Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on the lack of retention policies and procedures for Mohs slides, test procedures, analytical systems record, quality assessment records, and test reports, review of eight (8) randomly chosen Mohs patients test records, and interview with the administration representative (AR) and laboratory director (LD); the laboratory failed to have a retention policy for Mohs documents. The findings included: 1. On the day of survey, February 20, 2024, at approximately 11:30 a.m. no policy for retention of documents and records were found for Mohs including test procedure, analytical systems record, quality assessment records, and test reports at the time of survey. 2. The AR and LD confirmed by interview on February 20, 2024, at approximately 11:30 a.m. that the laboratory did not have a retention policy for Mohs. 3. The laboratory reports signed and dated by the LD performed and reported approximately 1,049 for Mohs procedures annually. D5821 TEST REPORT CFR(s): 493.1291(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 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 -- 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 surveyors' review of eight (8) Mohs patient records, interviews with the administration representative (AR) and laboratory director (LD), the laboratory failed to maintain their slides for all the Mohs phases reported. The findings included: 1. The surveyors reviewed eight (8) Mohs patient records. One (1) out of eight (8) records was discrepant in the number of slides recorded in the report and the number of slides presented at the time of survey. 2. On the laboratory's lab record log, it showed a total of four (4) slides that were prepared. However, at the time of the survey, only three (3) out of four (4) slides were located. Phase IIA was missing. 3. During an interview with the survey team, the AR and LD affirmed that the discrepancy in number 1 above was possibly due to a misplacement during storing. Further investigation is needed to be performed. Also, no