Dermatology Center Of Canyon County

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 a direct observation and an interview with testing personnel 1 (TP1) on 6/11 /2024, the laboratory failed to discontinue the use of expired potassium hydroxide (KOH). The findings include: 1. During the laboratory tour on 6/11/2024 a direct observation identified that the laboratory failed to discontinue the use of expired 20% KOH located in 11 of 11 patient rooms used in KOH slide examinations. EDM3 20% KOH lot 2122 expiration 5-2-2024 2. An interview with TP1 on 6/11/2024 at 2:45 pm confirmed the above finding. 3. The laboratory reports performing 300 KOH slide examinations annually. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, an interview with the laboratory lead on 9/30 /2022 and a lack of documentation, the laboratory failed to follow written procedures to assess testing personnel's training and competency for potassium hydroxide (KOH) examinations. The findings include: 1. A lack of training records identified three testing personnel listed on the CMS 209 that failed to have documentation of initial training for KOH examinations. 2. A lack of competency assessment records identified three testing personnel listed on the CMS 209 hired since the laboratory obtained a certificate of registration in November of 2021 that failed to have documentation of a six month competency assessment for KOH examinations. 3. An interview with the laboratory lead on 9/30/2022 at 9:10 am confirmed the above findings. 4. The laboratory reports performing 300 KOH tests annually. 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 lack of documentation, an interview with the laboratory director on 9/30 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 -- /2022, the laboratory failed to document, at least twice annually, the verification of accuracy for potassium hydroxide (KOH) examinations since obtaining a certificate of registration . The findings include: 1. A lack of documentation for bi-annual verification identified that the laboratory failed to document the verification of accuracy for KOH examinations at least twice annually since obtaining a certificate of registration in November 2021. 2. An interview with the laboratory director on 9/30 /2022 at 10:00 am confirmed that the laboratory has not performed bi-annual verification of KOH examinations. 3. The laboratory reports performing 300 KOH examinations annually. -- 2 of 2 --