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 Quality Assessment (QA) records and laboratory supervisor interview, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for pre-analytic systems. The findings include: a. On December 28, 2022 at 9:45 AM, the laboratory QA record was requested. b. The QA showed that since January 2022 the laboratory did not evaluate practices related to: test request, specimen submission and handling, specimen referral. c. The laboratory supervisor confirmed on December 28, 2022 at 9:53 AM taht the laboratory failed to evaluate and monitor the pre-analytic systems. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records reviewed and laboratory supervisor interview; its was determined that the laboratory director failed to ensure compliance with QA requirements. Refer to D5391. 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 --