Adventhealth Medical Group Family Medicine

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 18, 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: A review of personnel records and staff interview confirmed that the laboratory failed to establish a written policy to assess the six criteria's for employee competency for the specialty of hematology. The findings include: 1. The laboratory failed to have a written competency policy and procedure that include the six rerquired criteria for testing personnel for years 2020 and 2021. 2. An annual competency assessment was not performed for any of the staff for 2020 or 2021 in the specialty of hematology. 3. An interview with the Laboratory Manager and the new Technical Consultant on January 18, 2022, at approximately 4:00 PM, confirmed that the laboratory did not have a policy to assess the required six competency criteria for the testing personnel in the laboratory. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with Practice Manager, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. The laboratory's procedure manual did not include a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance) for staff to follow when sending specimens to reference laboratories (Gordon Hospital, LabCorp, and Quest Diagnostics). 2. During an interview on January 18, 2022 at 3:30 PM with the Practice Manager and the new Technical Consultant, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to a reference laboratory. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on maintenance log review and staff interview, the laboratory failed to monitor and document room temperature and humidity as required by the manufacturer. Findings include: 1. Maintenance log review revealed the laboratory failed to monitor room temperature and humidity in the laboratory as required by the manufacturer of the Sysmex analyzer for (January- December 2020). 2. During an interview with the Practice Manager and the new Technical Consultant on January 18, 2022, in an office across from the laboratory, confirmed there was no room temperature and humidity monitoring or documentation for 2020. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 21, 2019. 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: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff interviews, the laboratory failed to retain attestation statements for 3 testing events of 2018. Findings include: 1. Review of PT documents revealed the lab did not retain the attestation statements for 2018 Hematology event #3, Potassium Hydroxide (KOH) event #2, or Parasitology (Wet Prep) event #1. 2. Interviews with the clinical supervisor and laboratory advisor on 5/21/19 in the clinical supervisor's office at 11:45 AM confirmed the lack of aforementioned attestation statements. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) document review and staff interviews, the laboratory failed to review and evaluate the results obtained on proficiency testing performed for 1 testing event of 2018 in 2 sub-specialities. Findings include: 1. Review of 2018 PT results revealed the lab did not document review of the results received for mycology or parasitology for the 2018 testing event #1. 2. Interviews with the clinical supervisor and laboratory advisor on 5/21/19 in the clinical supervisor's office at 11:45 AM confirmed the lack of aforementioned reviews. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) document review and staff interviews, the laboratory failed to document