Dr George L Cain Jr Md Pllc

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 review of laboratory proficiency testing records, and interview with testing personnel (TP) #1, the laboratory failed to verify the accuracy of the Urine Microscopic testing at least twice annually for years 2023 and 2024. Findings Include: 1. Review of the proficiency records from 2023 and 2024, revealed the Urine Microscopic had not been verified as accurate. The laboratory chose proficiency testing as their way of verifying accuracy for Urine Microscopy and receives two events each year. The laboratory scored 50 % on the 1st events of 2023 and 2024. The laboratory has failed 2 of 3 proficiency events since the last survey. 2. Interview with TP #1 on 8/15/2024 at 11:30 a.m., confirmed the accuracy had not been verified on the Urine Microscopy for the year 2023 and 2024. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

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 laboratory personnel documented annual evaluations/competency and interview with staff, the Laboratory Director had not followed written policies to assess the technical consultant competency at least annually since the laboratory's last survey, 4/12/17. Findings include: There was no documentation of a competency or evaluation for the technical consultant reflecting the duties specific for that position (see D6049 in the regulations) for the year 2017 through the day of survey (9/26 /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 --