Summary:
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 lack of documentation, and interviews, it was determined the laboratory failed to follow written Quality Assessment policies and procedures to monitor, assess and correct problems identified in the laboratory. Findings Follow: A. Laboratory's operating procedures step 10 states," Standard Comparison of test Results: For non- waived test for which proficiency testing is not available, the laboratory will verify accuracy and reliability twice a year." B. Review of patient potassium hydroxide (KOH) Log from October 2022 revealed two out four testing personnel did not perform or complete the verify accuracy and reliability twice a year. Testing personnel #3 on the CMS 209 form, had zero of two comparison results. Testing personnel #4 on the CMS 209 form, had one of two comparison results. C. In an interview on 11/01/2023 at 13:30 pm, technical consultant confirmed two out four testing personnel did not perform or complete the verify accuracy and reliability twice a year. 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 --