If a laboratory receives a “not acceptable” result for any PT sample, the laboratory shall:

1. (a) Review each “not acceptable” result to determine:

   1. (1) What caused the error; and
   2. (2) What corrective action(s) the laboratory needs to take to correct the problem;
2. (b) Document in its own records the cause(s) and corrective action(s) the laboratory has taken to correct each problem that caused or contributed to the “not acceptable” result;
3. (c) Submit the results of its own investigation and a corrective action report to the department within 30 calendar days of receiving the results; and
4. (d) Initiate corrective action that is documented in a corrective action report submitted to the department before requesting a supplemental PT study.

Source. (See Revision Note at chapter heading for Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21