Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory records (patients charts) for 3 out of 7 Mohs surgical procedures performed in 2018 - 2019, observation of labeled Mohs histopathology slides, and interview with a medical assistant, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct discrepancies identified in the postanalytic systems. Findings included: a. Patient ID: "JG" 1) Progress notes on 3 /14/18 documented Mohs Micrographic Surgery, citing pathology number NC18-337, and Site location as Right jawline. 2) The Mohs histopathology slides #M18-086 were labeled as Right jawline. 3) Progress notes on 3/01/18 documented the biopsy as Left jawline, site "NC18-337". 4) The pathology report on 3/08/18 for "NC18-337" stated the site as Left jawline. 5) The medical assistant affirmed (1/08/18 @ 3pm) the aforementioned discrepancies in anatomic site and that the error was in the progress notes for 3/01/18. As a consequence, the pathology report was also in error. 6) Although the error in Site was identified during the Mohs surgery, the errors in the progress notes for 3/01/18 and pathology report on 3/08/18 had not been identified and corrected. b. Patient ID: "RA" 1) On 7/24/19, the Mohs Pathology Report corrected the Location from "Right Cheek" to "Left Cheek", after identification by the patient, physician, and chart notes. 2) However, the Mohs histopathology slides #M19- 153 were labeled as "R Cheek" (Right cheek). 3) The medical assistant affirmed (1/08 /18 @ 3pm) the error had been identified during the Mohs procedure, and that there was no mechanism to prevent or identify errors in the slides and make corrections. c. Patient ID: "BO" 1) On 8/28/19, the Mohs Pathology Report corrected the Location 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 -- from "Right Brow" to "Right Cheek". 2) However, the Mohs histopathology slides #M19-187 were labeled as "L Cheek" (Left Cheek). 3) The medical assistant affirmed (1/08/18 @ 3pm) the error had been identified during the Mohs procedure, and that there was no mechanism to prevent or identify errors in the slides and make corrections. d. The reliability of the chart notes and the labeling of Mohs slides could not be assured in the absence of written policy and practices to monitor, identify errors, and make corrections in a timely manner. The laboratory reportedly performed approximately 150 Mohs procedures annually in 2018 - 2019. . D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on survey findings and deficiency cited (D5891), the General Supervisor (Testing Person/ Technical Supervisor/ Laboratory Director) is herein cited for deficient practice in providing general oversight of the laboratory and personnel. Findings included: a. The General Supervisor (Testing Person/ Technical Supervisor/ Laboratory Director) failed to have a mechanism or practice to review records (patients progress notes, pathology reports, etc.) and Mohs slides to identify errors in documenting anatomice Sites and make timely corrections. -- 2 of 2 --