Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Acute Patient Care Laboratory on May 3, 2024 to June 14, 2024. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The laboratory was found out of compliance with the following conditions: D5400- Analytic Systems-493.1250 D6076 - Laboratory Director - 493.1441 D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the Florida Fire Prevention Code, observation and interview, the laboratory was not in compliance with the state of Florida regulations requiring a fire extinguisher from 03/18/2024 to 6/14/2024. Findings: Review of the Florida Fire Prevention Code 633.202 revealed the State Fire Marshall will adopt the edition of the Life Safety Code, National Fire Protection Association (NFPA)101. The Life Safety Code 39.3.5 Extinguishment Requirements noted, "Portable fire extinguishers shall be provided in every business occupancy in accordance with Section 9.9. Business occupancies are one of the few occupancies in the Code that mandates the presence of portable fire extinguishers. Subsection 38/39.3.5 requires portable fire extinguishers in every business occupancy in accordance with Section 9.9, which mandates that extinguishers be selected, installed and maintained in accordance with NFPA 10, Standard for Portable Fire Extinguishers." On 05/03/2024 at 9:30 AM, during a tour of the laboratory, there was no fire extinguisher observed in the laboratory. On 05/03 /2024 at 2:10 PM, the General Supervisor stated the laboratory did not have a fire extinguisher, and the laboratory was cited by the accreditation agency on 03/18/2024 for not having a fire extinguisher. On 06/14/2024 at 4:03 PM, the Laboratory Director stated they were working on getting a fire extinguisher for the laboratory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, and interview, the laboratory failed to verify and evaluate the accuracy of five toxicology analytes for 2022 and 2023 at least twice annually. Findings: The laboratory was enrolled in PT with American Proficiency Institute (API) for the following analytes: Barbiturates, Benzodiazepines, Buprenorphine, Opiates, and Oxycodone. Review of the API performance summary from the 2023 1st event listed the performance for the last three testing events (2022 1st and 2nd, 2023 1st) showed there were no proficiency testing scores for the first event in 2022. No other proficiency testing documentation for 2022 was available for review. Review of the API performance evaluation showed the laboratory received the following unsuccessful scores for 2023 2nd event for the analytes of Benzodiazepines 33%, Buprenorphine 33%, and Oxycodone 0 %. The performance review and