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Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient laboratory reports and an interview with the laboratory lead on 6/6/2022, the laboratory failed to indicate the address of the performing laboratory for wet prep testing. The findings include: 1. A review of patient laboratory test reports for vaginal wet prep testing identified that the laboratory failed to indicate the address of the performing laboratory. 2. An interview with the laboratory lead on 6 /6/2022 at 2:16 pm confirmed that the address of the performing laboratory for vaginal wet prep testing is not indicated on the test report. 3. The laboratory reports performing 1,016 vaginal wet prep tests annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of patient laboratory test reports and an interview with the laboratory lead on 6/6/2022, the laboratory failed to include the normal values for the reported vaginal wet prep analytes on patient laboratory test reports. The findings include: 1. A review of patient laboratory test reports identified that the laboratory failed to include the normal values for the analytes of a vaginal wet prep; yeast, bacteria, trichomonas vaginalis, epithelial cells, clue cells, white blood cells and the whiff test. 2. An interview with the laboratory lead on 6/6/22 at 2:16 pm confirmed the above findings. 3. The laboratory reports performing 1,016 vaginal wet prep tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory technologist, the laboratory failed to follow and document the quality assurance plan to assess the competency of two testing personnel performing wet mounts/potassium hydroxide (KOH) testing since the last survey on September 21, 2016. Findings: 1. A review of personnel documents and the laboratory quality assurance plan revealed the laboratory failed to perform competency assessments for 2 out of 14 testing personnel listed on the CMS-209 Personnel Report form performing wet mounts/KOH. 2. An interview on June 5, 2018 at 9:30 AM, with the laboratory technologist, confirmed the laboratory failed to perform and document the competency assessment for two testing personnel performing wet mounts/KOH since the last survey. 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 --