Pshmg Camp Hill Dermatology

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with Technical Consultant (TC) #2, the laboratory failed to establish a written procedure that included the laboratory's process for performing and evaluating proficiency testing (PT) for Potassium Hydroxide (KOH) and Scabies microscopic examinations performed for 22 of 22 months from 10/17/2023 through the date of the survey. Findings include: 1. On the day of the survey, 09/17/2025 at 10:33 am, review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) KOH PT records and procedure manual revealed the laboratory failed to establish a written procedure that included the laboratory's process for performing and evaluating PT testing for KOH and Scabies microscopic examinations performed from 10/17/2023 through 09/17/2025. 2. The laboratory reported an estimated annual test volume of 135 KOH Prep and Scabies examinations in 2024 (CMS 116, dated 09/11/2025). 3. TC#2 (CMS 209, dated 09/11 /2025) confirmed the findings above on 09/17/2025 at 11:50 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 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 the laboratory competency assessment records and interview with the Technical Consultant (TC) #3 (CMS 209), the Technical Supervisor (TS) (CMS 209 Personnel #1) failed to evaluate the annual competency assessment for 1 of 6 Testing Personnel (TP) who performed Microscopic Examination, Grossing, Inking, and Mapping in Dermatopathology laboratory in 2022 and 2023. Findings include: 1. On the day of survey, 10/17/2023 at 10:38 AM, the laboratory could not provide competency assessment records for TP # 6 (CMS 209) for their testing responsibilities in Dermatopathology laboratory in 2022 and 2023. 2. The laboratory's total estimated annual volume was 3250 (CMS 116). 3. The TC # 3 confirmed the findings above on 10/17/2023 at 12:02 PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Potassium Hydroxide (KOH) quality control (QC) records and interview with Technical Consultant (TC) #4, the laboratory failed to document a negative and positive control material, each day of patient testing for KOH microscopic examinations for 2020 and 2021 Findings Include: 1. On the day of survey, 11/09/2021 at 09:20 a.m., reviewed of the KOH microscopic examinations QC records, revealed the laboratory did not document a negative and positive control materials each day of patient testing for the following: 2020: - 5 of 5 days of patient testing in November. - 1 of 2 days of patient testing in December. 2021: - 3 of 3 days of patient testing in January - 5 of 5 days of patient testing in September. 2. The TC#4 confirmed the findings above on 11/09/2021 around 11:25 a.m. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) slide evaluation records and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative reactivity every day of patient testing for Immunohistochemical (IHC) stains performed in 2019, 2020, and 2021. Findings include: 1. On the day of survey 11/09 /2021 at 10:25 a.m., review of IHC Staining records revealed, IHC positive and negative controls were not documented in 2019, 2020 and 2021 2. The LD confirmed the finding above on 11/09/2021 around 11:30 a.m. -- 2 of 2 --