Nicklaus Children's Pediatric Specialists, Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 25, 2024. Nicklaus Children's Pediatric Specialists, LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 assess the appropriate

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/10/2022 to 05/13/2022 found the SOUTH FLORIDA PEDIATRIC PARTNERS clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited: - D5002. Bacteriology. -D5400. Analytical Systems. -D6000. Moderate Complexity Laboratory Director. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least 80 % in Bacteriology for the second proficiency testing (PT) event in 2021. Findings include: Review of Bacteriology American Proficiency Institute (API) PT records for 2020, 2021 and first event of 2022 , revealed a 40 % score in the second event of 2021 resulting in a failing score for the subspecialty of Bacteriology. During an interview on 05/10/2022 at 12:25 PM, Testing Personnel #A confirmed that the laboratory failed to receive a passing score of at least 80 % for Bacteriology in the second event of 2021. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to keep, 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 8 -- instrument print outs with the results for proficiency testing (PT) samples for all testing events of 2020 and 2021 for the Hematology specialty and failed to keep the reading results documentation for the Bacteriology results for five out six events reviewed for 2020 and 2021. Findings include: Review of American Proficiency Institute (API) PT records for 2020 and 2021, revealed that the laboratory failed to have the print outs of Complete Blood Analyzer instrument corresponding to the PT samples for all events of each year for Hematology Specialty and for Bacteriology Specialty, for the test Selective Streptococcus Throat Culture the laboratory failed to have record of the reading of the results for the first, second event of 2020 and for the first, second and third event of 2021. During an interview on 05/13/2022 at 11:30 AM, Testing Personnel # A confirmed that the laboratory failed to have print outs and reading documentation for the events of reference. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory did not meet the Condition for Bacteriology from 02/28/2020 to 05/13/2022. Findings include: -Failed to have a Quality Control (QC) policy in place for the Selective Streptococcus Throat Culture (STC). Refer to D5403. -Failed to perform QC for each new lot number and shipment of the Bacitracin Discs used for the STC. Refer to D5471. -Failed to have documentation to indicate that they checked the physical characteristics of each culture media lot, or that they checked each culture media lot with control organisms as part of the QC for the STC. Refer to D5477. -The laboratory tested 297 patients without QC during this period of time. 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 record review and staff interview, the laboratory did not meet the condition for analytic systems. Findings include: -Failed to perform Medonic M Complete Blood Cell Analyzer instrument calibration at least every six months for 2020 and 2021. Refer to D5437. This is a repeated deficiency from the survey of 2018. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 2 of 8 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A recertification survey conducted on 2-26-2020, found South Florida Pediatrics Partners clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview , the laboratory failed to establish and perform initial and six month competencies for 2 (TP#B and C) out of 4 testing personnel (TP) and annual competencies for 1 (TP#A) out of 4 TP , clinical consultant (CC) and technical consultant (TC) in 2019. Findings Include: A review of form CMS 209 Laboratory Personnel record displays that TP# A-D are testing personnel, CC#A is clinical consultant, and TC#A is a technical consultant . A review of Procedure Manual record revealed no personnel competency assessment policy . A review of 2019 Employee Competency Assessment record revealed that initial and six-month competencies were not performed for 2 (TP # B and C) out of 4 TP. Annual competencies was not performed for 1 (TP # A) out of 4 TP, CC # A and TC #A . During an interview on 2-27-2020 at 12:30 pm, The testing personnel A confirmed that initial and 6-month competency assessment were not done for two TP and the annual competency assessments were not performed for TP,CC and TC in 2019 . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide a quality assessment (QA) policy and preform QA monitoring and documentation for 2018- 2019. Findings Include: A review of the Procedure Manual record revealed no policy for QA monitoring. A review of Strep Culture and Hematology Log record displayed no QA review for missing lot numbers, missing patient ID numbers and test expirations from 2018 to 2019. A review of Hematology Controls record displayed no QA review for Hematology controls from 2018 to 2019. During an Interview on 2-26- 2020 at 12:30pm, the testing personnel A and laboratory manager confirmed that no QA policy and QA was not monitored and documentation for 2018 and 2019. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director failed to ensure proficiency testing enrollment for 1st out of 3 events in Hematology and Microbiology with the American proficiency institute (API) in 2019. Findings Include: A review of 2019 API Hematology Proficiency Testing record displayed missing evaluation scores for cell id, red blood cell count, hematocrit, hemoglobin, white blood cell count and platelets in 1st PT event of 2019. A review of 2019 API Microbiology Proficiency Testing record revealed missing bacteriology evaluation scores for strep throat culture in 1st PT event of 2019. During interview on 2-27-2020 at 12:30pm, the testing personnel A and laboratory manager confirmed failure to enroll in API 1st PT event for Hematology and Microbiology in 2019. -- 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 review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of bacteriology. Refer to D2028. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 19, 2018 on or about 1:00 PM, showed that the laboratory had unsatisfactory testing scores for the subspecialty of bacteriology for two consecutive testing events in 2018. D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of bacteriology. Findings include: On September 19, 2018 on or about 1:00 PM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance in the subspecialty of bacteriology as shown below. Event #1, 2018 bacteriology-0% Event #2, 2018 bacteriology-40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of bacteriology chemistry. Findings include: On September 19, 2018, on or about 11:00 PM , the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events in the subspecialty of bacteriology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2028. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of bacteriology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & -- 2 of 3 -- Medicaid Services (CMS) 153 and 155 reports on September 19, 2108 on or about 1: 00 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2018 bacteriology-0% Event #2, 2018 bacteriology-40% -- 3 of 3 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and interview with Testing Personnel # A (TPA), the laboratory failed 1 out of 1 event for Bacteriology during the year 2018. Findings include: Review of API proficiency records revealed that the laboratory failed the Bacteriology first event of 2018 with a 0 % score. During an interview on 8/28/2018 at 11:30 AM, the TPA confirmed that the laboratory failed the event of reference. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 Hematology analyzer Medonic M series user manual review and interview with Testing Personnel # A (TPA), the laboratory failed to document room temperature and humidity requirement to assure optimal operation of the analyzer 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 -- during 2016, 2017, 2018. Findings include: Review of the Medonic M series manual indicates that the operation temperature range is 18 to 32 C and humidity below 80 %. There was no log available for documenting the temperature and humidity of the laboratory room. During an interview on 8/28/2018 at 12:30 p.m., the TPA confirmed that there was no documentation of room and humidity control check. 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 calibration record review and interview with Testing Personnel # A (TPA), the laboratory failed to follow manufacturer instructions for the calibration process for one out of 3 years (2016-2018). Findings include: Review to the Medonic M series manual indicates to do the calibration at a minimum of every 6 months. Calibration record review showed the following calibration dates 3/11/2016, 7/28/2016, 9/25 /2017, 12/21/2017, 3/20/2018, 5/16/2018 During an interview on 8/28/2018 at 12:30 p. m., the TPA confirmed that there was no record of calibration performed between 7/28 /2016 to 9/25/2017. -- 2 of 2 --