Summary:
Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, five (5) Mycology patient records and interview with the laboratory director (LD), it was determined that the laboratory failed to document patient results upon its occurrence. The findings include: 1. An examination of patient charts revealed that the results for potassium hydroxide (KOH) tests were not recorded. The only documentation available for KOH testing is the patient log book, which merely includes the date of examination, patient name, and the examined location/site. 2. During the surveyor's review of 5 patient records for KOH tests in Mycology, covering the period from January 11, 2022, to October 17, 2023, all records were found to be discrepant in records and reports. While all patients undergoing KOH tests were listed in the patient log, their results were not documented in the charts. This raises concerns regarding the quality and reliability of patient testing. 3. It was the practice of the laboratory to perform daily checks but was limited solely to Dermatopathology records. 4. On March 7, 2025, at approximately 2:30 p.m., the LD affirmed by interview that the discrepancy noted in statement #2 were neither recognized when they occurred nor detected during the daily quality assessment checks. At the time of the survey, there were no records of