North Idaho Dermatology Pa

Summary Statement of Deficiencies 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 manager on 12/12 /2025, the laboratory failed to discontinue the use of expired potassium hydroxide (KOH) reagent prior to its expiration. The findings include: 1. A direct observation of the laboratory's reagents on 12/12/2025 identified that the laboratory failed to discontinue the use of Delasco 10% KOH w/DMSO, lot K2298A, expiration 9/30 /2025 prior to the expiration. 2. An interview with the laboratory manager on 12/12 /2025 at 10:30 am confirmed the use of the expired KOH reagent. 3. The laboratory reports performing 140 KOH slide examinations yearly. 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 D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the laboratory lead on 2 /11/2022 , the laboratory failed to verify the accuracy of potassium hydroxide (KOH) preparations. The findings include: 1. A review of laboratory KOH records identified that the laboratory failed to verify the accuracy of KOH preparations biannually for 2021. 2. An interview with the laboratory lead on 2/11/2022 at 12:50 pm confirmed that the laboratory failed to verify the accuracy of KOH preparations biannually for 2021. 3. The laboratory reports performing 140 KOH preparations annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of pathology laboratory policies and procedures and an interview with the laboratory lead on 2/11/2022, the Laboratory Director failed to approve, sign and date the laboratory policies and procedures. The findings include: 1. A record review of the pathology laboratory policies and procedures manual identified that the Laboratory Director failed to approve, sign and date 17 of 17 policies and procedures. 2. An interview with the laboratory lead on 2/11/2022 at 9:43 am confirmed that the 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 -- Laboratory Director failed to approve the policies and procedures for the pathology laboratory. 3. The laboratory reports performing 12,000 pathology tests annually. -- 2 of 2 --