May River Dermatology

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted on March 20, 2025, at the clinical laboratory of May River Dermatology by the South Carolina Department of Public Health's (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of Standard Level deficiencies found as a result of the March 20, 2025 survey: 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 records review, lack of documentation, and staff interview, the laboratory failed to have a written policy and procedure for employee competency assessments. Findings included: 1. Review of the laboratory policy manual reveals a lack of a written policy and procedure for employee competency assessments. 2. In an interview with the office manager on March 20, 2025 at 12:15 pm in the laboratory office, the finding was confirmed. 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 D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: During an onsite recertification survey on 03/15/2018, based on procedure manual review, lack of documentation, and testing personnel interview, it was determined that the laboratory failed to document daily stain acceptability for hematoxylin and eosin stains performed for seventeen out of eighteen months reviewed (April 2016 through March 2018). Findings include: 1. The procedure manual stated that stain quality and acceptability for hematoxylin and eosin stains performed in house will be documented on each day of testing. 2. Review of the laboratory's stain quality control records revealed that documentation of daily stain acceptability for hematoxylin and eosin stains performed was unavailable for review for seventeen out of eighteen months reviewed (April 2016 through March 2018). A monthly stain acceptability had been documented by the laboratory for the reviewed time period. 3. Testing personnel confirmed during an onsite interview on 03/15/2018 at 1:00 pm that the daily stain quality for hematoxylin and eosin stains performed was not documented for seventeen out of eighteen months reviewed (April 2016 through March 2018). 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 --