Ellis Pain Management

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 15, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to verify the accuracy of any unregulated test or procedure as required. 1. PT document review revealed no split sample verification documentation for urine specific gravity was available at the time of survey for 2018 (November and December), 2019, 2020, and 2021 thus far. 2. An interview in the conference room on 2/15/2021 at approximately 2:00 p.m. confirmed the lack of verification for urine specific gravity for the aforementioned time periods. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 -- This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the technical supervisor (TS) failed to evaluate TP performance at least annually after the first year as required. Findings include: 1. TP competency document review revealed there was no 2020 annual TP competency documents available at the time of survey for Staff #5 (CMS 209). 2. An interview with a technical consultant in the conference room on 2 /15/2021 at approximately 1:30 p.m. confirmed the aforementioned missing 2020 annual TP competency documents. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August, 07 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the 2017 CAP (College of American Pathology) Proficiency Testing(PT) documents and an interview with the laboratory's general supervisor, the laboratory director failed to ensure Proficiency Testing results were submitted within the timeframes established by the PT program. Findings include: 1.) A review of the 2017 CAP PT records revealed Event #2 of the Toxicology survey received a score of 0% "Failure to Participate" because results were not submitted to CAP on a timely basis. 2.) An interview with the laboratory's General Supervisor, at approximately 04: 00 pm on August 07, 2018 in the conference room confirmed the laboratory failed to submit Toxicology CAP PT results before the cut off date. 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 --