Snake River Dermatology

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 lack of documentation and an interview with the laboratory lead on 6/18 /2025, the laboratory failed to document, at least twice annually, the verification of accuracy for potassium hydroxide (KOH) examinations in 2023 and 2024. The findings include: 1. A lack of documentation for bi-annual verification once in 2023 and twice in 2024 identified that the laboratory failed to document verification of accuracy for KOH examinations at least twice annually in 2023 and 2024. 2. An interview with the laboratory lead on 6/18/2025 at 10:00 am confirmed that the laboratory failed to perform bi-annual verification of KOH examinations in 2023 and 2024. 3. The laboratory reports performing 150 KOH examinations annually 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 a direct observation and an interview with the laboratory lead on 6/18/2025, the laboratory failed to discontinue the use of expired urine Human Chorionic Gonadotropin (hCG) tests in 2023. The findings include: 1. A direct observation of the laboratory's hCG testing supplies on 6/18/2025 identified that the laboratory failed 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 -- to discontinue the use of 6 McKesson Consult urine hCG tests, expiration 7/31/2023 prior to the expiration. 2. An interview with the laboratory lead on 6/18/2025 at 10:50 am confirmed the above finding. 3. The laboratory reports performing 800 urine hCG tests annually -- 2 of 2 --

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 bi-annual verification documentation and an interview with the laboratory technicians on 6/07/2023, the laboratory failed to document, at least twice annually, the verification of accuracy for potassium hydroxide (KOH) examinations and Mohs surgical procedures in 2022 and 2023. The findings include: 1. A review of documentation for bi-annual verification of KOH examinations identified that the laboratory failed to document verification of accuracy for KOH for 2022 and 2023. 2. A review of documentation for bi-annual verification of Mohs surgical procedures identified that the laboratory failed to document verification of accuracy for Mohs surgical procedures for 2022. 3. An interview with the laboratory technicians on 6/07 /2023 at 9:39 am confirmed the above findings. 3. The laboratory reports performing 1500 KOH examinations and 600 Mohs surgical procedures 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 training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the MOHS technician on 8/23/2021, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F. R. 493.1451(b)(8)(9). The findings include: 1. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for 2020 for one (1) of two (2) testing personnel listed on the CMS 209 performing potassium hydroxide (KOH) testing. 2. An interview with the MOHS technician on 8/23/2021 at 1:07 pm confirmed the above findings. 3. The laboratory reports performing 100 KOH tests annually. 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 the MOHS technician on 8/23 /2021, the laboratory failed to discontinue use of 10%potassium hydroxide (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 2 -- reagent that had exceeded the expiration date. The findings include: 1. A direct observation identified a bottle of 10% potassium hydroxide from the manufacturer MCC, lot number 9220-02 that the laboratory failed to discontinue use for patient KOH testing by the expiration on 1/31/2021. 2. An interview with the MOHS technician on 8/23/2021 at 2:29 pm confirmed that the expired 10% potassium hydroxide was being used for patient testing. 3. The laboratory reports performing 100 KOH tests annually. -- 2 of 2 --

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 personnel documents, the procedure manual, and an interview with the laboratory technician, the laboratory failed to establish and follow written policies and procedures to evaluate the competency for 1 out of 1 testing personnel performing microscopic fungal examinations with potassium hydroxide (KOH) since the last survey on November 20, 2017. Findings: 1. A review of personnel documents revealed 1 out of 1 testing personnel failed to have competency assessment performed for testing fungal examinations using KOH since April 2018. 2. A review of the laboratory procedure manual revealed the laboratory failed to establish in writing a policy or procedure to assess the competency of testing personnel. 3. The laboratory performed approximately 70 KOH examinations in 2018. 4. An interview with the laboratory technician on July 9, 2019, at 9:15 AM, confirmed the laboratory failed to establish and follow written policies and procedures to assess the competency of testing personnel. 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: 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 -- Based on a record review and an interview with the laboratory technician, the laboratory failed to verify the accuracy of microscopic dermatopathology examinations at least twice a year since the last survey on November 20, 2017. Findings: 1. A review of laboratory documents revealed the laboratory failed to verify the accuracy of microscopic dermatopathology examinations at least twice a year. 2. The laboratory performed approximately 2600 dermatopathology examinations in 2018. 3. An interview with the laboratory technician on July 9, 2019, at 10:35 AM, confirmed the laboratory failed to document the accuracy of biopsy examinations at least twice a year. -- 2 of 2 --