Georgetown Pediatrics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 21, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 7, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure protection from physical, chemical, and electrical hazards as required 1. Observation during the laboratory tour revealed fire extinguisher (Serial #027289) and fire extinguisher (Serial #994587) had not been inspected since January 8, 2018. 2. An interview with Staff #2 (CMS 209) in the hallway near the laboratory confirmed the lack of aforementioned fire extinguisher inspection since January 8, 2018. D5781

Summary Statement of Deficiencies D0000 An offsite revisit survey was conducted on May 16, 2018, for all previous deficiencies cited on 4/12/2018. All deficiencies have been corrected. The facility is in compliance with with all regulations surveyed. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff interview, the laboratory failed to test PT samples with the laboratory's regular patient workload by testing personnel (TP) who routinely perform the testing in the laboratory. Findings include: 1. Medical Laboratory Evaluation (MLE) PT document review revealed Staff #4 (CMS 209) did not participate in testing of PT samples from 2016 through 2018 thus far. 2. An interview with Staff #2 (CMS 209) in a doctor's office on 4/12/18 at approximately 11:45 AM confirmed Staff #4 (CMS 209) did not participate in testing of PT samples from 2016 through 2018 thus far. 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 --