Preanalytical quality control practices in clinical laboratory

Preanalytical quality control practices in clinical laboratory

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  PRE-ANALYTICAL QUALITY CONTROL PRACTICES INCLINICAL LABORATORY DR RAJESH V BENDRE MD(PATH), DNB(PATH), DPB
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  Introduction- what isQuality?
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  Introduction- Why Qualityfor Individual Lab? Consequences of Poor Quality-  Inappropriate action  Over-investigation  Over-treatment  Mistreatment  Inappropriate inaction  Lack of investigation  No treatment  Delayed action  Loss of credibility of laboratory  Legal action Objectives of Quality- Support provision of high quality healthcare  Reduce morbidity  Reduce mortality  Reduce economic loss  Ensure credibility of lab  Error proof & Generate confidence in lab results  Consistency  Accuracy  Precision  Right result  First time  Every time  Invisible when GOOD  Impossible to ignore when BAD
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  Laboratory Errors
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  Laboratory Errors
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   Patient Identification:It is important to identify a patient accurately so that blood is collected from the correct person. Drawing blood from the wrong person, or labeling the correct patient’s sample with a different patient’s label can certainly contribute to laboratory error. (Mislabeling ???) Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Patient Preparation: Prior to collecting specimens for chemistry, certain patient variables need to be considered. For certain chemistry analytes, such as glucose and cholesterol, patients need to be fasting for at least 12 hours prior to venipuncture. Other analytes, such as cortisol and adrenocorticotropin, have diurnal variations, where the analyte is at its highest level in the morning, and the levels gradually decrease during the course of the day.
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   Selecting theSite: Selecting the appropriate site for venipuncture can contribute to a better quality sample. The preferred site is the median cubital vein. This vein is usually the easiest to access. Generally, there is less need to probe to find the vein, which in turn should cause less trauma during the venipuncture. This will usually be the most comfortable for the patient Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Site Preparation: Prior to venipuncture, the site should be cleansed with alcohol. Cleansing starts at the center of the vein, and should continue outward in concentric circles. Before performing the venipuncture, the alcohol should be allowed to air dry. This will help to ensure that the specimen is not contaminated with alcohol, as this can lead to hemolysis. Hemolysis can result in the spurious elevation of such analytes as potassium, lactate dehydrogenase (LD), iron and magnesium in the chemistry lab
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   Tourniquet Applicationand Time: The tourniquet should be applied approximately three to four inches above the venipuncture site. The tourniquet should be on the arm no longer than one minute. A good rule of thumb to determine the one- minute tourniquet time is to remove the tourniquet when blood starts to flow into the first tube of blood being drawn. Prolonged tourniquet time can lead to an increase in various chemistry analytes, including serum protein, potassium and lactic acid due to hemoconcentration of blood at the puncture site. Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Proper Venipuncture Technique: During phlebotomy, avoid probing to find the vein and achieve blood flow. Excessive probing and/or “fishing” to find a vein can result in a poor quality sample, including hemolysis. As mentioned previously, hemolysis can affect several chemistry analaytes.
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   Order ofDraw:  Following the correct order of draw during venipuncture is critical to ensure accurate test results.  The CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS) have established recommendations for the proper order of draw for evacuated blood collection tubes Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Proper Tube Mixing: All tubes with additives need to be inverted to mix the additive evenly with the blood. Plastic serum tubes and BD SST ™ tubes contain clot activator and should be inverted 5 times to mix the activator with the blood and help the specimen clot completely. Improper mixing of the tube after venipuncture could contribute to a gelatinous serum sample.
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   Correct SpecimenVolume: All blood collection tubes need to be filled to the correct volume. This will ensure the proper amount of blood for the amount of additive in the tube (blood to additive ratio). For example, if a 5 mL draw heparin tube is only filled with 3 mL of blood, the heparin concentration is erroneously high and may potentially interfere with some chemistry analytes. Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Expiration dates: Should also be checked on the evacuated tubes  Expired tubes should not be used, as they may have a decreased vacuum, as well as potential changes in any additives in the tubes
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  Proper Tube Handlingand Specimen Processing  Serum specimens: Namely red top tubes and BD SST™ gel tubes, need to clot completely prior to centrifugation and processing. Blood specimens in red top tubes should clot for 45 to 60 minutes, and those in BD SST ™ tubes should be allowed to clot for 30 minutes to ensure complete clot formation. Effects of Pre-analytical Variables on the Quality of Laboratory Testing  Blood from patients who are receiving anticoagulant therapy, such as heparin or coumadin, may take longer to clot. Tubes should be allowed to clot at room temperature, upright in a test tube rack, with the closures on the tubes. Spinning the tube too soon may result in a gelatinous and/or fibrinous serum sample that will require respinning.
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  Sample Collection  Anticoagulantof choice 3.8% or 3.2% Sodium Citrate?  3.2 % Preferred as the standard measure due to stability and closeness to the plasma osmolality  Anticoagulant/blood ratio is critical (1:9)  CLSI guideline is +/- 10 % of fill line  Order of Draw- special emphasis in collections post blood culture Sample transport- Separated citrated plasma at 2 to 6^C – upto 24hrs for PT but within 4hrs for aPTT & other coagulation assays OR frozen, ensure that specimen is not in direct contact with ice. Pre-preanalytical variables- Coagulation
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  13 21-May-2019 13:45 Cell Analyser-Daily Background Check WBC 0.05 x 10^3/L PASS RBC 0.00 x 10^6/L PASS Hgb 0.00 x g/dl PASS Plt 10.0 x 10^3/U FAILED Pre-Analytical Example Within Lab- For Coagulation- Platelet Poor Plasma • Recommended centrifugation to remove platelets to a count of less than 10 x 10^9/L (10,000/µL). For Automated Cell Counters • Daily Instrument Function checks- Background Counts Within Lab- For Urine Chemistry(24hrs)- • Recommended check for Urine PH & appropriate correction before testing, especially for Urinary calcium & Uric acid
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  What can wedo ? Implementation of Total Quality Management- There is no single approach to the implementation of TQM.  Oakland Model that is based on- Four Ps, which are:  Planning: policies and strategies;designing in quality.  Performance: Establishing a performance measurement framework; carrying out self-assessment and benchmarking.  Processes: Understanding and redesign; continuous improvement.  People: Managing the human resources; culture change; teamwork; communications; innovation and learning. Three Cs (culture, communication and commitment) Each organization needs to develop a programme that is suited to its own needs, taking into account its stage of organizational development, resources available, organizational culture, and customer requirements. Quality System Elements- PDCA Model -Deming PLAN Quality officer Quality manual DO Standard operating procedures (SOP's) Management of documents Infrastructural requirements Human resources requirements Equipment requirements Reagents & standards requirements CHECK Quality Indicators Internal audit External audit ADJUST Remedial actions (CAPA)
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  15 Continuing Education Training Job Descriptions Orientation Competency Assessment Job Qualifications Personnel Management
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  Orientation Competency Assessment Task-specific Training CompetencyRecognition Job Description Qualified Technician/Doctor Retraining 6monthly for 1st year & atleast Annually thereafter for all
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  Competency Assessment Methods Direct Observation  checklists  Indirect Observations  monitoring records  re-testing  case studies  Give previously analyzed specimens for testing  Provide written exercises to assess: • Problem solving skills • Knowledge • Interpretation Technologist Name Technologist Title Procedure for Evaluation Evaluation Date Evaluator Procedure item Accept Partial No Comment Read procedure manual Equipment set up appropriately Work area neat Reagent preparation Perform task accurately Perform task timely Other: Specify
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  QUALITY INDICATORS  Asstated by the ISO 15189:2012, Technical Requirements- “The laboratory shall establish QIs to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post examination processes”  The Working Group on Laboratory Errors and Patient Safety (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed consensus QI (2014, 2017)-  Testing process- 53 QIs - 28 preanalytical , 6 analytical & 11 postanalytical phases.  Support process- 5 QIs – 2 Employee competence, 2 clinical relationship, 1 Laboratory Information system  Outcome measures- 3 QIs
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  QUALITY INDICATORS- PREANALYTICAL
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  QUALITY INDICATORS LABORATORYBench Mark TESTING PROCESS- Pre Analytical Misidentification errors Incorrect sample type Incorrect sample quality- hemolysed, clotted, contaminated(Microbiology) Inappropriate time in sample collection 0.08% 0.05% 1-2% 0.05% Analytical Test with inappropriate/outlier IQC performances Test uncovered by an EQA-PT control Performances Unacceptable performances in EQA-PT schemes 2-3% (>95%)RCA compliance100% (>95%)RCA compliance 100% Post Analytical Data transcription errors Notification of critical values/alerts Appropriate Interpretative comments Inappropriate turnaround times (TAT) 0.02% Time- within15mins 100% Testwise compliance 100% Testwise TAT compliance 95% SUPPORT PROCESS- Employee competence Training followed by competency assessment as per schedule 100% Customer Satisfaction Surveys for both clinicians & patients (>95%)RCA compliance100% LIMS/IT Efficacy System Downtime, Interface errors No unplanned events OUTCOME MEASURES- Sample recollection Total including lab & clinician/patient reasons 2% Incorrect laboratory reports Total including lab & clinician/patient reasons (<1%)RCA compliance 100%
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  QUALITY AS LABCULTURE- IS A REPORTING CULTURE- As Quality Journey Continues…… Blame Culture Just Culture Focus on Fault Finding exercise Focus on Process & system improvement Lack/poor Quality awareness at all levels Improved Quality awareness at all levels Reactive Proactive Decentrailized quality leadership centrailized quality leadership High COPQ Low COPQ Compliance Focussed Best Practice Focussed Lab Centric Clinician/Patient centric
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   Reused Torniquet NeglectedAreas Requiring Focus-  Cotton used for disinfection  Post phlebotomy care including quality of sticking or bandage used  Hand Hygiene practices  Reused Needle Holder  Disposal as per Biomedical waste guidelines Inappropriately conducted above activities can inadvertently cause patient harm- transmission of infections like s.aureus, including MRSA have been described  Storage area for blood collection material
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  Adopt Newer Technology
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  Sample IdentificationWork station Sample inputTube loading Sample outputCentrifugation PRE-ANALYTICAL AUTOMATION Adopt Newer Technology
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  Future : Notvery Far
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  THANK YOU