Summary:
Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interviews with the clinic lead and Mohs supervisor, the laboratory failed to have a system in place to investigate and document complaints in 2022. The findings include: 1. Review of the laboratory's procedure manual revealed no policies or procedures in place for documentation and investigation of complaints. 2. Interview with the clinic lead and Mohs supervisor on 12/16/22 at 12:45 pm confirmed the laboratory failed to have a process in place for documentation and investigations of complaints against the laboratory. 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 observation of the laboratory, review of accessioning records and patient test records, the laboratory procedure manual, lack of records, and interview with the clinic lead, the laboratory failed to verify the accuracy of its' histopathology procedures twice a year in 2021 and 2022. The findings include: 1. Observation of the laboratory on 12/16/22 at 8:30 am revealed equipment and reagents in use for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performing patient testing for histopathology on tissue removed during Mohs surgical procedures. 2. Review of accessioning records and patient test records revealed the first Mohs case was performed on 04/29/21 (case #FTP21-001). Additional randomly selected reviews revealed case number FTP21-041 was performed on 10/13/21, case number FTP22-011 was performed on 04/08/22, and case number FTP22-050 was performed on 11/21/22. Accessioning records indicate approximately 102 patients Mohs surgeries/histopathology procedures have been performed since patient testing began on 04/29/21. 3. Review of the laboratory policy titled "Quality Assurance- Proficiency Testing" revealed that each Mohs surgeon would have six slides from each year -- three from Jan-June and three from July-December pulled at random with review of the cases by another Mohs surgeon to verify diagnosis. 4. There were no records for retrospective case review in 2021 and case reviews were not performed twice in 2022. 5. Interview with the clinic lead on 12/16/22 at 10:30 am confirmed the laboratory failed to follow its' own policy for twice a year verification of accuracy of its' histopathology procedures, resulting in the laboratory failing to verify the accuracy of histopathology procedures twice a year in 2021 and 2022 with patient testing performed. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of