Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at INTI FERNANDEZ MD AT MIA, INC from 09/07/2022 to 09/13/2022 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 and staff interview, the laboratory failed to ensure that the real time isothermal ID NOW COVID-19 test kit was not expired before using it for patient testing. The laboratory tested 39 patients with the expired test kit. Findings Include: During laboratory tour on 09/07/2022 at 01:30 PM, the surveyor found in the testing area two boxes in use of an expired ID NOW COVID-19 test kit from abbot for the detection of SARS-CoV-2, with lot number 1049071 an expiration date of 07 /18/2022. Record review of patients tested from 07/19/2022 to 09/07/2022 revealed the following tests performed: -One test on 07/19/2022, 07/25/2022, 07/27/2022, 08/06 /2022, 08/07/2022, 08/11/2022, 08/12/2022, 08/14/2022, 08/16/2022, 08/21/2022, 08 /29/2022, 08/31/2022. -two tests on 08/01/2022. -three tests on 07/23/2022, 09/02 /2022. -four tests on 08/28/2022. -five tests on 07/31/2022. -ten tests on 07/24/2022. For a total of 39 test. During a telephone call on 09/13/2022 at 3:00 PM with laboratory director, he confirmed that the laboratory performed the 39 tests with the expired kits. 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 --