Idaho Skin Institute Of Chubbuck

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory technician on 3/8/2021, the laboratory failed to retain quality control (QC) records, temperature logs and maintenance logs for at least two (2) years. Then findings include: 1. A review of laboratory records for 2019 identified that the laboratory failed to retain room temperature and humidity logs, microscope maintenance logs, cryostat temperature logs, daily maintenance logs and QC staining logs for Hematoxylin and Eosin stains for two (2) years. 2. An interview with the laboratory technician on 3/8/2021 at 2:34 pm confirmed that the laboratory failed to retain temperature, maintenance and QC logs from 2019. 3. The laboratory reports performing 2000 tests 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 D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a record review of personnel competency assessments and an interview with the laboratory lead, the laboratory director who is the technical supervisor failed to evaluate the competency of 3 out of 3 testing personnel who perform microscopic examinations for fungal presence using potassium hydroxide (KOH). This is a repeat deficiency from the last survey on September 9, 2016. Findings: 1. A review of personnel documents revealed the technical supervisor failed to evaluate the competency for 3 out of 3 mid-level practitioners who perform KOH examinations since the last survey. 2. An interview on October 23, 2018 at 9:150 AM, with the laboratory lead, confirmed the technical supervisor failed to assess and document the competency for the 3 mid-level practitioners. 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 --