Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory technologist, the laboratory failed to verify the accuracy of potassium hydroxide (KOH)/wet mounts and urine sediment exams at least twice annually since the last survey on June 1, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH/wet mounts and urine sediment exams, at least twice annually since the last survey. 2. An interview on April 26, 2018 at 1:00 PM, with the laboratory technologist, confirmed the laboratory failed to document the accuracy of KOH/wet mounts and urine microscopic exams at least twice annually. 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: 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 -- Based on a record review of final patient reports and an interview with the laboratory technologist, the laboratory failed to indicate the address of their laboratory and the name and address of the reference laboratory where tests were reported on patients for the period reviewed between September 2017 through October 2017. Findings: 1. A review of patient laboratory test reports, revealed the address of the laboratory and the name and address of the reference laboratory where tests were performed failed to be included on the patient's test reports. 2. An interview on April 26, 2018, at 1:45 PM, with the laboratory technologist, confirmed the address of the laboratory and the name and address of the reference laboratory failed to be indicated on patient reports. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a record review of personnel competency assessments and an interview with the laboratory technologist, the technical consultant failed to establish and follow procedures to assess the competency of testing personnel since the last survey on June 1, 2016. Findings: 1. A review of personnel documents and laboratory procedures and policies revealed the laboratory failed to establish a policy to assess the competency of 4 mid-level practitioners and 6 providers performing potassium hydroxide/wet mounts and urine sediment examinations since the last survey. 2. An interview on April 26, 2018, at 1:35 PM, with the laboratory technologist, confirmed the laboratory failed to establish in writing a policy to assess and perform competencies for the practitioners and providers. -- 2 of 2 --