Idaho Skin Surgery Center

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 potassium hydroxide (KOH) slide preparation documents and an interview with the laboratory lead on 11/15/2022, the laboratory failed to document, at least twice annually, the verification of accuracy for KOH slide preparations in 2021 . The findings include: 1. A review of KOH slide preparation bi-annual verification documentation identified that the laboratory failed to document verification of accuracy twice annually in 2021. 2. An interview with the laboratory lead on 11/15 /2022 at 9:38 am confirmed that the laboratory had not performed verification of accuracy for KOH slide preparations twice in 2021. 3. The laboratory reports performing 30 KOH slide preparations annually. 4. This is a repeat deficiency for KOH slide preparation bi-annual verification (5/30/2017). 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: 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 review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records and an interview with the laboratory lead on 11/15/2022, the technical supervisor failed to document initial training in 2022. The findings include: 1. A review of the CMS 209 identified one (1) new testing personnel performing moderate complexity testing hired after the last inspection(5/24/2021). 2. A review of training and competency assessment records identified one (1) of one (1) new testing personnel performing potassium hydroxide (KOH) slide preparations that failed to have documentation of initial training. 3. An interview with the laboratory lead on 11/15/2022 at 11:04 am confirmed there was no documentation of initial training for one (1) new testing personnel with a start date of February 2022. 4. The laboratory reports performing 30 KOH slide preparations annually. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on an observation of patient specimens, a procedure manual review, and an interview with the laboratory director, the laboratory failed to specify in writing a procedure for labeling histopathology specimens and skin scrapings for fungal and parasite specimens since the last survey on May 30, 2017. Findings: 1. An observation of 2 patient histology specimens in the laboratory on January 19, 2019 at 9:15 A.M., revealed the 2 skin biopsy specimens received in 2 separate petri dishes failed to be labeled with at least the patient ' s name or a unique identifier. 2. The laboratory performs approximately 877 histological examinations from Mohs procedures and 75 microscopic examinations for the presence of fungi and parasites. 3. A review of the procedure manual revealed the procedures for histology and fungal examinations failed to include a written procedure or policy for labeling and identifying patient specimens. 4. An interview on January 17, 2019 at 9:45 A.M., with the laboratory director, confirmed the procedures failed to include specimen labeling. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a procedure manual review and an interview with the laboratory director, the laboratory director failed to ensure a quality assessment program for the laboratory was established to detect errors in all phases of microscopic examinations from histopathology specimens and skin scrapings for fungal and parasite presence since the last survey on May 30, 2017. Findings: 1. A record review revealed the laboratory director failed to establish and write polices or procedures for a system to monitor, assess, and correct problems in the preanalytic, analytic, and post-analytic processes in the laboratory. 2. An interview on January 17, 2019 at 10:05 A.M., with the laboratory director, confirmed the laboratory failed to establish and write policies and procedures for a system to monitor all quality assessments activities for the laboratory's microscopic examinations. -- 2 of 2 --