Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 10/19/23. Faith Community Health Center laboratory was found not in compliance with the following requirements: D5215. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to review proficiency testing (PT) results to ensure their accuracy for one of five PT events reviewed (American Proficiency Institute [API] Hematology/Coagulation 2022 third event). Findings include: 1. Review on 10/19/23 at 10:10 a.m. of the laboratory's PT records revealed: *The cutoff date for returning the laboratory's PT results for the API Hematology/Coagulation third testing event was 11/23/22. *The Medonic hematology analyzer was shipped to the manufacturer for repairs. *The laboratory had been unable to process the PT samples. *The laboratory reported "Instrument Out of Service" for all 14 reportable analytes. *The performance summary for the testing event had been available for review on 12/12/22. *The following 14 reportable analytes had been scored "ungraded"- leukocyte (white blood cell) count erythrocyte (red blood cell) count, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, red cell distribution width (RDW), and white blood cell differential (including neutrophils, lymphocytes, and monocytes). *There was no documentation that the PT samples were processed for a self-evaluation once the 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 -- repaired analyzer was returned to service. *At 10:15 a.m., a request was made for any additional documentation concerning the review of the testing event from the laboratory staff and technical consultant (TC) A. No additional documentation was provided for review. Review on 10/19/23 at 10:10 a.m. of the Medonic hematology analyzer's maintenance records revealed: *The Medonic analyzer was shipped to the manufacturer for repair on 11/2/22. *The analyzer was returned to the laboratory on 11 /28/22. *The laboratory staff had performed verification testing on the repaired analyzer the week of December 5 through 8 of 2022. That testing included the processing of quality control samples and comparison testing of patient specimens with another laboratory. Interview on 10/19/23 at 10:15 a.m. with TC A revealed: *She had been on maternity leave at the time of the missed PT event. *There had been staffing issues during that time period. *The staff members working in the laboratory at the time of the missed PT event were no longer employed at the facility. *All PT reports and documentation were sent to the laboratory director for review. *The laboratory director reviewed all the PT performance reports and