Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing records for 2018 and 2019 and staff interview, it was revealed the laboratory failed to have documentation of performing a self-evaluation for 2 of 2 samples that were not graded by American Proficiency Institute. Findings include: 1. Review of the 2018 Chemistry- Miscellaneous- 1st event proficiency testing performance evaluation (signed by the laboratory director on 6/7/18) revealed the laboratory received a grade of 'Not Graded' for Urine drug screen Opiates sample UDS-02. 2. Review of the 2019 Chemistry- Miscellaneous- 1st event proficiency testing performance evaluation (signed by the laboratory director on 5/31/19) revealed the laboratory received a grade of 'Not Graded' for Urine drug screen Opiates sample UDS-01. 3. The American Proficiency Institute proficiency testing performance evaluation form states, "Laboratories are responsible for documenting and performing