Southeastern Dermatology, Pa

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 review of 2019, 2020, and 2021 laboratory records and interview with nurse manager 1/13/22, the laboratory failed to verify the accuracy of the potassium hydroxide(KOH)/Wet Prep test at least twice annually in 2019, 2020 and 2021, a period of approximately 3 years. Findings: Review of 2019, 2020, and 2021 laboratory records revealed no documentation the laboratory had performed a verification of accuracy for the KOH/Wet Prep test in 2019, 2020 and 2021. Interview with nurse manager at approximately 11:40 a.m. confirmed the laboratory had not performed a twice annual verification of accuracy for the KOH/Wet Prep test in 2019, 2020, and 2021. She stated the physician does not perform them that often. 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 493.1253. (7) Control procedures. (8)

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 review of laboratory policy and procedures, review of test verification records and office manager interview 12/13/18, the laboratory failed to verify the accuracy of fungal culture testing at least twice annually. The laboratory participates is split specimen testing with a reference laboratory to verify the accuracy of fungal culture testing. Review of laboratory policy "Verification of Accuracy for Fungus cultures using DTM" revealed the following..."Discrepancies in split specimen results....The results will be compared. If one is positive and one is negative, a repeat culture may be ordered. The physician can elect not to repeat culture if clinical findings suggested a positive result and patient was treated with clearing of condition." The laboratory policy for discrepancies in split sample results fails to include a review of the testing process that could possibly cause a discrepancy in results. For example: It does not include review of quality control. It does not include a review of clerical errors. It does not include a review of specimen transport problems. It does not include media storage problems. Review of fungal culture verification record "Quality Control Log: Worksheet" revealed the following split samples had discrepancies and failed to verify the accuracy of the laboratory's fungal culture testing: 1. Chart #47106, 2/5/18, laboratory results were positive; reference laboratory results were negative. "