Summary:
Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a lack of policies, procedures, specimen rejection logs and interview with the laboratory director (LD), the laboratory failed to have written policies, procedures, and quality assurance (QA) documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. Findings: 1. A request was made to review the preanalytical policies and procedures. None were made availiable at the time of survey. 2. A request was made to review the specimen rejection log for QA documentation. None were made availiable at the time of survey. 3. Interview with the LD 2/15/22 at 10:30 a.m. confirmed, the laboratory failed to have written policies, procedures, and QA documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. 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 --