Mercy Pain Management

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the iStat prothrombin time (PT), patient results, and interview with the technical consultant (TC) #2, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the iStat showed the laboratory failed to verify that the manufacturer's reference interval (normal range) were appropriate for the laboratory's patient population for the analyte: prothrombin time prior to the beginning of patient testing in July 2024. 2. Review of the performance specifications for the iStat showed the laboratory failed to verify that the manufacturer's reportable range for the analyte: prothrombin time prior to the beginning of patient testing in July 2024. 3. Interview with the TC #2 on October 2, 2024 at 10:00 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test 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 1 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance specification records for iStat and interview with the technical consultant (TC), the laboratory failed to provide documentation for accuracy and precision after the iStat was moved. Findings 1. Review of performance verification records for iStat, serial number 302376, showed no documentation for accuracy and precision after being moved to current facility October 20, 2022. 2. Interview with TC on January 11, 2023 at 9:00 AM confirmed the laboratory failed to provide documentation for accuracy and precision after the iStat was moved. 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 --