Chapter 3 Flashcards
Blood and urine specimens are most often tested, but examinations can also conducted on body tissues and other body fluids, including synovial, cerebrospinal, seminal, peritoneal, and pericardial fluids.
It is most important that the specimens be properly identified and collected.
Special patient preparation for some specimen collections, along with proper transportation to and handling in the laboratory before the actual analytical assay, are very important.
Quality assessment (QA) ensures reliability of results.
Valid results can be reported only when preanalytical quality control (QC) has been ascertained.
Enactment of Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) established a minimum threshold for all aspects of clinical laboratory testing.
The introduction of routine QC in the clinical laboratory was a major advance in improving the accuracy and reliability of clinical laboratory testing.
Errors occurring during the analytical phase of testing within clinical laboratories are now relatively rare.
CLIA
Clinical Laboratory Improvement Amendments
Clinical Laboratory Improvement Amendments
CLIA
The Joint Commission
TJC
Formerly the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO)
TJC requires hospital laboratories to be accredited by TJC itself, the Commission on Office Laboratory Accreditation (COLA), or the College of American Pathologists (CAP).
Per TJC, a periodic performance review (PPR) will be required for the laboratory accreditation program.
◦ The PPR is a formal standards evaluation tool intended to support continuous compliance and is being added to the accreditation process at the request of accredited laboratories.
TJC requires hospital
laboratories to be accredited by TJC itself
PPR
a periodic performance review (PPR) will be required for the laboratory accreditation program.
◦ The PPR is a formal standards evaluation tool intended to support continuous compliance and is being added to the accreditation process at the request of accredited laboratories.
CAP
the College of American Pathologists
COLA
the Commission on Office Laboratory Accreditation (COLA),
the Commission on Office Laboratory Accreditation (COLA),
COLA
the College of American Pathologists
CAP
CAP 15189 is
a voluntary, nonregulated accreditation to the ISO 15189:2007 Standard.
CAP 15189 requires a steadfast commitment to the laboratory management system and all interacting departments.
CAP 15189 does not replace CAP’s CLIA-based Laboratory Accreditation Program, but rather complements CAP accreditation and other quality systems by optimizing processes to improve patient care, strengthen the deployment of quality standards, reduce errors and risk, and control costs.
Pioneering clinical laboratories in the United States that use management systems such as Lean, which focuses on reducing waste, and Six Sigma,
a metric and methodology that focuses on reducing variability, can have an immediate and recognizable impact when properly applied.
When either of these systems was used to redesign workflow in high-volume core hematology and chemistry laboratories, a 50% reduction in average test turnaround time, a 40% to 50% improvement in labor productivity, and a comparable improvement in the quality of results were observed.
Key LEAN lessons
Key LEAN lessons
1◦ It is not possible to overcommunicate.
2.Continuously focus on improvement.
3 Engage all facets of an organization, not just a core team.
4 Actions speak louder than words.
5 Ideas flow from the bottom up.
6 Be respectful to every individual. Listen to and seriously consider their ideas.
1.A feedback loop is critical to overcome challenges.
2. Staff must be accountable to achieve success.
(From Coons J, Courtois H: LEAN lab puts patient safety first,
External standards have been set to ensure the quality of laboratory results reported through QA, as imposed by CLIA’88 and administered by CMS.
A clinical laboratory must be certified by CMS, by a private certifying agency, or by a CMS-approved state regulatory agency.
◦ Included in the CLIA’88 provisions are requirements for QC and QA, for the use of proficiency testing (PT), and for certain levels of personnel to perform and supervise the work in the laboratory.
Once certified, the laboratory is scheduled for regular inspections to determine compliance with the federal regulations, including CLIA’88.
CAP Quality Assessment Considerations
Supervision
Procedure manual
Specimen collection and handling
Results reporting
Reagents, calibration, and standards
Controls
Instruments and equipment
Personnel
Physical facilities
Laboratory safety
Quality Assessment
Error analysis includes active and latent errors. ◦ Active errors include:
◦ Failing to identify a patient before phlebotomy
◦ Missing a blood vessel during phlebotomy
◦ Errors with anticoagulants in collection tubes
◦ Errors with transportation system (such as a pneumatic tube) ◦ Errors with data entry
◦ Errors with instrument or computer (such as ignoring instrument flag)
Latent errors include:
Staffing problems (such as chronic shortages)
◦ Information technology (such as no interface with technology)
◦ Equipment malfunctions (such as old error-prone analyzers)
◦ Work environment (such as multitasking, poor lab layout, and disconnect between lab and patients)
◦ Policy and procedures (such as the relabeling of mislabeled or unlabeled tubes and lab requisition variation)
◦ Teamwork factors (such as poor communication between shifts and departmental “silos”)
◦ Management/organization (such as when profit is a goal, ignoring patient safety, and deemphasis on incident reports and interventions based on analysis)
Ways to improve overall errors include at least three strategies:
◦ Formal patient safety training, including discussion of disconnect between laboratory personnel and the patient
◦ Enhanced communication between patients and laboratory staff and providers directly caring for patients
◦ Quality improvement projects that involve patient outcomes data and feedback of the data to laboratory staff, with an analysis of the consequences of high-quality and low-quality work
Phases of testing
◦
Preanalytical (preexamination)
◦ Analytical (examination)
◦ Postanalytical (postexamination)
Most laboratory errors are related to the preexamination or postexamination phases of testing rather than the examination phase. Specimen-related errors continue to be a major problem..
The preanalytical phase of testing is particularly error prone, mainly because it is especially susceptible to human error.
Preanalytical errors
- Incorrectly ordered assay
- Specimen obtained from wrong patient
- Specimen procured at the wrong time
- Specimen collected in the wrong tube or container
- Blood specimens collected in the wrong order
- Incorrect labeling of specimen
- Improper processing of specimens
Analytical
- Oversight of instrument flags
- Out-of-control quality control results
- Wrong assay performed
Postanalytical - Reporting the wrong result
- Verbal reporting of results
- Instrument: laboratory information system incompatibility error
- Confusion about reference ranges
Postanalytical
- Reporting the wrong result
- Verbal reporting of results
- Instrument: laboratory information system incompatibility error
- Confusion about reference ranges
A means by which quality control between laboratories is maintained.
◦ Participation in a PT program involves receiving identical specimen samples periodically.
◦ Results of assays are graded for each participating laboratory according to designated evaluation limits, and the results are compared with those of other laboratories participating in the same PT program.
Incorporation into CLIA requirements
◦ CLIA regulations apply to FDA and non-FDA cleared and approved moderate-complexity or high-complexity assays.
◦ If a laboratory performs moderate-complexity or high- complexity tests for which no PT is available, it must have a system for verifying the accuracy and reliability of its test results at least twice a year. If a laboratory performs only waived tests, it is not required to participate in a PT program.
◦ Per CLIA’88, a laboratory must establish and follow written QC procedures for monitoring and evaluating the quality of the analytical testing process of each method to ensure the accuracy and reliability of patient test results and reports.
If a PT program is not available for a specific analyte, an alternate assessment of quality is needed. Several methods exists:
.
Several methods exists:
1.Internal Split-Sample—reexamine a specific patient sample by a different method or performed by a different technologist
Alternate Assessment
2.External Split-Sample—participate with another laboratory using the same method or another method
3.Audit Sample—analyze the same sample over time to assess reproducibility and stability of a method
Use Government and University Interlaboratory comparisons.
Reporting results
1◦ The introduction of computer-interfaced, online reporting is useful in communicating information correctly and efficiently.
2◦ The Delta check system monitors individual patient results. The difference between a patient’s present laboratory result and consecutive previous results that exceed a specified cutoff value is referred to as a Delta check.
3◦ The ongoing process of making certain the correct laboratory result is reported for the right patient in a timely manner and at the correct cost is known as continuous quality improvement (CQI).
Nonanalytical Factors in Quality Assessment
Qualified personnel
2. Established laboratory policies
3. Laboratory procedure manual
4. Test requisitioning
5. Patient identification, specimen procurement, and labeling
6. Proper procedures for specimen collection and storage
7. Specimen transportation and processing
8. Preventative maintenance of equipment
9. Appropriate methodology
Mean, median, and mode
Mean, median, and mode
◦ Mean = the average of a group of numbers
◦ Median = middle value of a body of data
◦ Mode = the value most frequently occurring in a list of numbers
Standard deviation (SD)
)
◦ A measure of the variability in a data set
Confidence intervals
◦ Reference range expressed as 95% or 2 SD on either side of the mean
Positive predictive value (PV)
equals the number of patients with an abnormal test result who have the disease divided mathematically by the total number of patients with an abnormal result.
PV also equals the number of true positives divided by the sum of true positives plus false positives.
Negative predictive value (PV)
Negative equals the number of patients with a normal test result who do not have the disease, divided by the total number of patients with a normal (negative) result.
Predictive values
◦ The prevalence vs ◦ The incidence
Predictive values
◦ The prevalence -of a disease is the proportion of a population who have the
disease.
◦ The incidence - of a disease is the number of persons found to have the disease within a defined period, such as a year, in a population of 100,000.
True of positive and negative
False of positive and negative
True positives are those patients who have a positive test result and who also have the disease in question.
True negatives are those who have a negative test result and who do not have the disease.
False positives are those patients who have a positive test result but do not have the disease.
False negatives are those who have a negative test result but do have the disease.
Accuracy describes how close a test result is to the true value.
◦ Reference samples and standards with known values are needed to check
accuracy.
Accuracy versus precision
Accuracy versus precision
◦ Accuracy is the closeness of the measured result to the true value. ◦ Precision can be expressed as standard deviation or coefficient of
variation.
The precision of a test, or its reproducibility, may be expressed as a known physical constant
standard deviation (SD) or the derived coefficient of variation (CV).
Variance is a general term that describes the factors or fluctuations that affect the measurement of the substance in question.
Calibration i
Calibration is the comparison of an instrument measure.
Control represents a specimen with a known value that is similar in composition, for example, to the patient’s blood. The value of a control specimen is known.
◦
Control specimens are t
Control specimens are tested in exactly the same way as the patient specimen and are tested daily or with the unknown (patient) specimen. Controls are the best measurements of precision an d may represent normal or abnormal test values.
uality assurance verifies the three phases of laboratory testing, but QC only evaluates the analytical part.
Two types of QC
uality assurance verifies the three phases of laboratory testing, but QC only evaluates the analytical part.
Two types of QC:
◦ Internal QC, statistical QC, that evaluates the daily precision of assay
measurements.
◦ External QC that evaluates the accuracy of assay measurements. This type of QC uses data generated from voluntary submission of internal QC control assay results (peer-groups) and data generated from required submission of specific control specimens (proficiency testing).
Documentation of QC includes preventive maintenance records, temperature charts, and QC charts for specific assays.
If a PT program is not available for a specific analyte, an alternate assessment of quality is needed.
Several methods exists:
1Internal Split-Sample—reexamine a specific patient sample by a different method or performed by a different technologist
Alternate Assessment
2External Split-Sample—participate with another laboratory using the same method or another method
3Audit Sample—analyze the same sample over time to assess reproducibility and stability of a method
Use Government and University Interlaboratory comparisons.
Reporting results
◦ The introduction of computer-interfaced, online reporting is useful in communicating information correctly and efficiently.
.
◦ The Delta check system monitors individual patient results. The difference between a patient’s present laboratory result and consecutive previous results that exceed a specified cutoff value is referred to as a Delta check.
◦ The ongoing process of making certain the correct laboratory result is reported for the right patient in a timely manner and at the correct cost is known as continuous quality improvement (CQI).
CLIA is
Clinical Laboratory Improvement Amendment
ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities
TJC is
Then join commission
Provide guidance to an organization quality improvement efforts.
PPR is
Periodic Performance Review
As management tool. which allows your organization to stay current with compliance issues and track and monitor progres
CAP IS
COLLEGE OF AMERICA PATHOLOGISTS
The leading organizations of board certified pathologist,
Serve patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
COLA is
Commission on Office Laboratory Accreditation
is one of the most recognized laboratory accreditors in the United States. It’s dedicated to improving healthcare and patient care in laboratories nationwide through its accreditation and educational services.
CAP IS
Meet standard CLiA, FDA AND oSHA
The leading organizations of board certified pathologist,
Serve patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
LAI IS
LABORATORY ACQUIRED INFECTIONS
All infections acquired through laboratories or laboratory related activities, whether they are symptomatic or asymptomatic in nature. LAI DUR TO A EIDE VARIETY OF BACTERIA, VIRUS, FUNGI, AND PARASITES.
OSHA IS
Occupation safety and health administration
Assure safe and healthful working conditions by setting and enforcing standards, and by providing training, outreach, education and assistance
ASCLS
is to make a positive impact in health care through leadership that will assure excellence in the practice of laboratory medicine.
NHSN IS
National Health care safety network
the nation’s most widely used healthcare-associated infection tracking system
CDC is
Center disease control
federal government agency whose mission is to protect public health by preventing and controlling disease, injury, and disability
MSDSs
Material safety data sheets
SDS IS
SAFETY DATA SHEET
