Physicians Lab Services, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/30/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to participate in 1 of 4 reviewed PT events from 2022, 2023 and 2024, resulting in an unsatisfactory performance. Findings included: 1. Review of laboratory's PT records from 2022, 2023 and 2024 revealed the laboratory was enrolled in the American Proficiency Testing Institute (API) PT for its toxicology testing. 2. Further review of the above PT records revealed the laboratory received a score of "0% (percent) - Failure to Participate" for Event 1 of 2024. There was no documentation of alternate PT testing and/or self-evaluation for that event, nor documentation of notification to API within the time frame for submitting proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing results about the circumstances associated with failure to perform PT. 3. In an interview on 08/30/2024 at 0940 hours in the breakroom, the Laboratory Director (as indicated on submitted Form CMS 116) confirmed the findings. 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 review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to document evaluation of "Not Graded" results for 1 of 6 analytes in 4 Chemistry-Miscellaneous PT events reviewed from 2022, 2023 and 2024. Findings included: 1. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as its PT provider. Review of API's instructions revealed: "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on 10/28/2022. The laboratory was found to be in compliance with the CLIA conditions of participation and certification is recommended. STANDARD LEVEL DEFICIENCIES remain. *************************** The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400- 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity; Laboratory Director 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. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the