Speight Family Medical Center

Summary Statement of Deficiencies 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 review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with the technical consultant, the laboratory failed to maintain complete blood count (CBC) PT instrument printouts for a period of two years for one of six events reviewed from 2021 and 2022. The findings include: 1. Review of the laboratory's API PT records revealed the instrument printouts for 2022 event two were not maintained. 2. Interview on 03/24/2023 at 01:30 pm with the technical consultant confirmed the laboratory did not maintain PT instrument printouts for one of six PT events (2022 event two) for a period of two years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5819 TEST REPORT CFR(s): 493.1291(j) All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility. This STANDARD is not met as evidenced by: Based on review of the technical consultant bi-monthly review records, review of the 2017-current complete blood count (CBC) records and interview with provider number one, the laboratory failed to maintain laboratory test reports or records in a manner that permits ready identification and timely accessibility, in 2017 to August 7, 2019. The findings include: 1) Review of the technical consultant August 2019 bi- monthly review record revealed the patient testing management review was not performed because the server was down. 2) Review of the 2017 to current date CBC records revealed the patient CBC reports are maintained in the monthly patient data logsheets listing all patient results in a cumulative monthly report. Each individual patient CBC report is not maintained, other than the CBC patient report that is scanned into the EMR. 3) Interview on November 13, 2019 at 3:20 p.m. with provider number one confirmed the electronic medical record (EMR) software was infected with the crysis ransomware virus August 8, 2019, resulting in all scanned data lost permanently, prior to August 8, 2019. The scanned data included all laboratory testing to include the complete blood count report. The cumbersomeness of retrieval for the 2017 to August 7, 2019 patient laboratory reports hampered efforts to replace the lost EMR patient laboratory reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --