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
