Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Baptist Primary Care Inc was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 record review and staff interview, the facility failed to ensure throat culture and urine culture plates were not expired prior to being used for patient testing. Two patients were tested with an expired Blood Culture plate used for Throat Cultures and 29 patients were tested with expired Hardy Chrome and Mueller Hinton plates used for Urine Cultures. The findings include: 1. The record review of the laboratory worksheet titled "Throat Culture QT Strep Test Log" showed two patients were tested on 7/19/21 with a blood culture plate with lot number 483245 and expiration date of 7 /15/21. 2. The record review of the laboratory worksheet titled "Uroplate Log" showed one patient was tested on 2/3/21 using Hardy Chrome media with lot number 473009 and expiration date of 2/2/21. One patient was tested on 10/28/21 using Hardy Chrome media with lot number 489282 and expiration date of 10/26/21. One patient was tested on 11/17/21, 11/18/21, 11/24/21, 11/28/21, 12/1/21, 12/3/21, and 3 patients were tested on 12/6/21 using Hardy Chrome media with lot number 490580 and expiration date of 11/16/21. 3. The record review of the laboratory worksheet titled "Uroplate Log" showed one patient was tested on 9/13/21, 9/23/21, 9/24/21, 10/1/21, 10/12/21, 10/20/21, 10/22/21, and 10/28/21. Two patients were tested on 9/15/21, 9/16 /21, 9/28/21, 10/21/21, and 10/26/21. All 18 patients were tested using Mueller Hinton 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 -- media with lot number 137806 and expiration date 9/12/21. During an interview on 2 /23/22 at 2:50pm with Testing Person D, it was confirmed the 29 patients were tested using expired culture media. -- 2 of 2 --