People · 5 of 6 services
Training and competency
The six-element program, documented.
Six elements · Documented · Ready for review
What you receive.
Competency is the most cited personnel requirement in the country, and almost always for documentation rather than for capability. Your staff can do the work. The file has to show that somebody qualified watched them do it.
- A competency program covering all six elements the regulation requires
- Assessment forms by test and by bench, in your document format
- A schedule: six months for the first year, annually after that
- A training program for new staff, with a documented sign-off path
- A tracking record showing who is current and who is due
- A file audit of what already exists, with the gaps listed
The six elements
What an assessment must include.
Direct observation
Of routine patient test performance.
Monitoring recording
Of results recording and reporting.
Record review
Intermediate results, QC, proficiency testing.
Instrument observation
Maintenance and function checks.
Blind samples
Previously analyzed or external material.
Problem solving
Assessment of problem solving skills.
The engagement
Audit the files, build the program, roll it out, run the first cycle.
File audit
Week 1
Program build
Weeks 2 to 4
Rollout and training
Week 5
First assessment cycle
Weeks 6 to 8
Before you engage
Price: fixed fee, by staff count and test menu.
Lead: a named partner, in your proposal.
How it starts: a 20-minute call, then a written scope and fee before any work begins.
Questions
How often is competency required?
Semiannually during the first year an individual tests patient specimens, and annually after that.
Who may perform the assessment?
The regulation assigns it to the technical supervisor or technical consultant for the specialty, and the file has to show that person did it.
Is training the same as competency?
No. Training happens before independent testing. Competency is the documented proof it held.
Cited on this page
- 42 CFR 493.1235, competency assessment (ecfr.gov)
- 42 CFR 493.1451, technical supervisor responsibilities (ecfr.gov)
Citations link to the official text. Nothing here replaces the current checklist issued by your accrediting body, and we read that checklist with you rather than in place of you.
Close the most cited gap.
Twenty minutes, then a written scope. Nothing starts until you sign it.