Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Weston Pediatric Physicians, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC) on 3/5 /2020, the laboratory failed to indicate on the patient final test report the name and address of the laboratory where the test was performed as evidenced by the following: The surveyor reviewed ten (10) patient final test reports from July 2019 through February 2020 in the laboratory's Electronic Medical Record (EMR), Epic. The review revealed: 1. The laboratory failed to indicate the correct name and address of the laboratory location where the test was performed for six (6) out of ten (10) patient final test reports. 2. The laboratory failed to indicate the correct name of the laboratory location where the test was performed for four (4) out of ten (10) patient final test reports. The name of the laboratory on the test reports was APP Weston Ped Phy. The laboratory's name is Weston Pediatric Physicians, PC. The TC confirmed on 3/5/2020 at 12:15 PM that the patient final test report did not contain the name and address of the laboratory or did not indicate the correct name of the laboratory where 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 -- the test was performed. The laboratory performs 161 CBC's, 2,278 throat cultures, and 276 urine cultures annually. -- 2 of 2 --