ASCP Quality & Professional Issues 2 — Questions and Answers
Question 1: What is the primary purpose of running quality control (QC) samples in the laboratory?
- To calibrate instruments daily
- To verify that test systems are producing accurate and reliable results (Correct answer)
- To train new employees on procedures
- To determine patient diagnosis
Correct answer: To verify that test systems are producing accurate and reliable results
Quality control samples with known values are run to verify that the analytical system is functioning properly and producing results within acceptable ranges.
QC materials are commercially prepared specimens with established target values and acceptable ranges. By running these controls at regular intervals, the laboratory can detect errors before they affect patient results. Results are plotted on Levey-Jennings charts and evaluated using Westgard rules. If QC falls outside limits, patient testing must be halted until corrected.
Question 2: A phlebotomist accidentally identifies the wrong patient before a blood draw. Under which category does this error fall?
- Analytical error
- Post-analytical error
- Preanalytical error (Correct answer)
- Instrument error
Correct answer: Preanalytical error
Patient misidentification is a preanalytical error because it occurs before the specimen is analyzed and is one of the most serious errors in phlebotomy.
Patient misidentification is the most critical preanalytical error because it can lead to wrong results being reported on the wrong patient, potentially causing incorrect treatment or fatal blood transfusions. Proper identification requires checking at least two unique identifiers by having the patient state them verbally.
Question 3: Which organization establishes the standards for phlebotomy procedures and order of draw?
- OSHA
- FDA
- CLSI (Correct answer)
- CLIA
Correct answer: CLSI
CLSI (Clinical and Laboratory Standards Institute) develops voluntary consensus standards for laboratory procedures, including the order of draw and venipuncture techniques.
CLSI is a nonprofit organization that develops globally recognized voluntary consensus standards. The key phlebotomy document is GP41: Collection of Diagnostic Venous Blood Specimens. While CLSI standards are voluntary, they are widely adopted and referenced by regulatory agencies like OSHA and CMS.
Question 4: What does HIPAA require regarding patient information during the phlebotomy process?
- Patient information must be shared with all healthcare workers
- Protected health information must be kept confidential and shared only on a need-to-know basis (Correct answer)
- Patients must sign a waiver before each blood draw
- HIPAA does not apply to phlebotomy procedures
Correct answer: Protected health information must be kept confidential and shared only on a need-to-know basis
HIPAA requires that all protected health information be kept confidential and only disclosed to authorized personnel with a legitimate need.
HIPAA's Privacy Rule protects all individually identifiable health information. During phlebotomy, this means verifying identity discreetly, not discussing patient information in public areas, keeping requisitions face-down during transport, and only accessing records when necessary. Violations can result in civil penalties up to $50,000 per violation.
Question 5: A phlebotomist notices that their QC result is 2.5 standard deviations above the mean. According to Westgard rules, what action should be taken?
- Accept the result and proceed with patient testing
- Flag as a warning and continue testing with increased monitoring
- Reject the run and troubleshoot before testing patients (Correct answer)
- Repeat the QC test once and accept if the second result is within 2 SD
Correct answer: Reject the run and troubleshoot before testing patients
A QC result exceeding 2 standard deviations strongly suggests a problem, and the run should be rejected and investigated before patient testing resumes.
Westgard rules evaluate QC data. The 1-2s rule is a warning (one result exceeds 2 SD), while 1-3s is a rejection rule (exceeds 3 SD). A result at 2.5 SD strongly suggests a problem. The technologist must stop patient testing, troubleshoot (check reagents, controls, calibration), correct the problem, and rerun QC.
Question 6: What is the consequence of failing to maintain proper chain of custody for a forensic blood specimen?
- The specimen must be redrawn
- The test results may be inadmissible in court (Correct answer)
- The laboratory loses its CLIA certification
- The phlebotomist receives a written warning only
Correct answer: The test results may be inadmissible in court
If chain of custody is broken, the specimen's integrity cannot be guaranteed, and the results may be deemed inadmissible as evidence in legal proceedings.
Chain of custody is a documented record tracking a specimen from collection to final disposition. If any gap or irregularity exists, defense attorneys can argue tampering or substitution, potentially rendering results inadmissible. Phlebotomists must follow strict protocols including witnessed collection, tamper-evident seals, and immediate documentation.
ASCP Quality & Professional Issues 2
What is the primary purpose of running quality control (QC) samples in the laboratory?