Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey for #2022012753 was conducted 9/14/22 through 9 /26/22 at HCA Florida Cape Coral Emergency, a clinical laboratory in Cape Coral, Florida. Complaint #2022012753 was substantiated. Based on the survey findings, an Immediate Jeopardy situation was identified and HCA Florida Cape Coral Emergency was notified at 1:30 p.m., on 9/21/22. The following Conditions were not met: D3000 Facility Administration 493.1100 D5400 Analytic Systems 493.1250 D6000 Moderate Complexity Laboratory Director 493.1403 HCA Florida Cape Coral Emergency is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the laboratory failed to maintain required room temperature for the Strep A cartridges being stored in the temporary laboratory location that they were moved to on 08/22/2022. Findings Included: Observation of room temperature revealed the following temperatures: 09/14/22 at 11: 35 AM 25.5 degrees Celsius 09/14/22 at 1:42 PM 26 degrees Celsius 09/15/22 at 5:55 PM 25.8 degrees Celsius Review of the manufacturer instructions for the Strep A Cartridges used on the Sofia analyzer state that they are to be "stored 20-25 degrees Celsius". The "Emergency Department Cape Coral Laboratory Services" has the room temperature range to be 18-24 degrees Celsius. From 08/22/2022 to 09/22/2022 the temperature was warmer than 24 degrees Celsius on 18 out of 32 days. 08/23/2022 - 25.6 degrees Celsius 08/24/2022 - 25.5 degrees Celsius 08/26/2022 - 24.9 degrees Celsius 08/29/2022 - 25.0 degrees Celsius 08/30/2022 - 24.5 degrees Celsius 09/06 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- /2022 - 24.8 degrees Celsius 09/07/2022 - 24.7 degrees Celsius 09/08/2022 - 24.6 degrees Celsius 09/09/2022 - 24.8 degrees Celsius 09/10/2022 - 25.0 degrees Celsius 09/11/2022 - 24.3 degrees Celsius 09/14/2022 - 24.7 degrees Celsius 09/16/2022 - 25.6 degrees Celsius 09/18/2022 - 24.9 degrees Celsius 09/19/2022 - 25.4 degrees Celsius 09/20/2022 - 25.6 degrees Celsius 09/21/2022 - 25.6 degrees Celsius 09/22 /2022 - 24.1 degrees Celsius There was no