Proficiency Testing
A program where an outside provider sends unknown samples to a lab to check accuracy against a peer group or reference value.
What is proficiency testing (PT)?
The classic chart used to plot control results over time against a mean and standard deviation lines.
What is a Levey–Jennings chart?
The periodic check that ensures test procedures are current—reflecting the latest method changes, reference ranges, and safety steps—with a documented review and approval.
What is SOP (procedure) review?
Before you let someone perform moderate/high complexity testing, you must have proof they meet the education/experience requirements for this role.
What are personnel qualifications?
Changing a date to make it appear a review, training, or competency happened earlier than it actually did—rather than documenting a late entry/correction.
What is Backdating?
After each event, this must be reviewed and signed, with investigation and corrective action documented for unacceptable performance.
What PT Performance Review?
These multi-rule criteria (like 12s, 13s, 22s, R4s) help decide when to accept or reject an analytical run.
What are Westgard rules?
The process that confirms an instrument’s reportable range remains accurate by testing materials across low, mid, and high levels (often at least every 6 months or after major changes).
What is calibration verification? (or AMR/Linearity)
This document defines required duties, reporting relationships, and minimum qualifications—auditors expect it in the job posting and the personnel file.
What is a job description?
This competency assessment method evaluates an employee’s ability to recognize and resolve atypical patient results or instrument errors without direct supervision
What is assessment of problem‑solving skills?
This prohibited practice occurs when a lab sends PT samples to another lab (or runs them on a different instrument/site) to obtain results before reporting.
What is PT referral?
When QC is out of range, this is the required next step before releasing patient results: stop, investigate, fix, and document.
What is corrective action?
The periodic check that confirms electronic results sent from the LIS/instrument interface arrive in the EMR exactly as intended (right patient, right test, right units, right reference intervals, right flags).
What is transmission verification? (Interface Check)
The documented process that happens before independent work—covering policies, safety, and how to perform and report patient testing for each assigned bench.
What is training and orientation?
The document that proves what benches/tests an employee was trained on, what methods were covered, and the dates and signatures showing completion.
What is a training checklist (training record)?
These ungraded/educational challenges (often used for non-regulated analytes) still must be reviewed, evaluated, and documented— including any follow-up or corrective action when performance is unacceptable.
What is alternative performance assessment? (Self-Evaluation or Peer Assessment)
This routine practice requires documenting that QC was acceptable (or corrected) before patient results were released—often with daily/shift sign-off and trend checks.
What is QC Review?
This review focuses on the LD result report itself—test name, methodology statement, units, reference interval/interpretive comment, limitations, and any required disclaimers.
What is result report content and format review?
The ongoing requirement to keep staff current on methods, policies, and patient safety—tracked with dates, topics, and attendance/credits.
What is continuing education?
CAP’s and CLIA record-retention guidance lists this minimum retention period for personnel competency assessment records.
What is 2 years?
In many PT programs, failing this many events out of three for the same analyte typically triggers an unsuccessful performance finding and a required investigation.
What is two out of three?
This QC requirement says you didn’t really do it unless you can show it: control results, review, corrective action, and who/when must all be recorded and retrievable.
What is QC documentation?
The periodic review that verifies required logs (temperature, maintenance, reagent lot-to-lot, QC) are complete, legible, signed, and corrected properly—no white-out allowed.
What is record (form) review?
Under CLIA and CAP, this collection of records must demonstrate an employee’s qualifications, training, authorization to perform testing, competency assessments, and ongoing compliance with laboratory requirements.
What is a personnel file?
This personnel requirement uses direct observation, result review, QC review, and problem‑solving evaluation to prove continued testing proficiency.
What is Competency Assessment?