Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on September 28, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on procedure manual (SOP) review and interview with testing personnel (TP), the laboratory failed to establish and follow written Quality Assessment (QA) policies and procedures to monitor and evaluate the overall quality of the laboratory systems and correct identified problems for each test performed. Findings: 1. Review of the SOP's provided revealed the lack of QA policies and procedures or a QA check list. 2. Interview with TP #7 (CMS 209 form) in the breakroom on 9/28/23 at 12:58 PM confirmed the lack of QA policy and procedures. 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 --