Summary:
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 review of proficiency testing (PT) and interview with testing personnel #1 the laboratory failed to ensure accuracy for histopathology was verified twice annually in 2018. Findings: 1. Review of PT showed no documentation of histopathology verification of accuracy for testing personnel #4 in 2018. 2. Interview with testing personnel #1 on March 20, 2019 at 12:15 PM confirmed testing personnel #4 failed to document accuracy for histopathology twice annually in 2018. 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 temperature logs, storage requirements and interview with testing personnel #1 the laboratory failed to document room temperature. Findings: 1. Review of surgipath tissue marking and margin dyes showed temperature storage 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 -- requirements "15-30 degrees Celsius". Laboratory could not provide documentation of room temperature. 2. Interview with testing personnel #1 on March 20, 2019 at 12:15 PM confirmed laboratory failed to document room temperature. -- 2 of 2 --