Pediatric Center Inc, The

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center Inc on March 25,2025 to April 18,2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 493.1421 Condition: Laboratory Testing Personnel 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 record review and interview, the Laboratory failed to retain refrigerator temperatures from January 2023 to December 2024. Findings Included: 1. On 03/25 /2025 at 10:11 AM, hematology controls were observed to be stored in a refrigerator in the laboratory. 2. Reviews of refrigerator temperatures revealed there were no documents retained from 2023 to 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 3/24/2025 at 1:20 PM, the Office Manager confirmed refrigerator temperatures were not retained for January 2023 to December 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 interviews, the Laboratory failed to create a competency assessment policy and perform annual competency assessments for 6 out of 6 testing personnel reviewed in 2024. Findings Included: 1. Review of 2024 Competency assessments revealed 6 testing personnel had no documentation of competency assessments done in 2024. 2. Review of Competency assessment policy revealed there was no policy for competency assessment. 3. On 3/25/2025 at 1:20 PM , the Medical Assistant confirmed annual competency assessments for 6 out of 6 testing personnel in 2024 were not documented. 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 3/25/2025 at 1:20 PM, the Medical Assistant confirmed humidity was not recorded in temperature log. 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 for 5 out of 5 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 11/6 /2023. b. Patient 2 was tested for CBC without identifying testing person on 4/17 /2023. c. Patient 3 was tested for CBC without identifying testing person on 10/14 /2024. d. Patient 4 was tested for CBC without identifying testing person on 9/26 /2024. e. Patient 5 was tested for CBC without identifying testing person on 1/28 -- 2 of 4 -- /2025. 2. Review of Test report policy revealed there was no written policy to identify who tested for complete blood count. 3. On 3/25/2025 at 1:20 PM, the Medical Assistant confirmed 5 out of 5 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 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 5 out of 5 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 11/20/2023. b. Patient 2 was tested for CBC with no last name and birthdate on 04/17/2023. . c. Patient 3 was tested for CBC with no birthdate on 10/14/2024. d. Patient 4 was tested for CBC with no last name and birthdate on 09/26/2024. e. Patient 5 was tested for CBC without a birthdate on 01/28/2025. 2. Review of specimen labeling and report policy revealed there was not written policy for how test reports are written and specimens are labeled. 3. On 03/25/2025 at 1:20 PM, the Office Manager confirmed 5 out of 5 CBC test report reviewed did not have documentation of written last names and birthdates. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the Laboratory failed to have qualified Testing Personnel for 3 out of 6 testing personnel sampled for testing of Total protein, (Testing Personnel C, D and E). See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have -- 3 of 4 -- earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to have qualified Testing Personnel for 3 out of 6 testing personnel sampled for testing of Total protein, (Testing Personnel C, D and E). Findings included: 1. Review of Laboratory Personnel Report CMS 209 (signed by the Laboratory Director ) revealed Testing Personnel C , D and E were listed as Testing Personnel. 2. Review of employment form revealed Testing Personnel C received their diploma at a foreign high school in Mexico. There was no foreign equivalence documentation for comparing a foreign degree to United States education High school standard. 3. Review of employment form revealed Testing Personnel D received their diploma at a foreign high school in Jamaica. There was no foreign equivalence documentation for comparing a foreign degree to United States High school education standard. 4. Review of employment form revealed Testing Personnel E received their diploma at a foreign high school in Jamaica. There was no foreign equivalence documentation for comparing a foreign degree to United States High school education standard. 5. Review of annual competency assessments revealed Testing Personnel C had an annual competency assessment done on 03/03/2025 , Testing Personnel D had an annual competency assessment done on 03/03/2025, and Testing Personnel E had an annual competency assessment done on 03/03/2025. 6. On 04/07/2025 at 6:43 PM, the Office Manager confirmed Testing Personnel C , D and E were not qualified for moderate complexity testing due to lack of foreign equivalences. -- 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 Boynton Beach, Florida. The Pediatric Center Inc is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 Emerald instrument reports for their proficiency testing results for 2 of 3 events in 2022 and failed to retain attestation forms for 2 of 3 events in 2021 and 3 of 3 events in 2022. Findings include: 1. 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 Emerald) used to perform the Complete Blood Count (CBC) were kept for the 2nd and 3rd testing events of 2022. 2. A record review of the API PT events showed no signed attestation forms were kept for the 1st and 2nd testing event of 2021 and the 1st, 2nd, and 3rd testing event of 2022. An interview with the Office Manager on 2/2/23 at 3:30 p.m. confirmed that the records from the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- instrument were missing and the attestation forms were not signed by the Laboratory Director or designee. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document remedial action for unsatisfactory proficiency testing results for the 3rd American Proficiency Institute (API) Hematology testing event of 2021. Findings included: Review of the API proficiency test (PT) results for the 3rd testing event in 2021 showed that the lab had unsatisfactory scores on the following three Hematology analytes and there was no documentation of remedial action: 60% Red Cell Count (RBC) 60% Hematocrit (HCT) 60% Hemoglobin (HGB) During an interview on 2/2/23 at 3:30 p.m., the Office Manager confirmed that there was no documentation of remedial action for the three unsatisfactory scores. 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 weekly maintenance was performed on the Cell Dyn Emerald analyzer for 2 of 2 years reviewed (2021 and 2022). The findings include: The Cell Dyn Emerald Instructions for Use booklet states, "Bleach Cleaning the system with a bleach solution is performed weekly and as needed if instrument use conditions cause frequent rejection of measured or quality control material out of range issues". The laboratory was unable to show documented weekly maintenance of the instrument. The interview with the Office Manager on 2/2/23 at 3:30 p.m. confirmed weekly maintenance was not documented. 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) -- 2 of 3 -- (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 Celldyn Emerald cell counter every six months per their procedure manual for two of two years reviewed. (2021-2022) The findings include: Review of the procedure manual on 2/2/23 showed that the laboratory's procedure was to calibrate the cell counter every six months. The calibration records show the cell counter was calibrated on 9/23/20, 6/4/21 (3 months late), 2/14/22 (2 months late), and 11/30/22 (3 months late). During an interview with the Office Manager on 2/2/23 at 3:30 p.m., it was confirmed that the machine had not been calibrated every 6 months. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/23/20 at The Pediatric Center Inc, a clinical laboratory in Boynton Beach, 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 9/23/20 revealed that the laboratory's procedure was to calibrate the cell counter every six months, but prior to the calibration performed on 9/23/20, the last calibration was performed on 8/6/2019. During an interview with testing person A at 11:30 a.m., on 9 /23/20, she confirmed that the machine had not been calibrated since that 8/6/2019. 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 retain all proficiency testing records. Findings include: Review of proficiency testing records for the past two years on 10/25/18 revealed that there were records missing and signatures missing from records. 1. For the first testing event of 2018, there was no raw data from the cell counter and no data entry form. 2. For the second testing event of 2017, the director had signed the attestion, but the testing person had not. There was no performance evaluation form. 3. For the first testing event of 2017, there was no performance evaluation form. 4. For the third testing event of 2016, the attestation was signed by the director, but not the testing person. 5. For the second testing event of 2016, there was no performance evaluation form. During an interview with testing person A at 12:30 p.m. on 10/25/18, she acknowledged that there were forms missing. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(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 -- 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 have documentation of calibration of the cell counter every six months as specified in their procedure manual. Findings include: The surveyor reviewed the procedure manual and the calibration records for the past two years on 10/25/18. The procedure for calibration indicated that the cell counter should be calibrated every 6 months. Review of calibration records and interview with testing person A at 12:40 p. m. on 10/25/18 revealed the only documented calibrations from 2016 to the present were 6/20/16, 2/16/17, 3/21/18, and 10/10/18. -- 2 of 2 --