1. The document discusses quality control measures across the pre-analytical, analytical, and post-analytical phases of laboratory testing. It emphasizes the importance of proper patient identification, specimen handling and integrity, and analytical process validation.
2. Key steps to ensure quality include implementing policies and training for patient identification, establishing criteria for specimen acceptance, participation in internal and external quality assessment programs, and verification of test procedures, reference ranges, and potential analytical interferences.
3. Continuous quality improvement requires monitoring analytical total allowable error and implementing peer review programs to prevent diagnostic errors.
1. The document discusses quality control measures across the pre-analytical, analytical, and post-analytical phases of laboratory testing. It emphasizes the importance of proper patient identification, specimen handling and integrity, and analytical process validation.
2. Key steps to ensure quality include implementing policies and training for patient identification, establishing criteria for specimen acceptance, participation in internal and external quality assessment programs, and verification of test procedures, reference ranges, and potential analytical interferences.
3. Continuous quality improvement requires monitoring analytical total allowable error and implementing peer review programs to prevent diagnostic errors.
1. The document discusses quality control measures across the pre-analytical, analytical, and post-analytical phases of laboratory testing. It emphasizes the importance of proper patient identification, specimen handling and integrity, and analytical process validation.
2. Key steps to ensure quality include implementing policies and training for patient identification, establishing criteria for specimen acceptance, participation in internal and external quality assessment programs, and verification of test procedures, reference ranges, and potential analytical interferences.
3. Continuous quality improvement requires monitoring analytical total allowable error and implementing peer review programs to prevent diagnostic errors.
LABORATORY QA biometrics, magnetic stripes, optical
character recognition (OCR), smart
cards, and voice recognition devices. PRE-ANALYTICAL 2. NONTECHNICAL: The problem of The pre-analytic testing phase occurs first in patient misidentification cannot be the laboratory process. This phase may include reduced without implementing specimen handling issues that occur even prior nontechnical methods along with to the time the specimen is received in the introduction of automated technology laboratory. for patient identification. This includes APPROPRIATE TEST ORDERING BY implementation by the organization of PHYSICIANS policies and procedures in the laboratory for patient identification per 1. Developing clear written procedures CLSI guidelines, training of medical 2. Regular training by and assessing of the professionals on guidelines and skills of the health care professionals procedures for patient identification, 3. Automating functions for support and specimen labeling, and patient safety executive operations measures; health care organizations 4. Monitoring quality indicators must follow the procedures which best 5. Improving communication among health help to reduce risk and to improve care and laboratory professionals patient safety. PATIENT-SPECIMEN IDENTIFICATION Specimen Collection, Transport, and The in patients should be asked to state their: Processing
Full name Specimen Integrity- The second most
Address essential requirement to reduce laboratory Birthdate error during the pre-analytical phase is specimen integrity. Specimen integrity depends Age and/or on the number of processes performed, such Unique identification number as specimen collection, maintenance of The laboratory technician, nurse, or treating specimen physiology, transportation, and physician must compare this information with processing. that listed on the identification wristband that The following steps will ensure specimen must be worn by the patient (when applicable) integrity: and the test requisition form or computer- generated labels for that patient. 1. The laboratory should formulate easily understood policies for collecting, Health care professionals should approach handling, and transporting specimens. the problem of patient misidentification via The laboratory must enforce standard the following methods: operating procedures (SOPs) for 1. TECHNICAL: The introduction of phlebotomy, which include proper automated systems for positive patient procedures for specimen collection; identification and specimen labeling universal precautions to be taken during strongly helps to prevent diagnostic and specimen collection; and disposal of medication errors. This can be achieved syringes, needles, and other materials by using traditional bar codes or by used during the specimen collection using the more innovative methods of process. radio frequency identification (RFID), 2. Laboratories should have evidence- Automated Analysis- Initially, when based criteria for specimen acceptance laboratory directors introduced that must be implemented for handling automated instruments into laboratories, the specimens before testing to assure these instruments were used mostly to the reliability of analytical results.11 perform the tests that were requested Laboratories should develop a most frequently. standardized flowchart to detect and to Validation of Analytical Procedures- appropriately treat hemolyzed, clotted, The laboratory must carry out validation and insufficient specimen material. of all analytical procedures to establish that the performance characteristics of NOTE: Important errors can occur during the the method(s) in question meet the pre-analytic phase with specimen handling and requirements for the intended analytical identification. Therefore, the pre-analytical application phase must have rigorous control measures to Verification of Reportable Range: A avoid unwittingly allowing problems or errors to minimum of 5 specimens with known travel further "downstream." values that cover the reportable range given in the kit insert should be analyzed in triplicate to assess the ANALYTICAL PHASE reportable range. The second phase is the analytic phases. This Verification of Precision: The phase includes what is usually considered the precision of the process indicates the "actual" laboratory testing or the diagnostic reproducibility of its results. Personnel procedures, processes, and products that will also calculate precision to a clinically ultimately provide results. acceptable level of variation to assure that the method meets clinical needs ANALYTICAL PROCESS QUALITY Verification of Analytical Accuracy: 1. The participation of the laboratory in an Analytical accuracy indicates the internal QC program and in external veracity of the result. A minimum of 20 quality assessment procedures does not patient specimens that span the entire directly ensure that the results reported testing range but do not exceed by the laboratory are accurate and measurement range are required to precise. determine this variable. 2. Laboratories usually do not calculate the Verification of Analytical Sensitivity: allowable total errors for all tests In this procedure, one calculates the performed on all analytes, although this lower detection limit. would improve the diagnostic process. Verification of Analytical 3. Different laboratory report reference Interferences: There is no approved values are nonspecific for age, sex, and protocol for performing this task, to our physiological conditions (such as knowledge. Most commonly, laboratory pregnancy). professionals test for lipemia, hemolysis, and elevated bilirubin levels, usually by Quality Improvement in the Analytical adding interfering materials to determine Phase whether doing so changes the results; also, these professionals determine - To improve the quality of the analytical potential interferences that are specific phase of testing, the following to the test and methodology used. processes must be streamlined: Verification of Reference Limits: Laboratory professionals adopt reference limits based on manufacturer laboratory, is the quality goal. When ATE is recommendations, reference laboratory low, the laboratory needs less stringent QC recommendations, and the reference rules; when ATE is high, the laboratory needs limits mentioned in published articles. more stringent QC rules. Each laboratory must verify its own PEER REVIEW reference limits by testing specific analytes in healthy populations. - Peer review is the most widely used Quality of Examination Procedures method to determine diagnostic accuracy and to prevent diagnostic - The laboratory must establish a well- errors in testing involving microbiology defined and well documented program and pathology specimens. for assessing and evaluating its POST-ANALYTIC PHASE examination procedures. The post-analytic phase is the final phase of The quality assurance program that should be the laboratory process. This phase culminates followed in the laboratory has 2 components: in the production of a final value, result, or in 1. Internal QC Program: The QC program the case of histology, a diagnostic pathology that is enacted by the laboratory at its report. own level to assess its daily CRITICAL VALUES: TURNAROUND TIME; performance. This program uses AND STAT VS. ROUTINE TEST PRIORITIES continual checks to ensure that the established reliability of the work of the TURNAROUND TIME – is defined laboratory does not fluctuate and that as the reporting interval reports have been validated before they CRITICAL VALUE – is a test result are released. It demonstrates not only that conveys life or death information the precision of results but is also a and is defined for “out of range” test checkpoint at which reagents, results that must be acted upon as instruments, and the proficiency of soon as possible laboratory personnel are assessed. STAT TEST – is defined as quick 2. External Quality Assurance Program: turnaround time, generally an hour or All the errors arising in the laboratory less from specimen receipt until test related to the accuracy and precision of result reporting the process of analysis cannot be ROUTINE TEST – turnaround detected merely by use of the IQC applies to specimens for patients program. Dependence on only without immediate need for results. intralaboratory statistics (as in IQC) can lead to lack of awareness of gradual or sudden changes in the test system, LESSON 2: UNDERSTANDING THE changes that are not under the control CLASSIFICATION OF LABORATORY of the laboratory. REAGENTS Calculation of the Allowable Total Error Types of reagents (ATE) Grignard Reagent The ATE is an analytical quality requirement Tollens' Reagent that sets a limit for the imprecision (random Fehling's Reagent error) and bias (systematic error) that are Collins Reagent tolerable in a single measurement or single test result. Calculated ATE, as performed by the Fenton's Reagent. Solvents SYNTHESIS GRADE CHEMICALS: Catalyst The primary purpose of this involves Enzymes organic synthesis and preparative tasks. LAB GRADE CHEMICALS: These are commonly called UNILAB, Laboratory LABORATORY REAGENTS Reagent (LR Grade chemicals), or Chemically Pure (CP). You can find - A laboratory reagent can be described them in educational or teaching labs. as a substance used to measure, Though their purity levels are high, the detect, or create other substances precise impurity levels remain during a chemical reaction conducted in anonymous. laboratories. In other words, we can say AR GRADE CHEMICALS: These are that these are the substances added to used for high precision work. In this, the laboratory tests to carry out a trace impurities are restricted to the chemical reaction or to check whether lowest possible limits for high precision. any reaction occurs or not. Such reagents get used mainly for analytical applications, research, and quality control. If such reagents meet WHAT IS REAGENT GRADING? the specifications of the American Chemical Society Committee on - the grading system is used to show how Analytical Reagents, it will be denoted pure a substance is. High grades are as AR (ACS). provided to the purest chemicals. As the ACS GRADE CHEMICALS: These level of impurities increases, the grades begin to get low. These impurities can reagents either meet or exceed all the be metal, water, or other chemicals. standards stated by the American Chemical Society (ACS). Their purity - Validated methods specify the grade of levels are exceptionally high, and they reagents to be used. It is important to are used in every domain wherever use specified grades; otherwise, errors quality factor can’t be ignored. So you can arise due to contamination from can easily find them in drug, food, or reagents themselves. On the other medical applications because they have hand, you can incur additional costs in above 95% purity. the analysis if you use a superior grade GENERAL REAGENT (GR) – These of reagent when your analysis does not are the reagent that meets or exceed have such high purity requirements. AR grade specifications. EXTRA PURE GRADE CHEMICALS: These are – suitable for laboratory HOW ARE REAGENTS GRADED? accreditations and also work requiring TECHNICAL GRADE CHEMICALS: compliance with pharmacopoeial You may know this as TG (Tech Grade) standard requirements. or Commercial Grade. It is used for low- grade applications like commercial or industrial purposes. Due to the present impurities, it isn’t utilized for drug, food, or medicinal purposes. You can also find it in qualitative testing. CHEMICALS BASED ON THEIR RESIDUE GRADE SOLVENTS – These APPLICATIONS. solvents suitable for pesticide residue analysis. ELECTRONIC GRADE CHEMICALS: – these have very stringent limits for metallic impurities as required for use in CONCLUSIONS electronic component industry as such as below ppt or ppb levels - Result precision is of utmost importance HPLC GRADE CHEMICALS: These in laboratory testing. The choice of the include adequately pure ion-pair right grade of reagent is essential for the reagents, solvents, and buffers used as application in hand, and it is also the mobile phase of High-Performance important to use reagents from the Liquid Chromatography (HPLC). same source for high precision of SPECTROSCOPY GRADE results. With the provided information on CHEMICALS: Various compounds are reagent grading, you will be able to pick gained through organic synthesis. the correct reagents and ensure the Nuclear magnetic resonance quality of your testing. spectroscopy is the technique used for their structural analysis. DIFFERENT TYPES OF PURE WATER FOR THE LABORATORY ACIDS ARE GRADED DIFFERENTLY. YOU CAN SEE A FEW EXAMPLES OF IT. SUPRAPUR (E – MERCK) – These have high purity grade acids having metallic impurities in ppb range. ENVIRONMENTAL GRADE (ANACHEMIA) – These include high purity acids refined through sub- boiling distillation ENVIRONMENTAL GRADE PLUS Type 1 Water (Ultrapure Water) (ANACHEMIA) – Here, you can find acids that get produced by additional Type I grade water, also known as Ultrapure distillation of environmental grade acids. Water, is the purest form of water to be produced. It’s used for the most critical applications and advanced analytical PESTICIDE RESIDUE ANALYSIS procedures. APPLICATIONS This includes: HR OMNI GRADE SOLVENTS (EMD) – These have GC impurities below • Cell and Tissue Cultures ppt/ppb levels as tested by ECD • Liquid Chromatography, including High detection. Performance Liquid Chromatography NANO GRADE – These meet ACS (HPLC) grade specifications. They are used for • Gas Chromatography extraction and pre-concentration • Inductively Coupled Plasma Mass applications. Spectrometry (ICP-MS) • Molecular Biology - Type I can also be used in applications water' through to 'drinking water' and that require Type II water. This is quite a provides a valuable, non-specific common practice that can help to avoid indication of the level of ions in the the generation of by-products during water. applications. THE RESISTIVITY OF WATER Type 2 Water - Reported as Mega-Ohms per centimeter Type II water grade doesn’t have the same (MO-cm) at 25oC, resistivity is related pureness of Type I, but still maintains high to conductivity: a high resistivity levels of purity. It is a good feed water for equals a low conductivity. As such, it clinical analyzers as the calcium build-up is also provides a measure of the reduced with this water type. water's ionic content. Unlike conductivity, resistivity is primarily used It can also be used in applications such as: in the assessment of ultrapure water. • General Lab Practices ORGANIC COMPOUND LEVELS IN WATER • Microbiological Analysis and preparation • Electrochemistry - Organic compounds can exist in water • FAAS (Flame ) in numerous forms and so measuring • General Spectrophotometry every single one individually is - It can also be used as feed water for Type I impractical. Instead, the most useful water production. indicator is considered to be the total organic carbon (TOC) content of the Type 3 Water (RO Water) solution. This is measured via a process - Type III grade water, also known as that oxidizes the organic compounds RO water, is water produced through present and then quantifies the the purification technology reverse oxidation products generated. TOC is as osmosis. Of all the pure water types it close as we can currently get to a has the lowest level of purity, but is 'universal indicator' for the presence of typically the starting point for basic lab organic impurities. applications, such as cleaning BIOLOGICAL CONTAMINATION OF WATER glassware, heating baths or media preparation. It can also be used as a - The presence of biological contaminants feed water for Type I water production. such as bacteria and other microorganisms is a common issue in untreated water. Bacterial levels HOW IS LABORATORY WATER PURITY reported as colony forming units per ASSESSED AND DEFINED? milliliter (CFU/ml) are kept low via filtration, UV treatment and sterilant solutions. THE CONDUCTIVITY OF WATER THE PRESENCE OF COLLOIDS IN LAB - Conductivity is reported as WATER microSiemens per centimeter (µS/cm) at 25oC and is the reciprocal of resistivity - Suspended particles can cause water and provides a measure of a fluid's turbidity (measured in Nephelometric ability to conduct electrical current. Turbidity Units, NTU) and are therefore Conductivity is typically used when filtered out of laboratory water as much assessing water ranging from 'raw as possible. This colloidal material is defined as being less than 0.5 µm in AMERICAN SOCIETY FOR TESTING AND size and may contain iron, silica, MATERIALS (ASTM) aluminium or organic materials. The Fouling Index (FI) is frequently used to - The ASTM uses D1193-06 and has four estimate the potential of water to block grades of water (see table below). filters under 0.45 µm filter conditions. - *Requires use of 0.2 μm membrane filter; **Prepared by distillation; BOARDS SETTING THE STANDARDS OF ***Requires the use of 0.45 μm WATER PURITY membrane filter.
WATER QUALITY PARAMETERS FOR ASTM
Clinical and Laboratory Standards Institute TYPES (CLSI) – formerly NCCLS Parameter Type Type Type Type IV - As of 2006, the CLSI has moved away I* II** III*** from the typical Type I, II and III Conductivity 0.056 1.0 0.25 5.0 designations, instead preferring to (μS/cm) at 25oC, suggest that water be simply ‘fit for max purpose’, and only describes one grade in significant detail: Clinical Reagent Resistivity (MΩ- 18.0 1.0 4.0 0.2 Laboratory Water. The CLSI has also cm) at 25oC, max briefly outlined other grades in less pH at 25oC – – – 5.0–8.0 detail, such Special Reagent Water TOC (μg/l), max 50 50 200 No limit (SRW) and instrument feed water. Sodium (μg/l), 1 5 10 50 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) max Silica (μg/l), max 3 3 500 No limit Parameter Grade Grade Grade Chloride (μg/l), 1 5 10 50 1 2 3 max pH value at 25 C – o – 5.0–7.0 Conductivity 0.1 1.0 5.0 (μS/cm) at 25oC, max Oxidisable matter – 0.08 0.4 Oxygen content (mg/l), max Absorbance at 254 nm 0.001 0.01 – and 1 cm optical path length, absorbance units, max. Residue after – 1 2 evaporation on heating at 110oC (mg/kg), max Silica (SiO2) content 0.01 0.02 – (mg/l), max