Pinnacle Dermatology

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 laboratory policies and procedures, lack of documentation, and interview with testing personnel (TP) #4; the laboratory failed to have one of one procedure for Potassium Hydroxide (KOH) preparations approved, signed, and dated by the current laboratory director. Findings include: 1. Review of laboratory policy and procedure manuals revealed no laboratory director approval, including signature and date, by the current laboratory director on the procedure titled, "Potassium Hydroxide (KOH)". 2. Interview with TP #4 on 11/13/2025, at 11:32 am, confirmed the laboratory failed to have the KOH procedure approved, signed, and dated by the current laboratory director. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #4; the laboratory failed to include all the required components of a laboratory test report for two of three patient test reports reviewed for Potassium Hydroxide (KOH) preparations. Findings Include: 1. Review of two of three patient test reports (MRN: A572216, MM0000818272) for KOH testing found the laboratory failed to indicate the test performed and the test result /interpretation, on the laboratory's test report. 2. On survey date 10-01-24, at 11:32 pm, TP #4 confirmed two patient test reports failed to identify the test performed and the test result/interpretation on the patient test reports. -- 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 review of the laboratory records and interview with laboratory personnel; the laboratory failed to establish policies and procedures to assess employee competency for 10 of 10 laboratory positions filled by personnel identified on the CMS-209. Findings Include: 1. Review of the laboratory procedure manual found no policy was established to monitor the competency of 2 of 2 technical consultants (TC), 2 of 2 Technical Supervisors (TS), 4 of 4 Clinical Consultants (CC), and 2 of 2 general supervisors (GS) identified on the CMS-209. 2. On survey date 05-31-2018, at 1:15 pm the laboratory director confirmed that no competency assessment policy was in place to ensure the competency of the above mentioned laboratory personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 493.1253. (7) Control procedures. (8)