Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Microscope Maintenance (MM) records and interview with the Laboratory Director (LD), the laboratory failed to follow MM procedure in the calendar year 2016. The finding includes: 1. The PM stated to perform MM annually but the laboratory did not perform in 2016. 2. The LD confirmed on 4/25/18 at 10:15 am that the MM procedure was not followed. 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 the Final Report (FR), Test Requisitions and interview 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 -- with the Laboratory Director (LD), the laboratory failed to ensure that FR indicated accurate information for accession prefix DASG on 3/23/18. The findings include: 1. Review of five out of five FR revealed that all reports had two Technical Component (TC) laboratory names listed on FR. 2. The TC was performed only at one location. 3. The LD confirmed and stated on 4/25/18 at 10:45 am that FR did not have accurate information. -- 2 of 2 --