Pediatric Center Inc, The

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center Inc. on March 26,2025 to April 18,2025 The Laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5400 493.1250 Condition: ANALYTIC SYSTEMS D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the Laboratory failed to retain refrigerator temperatures from February 2023 to July 2024. Findings Included: 1. On 3 /26/2025 at 10:11 AM, hematology controls were observed stored in a refrigerator in the laboratory. 2. Reviews of refrigerator temperatures revealed there were no documents retained from February 2023 to July 2024 for refrigerator temperatures with hematology controls. 3. Review of record retention policy revealed no documentation of a policy for retaining laboratory records. 4. On 03/26/2025 at 4:03 PM, the Medical Assistant confirmed refrigerator temperatures were not retained from February 2023 to July 2024. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to create a competency assessment policy and perform annual competency assessments for 3 out of 3 testing personnel in 2023. Findings Included: 1. Review of 2023 Competency assessments revealed 3 testing personnel had no documentation of competency assessments done in 2023. 2. Review of Competency assessment policy revealed there was no policy for competency assessment. 3. On 3/26/2025 at 4:03 PM, the Medical Assistant confirmed annual competency assessments for 3 out of 3 testing personnel in 2023 were not documented. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the Laboratory failed to complete their performance verification on the Cell Dyn Emerald Hematology analyzer before testing Patients for Hematology (See D5421). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to monitor the humidity for January 2025 to March 2025. Findings included: 1. Review of Cell-Dyn Emerald Operator's manual revealed, "maximum relative humidity 80% for temperature up to 90F (32 C)". 2. Review of Temperature Log revealed humidity was not recorded for January 2025 to March 2025. 3. On 03/26/2025 at 4:03 PM, , the Medical Assistant confirmed humidity was not recorded in the temperature log. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test -- 2 of 4 -- system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, record review, and interviews, the Laboratory failed to complete their performance verification on Cell Dyn Emerald Hematology analyzer before testing Patients for Hematology. Findings Included: 1. On 3/26/2025 at 12:10 PM, it was revealed that a new Cell Dyn Emerald instrument was in use for Hematology testing in January 2023. 2. Review of Cell-Dyn Emerald validation revealed it was not signed by a Testing Person or the Laboratory Director. There was no instrument documentation on calibration, quality control, accuracy and precision runs for the verification of complete blood count (CBC) tested on the new Cell Dyn Emerald Hematology analyzer. 3. On 03/26/2024 at 3:24 PM, the Medical Assistant stated 850 patients were tested for (CBC) from January 2023 to February 28,2025. 4. On 03/26/2025 at 4:03 PM, the Medical Assistant confirmed the Laboratory failed to complete their performance verification on the new Cell Dyn Emerald Hematology analyzer before testing Patients for Hematology. D5787 TEST RECORDS CFR(s): 493.1283(a) (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 record review and interview, the Laboratory failed to have test reports to identify the testing person who performed complete blood count (CBC) for 4 out of 4 patients reviewed. Findings included: 1. Review of Patient CBC reports revealed the following: a. Patient 1 was tested for CBC without identifying testing person on 06/07 /2023. b. Patient 2 was tested for CBC without identifying the testing person on 08/24 /2024. c. Patient 3 was tested for CBC without identifying the person testing on 09/06 /2024. d. Patient 4 was tested for CBC without identifying a person testing on 01/17 /2025. 2. Review of Test report policy revealed there was no written policy to identify who tested for complete blood count. 3. On 03/26/2025 at 4:03 PM, the Medical Assistant confirmed 4 out of 4 test report reviewed did not have documentation of Testing Person who performed the test. D5805 TEST REPORT CFR(s): 493.1291(c) (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 -- 3 of 4 -- 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 have test reports with 2 patient identifiers for 4 out of 4 Patients reviewed for complete blood count (CBC). Findings Included: 1. Review of Patient CBC reports revealed the following: a. Patient 1 was tested for CBC without a birthdate on 06/07/2023. b. Patient 2 was tested for CBC with no last name and birth date on 08/12/2024. c. Patient 3 was tested for CBC with no birthdate on 09/06/2024. d. Patient 4 was tested for CBC without a birthdate on 01/17/2025. 2. Review of specimen labeling and report policy revealed there was no written policy for how test reports are written, and specimens are labeled. 3. On 03/26/2025 at 4:03 PM, the Medical Assistant confirmed 4 out of 4 CBC test report reviewed did not have documentation of written last names and birthdates -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 2/2/23 at The Pediatric Center Inc, a clinical laboratory in Belle Glade, Florida. The Pediatric Center Inc is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. One CLIA Condition was not met 42 CFR 493.1250 Analytic Systems D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain the Cell- Dyn 1800 instrument reports for their proficiency testing results for 4 of 6 testing events reviewed. Findings include: A record review of the American Proficiency Institute (API) proficiency test (PT) events for 2021 and 2022 showed that no records from the instrument (Cell-Dyn 1800) used to perform the Complete Blood Count (CBC) were kept for the 1st and 2nd testing event of 2021 and the 1st and 2nd testing event of 2022. An interview with the Office Manager on 2/2/23 at 11:30 a.m. confirmed that the records from the instrument were missing. . D5400 ANALYTIC SYSTEMS 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 -- CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and staff interviews, the laboratory failed to ensure quality control was within acceptable range for complete blood count testing (refer to D5481), failed to perform daily, weekly, and monthly maintenance on the analyzer used for complete blood count testing (refer to D5429), and failed to perform instrument calibrations every 6 months (refer to D5437). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the overall quality of analytic systems. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure the weekly and monthly maintenance required for the Cell-Dyn 1800 was performed for two of two years reviewed (2021-2022). The findings include: The Cell-Dyn 1800 System Operator's Manual states "The CELL-DYN 1800 has been designed to require minimal routine maintenance. The Operator must routinely perform the scheduled maintenance procedures described in this section in order to ensure optimum performance. Failure to perform the scheduled maintenance procedures may result in inaccurate or imprecise analysis of whole blood specimens. Preventive Maintenance Schedule Perform the following procedures at scheduled intervals: Daily Perform Daily Startup (initialize from a STANDBY state) Perform Daily Shutdown Weekly Perform Auto Clean Clean the Aspiration Probe Exterior Monthly Rinse the Lyse Inlet Line Rinse the Reagent Inlet Line" The laboratory was unable to provide documentation showing daily, weekly, and monthly maintenance was performed in 2021 and 2022. The interview on 2/2/23 at 11:50 a.m. with Testing Person A confirmed the maintenance was not performed. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, -- 2 of 4 -- traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not calibrate the cell counter every six months per their procedure manual. The findings included: Review of the procedure manual and calibration records showed that the laboratory's procedure was to calibrate the cell counter every six months. The most recent calibration documented was 9/16/20. The laboratory was unable to provide calibration documentation for 2021 and 2022. During an interview with testing person A at 11:30 a.m. on 2/2/23, it was confirmed that the calibration records could not be located. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 record review and staff interview, the facility failed to ensure hematology quality control (QC) was in range prior to running patient specimens for 4 days in November 2022, 10 days in December 2022, and 5 days in January 2023. Findings include: The review of the Cell Dyn 1800 QC records showed the following: 1. On 11 /2/22 the Red Blood Cell count (RBC) for the low and normal control were out of acceptable range. 2. On 11/3/22 the White Blood Cell count (WBC) for the normal and high control were out of acceptable range. 3. On 11/4/22 the Hemoglobin (Hgb) for the low and high control were out of acceptable range. 4. On 11/25/22 the Hgb for the normal and high control were out of acceptable range. 5. On 12/1/22 the Hgb for the normal and high control were out of acceptable range. 6. On 12/6/22 the Hgb for the low and high control were out of acceptable range. 7. On 12/7/22 the Hgb for the normal and high control were out of acceptable range. 8. On 12/8/22 the WBC, Hgb, and Lymphocyte % for the normal and high control were out of acceptable range. 9. On 12/9/22 the Lymphocyte % for the normal and high control were out of acceptable range. 10. On 12/12/22 the WBC, RBC, and Hgb for the low control was out of acceptable range. The Lymphocyte % for the normal control was out of acceptable range. The WBC, Lymphocyte % and Hgb for the high control was out of acceptable range. 11. On 12/14/22 the Lymphocyte % for the normal and high control were out of acceptable range. 12. On 12/19/22 the RBC and Hgb for the low, normal, and high control were out of acceptable range. 13. On 12/21/22 the Hematocrit (Hct) for the normal and high control were out of acceptable range. 14. On 12/28/22 the RBC and Hct for the normal and high control were out of acceptable range. 15. On 1/2/23 the WBC and Hgb quality control were out of range for the low control. The WBC was out of range for the normal control. The Hgb was out of range for the high control. 16. On 1/10/23 the RBC for the low and high control were out of acceptable range. 17. On 1/11/23 the RBC for the low and normal control were out of acceptable range. 18. On 1/13/23 the low QC was out of acceptable range for WBC, RBC, and Hgb. The normal control was out of range for WBC, RBC, Hgb, Lymphocytes %, Hct, Platelets, -- 3 of 4 -- and MCH (mean corpuscular hemoglobin). The high control was out of range for WBC, RBC, Hgb, Lymphocytes %, Hct, Platelets, and MCH. 19. On 1/16/23 the Platelets for the low control and normal control were out of acceptable range. The laboratory policy for quality control signed by the laboratory director on 10/17/2016 states "Laboratory Staff must retain copies of quality control records, regardless if results are normal or abnormal. If results are abnormal, employee must follow protocol for bleaching and cleaning the machine. Staff understands the importance of retaining controls that are out of range" During an interview on 2/2/23 at 11:40 a.m. Testing Person A said staff were unaware of the meaning behind the quality control flags on the instrument print outs. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based of record review and interview, the Laboratory Director failed to ensure the laboratory's Quality Assessment (QA) program identified and corrected the problems of instrument maintenance not being performed as per manufacturer instructions, instrument calibrations not performed every 6 months, and quality control being out of range for 19 days of patient testing. Findings include: The review of the laboratory's "Quarterly QA report" signed by the laboratory director on 12/2/22 states "For the 4th quarter of 2022 All the daily controls and scheduled maintenance on the equipments and tests done within the premises of T.P.C. lab were reviewed and the technicians proficiency was evaluated and determined to meet our standard of care". The form lists the Emerald CBC unit daily controls and scheduled maintenance as being performed. The laboratory does not have a Cell-Dyn Emerald at this location. A single laboratory form titled "Quarterly Quality Assurance Checklist" was signed by the laboratory director on 3/4/22, 6/10/22, 9/9/22, and 12/16/22. The form shows check marks for the following: "Our Quality Control Policies were performed as specified: All required temperatures were taken and recorded; All reagents, controls, kits, etc that exceeded their expiration date were discarded; All instrument maintenance was performed and documented; Any necessary remedial action was performed and documented; All quality control/calibrations were performed and were within acceptable limits before patient test results were reported; Quality control results were examined for possible problems." The interview with the Office Manager on 2/2/23 at 11:30 a.m. confirmed the laboratory's QA program did not identify failures within the lab. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/23/20 at The Pediatric Center Inc, a clinical laboratory in Belle Glade, Florida. The Pediatric Center Inc is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not calibrate the cell counter every six months per their procedure manual. The findings included: Review of the procedure manual and calibration records on 9/16/20 revealed that the laboratory's procedure was to calibrate the cell counter every six months, but prior to the calibration performed on 9/16/20, the last calibration was performed on 10/1/2019. During an interview with testing person A at 9:25 a.m., on 9 /23/20, she confirmed that the machine had not been calibrated since 10/1/2019. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not have signed attestations for all of the proficiency testing performed for the past two years. Findings include: Review of proficiency testing records for the past two years on 10/25/18 revealed that some of the attestations were not signed, and some of the attestations were signed incorrectly. 1. For the second testing event of 2018, the attestation did not have the director's signature. 2. For the first, second, and third testing event of 2017, the testing person signed the attestion as testing person and director. During an interview with testing person A. at 10:00 a.m., she said that signing as the director was a mistake and that the director signed electronically when he entered proficiency testing results, but we could not locate the signed attestation for the second event of 2018. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record reveiw and interview with laboratory personnel, the laboratory failed to get a score of 80$ on all analytes in all testing events for the past two years. Findings include: Proficiency testing record review for the past two years on 10/26/18 revealed that the laboratory failed received the following unsatisfactory scores. 1. For the second testing event of 2016, the laboratory received 40% for red blood cell count. 2. For the third testing event of 2017, the laboratory received 60% for white blood cell count and 67% for white blood cell differential. During an interview with the office manager at 10:15 a.m. on 10/25/18, she confirmed that they had had some unsatisfactory scores in the past. -- 2 of 2 --