Alabama Dermatology Associates Pc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the of bi-annual accuracy verification documentation for KOH (potassium hydroxide), and an interview with the Laboratory Director (LD), the laboratory failed to perform accuracy verification for KOH, a moderate complexity test. This was noted for three of three events reviewed in 2025 and 2026. The findings include: 1. A review of the bi-annual accuracy verification documentation for KOH revealed the laboratory did not perform bi-annual accuracy verification for all testing personnel in the first and second half of 2025. 2. A further review of the bi-annual accuracy verification documentation for KOH revealed the laboratory did not perform bi-annual accuracy verification for the physicians performing KOH for the first half of 2026. 3. The above findings were confirmed by the LD during an interview on 10/6 /26 at 11:56am. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the laboratory tour, a review of the policy and procedures, and an interview with Histotech #1, the laboratory used expired chemical for Dermatology biopsy specimens. The surveyor noted the laboratory utilized expired Eosin stain since November 2023. The findings include: 1. A tour of the laboratory revealed the Eosin Y Aqueous chemical lot #113403 expired 11/2023. 2. A review of the policy and procedures 1.4 Chemical Handling and Storage, "Chemical storage areas shall be annually inspected for outdated chemical stock... and disposed of properly." 3. During an interview on 2-4-2025, at 9:54 AM, Histotech #1 confirmed the above findings. 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 --