Waccamaw Dermatology, Llc

Summary Statement of Deficiencies D0000 An announced onsite recertification survey was conducted at Waccamaw Dermatopathology Laboratory on October 23, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR Part 493. Laboratory Requirements. The following STANDARD LEVEL DEFICINCIES were found to be out of compliance: 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 testing personnel record review and testing personnel interview, the laboratory failed to assess the competency of two of three testing personnel (TP) performing high-complexity testing and general supervisor (GS) for 2025 as required (493.1413(b)(8)/ 493.1451(b)(8)). Findings included: 1. Review of personnel records revealed two out of three testing personnel due for an annual competency for 2025. 2. The surveyor requested the laboratory failed to provide competencies for the following testing employees: a. TP1 b. TP4 and GS 3. It was confirmed during an exit interview at 3:12 pm on October 23, 2025, in the office with testing personnel/general supervisor that an annual competency assessment had not been performed. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with 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 -- each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and testing personnel interview, the laboratory failed to document the reactions of the control slide(s) with each special stain as required 493.1273. Findings included: 1. Review of patient's report, accession # W25-3794 reveals a Periodic acid-Schiff (PAS) stain was performed and stated the result of the test; the reactions of the control slide was not available on the day of survey. 2. A review of policy/procedure for "Special Stain" reveals the lack of stating the necessity to document the control slide 's reactivity. 3. During an exit interview at 3:12 pm on October 23, 2025, in the office with testing personnel/general supervisor the above findings were confirmed. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on procedure manual review, testing personnel record review, and testing personnel interview, the laboratory director/technical supervisor failed to ensure that competency assessments were performed annually as required for testing personnel and general supervisor performing high-complexity testing. Reference (D5209) -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 10, 2024. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.1489 -(b)(2) - Unqualified Testing Personnel D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), and interview, the laboratory failed to employ one out of three individuals who meet the education qualification requirements to perform the functions of highly complex testing (D6171) in the specialty of Histopathology. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology 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 -- courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS-209), and an interview with the testing personnel (TP-1), the laboratory failed to ensure one of three laboratory employees performing tissue grossing procedures meet the TP qualification requirements for performing highly complex testing in the specialty of Histopathology. Findings: 1. The CMS 209 and employee files were reviewed. 2. The CMS 209 list 3 individuals (TP-1, TP-2, and TP-3) performing tissue grossing for procedures performed in the Histopathology laboratory. 3. Review of the education credentials of these laboratory employees revealed that 1(TP-3) out of 3 failed to meet the education requirement as defined 493.1489(b)(2)(ii)(A)(1) or (b)(2)(ii)(A)(2)(i) -- 2 of 3 -- and (b)(2)(ii)(A)(2)(iii) for high complexity testing. 4. Further review of the employee's education transcript showed the lack of any documented evidence of the following criteria: (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2)(ii)(A)(2) (i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; 5. On a Recertification survey conducted on 09/10/2024 at 3:15 PM, the laboratory director and TP1 confirmed the above findings. -- 3 of 3 --