Term
| Control of Nonconforming Testing |
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Definition
Procedures need to be in place in case of non conformance to specifications.
Actions need to be defined in case of non compliance Ie could be holding of work, notification of the client, recall of the work.
If this is a common occurrence, corrective action plan should be developed. |
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Term
Procedures need to be in place in case of non conformance to specifications.
Actions need to be defined in case of non compliance Ie could be holding of work, notification of the client, recall of the work.
If this is a common occurrence, corrective action plan should be developed. |
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Definition
Should be in place in the case of non conforming work.
Investigation should occur to determine the cause of a problem.
Actions should be taken to prevent reoccurrence of the problem.
Actions should be based on risk analysis. |
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Term
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Definition
| Preventive action should involve analysis of date, including trend analysis, risk analysis, and participation in proficiency testing. |
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Term
| Potential Sources of Error |
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Definition
Sample mishandling or recording errors
Faulty reagents, equipment, controls, or technique
Analyst Bias |
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Term
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Definition
Sample mix ups
Mislabeling tubes
Incorrect recording of data
Little or no control over the handling of the evidence outside of the lab |
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Term
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Definition
Care to attention to detail
Independent checks at all stages
Sample handling polices
Redundancy in testing
Analytical results are revived by two people.
Retesting |
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Term
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Definition
Testing includes proper controls
Following standard QC program
Regular proficiency testing
Regular monitoring of reagents |
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Term
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Definition
Foreign Material
Different Kinds (non biological materials)
1 Inadvertent contamination
2 Mixed Samples
3 Carryover contaminations |
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Term
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Definition
Subjective judgment, expectations or bias
Conscious or unconscious bias
Sins of omission rather than commission
Exculpating evidence might be ignored or rejected
Contradictory test results or evidence may be discontinued |
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Term
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Definition
Accountability is the acknowledgment and assumption of responsibility for actions, products, decisions, and polices including administration, governance and implementation within the scope of role or employment positions.
Includes being answerable for resulting consequences. |
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Term
| Why does it pay to be accountable? |
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Definition
Today’s executives do not have time to watch over employees shoulders
They need people who will do the job correctly the first time |
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Term
| What are employers looking for? |
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Definition
A rock
Someone who can make the right call
A fixer
A trusted source |
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Term
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Definition
Make deadlines a priority
Complete circle (finish products)
Keep in mind chain of accountability |
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Term
| Containment Level 1 (CL1) |
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Definition
| This applies to the basic laboratory that handles agents requiring containment level 1. CL1 requires no special design features beyond those suitable for a well-designed and functional laboratory. |
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Term
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Definition
| This applies to the laboratory that handles agents requiring containment level 2. The primary exposure hazards associated with organisms requiring CL2 are through the ingestion, inoculation and mucous membrane route. |
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Term
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Definition
| This applies to the laboratory that handles agents requiring containment level 3. These agents may be transmitted by the airborne route, often have a low infectious dose to produce effects and can cause serious or life-threatening disease. |
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Term
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Definition
| This is the maximum containment available and is suitable for facilities manipulating agents requiring containment level 4. These agents have the potential for aerosol transmission, often have a low infectious dose and produce very serious and often fatal disease; there is generally no treatment or vaccine available. |
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Term
| Negative Pressure Isolation Rooms |
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Definition
| Negative Pressure Isolation Rooms maintain a flow of air into the room, thus keeping contaminants and pathogens from reaching surrounding areas. |
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Term
| Positive Pressure Isolation Rooms |
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Definition
Positive Pressure Isolation Rooms maintain a flow of air out of the room, thus protecting the patient from possible contaminants and pathogens which might otherwise enter.
“Clean Rooms” |
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Term
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Definition
Open Labs- share lab space, equipment, meeting rooms, etc.
Closed Labs – needed for specialized testing that requires separate resources |
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Term
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Definition
A typical laboratory currently uses five times as much energy and water per square foot as a typical office building. Research laboratories are so energy-demanding for a variety of reasons:
Key aspects of sustainable design are as follows:
Increased energy conservation and efficiency
Reduction or elimination of harmful substances and waste
Improvements to the interior and exterior environments, leading to increased productivity
Efficient use of materials and resources
Recycling and increased use of products with recycled content |
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Term
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Definition
Several key issues affect the choice of a science park's location:
The proximity to research universities (almost 90 percent of research parks are located immediately adjacent to a university)
The availability of a highly educated workforce
Quality of life of the nearest city
Proximity to a major airport
Types and variety of research-based companies in the area
The ability to expand at the same site. |
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Term
| Control of nonconforming testing |
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Definition
There should be procedures in case of non-conformance to specifications.
Actions should be defined in case of such non-compliance, e.g., could be holding the work, or notification of the client, or recall the work.
If this appears to be a general problem, a corrective action plan should be developed |
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Term
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Definition
Should be in place in case of non-conforming work. Start with an investigation to determine the cause of the problem.
Actions should be taken to prevent recurrence of the problem.
Actions should be based on risk analysis. |
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Term
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Definition
Identify the need for improvements and potential sources of non-conformance.
This is a pro-active process to identify opportunities of improvement rather than reaction of identified problems or complaints.
Preventive action might involve analysis of data, including trend analysis, risk analysis and participation in proficiency testing. |
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Term
| Potential Sources of Error |
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Definition
Sample Mishandling or recording errors
Faulty reagents, equipment, controls, or technique
Evidence contamination
Analyst bias |
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Term
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Definition
Sample mix-ups
Mis-labeling tubes
Incorrect recording of data
Sample handling mix-ups
Little to no control over the handling of evidence outside the lab |
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Term
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Definition
Care attention to detail
Independent checks at all stages
Sample handling policies
Redundancy in testing
Analytical results reviewed by 2 people
Retesting |
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Term
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Definition
Testing includes appropriate controls
Following standard QC program
Regular Proficiency testing
Regular monitoring of reagents (lot #)
Human cell line K562 |
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Term
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Definition
Foreign material is mixed with evidence
Different kinds – non biological materials
Inadvertent contamination
Mixed Samples
Carryover contamination |
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Term
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Definition
Subjective judgement, expectations, or bias
Consciously or unconsciously
Sins of omission rather than commission
Exculpating evidence might be ignored or rejected
Contradictory test results or evidence may be discontinued |
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Term
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Definition
| The acknowledgment and assumption of responsibility for actions, products, decisions, and policies including the administration, governance and implementation within the scope of the role or employment position and encompassing the obligation to report, explain and be answerable for resulting consequences. |
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Term
| Why it pays to increase your accountability |
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Definition
Today’s executives don’t have time to look over their employees’ shoulders.
They need people who will do the job right the first time. |
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Term
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Definition
A Rock — Can your boss count on you 100 percent?
The right call - Are you known for making good decisions?
A Fixer - Are you willing to correct a mistake, even if it wasn’t your fault?
A Trusted Source - Be up-front when you do make a mistake and come prepared with a solution. |
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Term
| What is the NIST Policy on Traceability |
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Definition
| the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons, all having stated uncertainties." |
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Term
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Definition
| For calibration laboratories, the program for calibration of equipment shall be designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI) |
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Term
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Definition
AKA Unbroken Chain of Comparisons
Documented series of comparisons that successively link the value and uncertainty of a result with that of the intermediate reference standards |
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Term
| Supporting a Claim of Traceability |
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Definition
The provider of results of a standard must document:
a clearly defined particular quantity that has been measured
The measurement process or system used
Provide description of the chain of comparisons used to establish a connection to a particular stated reference.
The result has a documented uncertainty
a complete specification of the stated reference at the time the measurement system or working standard was compared to it
an ‘internal measurement assurance’ program for establishing the status of the measurement system or working standard at all times pertinent to the claim of traceability |
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Term
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Definition
AKA Uncertainty of Measurement
Done for each step in the traceability chain
Must be calculated or estimated according to the agreed methods
Must be stated so that an overall uncertainty for the whole chain may be calculated or estimated |
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Term
| ISO 17025 Estimation of Uncertainty of Measurement |
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Definition
Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement.
The laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. |
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Term
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Definition
Absolute Uncertainty – any uncertainty reading from a device/instrument expressed in units (mL, mg, etc.)
Relative Uncertainty – any uncertainty reading from a device/instrument expressed in unitless form (percent)
Propagation of Uncertainty – technique used to combine all uncertainties of an entire process
et = √(e12 + e22 + e23 +…) |
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Term
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Definition
Medical laboratories – Particular requirements for quality and competence
Published January 2003
Next version (2008) currently undergoing very preliminary work
CAN P-11B
QMP-LS and OLA
CAP |
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Term
| 23 quality system essentials |
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Definition
Organization and Management
QMS
Document Control
Examination of Referral Laboratories
External Services and Supplies
Identification of Non-conformities
Corrective and Preventative |
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Term
| What are Pre-examination Procedures? |
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Definition
Requisition
Patient identification, name of ordering physician, clinician’s address, type of primary sample, anatomic site (where appropriate), the test requested, patient gender, date of birth, pertinent clinical information as may be required for test interpretation |
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Term
| Pre-examination Procedures |
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Definition
Procedures for proper patient preparation and specimen collection
Monitor elapsed time for time critical tests
Specimen rejection criteria
Specimen storage requirements |
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Term
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Definition
Validated written or electronic procedure for performing the test
Review reference intervals at regular intervals |
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Term
| Assuring Quality of Examination Procedures |
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Definition
Lab shall have an internal quality control program to verify the quality of patient test results
Stability of method, frequency of testing, average number of samples tested |
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Term
| Assuring Quality of Examination Procedures |
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Definition
Determine the uncertainty of measurement for each test and report as appropriate
Insure calibration materials are traceable to SI units
Participate in EQA programs
Small private non-commercial
Large non-commercial (College of American Pathologists) |
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Term
| Types of Quality Documents |
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Definition
Policies
Processes
Procedures
Forms and records |
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Term
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Definition
May be paper or electronic
Must be controlled
Must be maintained for specified periods of time
Must be approved by lab management |
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Term
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Definition
ISO 15189 sets minimum standards
Available to laboratories who wish to certify to an international standard verifying laboratory commitment to quality |
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