Premier Dermatology

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the practice manager (PM); the laboratory failed to ensure accurate test results were transcribed into the patient chart for one of three mycology Potassium Hydroxide Preparation (KOH) patient test results. Findings include: 1. Review of the "Forefront Management, LLC Policy & Procedure" revealed the following information. "Documentation ...Positive: Presence of yeast, budding yeast, hyphae ..." 2. Review of the "Quality Control Log for KOH" revealed the following information: MRN: 1095336 Date Collected: 07/10/24 Test Ordered: KOH Interpretation +/-: - Physician Reviewing Sign: Not Indicated. 3. Review of the "Premier Dermatology Impression Plan" revealed the following information: "1. Tinea Pedis - KOH negative, Clinically suspicious for fungal and possible false positive ... 2. Plan: KOH Prep. A KOH prep was ordered and evaluated from the right foot ...Examination of the slide showed: branching hyphae." 4. On 10/30 /2024, at 11:30 a.m., the PM confirmed the KOH interpretation as negative. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual; patients' testing logs; and interview with the practice manager, the laboratory failed to establish and following written policies and procedures that ensure positive and optimum integrity of patients' specimens from the time of collection or receipt of specimen through completion and reporting of results. 1. Review of the laboratory's procedure manual revealed that there were no procedures that describes the requirements for patient specimen processing. 2. Review of patients' testing logs revealed that the same patients' Case numbers (SA026, SA027, SA028, SA029, SA030, SA031, SA032, SA033, SA034, and SA035) are assigned to 2 different patients for each number for 2 separate years (2019 and 2020). The surveyor could not differentiate case numbers written on the specimen log in 2019 from ones written on specimen logs in 2020. 3. On March 10, 2021 at 3:30 PM, the practice manager confirmed the surveyor's findings. 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 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 -- 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 493.1253. (7) Control procedures. (8)