Dermatology Boutique Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at DERMATOLOGY BOUTIQUE PA from March 03, 2025 to March 07, 2025 . The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 Quality Control (QC) records and Risk Management staff interview, the Laboratory failed to follow the laboratory policy for review of the control slide stain quality since March of 2023. The findings included: 1-Review of the CMS-209 form submitted on 03-03-2025 revealed that there is one testing personnel who is also the Laboratory Director. 2-Review of the daily QC records showed that the documentation had been signed by the technicians for 03/13/2023, 04 /14/2023, 05/12/2023, 09/29/2023, 11/17/2023, 12/18/2023, 06/21/204, 11/08/2024 and 01/17/2025, 01/31/2025, 02/5/2025, and 02/14/2025. 3-Review of the procedure QC Measure for Modified Hematoxylin & Eosin Routine Stain stated, "The Laboratory Director will review the slide in order to evaluate the stain quality." 4- Review of the policy and procedure manual signed and approved by the Laboratory Director did not match the "approved" signature from QC records in item 2. 5- Interview on 03/03/2025 at 1:24 AM with the Laboratory Risk Assessment Consultant, confirmed that the daily QC records approval were not the Laboratory Director's signature. 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 D0000 An announced CLIA recertification survey was conducted at Dermatology Boutique Pa on 7/17/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person A (TP A), the laboratory failed to retain quality control records for 1 out of 47 testing dates in the last 2 years. Findings include: Review of Daily Quality Control (QC) Worksheet for 2017(August to December), 2018 and 2019 (January to July) revealed that there was no record of the Daily QC Worksheet for testing Date 2/22/2019. During an interview on 07/17 /2019 at 2:30 PM, the TP A confirmed that the laboratory failed to keep the Daily QC worksheet for the day of reference. 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 --