Summary:
Summary Statement of Deficiencies D0000 Based on a CLIA Initial Survey performed on October 16, 2018 this facility was found to be non- compliant with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on monthly record reviews and staff interviews, the laboratory failed to follow written policies and procedures to monitor or assess the laboratory performance and the quality of services. Findings include: 1. Review of monthly records revealed the lab did not perform the monthly quality assurance (QA) checks since September 2017. 2. Interview with staff #1 (CMS 209 form) and the technical supervisor (CMS 209 form) on 10/16/18 in the consult office at 10:59 AM confirmed the QA forms were not completed since September 2017. 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 --