Pediatric Center

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a direct observation, a review of manufacturer's instructions for use (IFU) and an interview with the laboratory supervisor on 7/08/2025, the laboratory failed to follow the IFU for specimen processing for testing on the NanoEntek frend. The findings include: 1. A direct observation of the Globe Scientific centrifuge identified that the centrifuge speed and time were set at 3500 RPM for 3 minutes. 2. The NanoEntek frend IFUs for Thyroid-Stimulating Hormone (TSH), free thyroxine (FT4) and 25-hydroxy vitamin D stated that samples are to be centrifuged for 10 minutes at 3,000 RPM identifying that the laboratory failed to follow manufacturer's sample processing requirements. 3. An interview with the laboratory supervisor on 7/8/2025 at 10:49 am confirmed that they were not centrifuging samples at the correct speed and length of time for TSH, FT4 and 25-hydroxy vitamin D. 4. The laboratory reports performing 554 tests annually on the NanoEntek frend. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessment records and an interview with technical supervisor 2 (TS2) on 6/13/2023, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2021 and 2022. The findings include: 1. The CMS 209 identified 13 testing personnel performing bilirubin testing. 2. A review of competency assessment records identified three (3) of 13 testing personnel failed to have a six month competency assessment for bilirubin testing for 2022. 3. A review of competency assessment records identified eight (8) of 13 testing personnel failed to have an annual competency assessment for 2021 and 10 of 13 testing personnel failed to have an annual competency for 2022 for bilirubin testing. 4. An interview with TS2 on 3/13/2023 at 12:18 pm confirmed the above findings. 5. The laboratory reports performing 663 bilirubin tests annually. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on a review of quality control (QC) logs, patient test results and an interview with technical supervisor 2 (TS2) on 6/13/2023, the laboratory failed to perform tittered QC for antistreptolysin O (ASO) testing. The findings include: 1. A review of ASO patient test results and QC log identified that the laboratory failed to perform tittered positive QC when patient tests were tittered in 2022 and 2023. 2. An interview with TS2 on 6/13/2023 at 2:00 pm confirmed the laboratory failed to perform tittered QC for ASO testing. 3. The laboratory reports performing 15 ASO tests annually. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on a record review of the Nanoentek Frend instrument verification and an interview with technical supervisor 2 (TS2) on 6/13/2023, the laboratory director failed to ensure that new instrument verifications were adequate. The findings include: 1. A record review of the new instrument verification of the Nanoentek Frend, used for endocrinology and chemistry testing, identified that the laboratory director failed to review and approve the verification results for accuracy, precision and reportable range to ensure that they were adequate before beginning patient testing in May of 2022. 2. An interview with TS2 on 6/13/2023 at 2:11 pm confirmed that the laboratory director failed to review and approve the verifications of the Nanoentek Frend. 3. The laboratory reports performing 38 tests on the Nanoentek Frend annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 a record review of proficiency testing (PT) from American Proficiency Institute (API) and an interview with the Technical Supervisor (TS) on 8/13/2021, the laboratory failed to review PT and evaluate results that were less than 100% but greater than or equal to 80% for 2020 and 2021. The findings include: 1. A review of PT records from API for Microbiology 2020 event two identified that the laboratory failed to evaluate the results for gram stains with a score of 80% due to an unacceptable result for sample GS-09. 2. A review of PT records from API for Hematology/Coagulation 2020 event three identified that the laboratory failed to evaluate the results for Red Cell Count and MCH, performed on the Horiba ABX Micros 60, with a score of 80% due to unacceptable results for sample HEM-13. 3. A review of PT records from API for Hematology/Coagulation 2021 event one identified that the laboratory failed to evaluate the results for Hematocrit, MCHC, MCV and RDW, performed on the Horiba ABX Micros 60, with a score of 80% due to unacceptable results for sample HEM-01. 4. An interview with the TS on 8/13/2021 at 10:00 am confirmed that the laboratory failed to review and evaluate PT results from API that were less than 100% but greater than or equal to 80% for 2020 and 2021. 5. The laboratory reports performing 13,564 moderate and high complexity tests annually. 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 D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on patient record reviews, proficiency testing (PT) record reviews, and an interview with the technical supervisor, the laboratory testing personnel failed to indicate the dates of microbiology test performances and the testing personnel who performed microbiology cultures, which includes the date of media set-up, colony description, morphology, and quantitation, inhibition zone sizes, biochemical tests, and susceptibility tests since the last survey on September 19, 2017. Findings: 1. A review of the 2018 event 3 through 2019 event 1, American Proficiency Institute bacteriology sample laboratory worksheets, revealed the microbiology worksheets failed to include: a. The dates that each of the 5 samples on each event were inoculated and isolated; b. The isolated colony description, quantitation, and morphology; c. The dates of biochemical testing; d. And the person performing each step of testing from streaking of the plate to final sensitivity. 2. A patient record review on May 30, 2019, revealed the laboratory failed to indicate the dates for each sample inoculated, isolated, and biochemical test performed, as well as include the identity of the testing personnel who performed the tests. 3. The laboratory performed approximately 3200 aerobic, throat, and urine cultures and sensitivities in 2018. 4. An interview with the technical supervisor on June 26, 2019 at 11:15 AM, confirmed the laboratory bacteriology worksheets failed to include the dates for each step of testing and the identity of testing personnel. 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 -- D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on personnel record reviews and an interview with the technical supervisor, the laboratory failed to document training for 4 out of 4 testing personnel performing pediatric bilirubin tests on the Reichert Bilirubinometer since the last survey on September 19, 2017. Findings: 1. A record review revealed 4 out of 4 nursing testing personnel failed to have documented training records for the Reichert Bilirubinometer prior to performing bilirubin tests on patients. 2. The laboratory performed approximately 509 bilirubin tests on the Reichert in 2018. 3. An interview with the technical supervisor on June 26, 2019 at 10:55 AM, confirmed the 4 nursing testing personnel who performed pediatric bilirubin tests failed to have documented training prior to patient testing. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a record review of personnel competency assessments and an interview with the technical supervisor, the technical supervisor failed to evaluate the competency of 4 out of 4 testing personnel performing pediatric bilirubin tests on the Reichert Bilirubinometer since the last survey on September 19, 2017. Findings: 1. A review of personnel documents revealed the technical supervisor failed to evaluate the competency for 4 out of 4 testing personnel performing pediatric bilirubin since the last survey. 2. The laboratory performed approximately 509 bilirubin tests on the Reichert in 2018. 3. An interview with the technical supervisor on June 26, 2019 at 10: 15 AM, confirmed the technical supervisor failed to assess and document the competency for the 4 testing personnel. -- 2 of 2 --