Semans Dermatopathology Service

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the laboratory director (LD) and laboratory representative, the laboratory failed to document dermatopathology immunohistochemical (IHC) stain positive and negative reactivity for 24 of 24 patients tested from the beginning of 2023 through the date of survey, 02/03/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Immunohistochemical Stain Statement for Offsite Slide Production", which stated, "The Laboratory Director evaluates the immunohistochemical slides made off site. An interpretation of staining results (positive, negative, indeterminate) will be made and recorded in the pathology report and in a log." 2. Review of patient testing logs for IHC staining found no documentation of negative reactivity, only positive reactivity was documented for 24 of 24 patients tested with IHC stains from the beginning of 2023 through the date of survey, 02/03/2025. Report Date: Block #: IHC Stain(s): 01/27/2023 23-264 P63, CK-HMW 02/20/2023 23-594 S100 03/08/2023 23- 759 CD34, Sox-10 04/05/2023 23-1321 PGP9.5 04/20/2023 23-1504 CK20, TTF-1, Neurofilament 05/15/2023 23-1925 CK-HMW, P63 06/05/2023 23-1985 ER, PR, Her- 2, 06/12/2023 23-2348 Low-Risk HPV, High-Risk HPV 07/21/2023 23-2934 Sox-10, Fontana Masson 08/14/2023 23-3211 CD34 08/17/2023 23-3260 PGP9.5 11/03/2023 23-4667 Ber EP4, CK20, INSM-1, TTF-1 11/09/2023 23-4799 CD45, CK20, Neurofilament, TTF-1 01/24/2024 24-1 ER, PR, Her-2 03/04/2024 24-832 GATA-3, 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 -- Her-2, ER, PR 03/08/2024 24-898 ER, PR, Her-2, TTF-1 04/11/2024 24-1568 p63, CK HMW 04/19/2024 24-1763 Sox-10, CK AE1/AE3 05/22/2024 24-2166 Sox-10 06 /12/2024 24-2467 p63, CK HMW 07/02/2024 24-2725 Sox-10 01/15/2025 25-45 Sox- 10 01/18/2025 25-126 CK7, CK20, TTF-1 01/20/2025 25-241 CD34, Sox-10 3. Interviews with the LD and laboratory representative on 02/03/2025, at 11:20 am, confirmed that the laboratory failed to document dermatopathology IHC stain positive and negative reactivity for 24 of 24 patients tested from the beginning of 2023 through the date of survey, 02/03/2025. -- 2 of 2 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to document reactivity of hemotoxylin and eosin (H&E) staining for 5 of 5 patient test report dates reviewed. Findings Include: 1. Review of the laboratory procedure, "Quality Control Statement for Histotechnologists", stated H&E staining quality is check on a daily basis and logged on the "Daily Physician evaluation for grossing and histotchnologist" log. 2. Review of the "Daily Physician evaluation for grossing and histotchnologist" logs found the laboratory failed to document H&E staining acceptability on the in 2017 through the date of survey, 6-6- 2019. 3. A review of 5 of 5 patient testing dates found the laboratory failed to document H&E staining acceptability. Patient Identification Date P1 08-24-2017 P2 12-21-2017 P3 04-04-2018 P4 10-16-2018 P5 02-14-2019 4. Interview on 06-06- 2019, at 12:50 pm, the LD confirmed the facility failed to document the H&E staining acceptability each time of use in 2017 through the date of survey (6-6-2019). D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually 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 -- after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the LD failed to ensure annual competency assessments were completed for 1 of 1 high complexity testing personnel (TP) in 2017 and 2018 performing grossing for histopathology testing. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Grosser Laboratory, Competency Assessment Policy", which stated the following: "The grosser is assessed for competency in technical skills, problem solving, and procedural knowledge. This assessment is recorded initially after six months and annually thereafter as part of the performance review process. A copy of the results will be kept in their employee file." 2. Review of employee competency assessment records found the LD failed to ensure annual competency assessments were completed for TP #2 in 2017 and 2018. 3. On survey date 06-06-2019, at 12:50 pm, the LD confirmed competency assessments were not performed in 2017 and 2018 for TP#2. -- 2 of 2 --