Does your laboratory meet these standards?

The Laboratory director is responsible for ensuring acceptable quality.

CLIA 42 CFR 493.1445 - Standard; Laboratory director responsibilities states that s/he must:

(3) Ensure that— (i) The test methodologies selected have the capability of providing the quality of results required for patient care

(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and

(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;

 (6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;

(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;

(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly;

https://www.law.cornell.edu/cfr/text/42/493.1445

Risk management can be this simple

1. Set acceptable risk levels approved by the PIPS
2. Enter risk drivers
3. Use Mathematically-Optimized QC processes to meet defined limits

M.O.R.E. Quality separates risk, and sets acceptable risk levels by phases of initial, current and potential risk.  

How many MUR/year do you accept at method validation, at regular review and if the method was to fail unexpectedly? 

Contact [email protected] to participate in a risk evaluation program.