May River Dermatology, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 07, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: A review of laboratory personnel records and an interview with the laboratory director, revealed that the laboratory director failed to provide annual Competency Assessment for ALL its testing personnel. Findings include: 1. A review of testing personnel records revealed there were no competency evaluations for testing personnel (TP#s 4 and 5 CMS 209) in 2018 and 2019. 2. An interview with the laboratory director on August 07, 2019 at 12:45 PM in the review room confirmed that there were no annual competencies performed on testing personnel #s 4 and 5 on (CMS 209). D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 documents review, laboratory tour and an interview with the Laboratory director, it was determined that the laboratory failed to document weekly maintenance as written in the laboratory procedure manual. Findings include: 1.) Laboratory tour and maintenance documents review revealed no weekly change documented on slide staining solutions in the specialty of Histopathology in 2018 and 2019. 2.) An interview with the Laboratory director at approximately 12:15 pm on August 7, 2019 in the review room confirmed weekly changing of staining solutions were not documented in 2018 and 2019 in the specialty of Histopathology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an Initial CLIA Survey performed on February 14, 2018, this facility was found to be non- compliant with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. 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 general lab systems document review and staff interview, the laboratory failed to verify, at least twice annually, the accuracy of any non-regulated test or procedure as required. Findings include: 1. General lab systems document review revealed the laboratory failed to perform a twice-yearly verification for Potassium Hydroxide (KOH) testing. 2. An interview with the laboratory director on 2/14/18 in a medical office at approximately 4 p.m. confirmed KOH verification testing was not performed twice annually for 2016 and 2017. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish a policy and procedure for all tests, assays, and examinations performed by the laboratory. Findings include: 1. SOP review revealed the laboratory had not established a policy and procedure for twice yearly Potassium Hydroxide (KOH) peer review. 2. An interview with the laboratory director in the laboratory on 2/14/2018 at approximately 4 p.m. confirmed there was not a policy and procedure in the SOP for twice yearly KOH peer review. -- 2 of 2 --