Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of fungal reagent and interview with the laboratory director, the laboratory failed to ensure two of two Chlorazol Black E fungal reagents in use for patient testing not exceed the expiration date. Findings: 1. Observation of fungal reagent in use revealed two of two Chlorazol Black E fungal reagents, lot number 4346, expired December 12, 2016. 2. Interview with the laboratory director on July 31, 2018 at 09:30 AM confirmed fungal reagents were in use for patient testing after the expiration date. 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 review of test reports and interview with the laboratory director on July 31, 2018 at 09:30 AM confirmed, five of five selected test reports from 2018 failed to include the name and address of the laboratory location where the test was performed. -- 2 of 2 --