Allergy Immunology Diagnostic Lab Center

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview with testing personnel, staff A, the laboratory did not verify the accuracy of Enzyme Linked Immunosorbent Assay (ELISA) testing for two of two events in 2023 and did not verify the accuracy of immunodiffusion testing for one of two events in 2023. Findings include: 1. Review of the laboratory test menu showed the laboratory performs ELISA and immunodiffusion testing. 2. Review of laboratory records showed no evidence of twice annual accuracy checks of ELISA testing in 2023. Further review showed only one event for immunodiffusion testing in 2023. 3. Interview with the staff A on February 13, 2024, at 10:15 AM confirmed the laboratory had not verified the accuracy of the laboratory testing twice annually in 2023. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review laboratory policies and procedures and interview with testing personnel, staff A, the laboratory did not have a written policy and procedure to monitor, assess and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. Review of laboratory policies and procedures showed no evidence of a written policy or procedure to monitor, assess and correct problems identified in the general laboratory systems for preanalytical, analytical and postanalytical systems. 2. Interview with staff A on April 25, 2022 at 11:30 AM confirmed the laboratory did not have a written policy and procedure to monitor, assess and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. D5781