Roswell Pain Specialists, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 20, 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on document review and interview with the staff, it was determined the laboratory failed to document inspection of the Eyewash bottles as required. The Findings include: 1. The review of maintenance records revealed that the laboratory failed to document inspection on the Eyewash bottles, as required on a weekly basis, according to the procedure manual for 2019, 2020, and thus far 2021. 2. During an interview with the lab director and TP#2 (CMS-209) at 10:05 AM on 07/20/2021 during the lab tour, it was confirmed the laboratory failed to document inspection of the Eyewash bottles in 2019, 202 and 2021. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 26, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the LD did not sign the attestation statement for the 2017 Urine Drug Screen 2nd event. 2. An interview with Staff #1 (CMS 209) in the laboratory on 2-26-19 at approximately 1:00 p.m. confirmed the LD did not sign the aforementioned attestation statement. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are 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 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require