Laboratory QA/QC Full Review

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Questions and Answers

Which organization was the predecessor of the ISO and was disbanded during the Second World War?

AvP92

International Federation of the National Standardizing Associations (correct)

North Atlantic Treaty Organization

International Organization for Standardization

Which policy, adopted by the US military in 1942, resulted in significantly less reports of malfunctions and uncontrolled explosions of ammunition and equipment?

MIL-Q-9858 (correct)

BS 5750

ISO 9000

ISO 15189

Which system, adopted in 1968 by NATO, was based on the more stringent European system for military contractors?

ISO 17025

ISO 9001

ISO 15189

AQAP-1 (correct)

Which policy, adopted in 1979, expanded the scope of quality management systems to include general quality requirements for industrial, commercial, and governmental products and services?

BS 5750 Signup and view all the answers

Which ISO guideline forms the basis for quality operations in a variety of industries, including the services offered by analytical laboratories?

ISO 9000 Signup and view all the answers

Which of the following is a requirement for equipment maintenance records?

Computerized maintenance tracking Signup and view all the answers

What is the purpose of a chain of custody form?

To track samples through the laboratory Signup and view all the answers

What is the purpose of a standard operating procedure (SOP)?

To provide written procedures for laboratory operations Signup and view all the answers

What must be done if there are deviations from a standard operating procedure?

Document and approve the deviations Signup and view all the answers

What parameters are included in the validation of analytical methods?

Sensitivity, specificity, linearity, and reproducibility Signup and view all the answers

What is the purpose of having a logbook or record keeping method for equipment maintenance?

To document any maintenance performed on the equipment. Signup and view all the answers

What is a chain of custody form used for in a laboratory?

To track the samples received at the laboratory, record their condition, and document what happened to them during testing. Signup and view all the answers

Why is it important to validate computer tracking systems used for sample tracking?

To demonstrate that the system is reliable and ensures accurate tracking of samples. Signup and view all the answers

Which organization sets guidelines for the management of laboratories, including training policies and procedures for personnel?

ISO Signup and view all the answers

Who is responsible for the health and safety of employees in a forensic laboratory?

Management Signup and view all the answers

What is the purpose of providing training about the dangers inherent in a forensic laboratory?

To protect employees from chemicals Signup and view all the answers

Which of the following is NOT a piece of information typically provided in a Safety Data Sheet (SDS)?

None of the Above Signup and view all the answers

What does the NFPA Hazard Code symbol use to depict dangers?

Colors Signup and view all the answers

Under what circumstances can a single Safety Data Sheet (SDS) be saved for multiple bottles of the same chemical from different manufacturers?

When the chemical is identical in composition Signup and view all the answers

Which position in a forensic laboratory is responsible for the technical operations of the laboratory?

Technical Manager Signup and view all the answers

Which OSHA standard mandates that employers and employees must be informed of the hazards of all chemicals used within the laboratory?

Hazard Communication Standard Signup and view all the answers

What information should be included in a chemical inventory according to the Hazard Communication Standard?

Name, quantity, storage location, date of acquisition, manufacturer, CAS number Signup and view all the answers

Which of the following substances is considered a bloodborne pathogen?

Saliva in dental procedures Signup and view all the answers

What is the purpose of Universal Precautions in a laboratory setting?

To treat all human blood and human body fluids as if known to be infectious for HIV, HBV, and other bloodborne pathogens Signup and view all the answers

Which of the following is NOT considered ionizing radiation?

Visible light Signup and view all the answers

Which organization is responsible for reviewing and approving studies involving animals?

Institutional Animal Care and Use Committee (IACUC) Signup and view all the answers

Which organization provides accreditation for facilities that use animals?

Association for Assessment and Accreditation of Laboratory Animal Care Signup and view all the answers

Which studies are more stringently regulated?

Studies involving humans Signup and view all the answers

What is the purpose of an Institutional Review Board (IRB)?

To review and approve studies involving humans Signup and view all the answers

What are some of the training programs that may be provided by the organization?

Waste management and AIDS prevention Signup and view all the answers

Which of the following is a requirement for the technical leader of a horseracing and canine racing laboratory in the State of Florida?

A graduate degree with college credit courses in chemistry, pharmacology and toxicology or related subjects, course work in statistics, and 2 years of experience as an analytical chemist in a laboratory analyzing drugs in body fluids, including experience in giving evidence Signup and view all the answers

What are the degree/educational requirements for the technical manager or leader of a forensic testing laboratory or convicted offender DNA databasing laboratory?

A 4 year baccalaureate in a biology, chemistry, or forensic science related area, and a minimum of 12 credit hours or its equivalent including a combination of graduate and undergraduate course work or classes covering the subject areas of biochemistry, genetics, molecular biology, statistics and/or population genetics, and 3 years of forensic experience Signup and view all the answers

What are the degree/educational requirements for a DNA analyst?

A 4 year baccalaureate in a biology, chemistry, or forensic science related area, and college course work or classes covering the subject areas of biochemistry, genetics, molecular biology, and statistics and/or population genetics, and at least 6 months experience prior to working on unsupervised cases Signup and view all the answers

Which of the following is NOT a requirement for a laboratory conducting forensic DNA testing and convicted offender databasing?

Use of tamper evident seals Signup and view all the answers

What is the purpose of having separate areas for pre- and post-amplified DNA in a laboratory?

To prevent contamination or human error Signup and view all the answers

What is the recommended frequency for reevaluating the ventilation system in a laboratory?

Every 3 months Signup and view all the answers

Which reference provides details needed for a chemical hygiene program?

Prudent Practices Signup and view all the answers

What is the purpose of having a logbook or record keeping method for equipment maintenance?

To track the maintenance history of equipment Signup and view all the answers

What is the purpose of Universal Precautions in a laboratory setting?

To ensure the health and safety of personnel Signup and view all the answers

Which of the following is a requirement for a fume hood when perchloric acid is used?

It should have a continuous flow-monitoring device Signup and view all the answers

What is the purpose of a PCR set up cabinet in a DNA laboratory?

To minimize contamination of reaction mixes Signup and view all the answers

What is the purpose of an eyewash device in a laboratory?

To flush eyes in case of chemical exposure Signup and view all the answers

Which type of laboratory requires sinks, bench tops, electrical outlets, and hoods?

Wet chemistry laboratory Signup and view all the answers

What is the purpose of separate cabinets in a wet chemistry laboratory?

To store incompatible chemicals Signup and view all the answers

What is a requirement for stockrooms and storerooms?

Continuous mechanical ventilation Signup and view all the answers

What type of refrigerator must be used to store flammable liquids?

Explosion-proof refrigerator Signup and view all the answers

Where should gas cylinders be stored when not in use?

Outside the laboratory Signup and view all the answers

What must be done to ensure the safety of gas cylinders when stored?

Stored upright with valve protection caps on Signup and view all the answers

Which of the following is NOT a requirement for maintaining a sanitary animal care facility?

Storage of animals prior to removal from the site Signup and view all the answers

What is the purpose of limiting access to an animal care facility?

To prevent the spread of disease Signup and view all the answers

Who is responsible for providing veterinary care for the animals in an animal care facility?

The in-house veterinarian Signup and view all the answers

What is a requirement for the storage of animal waste in an animal care facility?

Sanitary storage Signup and view all the answers

What must be done to prevent the spread of disease in an animal care facility?

Limited access to the facility Signup and view all the answers

Which of the following is NOT a reason for restricting radioactive experiments to a small area?

New technology may allow analysis of samples in the future Signup and view all the answers

Why is it important to maintain a tracking system for the location of remaining specimens in a laboratory?

To easily locate specimens for further analysis Signup and view all the answers

What must a laboratory have in order to dispose of chemical, biological, and radioactive waste?

A separate waste disposal facility Signup and view all the answers

What are some of the other facilities that must be allocated space in a laboratory?

All of the above Signup and view all the answers

Why must corridors in a laboratory be unobstructed?

To provide easy access in case of emergency Signup and view all the answers

What studies are required to show the reliability of a forensic DNA testing laboratory?

<ol> <li>accuracy, precision and reproducibility 2. locus must be defined and characterized 3. species specificity 4. sensitivity, stability and mixture studies 5. database independence testing 6. allele and frequency distributions determined 7. non-probative sample study 8. match criteria established.</li> </ol> Signup and view all the answers

What is the purpose of internal validation studies in a laboratory?

To show the reliability of the technique as practiced by that laboratory. Signup and view all the answers

What do the FBI Quality Assurance Standards require in terms of studies completed by a forensic DNA testing laboratory?

The FBI Quality Assurance Standards require completion of accuracy, precision and reproducibility studies, locus definition and characterization, species specificity, sensitivity, stability and mixture studies, database independence testing, allele and frequency distribution determination, non-probative sample study, and establishment of match criteria. Signup and view all the answers

Which of the following components are key parameters that should be considered when validating an analytical procedure?

Linearity and precision of standard curves Signup and view all the answers

What must be included in the developmental validation of procedures for DNA laboratories?

Characterization of the locus and species specificity studies Signup and view all the answers

When must internal validation be conducted in a laboratory?

When developmental validation has been performed by another laboratory Signup and view all the answers

What studies are required by the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Databasing Laboratories?

Accuracy, precision, and reproducibility Signup and view all the answers

Which of the following components are important to consider when determining the uncertainty of a measurement?

All of the above Signup and view all the answers

What is the purpose of including an uncertainty budget in the measurement process?

To determine the overall measurement uncertainty Signup and view all the answers

What is the role of uncertainty in reporting quantitative measurement results?

To express the certainty or confidence in the measurement Signup and view all the answers

How can Type A uncertainty be determined in the absence of historical laboratory data?

From the repeatability data generated during method validation Signup and view all the answers

Which analytical technique is typically used to determine the chromatographic purity of a compound?

High performance liquid chromatography (HPLC) Signup and view all the answers

What is the purpose of checking the homogeneity of a compound preparation before quantitative analysis?

To ensure consistent concentrations throughout the mixture Signup and view all the answers

How is the extraction recovery of a drug or metabolite determined?

By comparing the peak area of a non-extracted standard solution to the peak area of an extracted solution Signup and view all the answers

How is the range of the standard curve and control samples established in an analytical procedure?

By confirming the linearity, accuracy, and precision of the analytical procedure Signup and view all the answers

Which equation represents the standard curve used in the validation of analytical procedures?

$y = mx + b$ Signup and view all the answers

What is the typical acceptable value for the y-intercept in the standard curve equation?

Less than 25% of the value of the minimum standard curve calibrator Signup and view all the answers

How is sensitivity generally reported in analytical procedures?

By reference to signal-to-noise ratios Signup and view all the answers

What is the typical signal-to-noise ratio considered acceptable for estimating the detection limit?

2:1 Signup and view all the answers

Which of the following is a recommended approach to establish accuracy in an analytical procedure?

All of the above Signup and view all the answers

How is precision expressed in the context of assay and quantitative determination of impurities?

Standard deviation and relative standard deviation Signup and view all the answers

What is the recommended number of determinations to assess accuracy?

9 determinations over 3 concentration levels Signup and view all the answers

What parameter should be less than 5% to demonstrate the stability of extracted biological samples?

Variation in peak area ratio Signup and view all the answers

Which type of maintenance is intended to protect the equipment and/or personnel?

Routine maintenance Signup and view all the answers

What is the purpose of equipment qualification?

To check compliance with previously determined standards Signup and view all the answers

What is the purpose of equipment inspection?

To verify conformation to specific requirements Signup and view all the answers

What is the purpose of a laboratory maintaining an equipment file?

To document equipment qualification and calibration Signup and view all the answers

Which step of instrument qualification involves testing the instrument to ensure it meets previously set specifications?

Operational qualification (OQ) Signup and view all the answers

Who usually performs the operational qualification (OQ) for more sophisticated instruments?

Vendor Signup and view all the answers

What is the purpose of performance qualification (PQ) in instrument qualification?

To demonstrate that the instrument consistently performs up to specifications Signup and view all the answers

What is the role of ISO 9001 in instrument qualification?

To certify the quality system of the vendor Signup and view all the answers

Which term refers primarily to items such as freezers, thermometers, and automatic pipettes?

Equipment Signup and view all the answers

What factors should be considered before purchasing equipment for a laboratory?

All of the above Signup and view all the answers

What must be done to ensure the quality of analytical data?

All of the above Signup and view all the answers

What are instrument specifications used for?

All of the above Signup and view all the answers

Which of the following is a requirement for calibration documentation?

The documentation must be traceable back to a NIST or international standard. Signup and view all the answers

What is the recommended number of points to be used for calibration?

Three points Signup and view all the answers

What units should numerical data be expressed in?

SI units Signup and view all the answers

What can instruments be calibrated against?

All of the above Signup and view all the answers

Which of the following is NOT an example of routine maintenance?

Cleaning the pump block on the genetic analyzer Signup and view all the answers

How often should routine and/or preventative maintenance be scheduled?

It depends on the equipment and its usage Signup and view all the answers

What is the purpose of calibration in a laboratory?

To detect and quantify inaccuracies in instruments Signup and view all the answers

What must be done before equipment can be returned to service after malfunctioning?

It must undergo calibration, verification, or testing to ensure proper functioning Signup and view all the answers

What should the documentation on a calibration be able to do?

Duplicate the procedure Signup and view all the answers

What can instruments be calibrated against?

Another instrument or apparatus, such as a NIST thermometer Signup and view all the answers

What should standards used for calibration be traceable back to?

A NIST or international standard Signup and view all the answers

How many points should be used to cover the entire operating range of an instrument during calibration?

Three or more points Signup and view all the answers

In what units should all numerical data be expressed?

SI units Signup and view all the answers

Which of the following is a requirement for maintaining the chain of custody in a forensic laboratory?

Having a secure trail of accountability Signup and view all the answers

What is the typical retention time for test articles in forensic laboratories?

Three years Signup and view all the answers

What must be done to ensure the quality of reagents and materials used in the analysis of test articles?

Unambiguous characterization Signup and view all the answers

Which of the following is NOT a requirement for field sample collection according to the text?

Documentation that sample collection equipment and containers are clean Signup and view all the answers

What is the purpose of a complete chain of custody according to the text?

To prevent sample mix-ups Signup and view all the answers

What is the purpose of adding a colored cleaning agent to the water in the toilet during urine sample collection according to the text?

To prevent dilution of the sample Signup and view all the answers

What is the purpose of a laboratory information management system (LIMS)?

To track samples and test results Signup and view all the answers

What is the purpose of a chemical information management system (CIMS)?

To store and work with chemical structures and reactions Signup and view all the answers

What is the purpose of an analytical information management system (AIMS)?

To serve as a central repository for all instrumental data Signup and view all the answers

Which of the following is NOT a requirement for the storage of samples in a laboratory facility?

Samples must be stored in an area with high levels of contamination Signup and view all the answers

Which of the following documents is NOT part of the chain of custody for a sample?

A document that describes the preparation of laboratory reagents Signup and view all the answers

What must be included in the documentation for instrument calibration?

The calibration method and calibration standards Signup and view all the answers

Which of the following is NOT a requirement for maintaining the chain of custody (COC) for forensic samples during transport?

Including the name and address of the requesting company or organization on the COC Signup and view all the answers

What information should be included in the sample log in a laboratory?

All of the above Signup and view all the answers

Which of the following procedures must be documented during sample analysis?

All of the above Signup and view all the answers

Which of the following best describes a closed system in the context of a LIMS (Laboratory Information Management System)?

A system that restricts access to authorized users only Signup and view all the answers

What is the role of personnel in a LIMS?

Adhere to written policies and be accountable for their actions Signup and view all the answers

When are electronic signatures considered acceptable in a LIMS?

When appropriate codes and passwords are in place Signup and view all the answers

What must be documented in a LIMS regarding system problems?

All problems with the system and corrective actions Signup and view all the answers

In a LIMS, what is the purpose of limiting access to authorized users?

To ensure the security and integrity of the data Signup and view all the answers

What is a LIMS?

A LIMS stands for Laboratory Information Management System. It is a closed system that controls access to electronic records and limits data access to authorized users. Signup and view all the answers

What are the responsibilities of personnel using a LIMS?

Personnel must adhere to written policies, be accountable and responsible for their actions, and document all problems with the system and corrective actions taken. Signup and view all the answers

In what situations are electronic signatures considered acceptable in a LIMS?

Electronic signatures are acceptable when appropriate codes and passwords are in place. Signup and view all the answers

What does it mean for a LIMS to be a closed system?

A closed system means that access to the system is controlled by authorized persons responsible for the content of electronic records in the system. Signup and view all the answers

Why is it important to limit access to a LIMS?

Limiting access to a LIMS ensures the security and integrity of the data, as well as compliance with regulatory requirements. Signup and view all the answers

Which of the following is NOT a suitable method for indicating an error in a laboratory notebook?

Using arrows or ditto marks Signup and view all the answers

What type of ink should be used when recording information in a laboratory notebook?

Ballpoint pen Signup and view all the answers

Which of the following is a requirement for a laboratory notebook?

Hard bound Signup and view all the answers

When should each procedural step be recorded in a laboratory notebook?

Immediately after being carried out Signup and view all the answers

What should be done upon completion of a procedural step in a laboratory notebook?

Initial and date the pertinent information Signup and view all the answers

Which of the following is a key component of a standard operating procedure (SOP)?

A detailed description of the equipment and apparatus used in an analysis Signup and view all the answers

Why are official SOPs required by some governmental agencies and granting organizations?

To ensure that analytical work is done using approved methods Signup and view all the answers

What is the purpose of preparing a standard operating procedure (SOP)?

To provide a detailed method for performing routine or repetitive tasks Signup and view all the answers

Why do funding agencies and accreditation bodies prefer the use of official SOPs?

To ensure that the analyses are conducted properly Signup and view all the answers

What is the purpose of a standard operating procedure (SOP) in terms of obtaining comparable data?

To ensure that interlaboratory results are comparable Signup and view all the answers

Which section of a Standard Operating Procedure (SOP) lists the apparatus and materials used in the analysis?

Apparatus/Materials Signup and view all the answers

What is the purpose of the Quality Control section in an SOP?

To establish procedures for instrument calibration and sample preparation Signup and view all the answers

What section of an SOP may contain specific methods for collecting, preserving, and handling a sample?

Sample Collection/Preservation/Handling Signup and view all the answers

What is the purpose of the Method Performance section in an SOP?

To evaluate the performance of the method Signup and view all the answers

Which section of an SOP briefly describes the equipment and general procedures followed in order to obtain data?

Method Summary Signup and view all the answers

Which of the following is a required element for an 'in-house' Standard Operating Procedure (SOP)?

Title of SOP Signup and view all the answers

What is the purpose of a Standard Operating Procedure (SOP)?

To ensure consistency and accuracy of results Signup and view all the answers

When should a laboratory prepare an SOP for a specific analyte in a specific matrix?

When an official SOP has never been developed Signup and view all the answers

What is the purpose of the scope section in an SOP?

To provide information about the concentration range and minimum detectable level of the analytes Signup and view all the answers

What must a laboratory do before using a method outlined in an SOP?

Demonstrate the accuracy, precision, selectivity, reproducibility, and repeatability of the method Signup and view all the answers

Which of the following is NOT a requirement for a standard operating procedure (SOP) according to the text?

Reviewed by multiple persons with appropriate training and experience Signup and view all the answers

What must be done before a revised SOP can be approved according to the text?

Make revisions to the original and revised SOPs Signup and view all the answers

What happens to the original SOP and its attached OCR after a revision is made according to the text?

They are placed in the archive Signup and view all the answers

What must be done when a document (or record) is altered or corrected according to the text?

Draw a single line through the altered text Signup and view all the answers

What should be done before a new or revised SOP can be useful according to the text?

Distribute copies of the revised SOP to staff members Signup and view all the answers

What is the purpose of using hard bound laboratory notebooks?

To ensure that all records are in ink and to have pre-numbered pages. Signup and view all the answers

When should each procedural step be written in a laboratory notebook?

Each procedural step should be written down immediately prior to being carried out. Signup and view all the answers

What information should be included in each procedural step in a laboratory notebook?

The person executing the step should initial and date (and possibly add the time) the pertinent information. Signup and view all the answers

What is the purpose of signing and dating each page in a laboratory notebook?

To provide a complete chain of custody and track the progress of the work. Signup and view all the answers

What is the purpose of using hard bound laboratory notebooks?

To ensure that all records are in ink and to have pre-numbered pages. Signup and view all the answers

Which of the following is a common use of study protocols?

Defining experimental parameters Signup and view all the answers

What is the primary purpose of a study protocol?

To lay out objectives and describe the experiment Signup and view all the answers

When are protocols usually required for laboratories?

For FDA and EPA studies Signup and view all the answers

What are the components of a well-written protocol?

Objectives and a detailed description of the experiment Signup and view all the answers

In which type of studies are protocols primarily found?

Clinical and environmental studies Signup and view all the answers

Which regulatory body mandates that studies funded by the FDA or EPA be conducted using protocols?

The Code of Federal Regulations (CFR) Signup and view all the answers

What is the role of an Institutional Review Board (IRB) in clinical studies?

To oversee the conduct of clinical studies Signup and view all the answers

Which agency requires that an IRB approve studies involving human subjects before any experimentation can begin?

The Department of Health and Human Services (DHHS) Signup and view all the answers

What is the purpose of a study protocol in the context of laboratory research?

To conduct studies funded by the FDA or EPA Signup and view all the answers

What is the role of the Code of Federal Regulations (CFR) in laboratory research?

To mandate the use of protocols in studies funded by the FDA or EPA Signup and view all the answers

Which of the following is a component of a study protocol?

Descriptive Title Signup and view all the answers

What is the purpose of a study protocol?

To define the purpose of the protocol Signup and view all the answers

What information should be provided about the sponsor in a study protocol?

Name and address Signup and view all the answers

Which of the following is the role of the sponsor in a study?

Providing financial support for the study Signup and view all the answers

What is the purpose of the Institutional Review Board (IRB) in a study?

Reviewing and approving the study protocol Signup and view all the answers

What must be included in the Informed Consent (IC) form for human participants in a study?

The purpose of the study and the participant's role Signup and view all the answers

Which of the following is a key consideration in experimental design when selecting test subjects?

The test group and the control group must be identical except for the variable being studied. Signup and view all the answers

Which of the following is a key consideration in experimental design when measuring a parameter?

The measurement should be a useful measurement rather than an observation. Signup and view all the answers

Which of the following is a key consideration in experimental design when selecting test subjects for a crossover experiment?

The second group should receive a placebo for a specified length of time. Signup and view all the answers

Which of the following is a requirement for amending a study protocol according to the text?

The amendment must be signed and dated by the investigator and the sponsor. Signup and view all the answers

What must be done if deviations from the study protocol occur according to the text?

A statement describing the deviation and its cause must be recorded and signed by the investigator. Signup and view all the answers

What is the purpose of an Informed Consent Form according to the text?

To inform participants about the study and obtain their voluntary consent. Signup and view all the answers

What is the purpose of SOPs (Standard Operating Procedures) according to the text?

To provide detailed instructions for various tasks and procedures in the laboratory. Signup and view all the answers

What is the purpose of an (animal) Owner Consent Form according to the text?

To obtain consent from the owner of an animal to participate in the study. Signup and view all the answers

What must be included in a description of collection sites according to the text?

Information about the location and characteristics of the collection sites. Signup and view all the answers

What are some examples of documents that should be included in a study protocol?

Example of Informed Consent Form, SOPs, Example of (animal) Owner Consent Form, Description of collection sites, Description of special equipment, Investigator qualifications Signup and view all the answers

When can a study protocol be amended?

The protocol can be amended prior to its use or a specific task in the protocol can be amended prior to its implementation Signup and view all the answers

What must be done if deviations from the study protocol occur?

A statement signed and dated by the investigator must be recorded describing the deviation and its cause (if known) Signup and view all the answers

Who must sign and date a study protocol amendment?

The investigator and the sponsor Signup and view all the answers

What should be done with a study protocol amendment?

It must be incorporated into the study protocol Signup and view all the answers

Which of the following is NOT a factor that determines the emphasis placed on quality, price, and turnaround in a laboratory?

The laboratory's reputation Signup and view all the answers

What is the purpose of conducting tests for analytes that are not specified by the customer?

To provide additional data for significant results Signup and view all the answers

What are matrix-matched standards used for in laboratory analyses?

To recognize and deal with interferences Signup and view all the answers

Which term is frequently used to refer to laboratory inspections?

Laboratory audits Signup and view all the answers

What is the goal of a laboratory audit?

To ensure compliance with regulations and improve the laboratory program Signup and view all the answers

According to ISO, what is an audit?

A systematic, independent and documented process for obtaining and evaluating it objectively to determine the extent to which the criteria are fulfilled Signup and view all the answers

What is the term used to describe a methodical examination and review of a laboratory program?

Laboratory audit Signup and view all the answers

What are the benefits of a laboratory inspection?

Identifying areas in the laboratory program that need correction and ensuring compliance with regulations Signup and view all the answers

What is the definition of a laboratory audit?

A laboratory audit is a systematic, independent and documented process for obtaining and evaluating information objectively to determine the extent to which the criteria are fulfilled. Signup and view all the answers

What is the goal of a laboratory audit?

The goal of a laboratory audit is two-fold: to ensure compliance with regulations and to provide information that leads to improvement of the total laboratory program. Signup and view all the answers

Why are laboratory inspections sometimes referred to as laboratory audits?

Laboratory inspections are sometimes referred to as laboratory audits because the term audit means a methodical examination and review, similar to how a laboratory audit assesses the total program rather than just the financial operations. Signup and view all the answers

Which of the following records may the auditor inspect in addition to the ones listed in the text?

Laboratory notebooks Signup and view all the answers

What should be done if a sample is spilled while in storage or being transferred to another area, according to the text?

Clean it up immediately Signup and view all the answers

What information should be provided to the auditor prior to their visit, according to the text?

All of the above Signup and view all the answers

What is the purpose of an accreditation audit?

To determine whether all standards have been met Signup and view all the answers

What is the major difference between an internal audit and an accreditation audit?

The internal audit is conducted by trained laboratory personnel, while the accreditation audit is conducted by an external examiner Signup and view all the answers

What does an inspection team primarily look for during a laboratory audit for accreditation?

The compliance with standard operating procedures Signup and view all the answers

Which organization or agency can provide accreditation for a laboratory that wishes to establish an accredited program at a new or non-accredited laboratory?

Department of Environmental Protection (DEP) Signup and view all the answers

What must a laboratory demonstrate during a laboratory audit to become accredited?

Fulfillment of all regulatory requirements Signup and view all the answers

What is the criteria for a laboratory to be deemed proficient in analyzing analytes during proficiency testing?

Analytical results falling within accepted limits Signup and view all the answers

Which of the following is NOT a possible outcome after a regulatory agency inspection?

The laboratory receives accreditation Signup and view all the answers

What does the audit report from the regulatory agency inspector typically contain?

Observations about the deficiencies Signup and view all the answers

What must the laboratory do in response to the audit report?

Provide documentation of how deficiencies were corrected Signup and view all the answers

What type of evidence may the regulatory agency require from the laboratory to demonstrate that deficiencies were corrected?

Photocopies of logbook pages Signup and view all the answers

Under what circumstances may the laboratory argue that a specific observation does not indicate a deficiency?

When the observation is not relevant to the deficiencies Signup and view all the answers

What is the purpose of an audit based on the Case Study in the module?

To ensure procedural proficiency/validity Signup and view all the answers

What happens after the regulatory agency inspector has departed?

The inspector will send an audit report to both the laboratory and the regulatory agency, noting the deficiencies observed and recommending whether or not the laboratory should receive accreditation. Signup and view all the answers

Can the laboratory continue operations while correcting deficiencies?

Yes, if the deficiencies are not serious, the laboratory can continue operations while correcting them. Signup and view all the answers

What must the laboratory provide to demonstrate how the deficiencies were corrected?

The laboratory must provide documentation, such as photocopies of logbook pages and raw data, to demonstrate how the deficiencies were corrected. Signup and view all the answers

What can the laboratory argue if a specific observation does not provide evidence of a deficiency?

The laboratory can argue that the specific observation does not provide evidence of a deficiency. Signup and view all the answers

What is the purpose of an audit based on the Case Study in the module?

The purpose of the audit is to verify operations throughout the lab and ensure prompt adjustments as needed to maintain accreditation and procedural proficiency/validity. Signup and view all the answers

Which statistical technique is used to determine whether two groups of data are different?

Chi-square test Signup and view all the answers

What is the purpose of Duncan's Separation of Means Procedure?

To statistically determine whether more than two averages are statistically different Signup and view all the answers

Which statistical technique is used to interpret laboratory data?

T-test Signup and view all the answers

What type of programs can perform statistical manipulations on tabulated data?

Spreadsheet programs like Excel and QuatroPro Signup and view all the answers

Which of the following is NOT mentioned as a source for finding equations required for statistical calculations?

Web documents Signup and view all the answers

What is the purpose of a calibration curve?

To determine the value for an unknown Signup and view all the answers

Which of the following can be used to obtain averages, standard deviations, and other statistics from tabulated data?

Hand-held scientific calculators Signup and view all the answers

What is the purpose of a t-test?

To determine whether two groups of data are different Signup and view all the answers

What is the purpose of the theoretical calculated value in statistical analysis?

To find the theoretical calculated value Signup and view all the answers

Which of the following is NOT mentioned as a program that can perform statistical manipulations on tabulated data?

Web documents Signup and view all the answers

Which organization provides information for federal agencies concerning record management?

United States National Archives and Records Administration (NARA) Signup and view all the answers

What is one area of interest addressed by the FDA?

Electronic records and signatures Signup and view all the answers

What is the subject of interest in relation to electronic records and signatures?

Trustworthiness and reliability Signup and view all the answers

What other organization addresses the subject of electronic records and signatures?

FDA Signup and view all the answers

What information does the NARA website provide for federal agencies?

Record management information Signup and view all the answers

What is one consideration when formulating laboratory record management policies?

Electronic records and signatures Signup and view all the answers

What does the NARA website provide that may be useful for formulating laboratory record management policies?

Information Signup and view all the answers

What is one area of interest in record management policies?

Electronic records and signatures Signup and view all the answers

What does the FDA address in relation to record management?

Electronic records and signatures Signup and view all the answers

What is one area of interest in relation to electronic records and signatures?

Trustworthiness and reliability Signup and view all the answers

Study Notes

Quality Management Systems

The International Organization for Standardization (ISO) was preceded by the International Federation of the National Standardizing Associations (IFNSA), which was disbanded during World War II.
The US military adopted a policy in 1942, resulting in fewer reports of malfunctions and uncontrolled explosions of ammunition and equipment.

Quality Control and Quality Assurance

In 1968, NATO adopted a system based on the stricter European system for military contractors.
In 1979, a policy expanded the scope of quality management systems to include general quality requirements for industrial, commercial, and governmental products and services.

Laboratory Management

The ISO 15189 guideline forms the basis for quality operations in various industries, including analytical laboratories.
Equipment maintenance records must include information on maintenance activities, repairs, and calibration.

Chain of Custody

A chain of custody form is used to track the possession and handling of evidence throughout the entire analytical process.
The purpose of a chain of custody form is to maintain the integrity of evidence and ensure accountability.

Standard Operating Procedures (SOPs)

A SOP is a written procedure that outlines the steps to be taken in a specific situation.
If there are deviations from a SOP, they must be documented and justified.

Validation of Analytical Methods

Parameters included in the validation of analytical methods include accuracy, precision, linearity, range, detection limit, and robustness.
Validation of computer tracking systems is essential to ensure the reliability and accuracy of data.

Laboratory Safety and Health

The International Laboratory Accreditation Cooperation (ILAC) sets guidelines for the management of laboratories, including training policies and procedures for personnel.
The laboratory supervisor is responsible for the health and safety of employees in a forensic laboratory.

Safety Data Sheets (SDS)

An SDS is not typically provided for multiple bottles of the same chemical from different manufacturers.
The NFPA Hazard Code symbol uses numbers to depict dangers.

Forensic Laboratory Operations

The technical leader of a forensic laboratory is responsible for the technical operations of the laboratory.
The OSHA standard mandates that employers and employees must be informed of the hazards of all chemicals used within the laboratory.

Chemical Inventory and Handling

A chemical inventory should include information on the chemical, its properties, and its handling procedures according to the Hazard Communication Standard.

Bloodborne Pathogens

Hepatitis B and HIV are considered bloodborne pathogens.
The purpose of Universal Precautions is to prevent exposure to bloodborne pathogens in a laboratory setting.

Institutional Review Board (IRB)

The IRB is responsible for reviewing and approving studies involving animals.
The IRB provides accreditation for facilities that use animals.

Laboratory Accreditation and Certification

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) provides accreditation for facilities that use animals.
Studies involving animals are more stringently regulated.

Training and Education

Training programs provided by the organization may include hazardous materials handling, laboratory safety, and emergency procedures.

Quality Assurance and Control

The purpose of internal validation studies is to demonstrate the reliability of a forensic DNA testing laboratory.
The FBI Quality Assurance Standards require studies to be completed by a forensic DNA testing laboratory.

Analytical Procedures

Key parameters to consider when validating an analytical procedure include accuracy, precision, linearity, range, detection limit, and robustness.
The developmental validation of procedures for DNA laboratories includes the evaluation of critical factors affecting the procedure.

Uncertainty and Error

Uncertainty is a key component in reporting quantitative measurement results.
The purpose of including an uncertainty budget in the measurement process is to account for all sources of uncertainty.

Analytical Techniques

Chromatography is typically used to determine the chromatographic purity of a compound.
The extraction recovery of a drug or metabolite is determined through the use of analytical techniques.

Instrumentation and Equipment

Equipment maintenance is intended to protect the equipment and/or personnel.
Instrument qualification involves testing the instrument to ensure it meets previously set specifications.

Calibration and Maintenance

Calibration is essential to ensure the quality of analytical data.
Instrument specifications are used to establish the performance requirements of an instrument.
Calibration documentation should include information on the instrument, calibration procedure, and calibration results.

Laboratory Operations

Routine maintenance should be scheduled regularly to ensure the quality of analytical data.
The purpose of calibration in a laboratory is to ensure the reliability and accuracy of data.

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Description

Test your knowledge on quality assurance (QA) and quality control (QC) with this quiz! Learn about the definitions and procedures involved in ensuring high-quality standards in various industries. Challenge yourself and see how well you understand the concepts of QA/QC.