Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Chelmsford Pediatrics, LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with the Testing Person (TP) on 11/21/19, the laboratory director failed to effectively review and evaluate PT results obtained on proficiency testing performed as specified in subpart H of this part as evidenced by the following: The surveyor reviewed American Association of Bioanalysts (AAB) PT records for calendar years 2018 and 2019 (5 testing events). The review revealed that the laboratory director failed to review and evaluate 3 out of 5 results for the following testing events: 1. AAB Nonchemistry Microbiology 2018 Event Q3. 2. AAB Nonchemistry Microbiology 2019 Event Q1. 3. AAB Nonchemistry Microbiology 2019 Event Q2. The TP interviewed on 11/21/19 at 11: 01 AM confirmed that the laboratory director failed to review and evaluate AAB PT results for 3 testing events in 2018 and 2019. 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 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 -- director must-- (e)(4)(iv) Ensure that an approved