Pediatric Specialists Of Marion County

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the manufacturer instructions for use (IFU), lack of documentation, and staff interview, the laboratory failed to follow the manufacturer's instructions for performing quality control (QC) on the McKesson Consult Diagnostics 120 Urine Analyzer for 12 of 12 months reviewed from March 2024 to March 2025. The findings include: 1. An observation of the laboratory on 03 /04/2025 at 8:45 a.m. revealed that it used a McKesson Consult Diagnostics 120 Urine Analyzer (ID: 197G10041F2) and McKesson Consult Diagnostics 10SG Urine Reagent Strips for patient testing. 2. A review of the McKesson Consult Diagnostics IFUs revealed the following QC requirements: - The user manual for the McKesson Consult Diagnostics 120 Urine Analyzer states to test "known positive and negative" controls when the laboratory opens a new canister of strips for testing, a new operator uses the analyzer, when test results seem inaccurate, and after performing maintenance or service on the analyzer. - The package insert for the McKesson Consult Diagnostics 10SG Urine Reagent Strips states to test positive and negative quality controls with each new lot, each new shipment of strips, and when you open a new bottle of reagent strips. Additionally, it states QC is needed when an opened container of test strips are stored for more than 30 days "to ensure reagent storage integrity", to train new users, confirm test performance, and "when patients' clinical conditions or symptoms do not match the results obtained on the test strips." 3. No documentation of quality control testing for the McKesson Consult Diagnostics 120 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Urine Analyzer or 10SG reagent strips was available for review. 4. An interview with testing person two on 03/04/2025 at 9:15 a.m. confirmed the laboratory had not performed urinalysis QC from March 2024 to March 2025. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of patient test reports, quality control (QC) records, and staff interviews, the laboratory failed to ensure that the Complete Blood Count (CBC) QC was within acceptable limits before reporting patient CBC results for two of five days reviewed in 2024 and 2025. The findings include: 1. Observation of the laboratory on 03/04/2025 at 8:45 a.m. revealed a Beckman Coulter DXH-520 hematology instrument (ID: 83961757) for performing patient CBC testing. 2. A random review of patient test reports revealed the laboratory performed CBC testing on 08/01/2024 (Patient: 11594), 10/16/2024 (Patient: 10378), 01/03/2025 (Patient: 14744), and 01/30/2025 (Patient: 13799). 3. A review of 2024 and 2025 QC records revealed the following unacceptable DxH 500 Series QC results: - On 10/16/2024, the Abnormal Low Level (Lot: 352416411) flagged the WBC, RBC, and LY# analytes out of range at 8:25 a.m. There was no successful run of the abnormal low level QC on 10/16/2024. - On 01/03/2025, the Abnormal Low Level (Lot: 352416711) flagged the WBC and LY# analytes out of range at 8:29 a.m., 8:35 a.m., 8:36 a.m., and 9:01 a. m. There was no successful run of the abnormal low level QC on 01/03/2025. 4. An interview with TP2 on 03/04/2025 at 1:30 p.m. confirmed the laboratory performed and reported patient CBCs on 10/16/2024 and 01/03/2025 without QC being within acceptable limits. Key: WBC = White Blood Cell count, LY# = Absolute lymphocyte count, RBC= Red Blood Cell count D5783

Summary Statement of Deficiencies 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 review of the laboratory's proficiency testing (PT) records, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS-209), and staff interview, the laboratory failed to ensure PT testing was performed by personnel who routinely perform patient testing for Complete Blood Count (CBC) in 2022 and 2023. The findings include: 1. Review of the laboratory's PT attestation statements and PT testing records revealed that six of six PT events were performed by Testing Person #1. 2. Review of the Form CMS-209 revealed two testing personnel who perform patient testing for CBC. 3. Interview with the Laboratory Director and TP1 on 2/27/24 at 12:10 p.m. confirmed that PT testing was not rotated among both testing personnel who perform patient testing for CBC in 2022 and 2023. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: 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 -- Based on observation of the laboratory, lack of procedures and staff interview, the laboratory failed to establish a policy for maintaining positive patient identification throughout the testing process. The findings include: 1. Observation of the laboratory on 2/27/24 at 09:15 a.m. revealed the Beckman Coulter AcT-Diff 2 Test System (System ID# 62484025) in use for Complete Blood Count (CBC) testing and an unlabeled lavender top Microtainer tube taped to the specimen rocker sitting atop the analyzer. Testing Personnel #1 stated the Microtainer sample to be a recently collected patient specimen. 3. Review of the procedure manual revealed a lack of procedure for specimen labeling. 4. Interview with the Laboratory Director and TP#1 on 2/27/24 at 12:10 p.m. confirmed the current laboratory practice was not to label their specimens with any patient identifiers. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, quality assurance records and staff interview, the laboratory director failed to approve, sign, and date the Quality Assurance Plan before placing into use. 1. Review of the laboratory procedure manual revealed an updated policy entitled "Quality Assurance Plan" that was not signed and approved by the Laboratory Director. 2. Review of the laboratory quality assurance records revealed signed annual Patient Quality Assurance Monitor forms for 2022 and 2023 correlating to the Quality Assurance Plan. 3. Interview with the Laboratory Director and testing personnel #1 on 2/27/24 at 12:10 p.m. confirmed that the Laboratory Director had not signed and approved the updated Quality Assurance Plan. 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 review of one patient final test report, and staff interview, the laboratory failed to ensure the laboratory name and address were on the final patient test report. The findings include: 1. Review of the final patient test report for patient #4 revealed the name and address of the laboratory were not on the report. 2. Interview with the Laboratory Director and testing personnel #1 on 2/27/24 at 12:10 p.m. confirmed the laboratory name and address was not included on the final patient test report. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) evaluation reports, the laboratory failed to maintain satisfactory performance in Red Blood Cell (RBC) for the1st and 2nd events of 2019 resulting in the first unsuccessful performance occurrence. (Refer to D2123 and D2130). D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) evaluation reports, the laboratory failed to participate in the specialty Hematology Complete Blood Count (CBC) for all analytes: Red Blood Cell (RBC), White Blood Cells (WBC), Hemoglobin (HGB), Hematocrit (HCT) Platelets (PLT) and automated WBC Differential for the 2nd event of 2019 resulting in a score of 0%. The findings include: 1. Review of the CMS 153 & 155 report revealed the RBC, WBC, HGB, HCT, PLT and automated WBC Differential with a score of 0% for the 2nd event of 2019. 2. Review of the API evaluation report revealed the RBC, WBC, HGB, HCT, PLT and automated WBC Differential with a score of 0% for the 2nd event of 2019. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) evaluation reports, the laboratory failed to maintain satisfactory performance in Red Blood Cell count (RBC) for the 1st and 2nd events of 2019 resulting in a first unsuccessful performance occurrence. The findings include: 1. Review of the CMS 153 & 155 report revealed the RBC count with a score of 20% for the 1st event and a score of 0% for the 2nd event of 2019. 2. Review of the API evaluation report revealed the RBC count with a score of 20% for the 1st event and a score of 0% for the 2nd event of 2019. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of 2016 and 2017 Proficiency Testing (PT) attestation records and an interview with the primary testing person, it was determined the laboratory did not involve one of two testing personnel in rotating PT samples for complete blood counts during the 2 year period. Findings include: 1. A review of PT records from 2016 and 2017 disclosed the primary lab person did all testing of PT samples. 2. An interview with the primary testing person at 11 AM on June 6, 2018 confirmed she was the only person running PT samples for the 2 year period. 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 procedure manual, employee training records for 2016-2017, and an interview with the lead testing person, the laboratory failed to document all competencies and training procedures performed initially for the new hire personnel using the six minimum required competency areas. Findings include: 1. Review of the procedure manual revealed competencies and training was required for new hire lab 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 -- personnel initially and at six months intervals during the first year. 2. Review of the employee training records for 2016-17 revealed no competencies and training were documented for one new hire lab testing person #2. 3. In an interview, June 6, 2018, at approximately 11:00 AM, the lead testing person confirmed the employee training records for 2016-17 were incomplete by missing the competencies and training for the new lab personnel initially upon hire. -- 2 of 2 --