Summary:
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 laboratory observation, review of patient test records, and staff interviews, the laboratory failed to ensure that it did not use potassium hydroxide (KOH) and Chlorazol Black E reagents beyond their expiration for the fungal testing of 55 patients from December 2023 through the survey date (11.12.2024). The findings include: 1. Observation of the laboratory on 11.12.2024 at 9:20 a.m. revealed two bottles of Delasco 10% potassium hydroxide (Lot: K20BC1) with an expiration date of 11.30.2023 and one bottle of Delasco Chlorazol Black E (Lot: K236K3) with an expiration date of 06.30.2024 used for dermatological fungal exams. 2. A review of patient test records revealed the laboratory performed KOH testing on 18 patients from 12.01.2023 to the survey date (11.12.2024) using expired 10% potassium hydroxide reagent and 37 patients from 07.01.2024 to the survey date (11.12.2024) using expired Chlorazol Black E reagent. 3. An interview with the lead histotechnician on 11.12.2024 at 11:45 a.m. confirmed the above survey findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report form (CMS-209), the laboratory's Competency Assessment policy, testing personnel (TP) records, and staff interviews, the technical consultant failed to evaluate annual competency for five of seven moderately complex testing personnel performing Potassium Hydroxide (KOH) and Direct Wet Mount patient testing in 2023. The findings include: 1. A review of the CMS-209 revealed seven persons (TP1, TP2, TP3, TP4, TP5, TP6, and TP7) who perform moderately complex patient testing. 2. A review of the "Competency Assessment" policy revealed the following statement: -"To ensure that all laboratory staff members are performing their job duties and responsibilities accurately and proficiently, an annual competency assessment will be performed." 3. A review of the laboratory's testing personnel records revealed no documentation of 2023 annual competency assessments for moderately complex testing personnel, TP1, TP2, TP3, TP5, and TP7, that performed KOH and Direct Wet Mount patient testing in 2023. 4. An interview with the lead histotechnician on 11.12.2024 at 11:45 a.m. confirmed the above survey findings. -- 2 of 2 --