Summary:
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 surveyor's review of the twice per year verification records and an interview with the laboratory director, the laboratory failed to verify the accuracy of interpretation of urine colony counts and microscopic urine sediment at least twice per year in calendar years 2019 and 2020. FINDINGS: The laboratory director confirmed on February 23, 2021 at approximately 2:00 PM, the surveyor's findings that the laboratory failed to verify the accuracy of interpretation of urine colony counts and microscopic urine sediment at least twice per year in calendar years 2019 and 2020. a. Approximately 200 patient samples were tested for urine colony counts for the calendar years 2019 and 2020. b. Approximately 50 patient samples were tested for microscopic urine sediment for the calendar years 2019 and 2020. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: 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 -- Based on a surveyor's review of the laboratory's QA policy and confirmed in an interview with the laboratory director, at this survey, the laboratory director failed to ensure that the laboratory's QA program was maintained for all phases of laboratory testing Refer to D5217. -- 2 of 2 --