Quality Management PDF 6/20/2024

6/20/2024 Quality Management 1 Preamble PowerPoints DO NOT cover the details needed for the Unit exam Unit Objectives are your study guide not this PowerPoint 2 1 ...

6/20/2024 Quality Management 1 Preamble PowerPoints DO NOT cover the details needed for the Unit exam Unit Objectives are your study guide not this PowerPoint 2 1  6/20/2024 Quality Management (QM) The overall process of guaranteeing quality patient care The laboratory’s policies, processes, procedures, and resources Quality system needed to achieve quality testing Testing controls Quality control Pre-examination Specimen collection, handling, and storage variables Reagent and test performance, instrument calibration and Examination variables maintenance, personnel requirements, and technical competence Post-examination Reporting of results and interpretation variables 3 Quality Management Documentation Procedure manuals Internal and external quality control Guidelines published by Standardization and equipment College of American maintenance Proficiency testing and record- Pathologists (CAP) and keeping the CLSI provide Safety programs complete instructions for Training, education, competency documentation assessment Scheduled, documented review processes Required by accrediting agencies 4 2  6/20/2024 Accrediting Agencies American The Joint College of American Association of Blood Commission (TJC) Pathologists (CAP) Banks (AABB) American Society of American Commission on Histocompatibility Osteopathic Laboratory and Immunogenetics Association (AOA) Assessment (COLA) (ASHI) 5 Urinalysis Procedure Manual Must be available in the work area Each procedure must include: Principle or purpose of the test Clinical significance Patient preparation Specimen type and method of collection Specimen acceptability and criteria for rejection Reagents, standards, and controls Instrument calibration and maintenance protocols and schedules 6 3  6/20/2024 Urinalysis Procedure Manual (cont.) Step-by-step procedure, calculations Frequency and tolerance limits for controls and corrective actions Reference values and critical values Interpretation of results Specific procedure notes Limitations of the method Method validation 7 Ongoing process Evaluating Current methods reviewed annually Procedures and New Procedure manual changes should be reviewed, referenced, and signed by a Methodology person with designated authority All personnel notified of changes 8 4  6/20/2024 Pre-examination Variables Variables occurring before Requires testing communication and Test requests adequate training Patient preparation and timing among health-care Specimen collection personnel outside the Specimen handling, transport, and storage clinical laboratory 9 TAT is defined as the amount of time required from when a test is ordered by the health-care provider until the results are reported to the health-care provider Turnaround TATs for stat and routine tests Time (TAT) Process improvement using cause and effect 10 5  6/20/2024 Procedure Manual-Specimen Collection and Handling 11 Procedure Manual Pre-examination Variables 12 6  6/20/2024 Internal Laboratory Quality Improvement Form 13 Patient misidentification Wrong test ordered Summary of Incorrect urine specimen type collected Preexamination Insufficient urine volume Variables Delayed transport of urine to laboratory Incorrect storage or preservation of urine 14 7  6/20/2024 Examination Variables 15 Manufacturer, name, and chemical formula Instructions for preparation Type of water used in preparation Clinical Laboratory Reagent Water (CLRW) Storage requirements Reagents Procedures for reagent quality control Label with date of opening or preparation Check reagent strips daily or each shift and when a new bottle is opened and record results Safety and health precautions 16 8  6/20/2024 Instrumentation and Equipment Operation, Calibration and Temperatures of refrigerators Prepare a calibration, control of Document all and water Calibration and routine limitations, refractometers, routine and baths disinfection of preventive dilution osmometers, nonroutine centrifuges maintenance procedures, reagent strip Recorded daily maintenance schedule recording readers 17 Testing Procedure 18 9  6/20/2024 The materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test QC procedures ensure that acceptable standards are met during the process of patient testing Quality QC is performed at scheduled times Control (QC) Must always be performed if reagents changed, instrument has malfunctioned, or test results are questioned by the provider Test results cannot be reported until the QC is verified 19 Verifies accuracy and precision Exposed to the same condition as a patient sample External QC Medically significant Run two levels of control material Record date of opening, manufacturer’s lot number, expiration date each time control is run Same person running controls must run patient samples Free of communicable disease (HIV, Hepatitis C, Hepatitis B) Calculate mean and standard deviation for control for each test Gaussian distribution Mean: average of the results from repeat testing of the control sample Standard deviation: average distance each value is from the mean Coefficient of variation: standard deviation expressed as a percentage from the mean Control range: ±2 SD or ±3 SD from the mean (95.5% to 99.7%) 20 10  6/20/2024 Corrective Actions Must be taken when control values are outside the tolerance limits Must be documented 21 Internal QC Internal monitoring included in the test system Internal and procedural: monitors addition of patient specimen and reagents, instrument and reagent interaction, test completion Electronic: electrical components of instruments in place of liquid control medium Verifies functional ability only 22 11  6/20/2024 PT/EQA: Unbiased validation of the quality of patient test results Testing of unknown samples provided by an external agency Proficiency Vendors supply materials to laboratory Testing/ Laboratory tests materials and returns results to External Quality vendor Assessment Accuracy is evaluated and compared with other laboratories using the same method of analysis Vendor statistically rates answers from all participating labs and returns report to lab director Corrective actions performed and documented 23 Alternative option that provides quality testing to meet CLIA regulations Individualized IQCP considers entire testing process Quality Control Plan Requires risk assessment, a QC control plan and quality assessment Involves selecting quality monitors which include QC and PT records, patient results, specimen rejection logs, TAT reports, preventive measures, corrective action, and follow-up records, and personnel competency records 24 12  6/20/2024 Personnel and Facilities 25 Processes that affect the reporting of results and correct interpretation of data Postexamination Use standardized reporting formats to minimize health-care provider confusion Variables Reference ranges included Electronic transmissions are the most common Autoverification is often programmed into many laboratory analyzers 26 13  6/20/2024 Postexamination Variables (continued) 27 Include specificity and sensitivity of tests in procedure manual Interpretation List all interfering substances in of Results manual A well-documented QA program ensures quality test results and patient care 28 14  6/20/2024 Postamble USE THE UNIT OBJECTIVES AS A STUDY GUIDE 29 15