Clinical Laboratory Science is defined as the health profession that provides laboratory services and information needed for the diagnosis and treatment of diseases. According to the Clinical Laboratory Improvement Act (CLIA) 1988, USA, a PATHOLOGY LABORATORY is a facility for examination of materials derived from the human body for which PURPOSE?

PATHOLOGY is defined as a branch of biological science. Which of the following CORRECTLY describes what Pathology deals with?

The FUNCTIONAL COMPONENTS of a Clinical Laboratory include several departments. Which of the following lists ALL the correct functional components mentioned for a clinical laboratory?

Under the CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) 1988 USA, pathology laboratories are classified based on the COMPLEXITY of tests they perform. WAIVED TESTS (Low Complexity) are defined as tests that can be performed at home because they are:

HIGH COMPLEXITY LABORATORIES perform tests listed under moderate complexity AND additional high complexity tests. Which of the following is EXCLUSIVELY performed in a HIGH COMPLEXITY laboratory?

EVIDENCE BASED MEDICINE (EBM) and EVIDENCE BASED LABORATORY MEDICINE are important concepts. Which statement CORRECTLY defines Evidence Based Medicine?

For a STANDARDIZED CLINICAL LABORATORY SETUP, which of the following is an essential requirement for LABORATORY PREMISES?

FIRE PREVENTION FACILITIES are essential in a clinical laboratory. Which of the following fire extinguisher should NOT be used on an ELECTRICAL FIRE?

INCOMPATIBLE CHEMICALS in a laboratory can cause dangerous reactions when they come into contact with each other. Which combination of chemicals is INCORRECTLY listed as incompatible?

According to OSHA (Occupational Safety and Health Administration) bloodborne pathogen standards, laboratory employees must be placed into one of THREE GROUPS based on their occupational exposure. Which group has ALL employees with occupational exposure to blood or other potentially infectious material?

The risk of becoming infected with HEPATITIS B VIRUS (HBV) from a NEEDLESTICK INJURY is significantly higher than for other blood-borne pathogens. What is the risk percentage for HBV infection from a single needlestick exposure?

IMPORTANT INSTRUCTIONS TO MINIMIZE INFECTIONS in laboratory workers include specific rules about pipetting. Which of the following statements is CORRECT according to laboratory safety guidelines?

When FINISHING WORK in the laboratory at the end of the day, what is the CORRECT ORDER of steps to follow when leaving the laboratory?

TRUE OR FALSE regarding laboratory safety: Which statement is CORRECT about NEEDLES and HEPATITIS B in the laboratory?

LABORATORY SAFETY SIGNS are standardized pictograms for various hazardous substances. Which symbol (sign) represents a CORROSIVE substance?

STORAGE FACILITIES in a clinical laboratory must meet specific safety requirements. Which statement about STORAGE OF FLAMMABLE CHEMICALS is CORRECT?

DECONTAMINATION of laboratory materials uses AUTOCLAVING as the PREFERRED METHOD. When an autoclave is unavailable, which ALTERNATIVE METHODS are recommended?

SODIUM HYPOCHLORITE is described as a universal disinfectant in clinical laboratories. What concentration of sodium hypochlorite is recommended for BLOOD SPILLAGE where LARGE AMOUNTS OF ORGANIC MATTER are present?

WASTE MANAGEMENT in a pathology laboratory categorizes waste into three distinct types. A SHARP OBJECT such as a used hypodermic needle falls under which category of waste?

STANDARD WASTE DISPOSAL PROCEDURE requires different disposal methods for different types of laboratory waste. Which statement about disposal of LIQUID WASTE (blood, plasma, serum, CSF) is CORRECT?

ELECTRICAL INSTALLATIONS in the clinical laboratory must meet specific safety standards. Which statement about electrical installation safety is CORRECT?

FIRST AID for ACID SPLASHES ON SKIN requires immediate specific action. Which is the CORRECT first response to an acid splash on the skin in the laboratory?

LABORATORY FIRST AID KIT should contain specific items. Which item in the first aid kit is used as a DISINFECTANT SOLUTION?

FACTORS THAT REDUCE PRODUCTIVITY of a laboratory are multiple and varied. Which of the following is NOT listed as a factor that INCREASES laboratory productivity?

LABORATORY MATHEMATICS — SI UNITS (Système International d'Unités). Which is the correct SI unit for MASS and what are its submultiples?

A MOLE (mol) is the SI unit for the amount of substance. How is a MOLE defined in practical terms for laboratory use?

TEMPERATURE CONVERSION between Celsius and Fahrenheit is important in laboratory mathematics. What is the FORMULA to convert FAHRENHEIT to CELSIUS?

CONVENTIONAL UNITS are still commonly used in many laboratories. The CONVERSION FACTOR for GLUCOSE from mg/dL (conventional) to mmol/L (SI units) is 0.0555. If a glucose result is 180 mg/dL, what is the equivalent in mmol/L?

NORMALITY (N) is a concentration unit used in laboratory chemistry. Which statement about NORMALITY is CORRECT?

IONIC STRENGTH of a buffer solution is an important concept in laboratory chemistry. For a 0.5 mol/L NaCl solution, what is the IONIC STRENGTH?

LABORATORY REGULATIONS require pathology laboratories to be certified by specific agencies. In the USA, which THREE TYPES OF AGENCIES can certify a pathology laboratory?

MEDICO-LEGAL PROBLEMS in clinical laboratories: Under the Consumer Protection Act (CPA) 1986, India, which entities can be SUED by patients for deficiency in service?

RESPONSIBILITIES OF THE LABORATORY WORKER include specific professional duties. Which statement about the laboratory worker's CONFIDENTIALITY obligation is CORRECT?

COMPRESSED AND LIQUEFIED GASES are used in clinical laboratories. Which safety requirement for GAS CYLINDERS is CORRECT?

THE MSDS (MATERIAL SAFETY DATA SHEET) is an essential laboratory safety document. What information must an MSDS provide for each chemical?

HEALTH AND SAFETY OF STAFF in the clinical laboratory requires an IMMUNIZATION PROGRAM. Which immunization is specifically mentioned as relevant to laboratory workers?

BIOLOGICAL SAFETY CABINETS (BSCs) in the laboratory are classified based on their protection level. According to the text, BSCs and FUME CUPBOARDS should be:

PRECAUTIONARY MEASURES FOR FIRE PREVENTION require laboratory workers to know how to respond. During a FIRE ESCAPE from a laboratory, what is the safest procedure?

The IMPORTANCE OF TEST REPORTS in clinical laboratory practice: Test reports are described as useful to the physician for several purposes. Which of the following is NOT one of the stated purposes of test reports?

LABORATORY SAFETY requires that BIOLOGICAL SAFETY CABINETS (BSCs) are used appropriately. According to Table 1.4 (Equipment to eliminate or reduce hazards), which hazard does a SPLATTER SHIELD specifically address?

PRECAUTIONS FOR PREVENTION OF TRANSMISSION OF PATHOGENS: According to OSHA, which additional items beyond blood and blood components are classified as POTENTIALLY INFECTIOUS and must be treated accordingly?

WATER SUPPLY safety in the clinical laboratory requires specific precautions. Which statement about laboratory water supply is CORRECT?

RADIOACTIVE WASTE disposal in the laboratory requires special procedures. What is the correct procedure for LIQUID RADIOACTIVE WASTE?

LABORATORY MATHEMATICS — PERCENT SOLUTION: A 10 g/dL (w/v) sodium hydroxide solution means how many grams of NaOH dissolved in what volume?

The SAFETY INSPECTION TEAM in the laboratory has a specific responsibility. What is their PRIMARY duty according to the text?

MICROBIOLOGY WASTE DISPOSAL requires specific autoclaving procedures. Which of the following items MUST be autoclaved before disposal according to the text?

LABORATORY MATHEMATICS — GAS CONCENTRATION: Common units for ELECTROLYTE CONCENTRATIONS in clinical laboratories are expressed in milliequivalents per liter (meq/L). If sodium concentration is 138 mg/dL and the equivalent weight of sodium is 23, what is the concentration in meq/L?

ACCIDENTAL SWALLOWING of laboratory reagents requires specific first aid. If a laboratory worker accidentally SWALLOWS A CORROSIVE ACID, what is the CORRECT immediate response?

MEDICO-LEGAL: In India under the Consumer Protection Act 1986, what is the TIME LIMIT for filing a consumer complaint against a pathology laboratory for deficiency in service?

LABORATORY PREMISES require that bench surfaces have specific resistance properties. Additionally, regarding ELECTRICAL SAFETY, which common cause of laboratory fires relates to REFRIGERATOR USE?

According to the CLIA classification, which of the following tests is correctly listed as a WAIVED (Low Complexity) test that can be performed even outside a formal laboratory setting?

MODERATE COMPLEXITY laboratories perform tests that are categorized under specific criteria. Which of the following is CORRECTLY listed as a MODERATE COMPLEXITY test?

FUTURE TECHNOLOGIES mentioned as dominating HIGH COMPLEXITY laboratories include several innovations. Which of the following is NOT listed as a future technology for high complexity laboratories?

ADEQUATE VENTILATION is an essential feature of the clinical laboratory premises. What is the recommended GENERAL ILLUMINATION level for a standardized laboratory?

HAND BASINS in the clinical laboratory are an essential hygiene requirement. How many hand basins are required at minimum per laboratory room?

SERVICES in a clinical laboratory include utilities for safe working. Which services must EACH LABORATORY ROOM have an adequate supply of, with proper inspection and maintenance programs?

PHYSICAL HAZARDS in the clinical laboratory include equipment-related hazards. According to the text, what SPECIFIC HAZARD is associated with WATER BATHS?

LABORATORY SAFETY guidelines state that APPROPRIATE PLASTICWARE should replace glassware in certain situations. Why is this recommendation made?

According to laboratory safety guidelines, which statement about DISINFECTANTS is CORRECT regarding their use when DILUTING BULK QUANTITIES?

According to the STANDARD WASTE DISPOSAL PROCEDURE, what should be done with REUSABLE MICROTIPS, MICROCUPS, SPECIMEN CONTAINERS, GLASSWARE, AND PLASTICWARE that have been used in the laboratory?

MINOR BURNS in the laboratory should be managed with a specific immediate first aid sequence. What is the CORRECT immediate first aid for MINOR BURNS?

ACETYLENE gas has specific incompatibilities. With which chemicals is ACETYLENE incompatible according to laboratory safety guidelines?

According to the Dr. Brown's Biosafety Quiz, which of the following statements about AIDS (HIV) transmission is CORRECTLY identified as TRUE?

LABORATORY SAFETY regarding CENTRIFUGE USE includes specific inspection requirements. What should be inspected INSIDE THE CENTRIFUGE CUP before centrifugation?

RUBBER GLOVES AND FACE MASKS are specifically required for which laboratory task according to safety instruction #11?

The TEXT mentions that ALL LABORATORY PERSONNEL — both laboratory workers AND NON-LABORATORY WORKERS — should receive specific safety information. What information should both groups be instructed about?

MEDICO-LEGAL: A doctor giving service FREE OF CHARGE at a CHARITABLE HOSPITAL or MEDICAL CAMP has a specific legal status under CPA 1986. What is their status?

LABORATORY MATHEMATICS — what is the SI UNIT for ELECTRICAL CURRENT and for AMOUNT OF SUBSTANCE respectively?

According to Table 1.6, what NUMERICAL VALUE is represented by the prefix NANO (n)?

In the SI UNIT TABLE (Table 1.9), what is the NORMAL RANGE for CREATININE in SI units (µmol/L) and what is the CONVERSION FACTOR from mg/dL to µmol/L?

The CONSUMER PROTECTION ACT 1986 applies to laboratories. When a laboratory OWNER purchases instruments, equipment, and diagnostic kits for the laboratory, what is their legal status under CPA?

LABORATORY MATHEMATICS — NON-SI UNITS used in the textbook (Table 1.7). What is the equivalent of ONE HOUR in SECONDS (the SI unit of time)?

The LABORATORY MANAGEMENT SYSTEM (LMS) described in Fig. 1.1 shows the complete flow of patient management. Which step in the LMS directly follows SPECIMEN COLLECTION?

MEDICAL NEGLIGENCE is defined in the context of medico-legal problems in clinical laboratories. Which definition CORRECTLY describes medical negligence?

PRECAUTIONS REGARDING FIRE AND EXPLOSIONS in the laboratory specify several important rules. Which of the following is a CORRECT precautionary rule?

The LABORATORY WORKER'S RESPONSIBILITY includes specific ETHICAL DUTIES. Which statement about the relationship between truth-telling and patient outcomes is CORRECTLY stated in the text?

LABORATORY MATHEMATICS — what is the ATOMIC WEIGHT of CALCIUM (Ca) according to the ATOMIC WEIGHT TABLE (Table 1.8)?

GAS CONCENTRATION AND PRESSURE units are used in laboratory measurements. What is the COMMON UNIT OF EXPRESSION for PARTIAL PRESSURE of a gas according to the text?

In the context of MEDICO-LEGAL ISSUES, what happens when a COMPLAINT IS FILED before a consumer forum and the DEFENDANT DOCTOR receives notification?

LABORATORY SAFETY requires proper handling of NEEDLES AFTER USE. What is the CORRECT procedure for needle disposal immediately after drawing blood?

The concept of a LABORATORY MANAGEMENT SYSTEM (LMS) is described in the text. What does QUALITY CONTROL in the LMS specifically check for?

The ATOMIC WEIGHT TABLE (Table 1.8) lists several elements. What is the ATOMIC WEIGHT of IRON (Fe) and its ATOMIC NUMBER?

LABORATORY REGULATIONS specify that BLOOD BANKS require inspection by specific agencies in addition to standard laboratory certifying bodies. Which ADDITIONAL AGENCY must inspect Blood Banks?

According to the TEXT, what is the CORRECT SEQUENCE for a laboratory technician to handle a situation where their SKIN COMES INTO CONTACT WITH PHENOL?

STUDENT RESPONSIBILITIES in the clinical pathology laboratory include bringing specific items. Which of the following is listed as a required PRACTICAL REQUIREMENT for each laboratory practical session?

ALKALI SPLASH IN THE EYES is described as more dangerous than acid splash. What is the CORRECT first aid for ANY ACID OR ALKALI splash in the eyes?

LABORATORY SAFETY — SAFE DRINKING WATER: The text mentions that laboratory workers should always have access to safe drinking water. Why is it important to ensure there is NO CROSS-CONNECTION between laboratory water sources and drinking water?

The STUDENT RESPONSIBILITIES section specifies what students should write in their JOURNAL for each practical experiment. Which of the following elements should be included in the journal entry?

LABORATORY REGULATIONS — According to the text, what specific form of LEGAL NOTICE can a laboratory owner receive from a PATIENT OR VOLUNTARY ORGANIZATION demanding explanation about treatment or an alleged injury?

The text states that APPROPRIATE DISINFECTANTS SHOULD BE USED CORRECTLY. Which of the following disinfectants is used for DECONTAMINATING ALL SURFACES (not just routine cleaning) at a SPECIFIC CONCENTRATION?

LABORATORY FACTORS — what is the MAIN FUNCTION of a CLINICAL PATHOLOGY LABORATORY as stated specifically in the text?

IMPORTANT NOTE in the text regarding the AUTOCLAVE and INCINERATION of contaminated waste states specific regulatory requirements. What approval is required for INCINERATION of contaminated waste?

LABORATORY MATHEMATICS — what does the term MOLARITY mean and how does 1 mol/L relate to millimoles and micromoles per litre?

According to the TEXT, what is the recommended action for PROPERLY DISCARDING specimens of BLOOD, PLASMA, or SERUM — and in which specific vessels should they be decanted?

LABORATORY MATHEMATICS: If a sample contains a TRIGLYCERIDE level of 1.50 mmol/L (SI), what is the equivalent value in mg/dL (conventional units)? The conversion factor from mg/dL to mmol/L is 0.0114.

According to the NOTE in the WASTE MANAGEMENT section, what is the AUTOCLAVE HOLDING TIME for decontaminating laboratory waste?

In the context of LABORATORY SAFETY, APPROPRIATE DISINFECTANTS should be used correctly. What is the MAIN REASON that sodium hypochlorite is described as CORROSIVE TO METAL?

MEDICO-LEGAL: Which statement about the legal duty to maintain CONFIDENTIALITY of patient records in relation to BLOOD BANK activities is CORRECT?

According to the LABORATORY MANAGEMENT SYSTEM (LMS) and the laboratory setup guidelines, what is meant by STANDARDIZATION of INSTRUMENTATION in achieving accurate test results?

Summarizing the COMPLETE CHAPTER: The laboratory environment can be a hazardous place to work. According to the opening statement of the LABORATORY SAFETY section, what is SAFETY described as in terms of technical excellence?

According to the text, the laboratory plays an important role beyond diagnosis and treatment. Which ADDITIONAL ROLE of the laboratory is specifically mentioned?

LABORATORY SAFETY: The text lists COMMON CAUSES OF FIRES in the laboratory. Which of the following combination lists ALL the common fire causes correctly?

According to the INCOMPATIBLE CHEMICALS section, ACETONE is incompatible with which chemical mixture?

LABORATORY SAFETY: What protective action should be taken when CONTAINERS OR GLASSWARE FILLED WITH CONTAMINATED MATERIALS ARE DROPPED AND BROKEN?

LABORATORY MATHEMATICS — ATOMIC WEIGHT TABLE: What is the atomic number and atomic weight of PHOSPHORUS (P)?

LABORATORY SAFETY: The text discusses SAFE PRACTICES for handling specimens. Which rule specifically addresses EATING, DRINKING, AND APPLYING COSMETICS in the laboratory?

LABORATORY MATHEMATICS — CHOLESTEROL CONVERSION: A patient's total cholesterol is 5.18 mmol/L (SI). What is the equivalent value in mg/dL using the conversion factor 0.0259 from mg/dL to mmol/L?

WASTE DISPOSAL: The standard procedure for TISSUES collected in FORMALIN requires which specific disposal method?

LABORATORY SAFETY: What is the CORRECT procedure to follow when a LABORATORY WORKER SUSTAINS BLEEDING from a wound caused by a laboratory accident?

LABORATORY MATHEMATICS: The BUN (Blood Urea Nitrogen) has a specific SI unit. According to Table 1.9, what is the CONVERSION FACTOR from mg/dL to mmol/L for BUN, and what is its NORMAL SI RANGE?

LABORATORY SAFETY: The text states that APPROPRIATE PROTECTIVE EQUIPMENT should NOT be worn outside the work area. What should happen to protective gear when a laboratory worker REMOVES it?

LABORATORY SAFETY: FACIAL BARRIER PROTECTION should be used in which specific laboratory situation?

LABORATORY SAFETY — TWO-PERSON RULE: The text specifically mentions this rule in the health and safety section. What does the TWO-PERSON RULE state?

LABORATORY SAFETY: What specific PPE is required when LABORATORY COATS are used as protective devices for eyes, nose, and mouth during high-risk procedures?

According to the LABORATORY REGULATIONS section, what obligation does OSHA impose on employers regarding laboratory workers' protection against BLOOD-BORNE PATHOGENS?

LABORATORY MATHEMATICS — ATOMIC WEIGHT: What is the ATOMIC WEIGHT of MERCURY (Hg) as listed in Table 1.8?

MEDICO-LEGAL: The text discusses what should happen when a doctor receives a SUMMONS from a consumer forum. What does Section S-27 of the Civil Procedure Code state about this process?

STORAGE FACILITIES: The text specifies that storage facilities for general laboratory items should be secure against specific hazards. Which hazards must storage shelves protect against?

LABORATORY MATHEMATICS: The text discusses GAS CONCENTRATION UNITS. What are the common units for expressing GAS CONCENTRATIONS?

The STUDENT RESPONSIBILITIES section mentions that students must NOT TALK during the practical. Additionally, when should students CLOSE GAS TAPS and DISCONNECT ELECTRICAL CONNECTIONS?

LABORATORY SAFETY: What is the CORRECT procedure when a laboratory worker ACCIDENTALLY SWALLOWS AN INFECTIOUS SPECIMEN?

LABORATORY MATHEMATICS: What is the MOLECULAR WEIGHT of SODIUM CHLORIDE (NaCl) and how many grams are needed to prepare 1 LITER OF 1 MOLAR NaCl SOLUTION?

MEDICO-LEGAL: The text discusses the role of a PATHOLOGIST in maintaining confidentiality for BLOOD BANK activities. What specific recommendation is made about writing details on BLOOD BOTTLES?

TOTAL QUALITY MANAGEMENT (TQM) — According to the text, a pathology laboratory management committed to meeting customer needs should approach each task by answering FIVE QUESTIONS. What is the FIRST question that must be answered?

TOTAL QUALITY MANAGEMENT FRAMEWORK: The traditional framework for managing quality in a healthcare laboratory emphasizes establishment of four components. What are these FOUR COMPONENTS?

QUALITY LABORATORY PROCESSES (QLPs) — The text lists STANDARD DIMENSIONS for planning and designing a laboratory. What is the specified LABORATORY COUNTER WIDTH?

QUALITY ASSURANCE (QAS) — The WHO definition of Quality Assurance summarizes it as a set of specific criteria. Which summary CORRECTLY represents the WHO definition?

QUALITY ASSURANCE — The text lists FIVE ESSENTIAL ELEMENTS of a quality assurance program. What is the FIRST essential element?

QUALITY CONTROL (QC) — The text provides a specific definition of QC. Which statement MOST ACCURATELY defines Quality Control?

PREANALYTICAL ERRORS — According to the text, what PERCENTAGE of laboratory errors can be attributed to the PREANALYTICAL PHASE of specimen testing?

ANALYTICAL VARIABLES — The text defines TRUENESS and ACCURACY as related but distinct concepts. What is the CORRECT definition of ACCURACY according to the text?

ANALYTICAL VARIABLES — The text defines SENSITIVITY and provides a formula. What does SENSITIVITY measure and what is its FORMULA?

SPECIFICITY — The text defines analytical specificity and its formula. A test has 90% SPECIFICITY. What does this mean in clinical terms?

REFERENCE AND CONTROL MATERIALS — The text distinguishes between PRIMARY and SECONDARY REFERENCE MATERIALS. What is the role of PRIMARY REFERENCE MATERIAL?

QC CHART DEFINITIONS — The text defines STANDARD DEVIATION (SD). What is the FORMULA for calculating Standard Deviation?

LEVEY-JENNING CHARTS — The text explains the GAUSSIAN CURVE (normal distribution) for interpreting QC charts. What PERCENTAGE of values falls within FIRST STANDARD DEVIATION (1SD) from the mean?

LEVEY-JENNING CHART PATTERNS — The text describes DRIFT in QC values. What does DRIFT indicate in the context of Levey-Jenning charts?

QC CHART DEFINITIONS — The text defines SHIFT in the context of quality control charts. What is a SHIFT in QC chart terms?

QC TERMINOLOGY — The text defines OUTLIERS and BIAS. What are OUTLIERS in QC chart interpretation?

COEFFICIENT OF VARIATION (CV) — The text gives the formula for CV. If the mean glucose is 98 mg/dL and the SD is 2.5 mg/dL, what is the CV?

PERCENT BIAS — The text explains the importance of determining % BIAS. Using the formula from the text, if the TRUE VALUE of urea nitrogen control is 35 mg/dL but the laboratory REPORTED VALUE averages 32 mg/dL, what is the % BIAS?

WESTGARD MULTIRULE CHARTS — What does the WARNING RULE 1₂s indicate in Westgard multirule interpretation?

WESTGARD RULES — What does the REJECTION RULE 1₃s indicate and what type of error does it detect?

WESTGARD RULES — What does the REJECTION RULE 2₂s indicate?

WESTGARD RULES — What does the REJECTION RULE R₄s indicate and what type of error does it detect?

WESTGARD RULES — REJECTION RULE 4₁s detects which type of error and what is its definition?

WESTGARD RULES — The REJECTION RULE 10x requires how many consecutive observations on one side of the mean, and what does it indicate?

CUSUM CHARTS — The text describes Cusum charts as providing BETTER DETECTION of certain types of errors compared to Levey-Jenning charts. For which type of error is the Cusum chart SPECIFICALLY MORE EFFECTIVE?

REFERENCE RANGE — The text gives a specific formula for calculating REFERENCE RANGE. If the mean fasting blood glucose is 90 mg/dL and 1 SD = 10 mg/dL, what is the REFERENCE RANGE?

SIX SIGMA PROCESS — The text defines Six Sigma. What is the DMAIC methodology used in Six Sigma and what does it stand for?

FIVE Q FRAMEWORK — The text describes the 'Five Q' framework for managing quality. In this framework, what does QP (Quality Planning) provide?

FINANCIAL ASPECTS — The text defines MANAGEMENT in the context of laboratory financial management. Which statement CORRECTLY defines Management?

ROOT CAUSE ANALYSIS (RCA) — The ISHIKAWA DIAGRAM (Fish Bone Diagram) uses FOUR M CATEGORIES as starting points. What are the four M categories?

ROOT CAUSE ANALYSIS — The text explains how to perform RCA using the 'ASK WHY 5 TIMES' method. Using the text's example of a broken beaker and injured technician, what was the FINAL ROOT CAUSE identified at Question 5?

ACCREDITATION AND CERTIFICATION — The text defines ACCREDITATION. Which statement CORRECTLY defines accreditation?

ISO STANDARDS — The International Organization for Standardization (ISO) is described in the text. Where is ISO LOCATED and how many TECHNICAL COMMITTEES does it have?

ISO/IEC 17025:2005 — The text distinguishes ISO/IEC 17025 from ISO 9001. What is the KEY DIFFERENCE between these two standards?

ISO 15189:2007 — The text states that ISO 15189:2007 is specifically for MEDICAL LABORATORIES. What was the REASON that ISO 15189 was created when ISO 17025 already existed?

QUALITY COUNCIL OF INDIA (QCI) — The text states that QCI is governed by a Council of how many members and who is the Chairman appointed by?

NABH — National Accreditation Board for Hospitals and Healthcare Providers. The text states that NABH's accreditation is recognized internationally. India became the WHICH NUMBER country to join the ISQUA (International Society for Quality in Health Care) accreditation group?

NABL (National Board for Testing and Calibration Laboratories) — The text classifies laboratories by size for determining fee structure. What is the patient volume that defines a LARGE LABORATORY?

NABL QUALIFICATION NORMS — What is the qualification required for a technical person performing tests in a NABL-accredited laboratory (Technical Staff)?

CLIA 1988 — The text states that the CLIA '88 is an amendment to which original Act, and what is its PURPOSE?

CLSI (Clinical and Laboratory Standard Institute) — The text provides CLSI's VISION and MISSION statements. What is the VISION of CLSI?

FMEA AND FRACAS — The text discusses these two risk management tools. What does FRACAS stand for and what does it measure?

COST OF CONFORMANCE AND NON-CONFORMANCE — The text describes two types of quality costs. What are PREVENTION COSTS as stated in the text?

ORGANIZATION AND OPERATION OF THE LABORATORY — The text describes three essential requirements for effective clinical laboratory operation. What are these THREE REQUIREMENTS?

EMPLOYEE'S PERSONAL FILE RECORD — The text lists components of an employee's personal record. Which item is SPECIFICALLY INCLUDED in the personal file?

VARIOUS WAYS OF MAINTAINING INTERNAL QUALITY CONTROL — The text lists five main ways of maintaining IQC. What is the SECOND listed way of maintaining internal quality control?

TYPES OF ERRORS IN QC PROGRAM — The text categorizes errors into three types: INTRINSIC, SYSTEMATIC, AND RANDOM. What does INTRINSIC ERROR include and how is it CORRECTED?

EXTERNAL QUALITY CONTROL (EQC) — The text describes the basic operation of External QC programs. What happens when the DIFFERENCE BETWEEN REPORTED VALUE AND TRUE VALUE is STATISTICALLY SIGNIFICANT in an EQC program?

HCFA/CLIA PROFICIENCY TESTING CRITERIA — According to Table 6.8, what is the acceptable performance criterion for GLUCOSE in routine chemistry proficiency testing?

ISO 15189:2007 DOCUMENTATION — The text lists 83 documentation requirements for medical laboratories. What is requirement NUMBER 1 specifically stated in the text?

QUALITY CONTROL — The text describes the relationship between INTERNAL QC and EXTERNAL QC. Which statement CORRECTLY describes this relationship?

TWO PHASES OF INTERNAL QUALITY CONTROL — The text describes two phases of IQC. What are these TWO PHASES and what does the PREVENTIVE PHASE involve?

ANALYTICAL PROCEDURE VARIANCE — The text lists reasons why analytical procedure variance may be observed. Which of the following is NOT listed as a cause of analytical procedure variance?

RANDOM ANALYTICAL ERRORS — The text lists examples of RANDOM ANALYTICAL ERRORS. Which of the following is correctly identified as a random error according to the text?

POSTANALYTICAL ERRORS — The text discusses post-analytical errors and how to prevent them. What are postanalytical errors and how should they be PREVENTED?

SPECIMEN COLLECTION ERRORS — The text states that PROLONGED TOURNIQUET APPLICATION causes specific physiological changes. What happens when a tourniquet is applied too long?

SPECIMEN CONTAINER SELECTION — The text discusses specific container issues affecting laboratory results. Which statement about PLASTIC CONTAINERS is CORRECT according to the text?

DETERMINANT (SYSTEMATIC) ERRORS — The text explains that systematic errors can be classified as CONSTANT or PROPORTIONAL. What is the difference between these two types of systematic error?

QUALITY ASSESSMENT (QA) — The text defines QA and notes four specific measures. According to the text's NOTE, Quality Assurance requires identification of problems through which process, and elimination through which process?

HCFA/CLIA PROFICIENCY TESTING — According to Table 6.8, what is the acceptable performance criterion for BLOOD GAS pH in proficiency testing?

ANALYTICAL VARIABLES — DRUG INTERFERENCE — The text distinguishes between two types of drug interference. What is the difference between METHODOLOGIC and PHYSIOLOGIC drug interference?

WESTGARD RULES PROCEDURE — The text describes a decision-making procedure using Westgard rules. When BOTH control observations fall within the 2SD range, what should the laboratory do?

SIX SIGMA — The text gives specific sigma performance levels. What SIGMA METRIC VALUE is considered 'BEST' performance and what is considered 'WORST' performance?

GRAPHICAL ASSESSMENT OF PROCESS CAPABILITY — The text describes a graphical tool using sigma metrics. The Y-axis represents which measurement and the X-axis represents which measurement?

CONTROL OF PATIENT DATA — The text discusses methods of using PATIENT DATA for quality control. What is the LIMIT CHECKS method for QC using patient data?

ADEQUATE SPINNING OF SPECIMEN — The text discusses the consequences of INADEQUATE SPINNING of a sample tube. What specific analytical effects does inadequate spinning cause?

DOCUMENTATION REQUIREMENT — ISO 15189:2007 Requirement NUMBER 57 addresses the RECORD OF REPORTS. What should the laboratory ensure about REPORT ATTRIBUTES according to this requirement?

GENERAL PRINCIPLES OF ROOT CAUSE ANALYSIS — According to the text, how many GENERAL PRINCIPLES of RCA are listed, and what does principle 5 state?

RCA CAUSAL TREE — The text mentions that the RCA beaker example had a CAUSAL TREE. How many types of causes were identified and how many were HUMAN errors vs ORGANIZATIONAL factors?

ISO 15189:2007 TERMS AND DEFINITIONS — The text defines CRITICAL VALUES. What is the specific definition of Critical Values in ISO 15189:2007?

ISO 15189:2007 TERMS AND DEFINITIONS — The text defines TURNAROUND TIME. What is the ISO 15189:2007 definition of Turnaround Time?

BUILDING A POSITIVE CULTURE — The text discusses components that help build a positive culture in a laboratory organization. Which is mentioned as the FIRST component for building positive culture?

MAKE-VERSUS-BUY DECISIONS — The text lists six parameters that mainly contribute to make-versus-buy decisions. What is the FIRST parameter listed?

UTILIZATION MANAGEMENT — The text describes three types of laboratory UTILIZATION problems. Which statement CORRECTLY defines MAL-UTILIZATION?

ISO 15189:2007 DEFINITIONS — The text defines METROLOGICAL TRACEABILITY. What is the ISO 15189:2007 definition of Metrological Traceability?

QUALITY ASSURANCE — According to the text, the ANALYTICAL CYCLE is described as complex with preanalytical and postanalytical elements. What does the text state about WHO should realize that quality assurance is their MUTUAL RESPONSIBILITY?

INTERNAL QC CLINICIAN REQUIREMENTS — The text lists eight requirements that IQC must meet for clinicians. What is REQUIREMENT NUMBER 1 from this list?

VALIDATION OF METHODS — The text states that the AIM of validation of test and calibration methods is to DEMONSTRATE WHAT?

PROFICIENCY TESTING SUCCESS CRITERIA — The text gives specific criteria for a laboratory to be considered TOTALLY SUCCESSFUL in a proficiency testing category. What are these criteria?

ESSENTIAL ELEMENTS OF QAS — According to the text, TECHNICAL PROCEDURES for quality assurance involve control of PREANALYTICAL VARIABLES. Which item is listed as a preanalytical variable to be controlled in the SPECIMEN TRANSPORT category?

ISO 15189:2007 TERMS — The text defines BIOLOGICAL REFERENCE INTERVAL. Which definition CORRECTLY describes this ISO term?

ISO 15189:2007 TERMS — The text defines MATRIX EFFECT. What is the ISO 15189:2007 definition of Matrix Effect?

NABL SCOPE OF ACCREDITATION — The text lists the specific disciplines covered under NABL accreditation scope for medical laboratories. Which discipline is listed as requiring at least 300 SPECIMENS PER YEAR for eligibility?

CLSI RISK MANAGEMENT — The text introduces HAZARD ANALYSIS as a CLSI risk management concept. What is the purpose of HAZARD ANALYSIS according to the text?

HCFA/CLIA PROFICIENCY TESTING — According to Table 6.8, what is the acceptable performance criterion for CHLORIDE in routine chemistry proficiency testing?

QUALITY ASSURANCE — MONITORING ANALYTICAL QUALITY — The text lists methods for monitoring analytical quality. Which approach involves using PRIMARY AND SECONDARY STANDARDS, CALIBRATORS, and QUALITY CONTROL SERA?

DOCUMENT CONTROL — ISO 15189:2007 describes requirements for DOCUMENT CONTROL. How frequently should documents be periodically reviewed and updated, and what happens to OBSOLETE DOCUMENTS?

DIRECT AND INDIRECT COST ACCOUNTING — The text discusses cost categories for laboratory financial management. What are the EXAMPLES of DIRECT COSTS listed in the text?

ISO 15189:2007 TERMS — The text defines PREEXAMINATION PROCESSES and POSTEXAMINATION PROCESSES. What is the STARTING POINT for PREEXAMINATION PROCESSES?

ADDITIONAL WESTGARD MODIFICATIONS — The text describes additional modified Westgard rules beyond the basic five. What does the RULE 7T require?

QUALITY ASSURANCE AIMS — The text states that quality assurance AIMS at ensuring specific conditions. What does quality assurance AIM to ensure for laboratory staff and clinicians?

WESTGARD RULES — SYSTEMATIC ERRORS — The text states that systematic errors (bias, shifts, and trends) usually cause which Westgard REJECTION RULES to be violated?

INVENTORY CONTROL — The text describes inventory control under the section on Other Aspects of Internal Quality Control. What information should PROPER LABELING OF REAGENTS AND MATERIALS INCLUDE?

GENERAL PRINCIPLES OF RCA — The text states that RCA involves identifying the root cause of a problem and then documenting a CORRECTIVE ACTION. In the general process for performing and documenting RCA, what is STEP 3?

ISO 15189:2007 REQUIREMENTS — The text lists specific documentation requirements. Requirement NUMBER 65 addresses DETECTION OF NONCONFORMITIES. What does this requirement state?

CONTROL OF ANALYTICAL VARIABLES — The text lists three aspects of Internal Quality Control for controlling analytical variables. What is the THIRD aspect listed?

PROFICIENCY TESTING PROGRAMS — The text states that proficiency testing (PT) uses simulated patient specimens. What is the COMMONLY USED EVALUATION CRITERION for proficiency testing results?

ISO STANDARDS — According to the text, what is the main purpose of ISO as described in the text?

HUMAN ERROR AND FMEA — The text discusses human error in the context of laboratory quality and safety risks. What is specifically stated about HUMAN ERROR as a CAUSE of quality and safety risks?

TOTAL QUALITY MANAGEMENT — FINAL SUMMARY: The text states that a product or service is of quality 'not because it is hard to make or extremely technical or complicated.' What IS the definition of a product or service being 'of quality' according to the text's DEFINITION OF QUALITY?

QUALITY LABORATORY PROCESSES (QLPs) — The text lists QLPS as including many aspects of a pathology laboratory. Which of the following is specifically listed as a QLP related to STAFF MANAGEMENT?

QUALITY ASSESSMENT (QA) — The text defines Quality Assessment as primarily concerned with BROADER MEASURES of laboratory performance. What specific measures does Quality Assessment monitor?

LABORATORY DESIGN — QLPs include STANDARD DIMENSIONS for laboratory planning. What is the required LABORATORY COUNTER TO WALL CLEARANCE as specified in the standard dimensions?

PATIENT PREPARATION AS PREANALYTICAL VARIABLE — According to the text, patient preparation is affected by many factors. Which of the following factors specifically mentioned in the text can AFFECT LABORATORY TESTS?

INTERPRETATION OF LEVEY-JENNING CHARTS — The text provides specific interpretation guidance for QC chart patterns. What does an EXCESSIVE SCATTER pattern on a Levey-Jenning chart indicate?

LEVEY-JENNING CHART PREPARATION — The text describes the EXPERIMENT 6.1 for preparing a Levey-Jenning chart. After how many WEEKS should at least 20 values be obtained for chart preparation?

CUSUM CHART CALCULATION — The text explains how to calculate the CUSUM VALUE. If the mean glucose is 100 mg/dL and the individual test values on consecutive days are 98, 101, 104, 97, what is the CUSUM VALUE on DAY 4 (value = 97 mg/dL)?

STANDARD DEVIATION CALCULATION — From the text's Table 6.1 example (20 glucose values), the sum of column A (all values) is 2001 and the sum of column C (squared differences) is 159. What is the STANDARD DEVIATION calculated from these values?

REFERENCE RANGE DETERMINATION — The text gives specific conditions for determining the reference range of a test. What EXCLUSION CRITERIA should be applied when selecting REFERENCE INDIVIDUALS for establishing reference ranges?

SIX SIGMA — The text describes the laboratory application of Six Sigma process. What does the text state about the SIX SIGMA FORMULA for laboratory measurements?

NABL SCOPE — The text provides specific notes about IMMUNOLOGICAL TECHNIQUES in NABL accreditation. What does the text state about immunological tests in relation to disciplines?

COST OF CONFORMANCE — The text explains APPRAISAL COSTS as part of the cost of conformance. What are APPRAISAL COSTS and what examples does the text give?

RCA CLASSIFICATION — The text lists FIVE CLASSES of RCA based on what they are applicable to. Which class SPECIFICALLY considers fields such as change management, risk management, and systems analysis?

HCFA/CLIA TABLE 6.8 — What is the acceptable CLIA proficiency testing criterion for CALCIUM (TOTAL) in routine chemistry?

ISO 15189:2007 ETHICAL CONDUCT — The text describes ethical conduct requirements for laboratory management. Which statement describes the ETHICAL CONDUCT requirements?

QUALITY CONTROL — The text states that QC must have THREE SPECIFIC CHARACTERISTICS. What are these characteristics?

ISO DEFINITIONS — The text provides ISO definitions as part of accreditation concepts. What is the ISO definition of COMPLIANCE?

LABORATORY ORGANIZATION — The text describes FIVE MAIN FACILITY DESIGN PROCESSES for organizing the clinical laboratory. What is the FIRST design process listed?

CLIA '88 SCOPE — The text describes what CLIA '88 covers and what it EXCLUDES. Which of the following is EXPLICITLY EXCLUDED from CLIA '88 coverage?

ISO DEFINITIONS — The text defines QUALITY AUDIT as one of the ISO definitions. What is the ISO definition of QUALITY AUDIT?

SIGMA INTERPRETATION — The text states that when sigma performance falls below a specific threshold, the method is NOT ACCEPTABLE. What is the significance of a SIGMA VALUE OF 3.0 FOR LABORATORY METHODS?

BUDGETING — The text describes two types of BUDGETING in laboratory financial management. What is the difference between INCREMENTAL BUDGET and ZERO-BASED BUDGET?

RCA GENERAL PRINCIPLES — The text states that RCA should be performed as SOON AS POSSIBLE after the error occurs. What is the specific reason given for this timing requirement?

CONTINUOUS EDUCATION OF STAFF — ISO 15189:2007 Requirement 68 addresses continuous education. What does this documentation requirement state?

BASIC ELEMENTS OF ROOT CAUSE — The text lists BASIC ELEMENTS OF ROOT CAUSE under four categories. What are the METHODS elements listed under root cause categories?

HEMATOLOGY CLIA CRITERIA — According to Table 6.5 in the text (Hematology tests), what is the CLIA acceptable performance criterion for HEMOGLOBIN?

QUALITY MANAGEMENT TERMS — The text lists many ISO definitions. What is the ISO definition of QUALITY IMPROVEMENT?

LABORATORY MANAGEMENT — PERSONNEL QUALIFICATIONS FOR HIGH COMPLEXITY LABORATORY — The text specifies qualifications for a LABORATORY DIRECTOR of a HIGH COMPLEXITY laboratory. What is one of the qualification options?

JURAN'S QUALITY IMPROVEMENT — The text mentions Juran's project-by-project quality improvement process. How many STEPS does this methodology outline?

SIGMA METRICS AND DPM — The text provides specific error rate conversions to DEFECTS PER MILLION (DPM) and sigma values. What DPM value corresponds to a 1.8% ERROR RATE and what is its sigma performance?

ISO DEFINITIONS — The text provides many ISO definitions. What is the definition of TRACEABILITY in the ISO context?

LABORATORY SPACE DESIGN — QLPs mention laboratory space division. The text states that laboratory space may be divided based on SPECIFIC SUBJECTS. What subjects are specifically mentioned?

QUALITY COUNCIL OF INDIA — The text describes QCI's structure including subsidiary boards. What is the FULL NAME of NABET within the QCI structure?

ANALYTICAL VARIABLES CONTROL — Validation of glassware, reagents, equipment, and instruments requires government certified validation. The text states this is done to ensure what TWO SPECIFIC PURPOSES?

DELTA CHECKS — The text describes DELTA CHECKS as a patient data-based QC method. For which specific types of tests are delta checks NOT applicable?

NABL MULTI-LOCATION RULE — The text provides specific rules about laboratories operating at MULTIPLE LOCATIONS. What rule applies to a laboratory OPERATING AT MORE THAN ONE LOCATION WITHIN A CITY having the SAME LEGAL IDENTITY?

ISO 15189:2007 — VERIFICATION AND VALIDATION DEFINITIONS — The text provides ISO definitions for both VERIFICATION and VALIDATED. What is the difference between these two terms?

PERFORMANCE APPRAISALS — The text includes a NOTE about effective performance appraisals. What does the note state about OBJECTIVE PERFORMANCE GOALS?

INTRA-LABORATORY DUPLICATES — The text describes control of analytical quality using patient data. What are INTRA-LABORATORY DUPLICATES and how are they used?

EXTERNAL QUALITY CONTROL — The text states that EXTERNAL QC PROGRAMS are sponsored by specific entities. Who SPONSORS External QC programs?

CLIA CERTIFICATES — The text lists five types of CLIA certificates issued by CMS. What is the CERTIFICATE OF PROVIDER-PERFORMED MICROSCOPY (PPM) issued for?

DEMING QUALITY PRINCIPLE — The text references W. Edwards Deming in the context of quality improvement. What specific PRINCIPLE is attributed to Deming in the text?

ISO 15189 REQUIREMENTS — Requirement NUMBER 54 addresses DATA OF ALL INTERNAL QC MEASURES. What must the laboratory document under this requirement?

LABORATORY FINANCIAL MANAGEMENT — OUTSOURCING — The text defines OUTSOURCING in the context of laboratory financial management. What is the definition given?

CLSI EDUCATION PROGRAMS — The text describes CLSI's education activities. What TYPES OF EDUCATIONAL PROGRAMS does CLSI conduct?

HIGH-SENSITIVITY ASSAYS — The text makes a special note about HIGH SENSITIVITY ASSAYS. Which specific HIGH SENSITIVITY ASSAYS are mentioned as being MORE SUSCEPTIBLE TO ERRORS?

ISO 15189:2007 DOCUMENTATION — The text lists Requirement 44 under SPECIMEN EXAMINATION PROCESSES. What is this requirement?

IMPORTANCE OF DETERMINING CV — The text explains WHY comparing standard deviations alone between two methods can be misleading. What is the TEXT'S REASONING for using CV instead of SD for comparison?

ISO 15189 REQUIREMENTS — Requirement 58 in the text addresses a CONTINGENCY PLAN. What is the documented contingency plan required for?

TOTAL QUALITY MANAGEMENT — COMPREHENSIVE REVIEW: The text identifies FIVE 'Q' COMPONENTS and their specific roles in the overall quality system. According to the text, what does QLP (Quality Laboratory Processes) SPECIFICALLY DO in the Five Q framework?

TOTAL QUALITY MANAGEMENT — The text states that the GENERAL GOAL of quality in every case is to meet requirements in a specific manner. What is the COMPLETE STATEMENT of this general quality goal?

INTERNAL QUALITY CONTROL — The text describes quality control in a Pathology Laboratory as being conducted by TWO METHODS. What are these two methods?

INTERNAL QUALITY CONTROL — The text defines what INTERNAL QUALITY CONTROL enables the laboratory to ensure. What can the laboratory ENSURE through internal quality control?

QUALITY ASSURANCE — The text discusses QA as involving elements BEYOND just analytical process control. What does the text state can be EXPECTED WITHOUT establishment of an efficient internal quality control program?

QUALITY ASSURANCE — The text describes what QAS programs MONITOR AND EVALUATE. How does the text define what a QAS program does in general?

ANALYTICAL VARIABLES — The text lists SOURCES OF VARIATION in the analytical phase. Which of the following is listed as a source of analytical variation?

REFERENCE AND CONTROL MATERIALS — The text defines CONTROL MATERIAL specifically. What is the text's definition of CONTROL MATERIAL and its specific use?

QUALITY ASSESSMENT — The text describes how QA PROGRESS can be measured. What specific methods does the text state can be used to measure laboratory progress through QA?

INTERNAL QC — The text describes VARIOUS WAYS OF MAINTAINING INTERNAL QC including a specific approach using PRIMARY STANDARDS. What specific practice is described regarding primary standards in each batch of unknown specimen analysis?

ERRORS IN QC PROGRAM — The text describes how SYSTEMATIC ERRORS can be corrected. What is the CORRECTION METHOD for systematic errors according to the text?

LEVEY-JENNING CHART — The text describes what happens in a NORMAL (GOOD CONTROL) LEVEY-JENNING CHART. According to the L-J chart interpretation, when values are observed BETWEEN FIRST STANDARD DEVIATION RANGE, what does this indicate?

RANDOM ERRORS AND WESTGARD RULES — The text explains what RANDOM ERRORS usually affect and which Westgard rules are usually violated. What do random errors affect and which rules detect them?

STANDARD ANALYTE in QC — The text defines STANDARD (standard substance) as used in formulating Quality Control charts. What is the definition of STANDARD?

QC DEFINITIONS — The text defines ANALYTE for QC chart formulation. What is the text's definition of ANALYTE?

LEVEY-JENNING CHART — The text gives a specific description of what the L-J CHART FIGURE 6.4 shows. What do the X-AXIS and Y-AXIS represent on the Levey-Jenning chart?

BIAS IN QC CHARTS — The text defines BIAS specifically for QC chart interpretation. What is the definition of BIAS as given in the text?

SIX SIGMA — The text describes the SIX SIGMA PROCESS as involving a specific description of a PROCESS. How does the text define a PROCESS in the Six Sigma context?

SIX SIGMA — The text describes the Six Sigma application in terms of LABORATORY ERROR ASSESSMENT. What is the primary approach described for ASSESSING PROCESS PERFORMANCE in laboratory sigma metrics?

LABORATORY FINANCIAL ASPECTS — The text defines CAPITAL ASSET and FIXED COST. What is the TEXT'S definition of FIXED COST?

NABL REQUIREMENTS — The text states that laboratories applying for NABL accreditation must comply with certain requirements. What standard must ALL MEDICAL LABORATORIES comply with regardless of their level or place?

DOCUMENTATION REQUIREMENTS ISO 15189 — The text lists 83 ISO 15189:2007 documentation requirements. What is REQUIREMENT NUMBER 75?

ISO 15189 MANAGEMENT COMMITMENT — The text describes laboratory management responsibilities under ISO 15189:2007. Which specific item must laboratory management ENSURE regarding COMMUNICATION PROCESSES?

LABORATORY OPERATIONS — The text discusses UTILIZATION MANAGEMENT and outlines attributes of a LABORATORY OUTREACH PROGRAM. What is identified as the first attribute for technical operations in such a program?

ISO DEFINITIONS — The text provides ISO definitions for multiple terms. What is the ISO definition of QUALIFICATION?

ISO 15189:2007 — ORGANIZATION AND MANAGEMENT RESPONSIBILITY — The text states that clinical laboratories must meet certain requirements when carrying out work. What types of facilities does ISO 15189:2007 apply to?

MEASUREMENT ACCURACY — The text discusses TRUENESS in the context of ISO 15189:2007 definitions. What is the ISO definition of TRUENESS (Measurement Trueness)?

ISO 15189 DEFINITIONS — The text defines LABORATORY DIRECTOR and LABORATORY MANAGEMENT. What is the ISO 15189:2007 definition of LABORATORY DIRECTOR?

SIGMA METRICS — TABLE 6.3 CLIA CRITERIA — The text provides Table 6.3 listing CLIA criteria and sigma precision requirements. What is the CLIA acceptable performance for ALT (Alanine Aminotransferase) and what precision is needed for 5-SIGMA performance?

REFERENCE RANGE — The text discusses the INDIRECT METHOD for establishing reference ranges. What assumption does the INDIRECT METHOD make about clinical laboratory analysis results?

LABORATORY ERRORS — The text states a classic principle about PROBLEMS arising in quality management. What does the text state about where problems PRIMARILY ARISE from?

CLIA TABLE 6.6 — TOTAL ALLOWABLE ERROR — The text provides Table 6.6 listing common analytes and their allowable total error (TEa). What is the TEa for GLUCOSE according to this table?

FIVE Q FRAMEWORK — The text describes the Five Q framework as also defining HOW QUALITY CAN BE MANAGED OBJECTIVELY. What CYCLE does the text mention alongside the Five Q framework?

LABORATORY DESIGN NOTE — The text provides specific NOTES about laboratory design requirements. What SPECIFIC REQUIREMENT is stated regarding a BATHROOM in laboratory design?

HCFA/CLIA CRITERIA — TABLE 6.8 HEMATOLOGY — According to Table 6.8, what is the CLIA acceptable performance for PLATELET COUNT in proficiency testing?

QUALITY IMPROVEMENTS — According to the text, JURAN'S QUALITY IMPROVEMENT step 3 specifically identifies what?

ISO DEFINITIONS — The text defines PRODUCT in ISO terms. What is the ISO definition of PRODUCT?

COMPETENCE — The text provides the ISO 15189:2007 definition of COMPETENCE. What is this definition?

LABORATORY SAFETY REFERENCE — The text describes various QUALITY LABORATORY PROCESS (QLP) elements. Which QLP element specifically provides access to MEDICO-LEGAL REFERENCE material?

CLIA — The text discusses CLIA '88 regulations regarding WAIVER TESTS. Which statement about CLIA WAIVER TESTS is correct?

IMPORTANCE OF LABORATORY — The text states a specific percentage regarding how medical decisions are based on laboratory results. What percentage of all medical decisions is based on laboratory results?

CERTIFIED REFERENCE MATERIAL — The text defines CRM (Certified Reference Material). What is the definition of a CERTIFIED REFERENCE MATERIAL (CRM)?

LABORATORY MANAGEMENT — DEVELOPING A SYSTEM FOR MEASURING PERFORMANCE — The text describes how laboratory performance can be measured. Which FOUR WAYS of measuring progress in an organization are listed?

ISO 15189 DEFINITIONS — The text provides the ISO definition for BIOLOGICAL REFERENCE INTERVAL and gives examples of PARTITION CRITERIA. What are the MOST FREQUENTLY USED partition criteria for subdividing reference populations?

LABORATORY ACCREDITATION — The text discusses the NABH structure and its relationship to QCI. Which statement about NABH is CORRECT according to the text?

CLSI FOUNDING — The text describes the founding of CLSI. In what YEAR did CLSI hold its founding meeting and HOW MANY clinicians and laboratory scientists were represented?

ISO 15189:2007 TERMS — The text provides the ISO 15189:2007 definition of PRIMARY SAMPLE (SPECIMEN). What is this definition?

SIGMA PROCESS DESCRIPTION — The text describes the SIX SIGMA PROCESS in terms of what it PROVIDES. What does Six Sigma provide according to the text?

HOSPITAL ACCREDITATION — The text mentions that out of approximately HOW MANY medical laboratories in India, accredited labs were not even 100 at the time of writing?

LABORATORY FINANCIAL TERMS — The text defines DEPRECIATION in the context of laboratory financial management. What is DEPRECIATION and what is its special FINANCIAL CHARACTERISTIC?

TOTAL QUALITY MANAGEMENT — FINAL CONCEPT: According to the text, when TQM is committed to meeting customer needs, this is done through an ONGOING PROGRAM that provides specific functions. What THREE SPECIFIC FUNCTIONS does TQM provide as an ongoing program?