Golden Isles Healthcare, Llc

Summary Statement of Deficiencies D0000 A recertification survey was performed on , October 18, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to participate in the 2023, 3rd event for the Specialty of Hematology. Findings: 1. Review of the API PT documents for 2023, 3rd event , for the Specialty Hematology, the laboratory failed to submit the results before the submission deadline. 2. Staff interview with the Lab Supervisor, on 10/18/2024, at approximately 1 pm, in the break area, confirmed the statement above. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. 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 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview the Laboratory Director (LD) failed to verify that the PT results were returned by the submisson date for the 2023, 3rd event for the Specialty Hematology. The laboratory received a score of 0%. Findings: 1. Review of the API PT documents for 2023, 3rd event, for the Specialty Hematology, the laboratory failed to submit the results before the submission deadline. 2. Staff interview with the Laboratory Supervisor, on 10/18/2024, at approximately 1 pm, in the break area, confirmed the above aforementioned statement -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 20, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on competency documents review and staff interview, the Laboratory Director (LD) failed to review and sign off on the Testing Personnel(TP) competencies. Findings include: 1. Competency document review revealed the Laboratory Director (LD) did not review or sign off on the Testing Personnel (TP) competencies for 2020, 2021, and 2022. 2. During an interview with Testing Personnel #1 (CMS-209) on October 20, 2022 at approximately 2:30 PM in the waiting room area, confirmed that the Laboratory Director(LD) did not review or sign off on competencies for Testing Personnel for years 2020, 2021, or 2022. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for 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 -- monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on competency records and staff interview, the Laboratory Director failed to assure that the competency records were reviewed and signed off for the Testing Personnel(TP). The Finding include: 1. Competency records revealed that the Laboratory Director did not review or sign off on the competency records for the Testing Personnel for 2020, 2021, and 2022. 2. During an interview with the Testing Personnel#1 (CMS-209) on October 20, 2022 at approximtely 2:40 PM, in the waiting area, confirmed that the Laboratory Director did not review or sign off on the competency records for the Testing Personnel. -- 2 of 2 --