Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on patient test record review and interview with the technical consultant, the laboratory quality assessment plan failed to include a procedure to monitor 1 of 2 test reporting systems used by the laboratory to ensure the identity of the person performing the tests was accurately reported for potassium hydroxide (KOH) testing for 2 of 2 test reports reviewed. The laboratory performed approximately 20 to 40 tests per year. Findings include: 1. Patient test records reviewed for patient 1205544 for tests performed on 03/01/2018 and patient 268771413 on 06/12/2018 had medical assistants names recorded as the testing person for KOH test reports of "No yeast or fungi observed". 2. In an interview on 07/26/2018 at approximately 11:30 A.M. the technical consultant stated only physicians performed the KOH testing but the results were entered into the test report by medical assistants and the laboratory information system credited the medical assistants as the testing persons instead of the scribe for entering the tests. 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 --