USCIS Quality Control & Assurance 4 — Questions and Answers
Question 1: A lab technician performing gonorrhea NAAT testing for I-693 applicants notices the internal amplification control failed on three of ten samples. What is the most appropriate action?
- Report all three samples as negative since no band was detected
- Repeat testing on those three samples; failed internal controls indicate inhibition or assay failure (Correct answer)
- Report all ten samples as invalid
- Discard the samples and document refusal to test
Correct answer: Repeat testing on those three samples; failed internal controls indicate inhibition or assay failure
A failed internal amplification control signals possible PCR inhibition or assay failure, requiring repeat testing of those specific samples.
Question 2: What is the purpose of delta checks in a clinical laboratory performing I-693 tests?
- To verify that two different QC levels pass simultaneously
- To compare a patient's current result with their previous result to detect specimen mix-ups or abrupt changes (Correct answer)
- To compare results between two different analyzer platforms
- To confirm that the laboratory's proficiency testing score is acceptable
Correct answer: To compare a patient's current result with their previous result to detect specimen mix-ups or abrupt changes
Delta checks flag significant changes from prior results for the same patient, helping identify specimen errors or clinically important changes.
Question 3: A clinic administers the MMR vaccine to an I-693 applicant but cannot locate the VFC (Vaccines for Children) temperature log for the previous weekend. What is the required quality assurance action?
- Assume temperatures were acceptable since no alarm was heard
- Document the missing monitoring period, investigate if vaccines were compromised, and report to the VFC program coordinator (Correct answer)
- Administer booster doses to all patients vaccinated that weekend
- Destroy all remaining MMR vials from that shipment immediately
Correct answer: Document the missing monitoring period, investigate if vaccines were compromised, and report to the VFC program coordinator
Missing temperature logs must be documented, investigated, and reported to the VFC coordinator to determine if vaccines remain viable.
Question 4: Which of the following best describes the difference between quality control (QC) and quality assurance (QA) in an I-693 examination setting?
- QC is performed monthly; QA is performed daily
- QC monitors test accuracy in real time; QA is a broader system-wide review of all processes affecting test quality (Correct answer)
- QA is only applicable to the physician examination, not laboratory testing
- QC and QA are interchangeable terms with no meaningful distinction
Correct answer: QC monitors test accuracy in real time; QA is a broader system-wide review of all processes affecting test quality
QC refers to real-time monitoring of test performance, while QA encompasses all policies and procedures ensuring overall quality throughout the examination process.
Question 5: A syphilis RPR test is reported as reactive with a titer of 1:32. The confirmatory treponemal test (e.g., TP-PA) is non-reactive. What is the most likely quality assurance concern?
- The RPR result is a false positive and no QC action is needed
- Specimen mix-up or prozone effect should be investigated before reporting results (Correct answer)
- The TP-PA test is always wrong when titers are high
- This result pattern confirms active syphilis with no further testing needed
Correct answer: Specimen mix-up or prozone effect should be investigated before reporting results
A discordant RPR/treponemal pattern may indicate prozone effect (very high antibody titers blocking agglutination) or specimen mix-up, requiring investigation.
Question 6: A civil surgeon's office manager reviews I-693 forms and notices several forms report HIV test dates that are three months old. Under CDC/USCIS guidelines, what is the quality assurance issue?
- HIV tests are valid for up to one year for immigration purposes
- HIV test results must be obtained within a specified timeframe per CDC Technical Instructions, and outdated results require retesting (Correct answer)
- The forms are acceptable since HIV status rarely changes
- Only the physician signature date matters, not the test date
Correct answer: HIV test results must be obtained within a specified timeframe per CDC Technical Instructions, and outdated results require retesting
CDC Technical Instructions specify timeframes for required laboratory tests; results outside those windows are not acceptable for the I-693.
Question 7: What is the primary reason civil surgeon laboratories must maintain a 'chain of custody' for specimen handling?
- To allow billing for additional specimen processing fees
- To ensure specimens are traceable from collection to result reporting and detect any handling errors (Correct answer)
- To comply with HIPAA privacy requirements for electronic records
- To satisfy FDA device approval conditions for test kits
Correct answer: To ensure specimens are traceable from collection to result reporting and detect any handling errors
Chain of custody documentation ensures accountability at every step, enabling error detection and supporting result integrity.
USCIS Quality Control & Assurance 4
A lab technician performing gonorrhea NAAT testing for I-693 applicants notices the internal amplification control failed on three of ten samples.
What is the most appropriate action?