Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ALYSA R HERMAN MD PA on April 03, 2025 to April 10, 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: D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain documentation of their quarterly quality control (QC) sheets from July through December of 2023 (Q3 and Q4), and from January through December of 2024 (Q1, Q2, Q3, and Q4). Findings included: 1-Review of the quarterly QC sheets revealed no documentation for Hazard Material and Waste Management for the quarterly checks (Q3 and Q4) of 2023, and no documentation for Q1, Q2, Q3, Q4 of 2024. 2-Review of the Laboratory Procedure Manual for MOHS "QUARTERLY" QUALITY CONTROL stated "On a quarterly basis the HISTOTECH will perform safety checks, evaluate equipment, search for discrepancies compile the Quarterly Quality Control Form and the Quarterly Quality Assurance. 3-Interview on 04/03/2025 at approximately 1:00 PM with the Risk Management consultant stated that he did not know where quarterly checks QC sheets were from July 2023 through December 2024. 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 --