Psh Cmg Andrewspatel West

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of 1 of 5 Blood Cell Identification PT results in 2020, 1 of 5 Routine Chemistry and 1 of 5 Blood Cell Identification PT results in 2021. Findings Include: 1. On the day of survey, 10/04/2022 at 09:40 am, review of API proficiency testing records revealed that the laboratory did not verify the accuracy for the following analytes that were not graded by the proficiency testing agency: - API 2020 Hematology/Coagulation-3rd Event: Blood Cell Identification sample BCI-11, the laboratory response (microcytic, red blood cell) was not graded due to lack of consensus. - API 2021 Chemistry Core-1st Event: Routine Chemistry analyte AST /SGPT sample CH-02 was not graded due to lack of consensus. -API 2021 Hematology/Coagualtion-2nd Event: Blood Cell Identification sample BCI-07, the laboratory response (myelocyte) was not graded due to lack of consensus. 2. The TS confirmed the findings above on 10/04/2022 around 10:55 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory personnel interview with the Laboratory Supervisor and Technical Supervisor-2 and review of the competency records, the Laboratory failed to follow written policies to assess employee competency for one of 2 Technical Supervisors, from (03/09/2018) through the date of the survey (06/15/2020). Findings: 1. Review of the competency records revealed no documentation of competency for Technical Supervisor-2 from (03/09/2018) through the date of the survey (06/15 /2020). 2. Laboratory policies and procedures reviewed at the time of the survey (GenLAB6 version 1), revealed that the Technical Supervisor was required to be evaluated yearly by the Laboratory Director. 3. During the survey (09:54 06/12/2019), the Laboratory Supervisor confirmed, the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --