Pediatric Affiliates, Pa

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of Bacitracin Discs (BD) and interview with the Testing Personnel (TP), the laboratory failed to discard expired (BD) from 9/30/24 to the date of survey. The findings include: 1. On the 10/1/24 the laboratory had expired BD Lot # 3062072 expired 9/30/24 2. The TP confirmed on 10/1/24 at 11:00 am that the laboratory Failed to discard expired BD. 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 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) Accession Log (AL), Electronic Medical Record (EMR) and interview with the Office Manager (OM) the laboratory failed to ensure test results were reported accurately into the EMR on 4/1/19. The finding includes: 1. A review of ten AL entries revealed one patient has a result of "Pos" in the AL but the EMR had "Negative". 2. The OM confirmed on 2/7/20 at 1:30 pm that the laboratory did not ensure test results were accurately recorded in the EMR. 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 --

Summary Statement of Deficiencies D5807 TEST REPORT 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 surveyor review of the Final Report (FR) and interview with the Office Manager (OM), the laboratory failed to include the Normal Reference Intervals (NRI) for Urine Culture tests from 12/22/15 to the date of survey. The OM confirmed on 2/1 /18 at 10:55 am that the laboratory failed to include the NRI on the FR. 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 --