Basic Knowledge CH 1 and CH 3 Flashcards
established quality standards for all laboratory testing to ensure accuracy, reliability, and timeless of pt test results, regardless of where the test was performed.
CLIA 88 Clinical Laboratory improvement amendement of 1988
Types of Certificate under CLIA 88
- Waiver
- PPM (Provider Performed Microscopy)
- Registration
- Compliance
- Accreditation
-Cleared by FDA for home use
- Simple methodologies that pose no risk of harm to patient if preformed incorrectly
EX: Pregnancy Test, Glucose monitoring Hgb-Copper Sulfate
Waived testing
Automated clinical laboratory equipment
ex: microscopic analysis of urine sediment, culture inoculations, gram stains
Moderate Complexity Testing (Non-waived)
Require clinicals Laboratory expertise beyond normal automation to perform
ex: peripheral smears, flow cytometry, gel electrophoresis, and most molecular diagnostic tests
High Complexity Testing (Non-waived)
Can conduct unannounced or announced inspections of any accredited or CLIA exempt lab at any time during normal operating hours
Department of Health and Human Services (HHS)
Primary Accrediting Organizations
- (COLA) Commission on Office Laboratory Accreditation
- (CAP) College of American Pathologist
- (TJC) The Joint Commission
MAINTAIN COMPLIANCE
Requires that training in handling chemical hazards, as well as training in handling infectious materials(standard precautions), be included for all new test personnel.
OSHA ( The US Occupational Safety and Health Administration)
A private alternative to help laboratories stay in compliance with the new CLIA regulations
COLA (Commission on Office Laboratory Accreditation)
A federal agency with responsibilities that include the Medicare and Medicaid programs; Regulation of all non-research laboratory testing performed on humans in the US.
CMS (Centers for Medicare and Medicaid)
A global driver of quality improvement and pt safety in healthcare
TJC (The Joint Commission)
Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care
CAP (college of pathologies)
Test performed at the bedside of the patient or near the site where the patient is; a decentralized form of laboratory testing-the laboratory goes to the patient.
POCT (Point of care testing)
The pt is aware of, understands, and agrees to the nature of the testing to be done and what will be done with the results reported.
Informed Consent
Any results obtained for specimens from patients must be kept strictly confidential. Any information including the types of measurements being done, must also be kept in confidence.
HIPPA (Health Insurance Portability and Accountability Act
Results of laboratory testing are to be used in a court of law, a specific chain documentation is required, whereby all steps of the testing are recorded, from specimen collection to the issuing of the results reported.
Chain of Custody
The discipline deals with good or bad or a set of moral principles.
Ethics
Identifies the specialties, subspecialties, and specific analytes or tests that require testing participation. Required by CMS under CLIA regulations fro non-waived tests.
Proficiency Testing
A phase of testing that is highly susceptible to human error
- Test selection
- Patient ID
-Collection of the sample
-Handling of the sample
-Pipetting
- Centrifugation
Pre-analytical testing
All parts of testing related to equipment functions, quality control, sample mix-ups in the lab, and any interferences with the true results
Analytical Testing
The final phase of the total testing process.
Test records must contain relible ID of patient specimens, traceability of specimen, and who performed the test
Test reports include the result and interpretation that is forwarded to the requesting clinician
Post analytical testing
Director, technical consultant, clinical consultant, and testing personnel
Moderate complexity
Direct and Testing personnel
PPM
Director, Technical supervisor, Clinical consultant, general supervisor, and testing personnel.
High complexity
Lab performing only waived test
Waiver
Lab where a physician, supervised midlevel practitioner, or a dentist performs specific microscopy procedures during a patient’s visit (moderate complexity tests)
PPM
Allows a lab to perform non-waived testing until inspection for compliance can be completed
Registration
Given to a lab once deemed compliant with CLIA regulation after inspection; given to labs performing moderate and/or high complexity testing
Compliance
issued to a lab that has successfully been accredited by an accreditation organization approved by CMS
Accreditation
Provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.
American society for clinical pathology (ASCP)
Established for the desire for greater autonomy and control over the direction of the profession by nonphysician laboratory professionals.
American Society for Clinical Laboratory Science (ASCLS)
What is the value of quality in the clinical laboratory?
It is the elimination of errors such as
- Ordering an inappropriate test
- Not ordering an appropriate
- Reporting an incorrect inaccurate test results
- Not interpreting an appropriate test result properly
Only by using the various_________systems can the________ of results be ensured. No matter how carefully a lab assay has been carried out, valid lab results can be reported only when preanalytical ______ has been ascertained.
Quality assessment, reliability, quality control
The ability of a laboratory assay to produce consistent results when testing is repeated successively
Reliability
Set of laboratory procedures designed to ensure that a test method is working properly and that the results meet the diagnostic needs of the physician. Improves the accuracy and reliability of testing and reduces the need for retesting and unnecessary procedures and treatments.
Quality Control
What category if tested is required to abide by certain QA standards as imposed by CLIA 88 and administrated by CMS
Non waived
Occurs at the interface between a healthcare worker and the patient.
- Missing blood vessels during phlebotomy
- Error with data entry
- Failing to identify a pt before phlebotomy
Active Errors
Related to the organization or design of a laboratory.
-Staffing problems
- Equipment malfunction
-Teamwork Factors
Latent Error
Proficiency testing is required by _______ for (waived/nonwaived) test only.
CLIA , nonwaived
Name 4 alternate assessment methods for proficiency testing.
External split sample, Internal split sample, Audit sample, and use government and university interlaboratory comparison.
Participate with another laboratory using the same method or another method
External Split Sample
Reexamine a specific patient sample using a different method or a different technologist.
Internal split sample
Analyze the same sample over time to assess the reproducibility and stability of a method
Audit sample
What phases of testing are evaluated by quality control and by quality assurance?
Pre-analytic factors, analytical factors, and post-analytical factors
Evaluates the daily precision of assay measurements
Internal QC or statistical QC
Evaluates the accuracy of assay measurements. Use data generated from voluntary submission of internal QC control assay results and data generated from required submission of specific control specimen.
External QC
Which westgard multirules detect random error?
1(3s) and R(4s)
Which westgard multirules detect systematic errors?
2(2s), 4(1s) and 10(x)
List the 9 nonanalytical factors that support quality testing
- Qualified personal
- Established laboratory policies
- Laboratory procedure manual
- Test requisitioning
- Patient identification, specimen procurement and labeling
- Proper procedure for specimen collection and storage
- Specimen transportations and processing
- PM of equipment
- Appropriate methodology
Errors that are occurring over a period of time.
- Change in the mean of the control values
- Gradual and demonstrated as a trend in control values
- Abrupt and demonstrated as a shift in control values
Systematic error
An unpredictable error with no obvious pattern. It can occur by chance alone.
- An unexpected deviation away from the calculated mean
- There is acceptable(expected) random error as defined and quantified by standard deviation.
- There is unacceptable(unexpected) random error that is any data point outside the expected population of data.
Random error
- Detecting errors in equipment reagents, or individuals techniques.
- Confirming the stability and accuracy of testing compared with reference values.
- An increase in the frequency of both high and low minimally acceptable values (Dispersion
- Progressive drift with a statistical trends.
An abrupt shift with an average value of 3 days
Control specimen
According to CLIA regulations, a minimum of____ control specimen must be run in every 24 hour period when patient specimen are being run
2
What length of time would qualify as a shift or trend in QC data when looking at a levey-jenning chart?
3 days
Represents a specimen with a known value that is similar in composition to, for example patients blood. The best to measure of precision and may represent normal or abnormal values.
Control
Highly purified substance of a known composition. Best way to measure accuracy.
Standard
Used in part to account for certain unavoidable error caused by sampling variability and imprecision of the methods themselves.
Confidence intervals (95%)
A comprehensive set of policies, procedures, and practices is necessary to ensure the lab’s results are reliable. To monitor and evaluate the overall quality of the total testing process (pre-analytical, analytical. and post-analytical)
Quality assurance
The agreement among replicate measurements aka how close the single values are to one another.
Precision
The agreement between the measured quantity and its true value aka how close the value is to the “true” value
Accuracy
Used to identify unacceptable runs and then to evaluate the source and magnitude of the deviation to decide whether results are to be released to patient charts
Levey-Jennings QC Chart
A voluntary process by which a nongovernmental agency grants recognition to an individual who has met certain education requirements and demonstrated entry-level competency by examination
Certification
A mandatory process by which some states(government regulated) grant permission to an individual or organization to engage in a given occupation
Licensure
- Proficiency Testing Programs
- Management of patient testing
- Quality assessment programs
- Quality Control systems
-Personal Requirements
-Inspections and site visits
-Consultations
CLIA 88 Regulations
- Deterioration of the instrument light source
- Gradual accumulation of debris in sample/reagent tubing
- Gradual accumulation of debris on electrode
surfaces - Aging of reagents
- Gradual deterioration of control materials, incubation chamber temperature(enzymes only), light filter integrity, and calibration.
Causes of Trending
- Sudden failure or change in the light source
- Change in reagent formation or lot
- Major instrument maintenance
Sudden change in incubation temperature(enzymes only), room temperature, or humidity - Failure in the sampling system or in reagent dispense system
-Inaccurate calibration/recalibration
Causes of Shifting
Normal group of individuals free from disease and represents 95% of the population
Reference interval (normal range, normal value, reference range)
- Testing the abilities, skills, knowledge of the individual
-Known(previous tested) sample - Focuses on the individual performing patient testing; Does the person possesses the skill and knowledge to report accurate results?
- Checked semiannually during the first year of employment and annually thereafter
Competency
- Testing the processes of the lab
- Unknown samples
- Focuses on the laboratory’s ability to report accurate test results and compares the lab’s results to peer lab, reference standards, or reference labs
- Performed periodically throughout the year for most tests performed and rotated among staff
Proficiency
- Direct observations of routine patient testing to include patient preparation(if applicable), specimen handling, processing and testing
- Monitoring the reporting of test results
- Review of intermediate test results or worksheet ,QC records, PT results, and preventive maintenance records.
- Direct observations of performance of instrument maintenance and function checks
- Assessment of testing performance through testing previously analyzed specimen, internal blind samples, or external PT samples.
- Assessments of problem solving skills
6 areas of competency required by CLIA
event where personnel could exercise more control
Adverse incident
Risk management must report serious adverse incidents to the state within 15 days
CODE 15
Occurrence that results in an unanticipated death or major loss of function unrelated to patient’s current condition
Sentinel event
Process variation for which a recurrence carries significant chance of a serous adverse event
Near Miss
In-depth analysis of an occurrence by a multidisciplinary team if involved employees
Root Cause analysis
