Summary:
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 surveyor review of laboratory accession log, patient Electronic Medical Record (EMR) and interview with the office manager/testing person and the laboratory director, the laboratory failed to ensure that patient test reports are accurate and complete as part of patients permanent medical record. FINDINGS: 1. On May 3, 2018 at approximately 11:30 AM the office manager/testing person and the laboratory director confirmed surveyor finding that the patient with initials M.M. had Rapid Strep test result indicated on the daily accession log as negative. The Rapid Strep test result for M.M. in the EMR was reported as positive Rapid Strep test. 2. The laboratory has a policy to confirm all patients' negative Rapid Strep tests by performing overnight throat culture testing. seven out of seven randomly selected negative Rapid Strep tests did not indicate throat culture results on the daily accession log. The office manager/testing person confirmed that the negative throat culture tests results are not noted on the daily accession log. 3. Three out of seven randomly selected Influenza A & B test results on the patients' accession log, did not have corresponding EMR charts. The office manager/testing person and the laboratory director stated that the tests were freebies and the three individuals with no EMR charts, were either employees or student interns and not patients of the practice. 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 -- D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a surveyor review of laboratory QA records and confirmed in an interview with the laboratory director and the office manager/testing person at the time of the survey, the director director failed to follow the QA procedure to perform effective QA reviews and identify QA system failures. Refer to D5805 -- 2 of 2 --