Summary:
Summary Statement of Deficiencies 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 the lack of Quality Assessment (QA) activities records review and laboratory supervisor interview, it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2022. The findings include: a. On December 9, 2022 at 9:45 AM, the laboratory QA was requested. No QA record was available. b. Since January 2022 the laboratory did not evaluate practices related to: Patient confidentiality, specimen identification and integrity, compliant investigation, communications and personnel competency. c. The laboratory supervisor confirmed on December 9, 2022 at 9:50 am that the general laboratory system QA evaluations were not available. 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 the lack of Quality Assessment (QA) activities records and laboratory supervisor interview, it was determined that the laboratory failed to evaluate and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- monitor the pre-analytic systems requirements since January 2022. The findings include: a. On December 9, 2022 at 9:45 AM, the laboratory QA record was requested. No QA records was available. b. 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 9, 2022 at 9: 50 AM, that the pre-analytic system QA evaluations were not available. 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 the lack of Quality Assessment (QA) records and laboratory supervisor interview, it was determined that the laboratory failed to evaluate and monitor the analytic systems requirements since January 2022. The findings include: a. On December 9, 2022 at 9:45 AM, the laboratory QA record was requested. No QA records was available. b. Since January 2022 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment, instruments, reagents, materials, specimen and reagent storage conditions, system maintenance and function checks, verification of method performance specifications, calibration, control procedures, comparison of test results, test records,