Summary:
Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Rheumatoid Factor (RA) in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed total Rheumatoid Factor (RA), which is listed in the subpart I of 42 CFR part 493. b. The laboratory enrolled Diagnostic Immunology PT program with College of American Pathologists (CAP) for total RA testing. c. The laboratory failed to participate the 2018 CAP second PT event and resulted in no scores for that PT event, which was unsatisfactory RA performance for the testing event. d. The laboratory performed RA in approximately 30 patient sample each month. 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). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) result reports by College of American Pathologists (CAP), and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to verify and ensure the accuracy of RF IgM, qual (RF); Anti-tTG IgG, qual (tTG); and Parathyroid Hormone (PTH) , CAP assigned a proficiency testing score that did not reflect laboratory test performance. The findings included: a. The laboratory performed RF and PTH testing which are not listed in the subpart I of 42 CFR part 493. b. In order to verify and ensure the accuracy of the testing, the laboratory elected to enroll with CAP PT programs to verify, at least twice annually, and ensure the accuracy of RF, rTG and PTH testing systems. c. The laboratory obtained Exception Reason Codes of [26] = Educational challenge, for RF in S-C 2018 Diagnostic Immunology for samples RF- 11 thru RF-15, and for rTG in CES-A 2019 for samples CES-01 thru CES-03. d. The laboratory obtained Exception Reason Codes of [20] = No appropriate target/response cannot be graded, for PTH in Y-A 2019 Ligand-Special for samples ING-01 thru ING- 03. e. The laboratory failed to address and document actions taken to verify and ensure the accuracy of RF, rTG, and PTH testing systems when the PT provider assigned a proficiency testing score that did not reflect laboratory test performance. 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 review of the laboratory's temperature charts and interview with the laboratory testing personnel, it was determined that the laboratory has defined acceptable temperature ranges for proper storage of reagents, specimens, but failed to monitor its daily temperature and failed to document