Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, onsite validation survey, Baptist Emergency at Town Center was found to be not in compliance with the CLIA laboratory requirements of 42 CFR 493. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure PT (prothrombin time) and APTT (activated partial thromboplastin time) quality control (QC) material was being performed every eight hours for two of three months reviewed (February 2024 and March 2024). The findings include: The record review on 4/17/2024 of the quality control documentation for PT/APTT testing showed QC was not performed every 8 hours of operation for the following dates: February 1, 2024: QC was performed at 5:31am and not again until 2:47pm for a difference of 9 hours and 16 minutes. February 5, 2024: QC was performed at 5:39am and not again until 3:00pm for a difference of 9 hours and 21 minutes. March 2, 2024: QC was performed at 4:30am and not again until 1:26pm for a difference of 8 hours and 56 minutes. March 4, 2024: QC was performed at 5:14am and not again until 3:16pm for a difference of 10 hours and 2 minutes. March 12, 2024: QC was performed at 9: 10pm and not again until 6:14am for a difference of 9 hours and 4 minutes. March 13, 2024: QC was performed at 6:14am and not again until 3:37pm for a difference of 9 hours and 23 minutes. March 14, 2024: QC was performed at 1:07pm and not again until 10:28pm for a difference of 9 hours and 18 minutes. March 18, 2024: QC was performed at 5:15am and not again until 2:24pm for a difference of 9 hours and 9 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 -- minutes. March 21, 2024: QC was performed at 5:25am and not again until 3:21pm for a difference of 9 hours and 56 minutes. During the interview with the General Supervisor on 4/17/24 at 10:51am, it was stated that quality control is to be performed every 8 hours and "sometimes they get busy". It was stated the instrument (Stago Satellite) will not allow patients to be run without quality control. -- 2 of 2 --