Diosdado Non Medical Services, Llc

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisor (TS), the laboratory failed to ensure that microscope maintenance was performed from 12/14/2018 to the date of the survey.The finding includes: 1. The PM stated maintenance was required annually. 2. There was no evidence that maintenance was performed from 12/14/2018 to the date of survey. 3. The TS confirmed on 5/20/21 at 10:00 am that the laboratory did not ensure maintenance was performed. 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 --

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 the Final Report (FR), Test Requisitions and interview with the Techincal Consultant (TC), the laboratory failed to ensure that FR indicated accurate information from 3/29/17 to the date of survey. The finding includes: 1. Review of five out of five FR revealed that the Technical Component (TC) laboratory name was not listed on FR. 2. The TC confirmed and stated on 12/14/18 at 1:00 pm that FR did not have accurate information. 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 --