) may conduct inspections of any lab at any time during its hours of operation to assess compliance: -Determines that testing is being performed or the lab is operated in a manner that does not constitute an imminent or serious risk to public health -Evaluates complaints from the public -Determines whether the lab is performing tests in addition to procedures for which the lab is certified to do
Questions And Answers
-Every lab must enroll in a PT program -Must run samples as patient samples (waived tests are not tested in the PT program) -Testing of PT Samples: -Treat test samples the same as patient samples -Must be performed by routine personnel (bench tech) -Labs cannot discuss results of samples in the PT program to other labs (That's cheating!) -Labs cannot send PT samples to other labs -Labs must document the handling, preparation, processing, examination, and each step in the testing and reporting of PT samples. They must also keep a copy of all documentations -Successful Participation and Performance: -Satisfactory is 80% -Immunohematology must be 100% accurate -Unsuccessful Proficiency Testing: -Unsatisfactory performance is when a test is incorrect 2 out of 3 tries for analytes -Unsatisfactory testing event score is graded differently than analyte testing, but follows the same rule of "2 out of 3"
Questions And Answers
-Common causes: Clerical errors, instrument or method codes, calibration bias, and failure to return results by due date -Alternate Proficiency Testing: -Split Sample Testing: An alternative performance assessment system for determining the reliability of analytical testing. These tests are for analytes not yet approved in the PT program Patient Test Management - correct answer ✅A system for labs with moderate or high complexity testing that provides for proper patient preparation, specimen collection, identification, preservation, transportation, and processing for accurate result reporting Preanalytical Testing - correct answer ✅Labs must monitor and evaluate overall quality of testing by identifying problems, such as inappropriate test requests, order entry, patient/specimen misidentification, sample collection (hemolysis, clotting, etc.), inappropriate container, handling, storage, and transportation
Questions And Answers
Analytical Testing - correct answer ✅Labs must monitor and evaluate the overall quality of the analytical systems and correct identified problems (machine malfunctions, sample mix-ups, etc.) Calibration - correct answer ✅Is the process of testing and adjusting an instrument, kit, or test system to provide a known relationship between the measurement response and the value of the substance that is being measured by the test procedure Quality Control (QC) - correct answer ✅Is a procedure or set of procedures intended to ensure that a manufactured product or control material adheres to a defined set of quality criteria or meets the requirements of the client or customer Specimen Integrity - correct answer ✅This is determined based on the methodology used and the manufacturer's instructions for said methodology
Questions And Answers
Post-Analytical Testing - correct answer ✅Labs must monitor and evaluate overall quality of post-analytical systems by correcting problems such as: erroneous validation, failure in reporting/addressing the report, excessive turnaround time, improper data entry and manual transcription error, failure/delay in reporting critical values, delayed/missed reaction to lab reporting, incorrect interpretation, inappropriate/inadequate follow-up plan, and failure to order appropriate consultation Test Records - correct answer ✅-Must identify the person performing the testing procedure -These records must include instrument printouts and be held for at least 2 years -Immunohematology records are held for 5 years -Documentation must include: -Patient identification number, accession number, or unique identifier -Date and time of specimen receipt into lab -Conditions of specimens that do not meet the lab's criteria for specimen acceptability
Questions And Answers
Specimen Submission, Handling, and Referral - correct answer ✅-Criteria for written policies and procedures: -Methods used for preparation of patients, specimen collection, specimen labeling, specimen preservation, conditions of specimen transport, and specimen processing -Assure positive identification and optimum integrity of the patient specimens from time of collection until testing has been completed and results reported -Referral specimens must have written instructions available to clients as well as information from the points above included Procedure Manual for Quality Control - correct answer ✅-Must include: -Requirements for specimen collection and processing, and specimen rejections -Procedures for microscopic examinations, including detection of inadequately prepared slides -Step-by-step performance of the procedure, including test calculations and interpretation of results -Preparation of solutions, calibrators, controls, reagents, stains, and other materials used in testing -Calibration and calibration verification procedures
Questions And Answers
-Reportable ranges for patient test results established -Control procedures -Remedial action to be taken when calibration or control fails -Limitations in methodologies, including interfering substances -Reference ranges (normal values) -Panic values (Life-threatening results) -Literature references -Criteria for specimen storage to ensure specimen integrity until testing is completed -Protocol for reporting patient results and panic values -Course of action to be taken if a test system becomes inoperable -Criteria for referral specimens, including procedures for specimen submission and handling -Procedures must be approved, signed, and dated by the director -Procedures must be pre-approved, signed, and dated by initial director if director of lab changes -Each change must be approved, signed, and dated by current director of lab -Lab must maintain a copy of each procedure with dates of initial use and discontinuance (must be maintained for 2 years)
Questions And Answers
-Instrument maintenance -Instrument calibration -QC -Written testing procedures -Recording patient results -Verification of normal range -Test analysis -Controlled Temperature Monitoring -Competency of personnel -Post-Analytical Factors: -Verification of accuracy of calculations (dilutions) -Reporting results to healthcare provider -Identification and notification of panic values -Filing, charting, or storage of patient results -Test interpretation -Test report legibility -Data retrieval -Reports mailed to the proper address
Questions And Answers
Differences between Quality Assurance and Quality Control - correct answer ✅-Quality Control: -One component of QA -Involves only the analytical phase of testing -Ensures accuracy of test results -Performed daily or whenever lab testing is performed -Quality Assurance: -Monitors and evaluates all aspects of testing -Involves preanalytical, analytical, and post-analytical phases of the total testing process -Uses QC data to review, evaluate, and assess to identify potential problems -Determines areas that require improvement -Is conducted over a period of time (monthly, quarterly, yearly) Quality Control as a Whole - correct answer ✅-Control procedures verify that patient results are unaffected by day-to-day variation caused by the test system, environment, or operator -QC improves the accuracy and reliability of testing and reduces the need for retesting and unnecessary procedures and treatments
Questions And Answers
-Concentration is determined by an analytical method of stated reliability -Calibrated with primary calibration standards -Are prepared from pure substances of known composition from partially purified substances such as enzymes or proteins, or natural products such as human or bovine serum Calibration vs Controls - correct answer ✅-Calibration: -Sets instrument to a specific parameter by using a calibration cuvette or a liquid calibrator -Must occur before running controls -Are sometimes standards -Do not use as controls! -Controls: -Validates run after calibration -Is patient-like -Usually comes in 2 levels -Acceptable ranges are in package insert -Tests accuracy and precision of method
Questions And Answers
-Do not use as calibrator! -Each lot number has different assayed values Precision vs Accuracy - correct answer ✅-Accuracy: -The agreement between the measured quantity and its true value (How close the value is to the "true" value) -Inaccuracy is monitored by: -If the true value of the control is not known -Calculating the average of the normal or daily mean of results obtained -Determining reference values of healthy subjects for each test and then monitoring changes in reference values overtime -Precision: -Agreement among replicate measurements (How close the single values are to one another) -Imprecision is seen as: -The standard deviation or coefficient of variation of the results in a set of replicate measurements determined after following a stated protocol or design
