Skin Surgery Centre Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Skin Surgery Centre, LLC, CLIA ID 19D2060138, on September 30, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level 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: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's "Training and Information" and "Proficiency Testing Competency and CLIA competency assessment" policies revealed the laboratory did not include the following: a) written procedures related to initial training for doctors who serve as testing personnel b) documentation utilized for semi-annual competency assessment for new testing personnel 2. In interview on September 30, 2025 at 11:12 am, the Operations Manager confirmed the laboratory's written competency assessment policy did not include the identified information. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever 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 -- necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure complete policies and procedures for assessing personnel competency were established. Refer to D5209. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on November 17, 2021 at The Skin Surgery Centre, LLC, CLIA ID # 19D2060138. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, maintenance logs, and interview with personnel, the laboratory failed to establish complete maintenance policies for the air vent/fume hood. Findings: 1. Review of the laboratory's "Air Vent/Fume Hood Policy" revealed the following tasks: a) "Dust air vent monthly, document" b) "Replace filter as required by manufacturer, document" 2. Review of the laboratory's "Fume Hood/Air Vent Log" for 2019, 2020, and 2021 revealed the following maintenance tasks: a) 2019: "Dust air vent monthly, document. Replace filter as required by manufacture [sic], document. Grounding to be checked and documented annually." b) 2020: "Dust air vent monthly, document. Replace filter as required by manufacture [sic], document." c) 2021: "Dust air vent monthly, document. Replace filter as required by manufacture [sic], document. Grounding to be checked and documented annually." 3. In interview on November 17, 2021 at 11:01 am, the Laboratory Manager stated she was unsure why grounding was listed as a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- maintenance task on the 2021 log sheets, as the laboratory discontinued performing that task. The Laboratory Manager confirmed the laboratory's policy differs from tasks indicated on the log sheets. D5781

Summary Statement of Deficiencies D0000 A Certification Survey was performed on May 6, 2019 at Skin Surgery Centre- Mandeville, CLIA ID # 19D2060138. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultants, Technical Supervisors, and General Supervisors were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 and Personnel 3 serve as the laboratory's Clinical Consultants, Technical Supervisors, and General Supervisors. 2. Review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed "Documented competency is required for individuals Clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to comply with the procedures in their competency assessment in addition to a competency based on their federal regulatory responsibilities. Results of each Competency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent record." 3. Further review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed frequency of performance of the assessment was not included. 3. Review of personnel records revealed competency assessments for the duties of Clinical Consultant, Technical Supervisor, and General Supervisor were not Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- performed. 4. In interview on May 6, 2019 at 2:20 pm, Personnel 5 stated the Laboratory Director did not perform competency assessments for the identified personnel for their duties as Clinical Consultant, Technical Supervisor, and General Supervisor. II. Based on record review and interview with personnel, the laboratory failed to follow their established policy to assess competency of Testing Personnel. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the following testing personnel: Personnel 1 Personnel 2 Personnel 3: hire date August 2018 2. Review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed "Evaluation and documenting competency of personnel responsible for testing is required at least semi annually during the first year the individual sees patient specimens. After the first year, competency assessment must be performed at least annually." 3. Further review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed "The following procedures are requirements for assessment of competency for all personnel performing laboratory testing. 1. Direct observation of routine patient test performance, including preparation, if applicable specimen handling, processing and testing. 2. Monitoring the recording and reporting test results 3. Review of intermediate results, and preventative maintenance records 4. Direct observation of performance of instrument maintenance procedures and function checks 5. Assessment of test performance through testing previously testing samples 6. Assessment of problem solving skills Competency assessment, which includes the procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform." 4. Review of personnel records revealed the laboratory did not have documentation of performance of competency assessments for the identified testing personnel: Personnel 1: 2017 and 2018 Personnel 2: 2017 and 2018 Personnel 3: initial and semi-annual: due February 2019 5. In interview on May 6, 2019 at 2:20 pm, Personnel 4 stated the laboratory did not have documentation of competency assessments for the identified testing personnel. In further interview Personnel 5 stated the laboratory did not perform competency assessments on the physicians who perform Mohs. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to label reagent utilized for Histopathology staining with an expiration date and storage requirements. Findings: 1. Observation by surveyor during the laboratory tour on May 6, 2019 at 1:20 pm revealed one (1) gallon sized bottle of clear liquid without a manufacturer's label located in the flammable cabinet. 2. Further observation revealed the bottle had the following information handwritten on the bottle: "Buling rcvd 4-23-19." The initials of the person who received the bottle was included 3. In interview on May 6, 2019 at 1:23 pm, Personnel 4 stated the identified bottle was bluing reagent. Personnel 4 further stated she was unsure of what happened to the manufacturer's label as she did not receive the bottle in the lab. 4. Review of the laboratory's "Quality Control Policies and Documentation" under the "Reagent" -- 2 of 4 -- section revealed: a) "Reagents must be examined upon arrival for any damage to containers" b) "Reagent lot numbers and expiration dates must be recorded" 5. Review of the laboratory's reagent log revealed the identified reagent was not documented as being received. 6. In interview on May 6, 2019, Personnel 4 and Personnel 5 confirmed the identified reagent was not labeled with the required information. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform annual maintenance for the fume hood per laboratory policy. Findings: 1. Review of the laboratory's "AIR VENT/FUME HOOD POLICY' revealed "Grounding to be checked and documented annually." 2. Review of the laboratory's fume hood maintenance logs and service records for 2017 and 2018 revealed the laboratory did not have documentation that grounding was performed. 3. In interview on May 6, 2019 Personnel 5 stated she could not find the service records for the fume hood. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel were performing the test methods as required for accurate and reliable results. Refer to D5415. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure required maintenance was performed to ensure acceptable levels of performance. Refer to D5433. D6103 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were followed for assessing personnel competency. Refer to D5209 I and D5209 II. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (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 record review and interview with laboratory personnel, the Technical Supervisors failed to document the evaluation of competency for testing personnel performing Histopathology. Refer to D5209 II. -- 4 of 4 --