QA QC revision Flashcards
What are the hierachy of lab quality managment?
What does HIPAA do?
- protect health insurance coverage for individuals who change or lose jobs
- stablish standards forfor health care data (security and privacy)
what does CLIA cover?
What is quality assurance (QA)?
- Assess the effectiveness of the lab’s policies and procedures
- Identify and correct problems
- Assure the accurate, reliable, and prompt reporting of test results
- Assure the adequacy and competency of the staff
How does CLIA check for QA?
- Patient test management
- Quality control
- Proficiency testing
- Test comparisons
- Relate results to clinical data
- Personnel
- Communications
- Complaints
- Staff review
- Records
How does CLIA define a laboratory?
- A facility that performs testing on materials derived from the human
body for the diagnosis prevention, or treatment of disease or
assessment of the health of human beings.
Who needs a CLIA certificate?
- All facilities that perform even one applicable test (including waived
tests) on “materials derived from the human body for the purpose of
providing information for the diagnosis, prevention, or treatment of
any disease or impairment of, or the assessment of the health of,
human beings.” - Laboratories must obtain a certificate from the CLIA program that
corresponds to the complexity of tests performed.
How often are CLIA-regulated
laboratories inspected?
- Must pass initial inspection
- Re-inspected biennially (once every two years)
Labs may elect to achieve accreditation from one of several
approved programs granted “deemed” status by CMS - For high complexity laboratories this includes the Joint Commission and CAP.
What is the Joint Commission?
- Private non-profit organization which performs hospital accreditation.
- Performs unannounced inspections of hospitals every 3 years.
- The Joint Commission (along with CAP) is granted the ability to inspect and
accredit laboratories. - Inspectors are employees of the organization (funded by accreditation fees
paid by member organizations). - The inspections of laboratories occur every two years.
Hospitals every 3 years, labs every 2 years with joint commission
What is College of American Pathologists (CAP)?
- Professional organization for board-certified pathologists.
- A CMS “deemed” organization.
- Is permitted by CMS to conduct laboratory inspections and grant
accreditation. - Inspections are carried out by peer members (designed to meet CLIA
regulations). - Also provides proficiency testing for CLIA requirements.
CAP provides Prof testing for CLIA requirment
If you get CAP deficiency, how long do you have to respond to it?
30 days
Exam Q: Personel requirment
What is the minimum requirment for personel in lab performing high complxity testing?
- Bachelor’s degree (relevant scientific field)
- Associate degree in a chemical or biological science, or medical laboratory
technology AND specific course/laboratory training requirements (semester
hours specifications AND completion of clinical laboratory training program OR
3 months of documented laboratory training in each high-complexity specialty) - ACMG guidelines specify “or have at least 5 years of relevant laboratory
experience” - All personnel must have satisfactory training records
- Competency must be assessed at least once annually
Competency test once a year
Exam Q: Supervisor requirment
What is the minimum general supervisor requirments?
For clinical cytogenetics or molecular genetics:
* Bachelor’s degree (relevant scientific field)
* At least 3 years of experience in a clinical cytogenetics/molecular genetics
laboratory, respectively (ACMG)
- Note that CAP specifies:
- “At least two years” – Cytogenetics
- “At least four years” – Molecular genetics
Which of the following combinations of educational
experience are sufficient to be a laboratory director?
(select all that apply)
a. Masters in medical laboratory science and eight years of experience
supervising high-complexity testing
b. PhD in any discipline AND current certification by a board approved
by HHS
c. PhD in chemical, physical, biological or clinical laboratory science
AND two years of experience supervising high-complexity testing
d. MD or DO AND certification in anatomic or clinical pathology
e. MD or DO AND one year of laboratory training during
residency/fellowship
d and e
PhD should be in chemical, physical, biological or clinical laboratory science not any discipline
Exam Q: Lab director requirment
What is the minimum requirment for a lab director?
MD, DO or DPM licensed to practice in jurisdiction AND one of the following:
* Certification in anatomic or clinical pathology
* One year of laboratory training during residency/fellowship
* Two years of experience supervising high-complexity testing
Doctoral degree in chemical, physical, biological or clinical laboratory science AND have current certification by a board approved by HHS
What criteria are not needed in cerification that iare needed in validation?
Analytical sensitivity and specificity
What is Accuracy and how is it determined?
Determines how close the test result to the true value.
Test specimens with known results using the assay.
What is Precision and how is it determined?
- Determines how close the test results are to one another.
- Controls for day-to-day, run-to-run, or technician-to-technician variability.
- Test the same sample multiple times and determine whether the results are the same.
What is analytical sensitivity and how is it determined?
- What is it?
- The proportion of true positive test results to
the total number of positives (patients with
disease). - How is it determined?
- Run samples that are known positives and
determine how many have a positive test
result with the assay. - Sensitivity = true positive/total positive = true
positive/(true positive + false negative)
What is analytical specificity and how is it determined?
- What is it?
- The proportion of true negative test results to
the total number of negatives (patients
without disease). - How is it determined?
- Run patients that are known negatives and
determine how many have a negative result
with the assay. - Specificity = true negative/total negative =
true negative/(true negative + false positive)
