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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 competency assessment records and interview with the Regional Clinic Manager (RCM), the laboratory failed to establish a competency assessment procedure to assess 2 of 3 Clinical Consultants (CC) for their supervisory responsibilities from 03/15/2021 to the day of survey. Findings Include: 1. On the day of survey, 05/05/2023 at 2:15 pm, the laboratory could not provide a competency assessment procedure to assess the competency for 2 of 3 CC (CMS 209 personnel #2 and #3) from 03/15/2021 to the day of survey. 2. The laboratory could not provide competency assessment documentation for 2 of 3 CC (CMS personal #2 and #3) from 03/15/2021 to 05/05/2023. 3. The RCM confirmed the findings above on 05/05/2023 around 2:45 pm. 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 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 procedure manuals and interview with the regional clinical manager, clinical team lead #1 and #2, the laboratory failed to establish a competency assessment procedure to assess 1 of 2 clinical consultants, 1 of 2 technical consultants and 1 of 2 technical supervisors for their delegated duties in 2020 and 2021. Findings include: 1. On the day of survey, 03/15/2021, the laboratory could not provide a competency assessment procedure that assess 1 of 2 Clinical consultants, 1 of 2 technical consultants and 1 of 2 technical supervisors for there delegated duties in 2020 and 2021. 2. On the Laboratory Personnel Report (CMS 209 form) testing personnel (TP) #2 was listed as a clinical consultant, a technical consultant for potassium hydroxide microscopic examinations, scabies microscopic examinations and a technical supervisor for Histopathology. 3. The laboratory was unable to provide consultant and supervisory competency assessment records for TP #2 in 2020 and 2021. 4. The clinical manager, clinical team lead #1 and #2 confirmed the findings above on 03/15/2021 around 12:40 pm. 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 D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based upon laboratory personnel record review, and interview with the Laboratory Regional Clinic Manager, on the date of the survey (10/17/2018), the Laboratory Director failed to ensure that annual competency was documented from Feburary 22 2017 to October 17, 2018. Findings include: 1. At the time of the survey (09:30 10/17 /2018)Annual competency records were not found for 2 of 2 testing personnel. 2. During the survey, the Laboratory Regional Clinic Manager confirmed the above finding. 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 --