Central Dermatology Center

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory policy, absence of QA (quality assessment) records and interview with histotechnician 04/17/24, the laboratory director failed to ensure the QA program was maintained since time of last survey 05/27/21, a period of approximately 35 months. Findings: Review of laboratory policy "Policy for Monthly QA Testing" revealed "Each month a monthly QA Checklist and Monthly Patient QA checklist will be completed....These checklists will be signed by the Laboratory Director.". Review of laboratory records for 2021, 2022, 2023, and 2024 revealed no documentation of monthly "QA Checklist" or monthly "Patient QA Checklist". Interview with histotechnician at approximately 12:00 p.m. confirmed the laboratory had not maintained the QA program. They stated they had been told it was not necessary. 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) 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 observation and review of patient logs 5/27/21, the laboratory failed to discard KOH (potassium hydroxide) solution that exceeded its expiration date, and the expired KOH was used for patient testing. During a tour of the laboratory at approximately 10:45 a.m., the surveyor observed one bottle of KOH 20% with DMSO (lot #1904406) with an expiration date of 2/13/20 in a drawer in the laboratory, available for use. Review of patient logs revealed approximately 105 patients were tested from 2/14/20 to 5/27/21 using the expired KOH. 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 --