Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: The surveyor's review of the Excel Dermatology of Hawaii Laboratory Manual and an interview with the laboratory director revealed the the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified with its mycology, parasitology, and histopathology testing. The findings include: 1. The laboratory began potassium hydroxide (KOH) examinations, and Mohs micrographic dermatologic evaluations in July 2025. 2. No documentation was presented for review to indicate the laboratory established policies and procedures for monitoring, evaluating, and correcting problems related to its KOH examinations and Mohs micrographic dermatologic evaluations. 3. The laboratory director interviewed on 8/20/2026 at 10:15 AM confirmed the laboratory did not establish polices and procedures for an ongoing mechanism to monitor, assess, and correct problems related to patient information confidentiality, specimen identification and integrity, twice a year KOH and Mohs accuracy checks, complaint investigations, and communications. 4. The laboratory performed an annual volume of 20 KOH examinations and 500 Mohs micrographic dermatologic evaluations. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by 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 -- 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: The surveyor's review of the Excel Dermatology of Hawaii Laboratory Manual and an interview with the laboratory director revealed the laboratory failed to have a written potassium hydroxide (KOH) procedure available for the mycology and parasitology examinations it performed. The findings include: 1. No documentation was presented for review to indicate the laboratory established a procedure for the KOH testing it performed. 2. The laboratory director interviewed on 8/20/2026 at 10:05 AM stated KOH mycology and parasitology examination findings were compared against black and white copies of photos taken from a medical textbook. The laboratory director confirmed the laboratory did not establish a written KOH procedure to include but not limited to specimen requirements, step by step performance instructions, quality control, equipment maintenance, and twice a year accuracy checks. 3. The laboratory performed 12 KOH examinations between 1/8/2026 and 8/12/2026. -- 2 of 2 --