Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations of expired reagents and a telephonic interview with the laboratory director, the laboratory failed to properly dispose of expired reagents used for histology staining. Findings include: 1. An observation during the walk through of the laboratory areas with the general supervisor confirmed the following expired reagents of Hematoxylin and Eosin in 2017. 2. In an interview, on May 17, 2018, at 10:00 AM, the laboratory director confirmed the two reagents, Hematoxylin and Eosin were still labeled past their expiration dates in 2017. 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. 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 arterial blood gas (ABG) patient reports for 2016-18 and an interview with the general supervisor, the laboratory failed to indicate the address of the laboratory location of the ABG patient report for one of ten audited patient reports for 2016-18. Findings include: 1. A review of one of ten audited patient reports was missing the address of the laboratory location for February 10, 2017. 2. In an interview, on May 17, 2018, at 3:30pm, the general supervisor confirmed the address of the laboratory location for February 10, 2017 was missing from the test report. -- 2 of 2 --