Pediatric Associates

Summary Statement of Deficiencies D0000 A recertification survey was conducted on January 19, 2023. Pediatric Associates clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, the laboratory failed to include the units of measurement on the laboratory test results reports for three of three patients, (#1, #2, #3) tested for Bilirubin on the Unistat Bilirubinometer. Findings: Review of the package insert for the Bilirubin controls listed the units of measurement as mg/dL (milligrams /deciliter). Review of the laboratory test results reports showed the unit of measurement were not listed for three of three patients' reports (#1, #2, #3) tested for Bilirubin. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 01/16 /2023, the laboratory had an annual test volume for the specialty of routine chemistry of 150 tests. On 01/19/2023 at 2:45 PM, the Practice Manager stated the reports did not include units of measurement. D5807 TEST REPORT 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 -- CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to include the normal values on the laboratory test results reports for three of three patients (#1, #2, #3) tested for Bilirubin on the Unistat Bilirubinometer. Findings: Review of the laboratory test results reports showed the normal values were not listed for three of three patients' reports (#1, #2, #3) tested for Bilirubin. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 01/16/2023, the laboratory had an annual test volume for the specialty of routine chemistry of 150 tests. On 01/19/2023 at 2:45 PM, the Practice Manager stated the reports did not include the normal values. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 8, 2020. Altamonte Pediatric Associates clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 5 out of 5 events (2019 1st, 2nd, 3rd and 2020 1st, 2nd). Findings: Review of the College of American Pathologists proficiency testing (PT) attestation forms for microbiology, showed that high complexity Testing Personnel B performed all the PT for 2019 (1st, 2nd, 3rd events) and 2020 (1st, 2nd events). Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 12/1/20 showed there were 12 (#A, B, C, D, E, F, G, H, I, J, K, L) testing personnel who performed high complexity testing. During an interview on 12/8/20 at 10:10 AM, the moderate only Testing Personnel B stated that high complexity Testing Personnel B performed all the microbiology PT. 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 --