Summary:
Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interviews with the Laboratory Director (LD) and Histopathology processor (HP), the LD failed to provide overall management and direction in accordance with 493.1445 of this subpart for the MOHS tissue biopsy testing procedures performed in the specialty of Histopathology. This deficient practice had the potential to affect all patient MOHS cases from 04/27/2021 to 12/12 /2022. Findings Include: 1. The LD failed to ensure that performance verification activities were conducted, documented and acceptable to determine accuracy, precision and other pertinent performance characteristics when the laboratory equipment (cryostat, manual stain station and microscope) utilized for the MOHS testing was moved on 05/02/2022. (Refer to D6086) 2. The LD failed to ensure that the HP was processing MOHS tissue biopsy specimens as required for accurate and reliable results. (Refer to D6087) 3. The LD failed to ensure that the quality assessment program was maintained to assure the quality of laboratory services provided. (Refer to D6094) 4. The LD failed to ensure that patient MOHS tissue biopsy test results were only reported when the test system was functioning properly and when the room humidity was monitored and documented according to the manufacturer's operating specifications. (Refer to D6097, Item 1) 5. The LD failed to ensure that patient MOHS tissue biopsy test results were only reported when the system was functioning properly and Histopathology reagents, solutions and stains were not used beyond their expiration dates. (Refer to D6097, Item 2) D6086 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Director (LD) and Histopathology processor (HP), the LD failed to ensure performance verification activities were conducted and documented to determine accuracy, precision and other pertinent performance characteristics when the laboratory equipment (cryostat, manual stain station and microscope) utilized for the MOHS testing were moved on 05 /02/2022. This deficient practice had the potential to affect all patient MOHS testing procedures from 05/02/2022 to 12/12/2022. Findings Include: 1. Review of the laboratory's "Performance Verification of Cryostat Leica CM1860 after office relocation" procedure provided for inspection review found the performance verification activities included the following: *instrument positioning with appropriate wall clearance *the cryostat was not turned on for a minimum of 4 hours after delivery *the cryostat was connected to a dedicated electrical circuit without an extension cable *an electrician verified the electrical circuit met the manufacturers requirements for operation *operating temperature of 0 to -35 degrees of Celsius was obtained *the temperature was maintained for 5 days prior to putting cryostat in use Accuracy and precision studies were not performed and documented, as required. 2. Review of the laboratory's "Performance Verification of Cryostat Leica CM1860" also provided for inspection review found the optimal room temperature and humidity conditions specified and instructions that they would be documented on the day of use. Accuracy and precision studies were not performed and documented, as required. 3. The Inspector requested all of the laboratory's performance specification documentation for the cryostat, manual stain station and microscope after it was moved to the current laboratory location on 05/02/2022 from the LD and HP. The LD and HP confirmed the laboratory only documented the items listed above for the cryostat, did not perform and document accuracy and precision studies as required prior to patient MOHS testing and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 12/12/2022 at 10:25 AM. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Director (LD) and Histopathology processor (HP), the LD failed to ensure that the HP was processing MOHS tissue biopsy specimens as required for accurate and reliable results. Between 04/27/2021 and 12/12/2022, 64 patient MOHS specimens required a re-cut due to no epidermis or the lack of a complete epidermis. This deficient practice had the potential to affect all patient MOHS specimens between 04/27/2021 and 12/12/2022. Findings Include: 1. Review of the laboratory's "Part 3: Laboratory Procedures Mohs Micrographic Surgery Specimen Processing" policy and procedure revealed the -- 2 of 4 -- following statements: "A detailed map is made to correlate with the tissue removed. The cut edge of the tissue is inked with blue (broken lines on map) and red dye (solid lines on map) to demonstrate margins. ...6. Check under microscope for the red ink, blue ink, and complete half circle of skin. All three need to be present for a proper section." 2. Review of the laboratory's "MOHS Histology QA/QC Log" from 04/27 /2021 to 12/12/2022 found documentation of 64 patient MOHS tissue biopsy specimens indicating "re-cut" due to no epidermis or the lack of a complete epidermis. 3. The Inspector requested the laboratory's documentation of the sole HP's re-training and/or remedial