Vanguard Medical Specialists, Llc

Summary Statement of Deficiencies 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 procedures manual, and an interview with the clinical manager (not included on CMS Form 209), the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of personnel in the positions of Clinical Consultant (CC), Technical Supervisor (TS), General Supervisor (GS), and testing personnel (TP), since the laboratory's last survey was conducted on 3/26/2021. The laboratory conducts approximately 23,000 histopathology tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for the CC, the TS, the GS, or for TP listed on CMS Form-209 since the last survey was conducted on 3/26/2021. 2. Based on an interview with the clinical manager (not on CMS Form 209) on February 8, 2024, at approximately 10:30 AM, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency of personnel in the positions of CC, TS, GS, and TP. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 review of the laboratory's policies and procedures manual, and an interview with the clinical manager (not on CMS Form 209), the laboratory director (LD) failed to ensure that the laboratory's policies and procedures manual for quality assurance, histopathology, and dermatopathology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 3/26/2021. The laboratory conducts approximately 23,000 histopathology tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, histopathology, and dermatopathology revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with the clinical manager (not on CMS Form 209), on February 8, 2024, at approximately 10:00 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for quality assurance, histopathology, and dermatopathology prior to their use in the laboratory. -- 2 of 2 --

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 a lack of accuracy verification (comparison testing) documentation and staff interview and confirmation, the laboratory failed to twice annually verify the accuracy of potassium hydroxide (KOH) skin preparation fungal and yeast examinations. No records were provided to show any comparison activity was conducted for this test in the year 2020 and four of ten providers (TP #1, TP #4, TP #6 and TP #9) had documentation that one accuracy verification was performed in the year 2019. Approximately 200 patient specimens are tested annually. During the interview at approximately 11:30 am, staff confirmed that accuracy verification had not been performed by any of the providers for the year 2020. Based on lack of accuracy verification (comparison testing) documentation and staff interview and confirmation, the laboratory failed to twice annually verify the accuracy of Mohs Surgery slide examinations by TP#1 and TP #8 where no records were provided to show any comparison activity was conducted for this test in 2020. During the interview at approximately 12:30 pm, staff confirmed that accuracy verification was being performed but that no records had been kept and had only been noted in the patient's electronic medical record. 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 --