Nicklaus Children's At Galloway

Summary Statement of Deficiencies D0000 A recertification survey conducted on 07/03/2024 found the NICKLAUS CHILDREN'S PEDIATRIC SPECIALISTS, LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to sign attestation for Proficiency Testing for Hematology specialty for two out of two events reviewed. Findings included: Review of American Proficiency Institute (API) Proficiency Testing (PT) records for third event of 2023 and first event of 2024, revealed that the laboratory failed to have attestation signed for the events of reference for the Hematology Specialty tests: Erythrocyte count, Hematocrit, Hemoglobin, Leukocyte count, Platelet count, White Blood Cell Differential and Red Cell Distribution (RDW). During an interview on 07/03/2024 at 12:00 PM, the office manager confirmed that the laboratory failed to sign attestations for the events 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. 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 -- (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 observation, record review and staff interview, the laboratory failed to document room humidity and temperature requirement to ensure optimal operation for the Coulter Ac-T Diff 2 Analyzer for 2 out of 2 years reviewed. The findings included: An observation of laboratory on 07/03/2024 at 11:00 AM, indicated that no thermometer and humid meter located by the analyzer. A review of Coulter Ac-T diff2 Hematology Analyzer manual revealed a requirement for optimal operation a range of room temperature of 16 to 35 Celsius and Humidity between 20 to 85 %. A review of temperature logs for 2022 (September to December), 2023 and 2024 (January to June) revealed no documentation of room humidity and temperature. During an interview on 07/03/2024 at 1130 AM, the Office Manager confirmed that there was no documentation of the room temperature and humidity for the period of reference. 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 interview with office manager, the laboratory director (LD) failed to assure that the facility enrolled in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for Hematology Specialty during the first and second event of 2023. Findings included: Review of American Proficiency Institute (API) PT records for 2023 revealed blank results in the first and second event of 2023. During an Interview on 07/20/2024 at 12.30 PM, the office manager confirmed that the LD failed to ensure the facility to enroll PT program for first and second events of 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 17, 2022. South Florida Pediatrics Partners clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and staff interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for four (2020 2nd, 2021 1st, 3rd, 2022 1st) of six events (2020 2nd, 3rd, 2021 1st, 2nd, 3rd, 2022 1st) for the specialty of hematology. Findings: Review of the American Academy of Family Physicians (AAFP) PT attestations for hematology showed Testing Personnel B performed the PT for the 2020 2nd event, 2021 1st and 3rd events, and 2022 1st event. Review of the AAFP PT records for hematology testing listed the following submission deadlines: 2020 2nd event 06/24/2020 2020 3rd event 10/28/2020 2021 1st event 04/02/2021 2021 2nd event 06/30/2021 2021 3rd event 10 /27/2021 2022 1st event 03/30/2022 Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 08/17/2020 for the survey on 08/18 /2020, listed four Testing Personnel (A, B, C, D). Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 05/10/2022 for the survey on 05/17/2022, listed two Testing Personnel (A, B). Testing Personnel A and B were currently employed at the laboratory and had competency evaluations performed on 09 /15/2020, 03/20/2021, 09/20/21, and 03/21/2022. Testing Personnel C and D are no longer employed by the laboratory and had competency evaluations performed on 09 /15/2020, 03/20/2021, and 09/20/21. On 05/17/2022 at 11:17 AM, 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 3 -- B acknowledged she had performed four of the six proficiency testing. On 05/17/2022 at 1:40 PM, Testing Personnel B stated Testing Personnel C left in February 2022 and Testing Personnel D left in October 2021. 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, the laboratory failed to have maintain copies of the testing results (instrument printouts) from the proficiency testing (PT) for four (2020 2nd, 3rd, & 2021 2nd, 3rd) of six (2020 2nd, 3rd, 2021 1st, 2nd, 3rd, & 2022 1st) events for the specialty of hematology. Findings: Review of the American Academy of Family Physicians (AAFP) PT records showed the instrument printouts from the Beckman Coulter ACT diff 2 hematology analyzer for the 2020 2nd and 3rd events, and the 2021 2nd and 3rd events were missing. On 05/17/2022 at 11:15 AM, Testing Personnel B stated she did not know they needed to keep the instrument printouts. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Quality Control (QC) documents (background counts and daily controls) for six of six patient (#1, #2, #3, #4, #5, #6) testing dates reviewed. Findings: Review of QC for the background checks and daily controls (low, normal, high) run on the Beckman Coulter AcT diff 2 hematology analyzer revealed the background counts and/or daily controls were missing. Patient #1 had a complete blood count (CBC) on 03/01/2021, no background counts or daily controls were available for review. Patient #2 had a complete blood count (CBC) on 04/07/2021, no background counts were available for review. Patient #3 had a complete blood count (CBC) on 09/17/2021, no background counts or the low and high daily controls were available for review. Patient #4 had a complete blood count (CBC) on 01/28/2022, no background counts or daily controls were available for review. Patient #5 had a complete blood count (CBC) on 02/23/2022, no background counts or daily controls were available for review. Patient #6 had a complete blood count (CBC) on 03/02/2022, no background counts or daily controls -- 2 of 3 -- were available for review. On 05/17/2022 at 1:30 PM Testing Personnel B stated she did not know where the missing background counts and daily controls were located. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to perform calibration on the Beckman Coulter AcT diff 2 hematology analyzer at least once every 6 months from 06/17/2021 to 05/17/2022. Findings: Review of the operations manual for the Beckman Coulter AcT diff 2 hematology analyzer noted "Coulter recommends that you calibrate your instrument according to the regulations required by your inspecting agency." Review of the laboratory's calibration documentation on the hematology analyzer showed the last calibration was completed on 06/16/2021. No other documentation of calibrations performed after 6/16/2022 were available for review. On 05/17/2022 at 12:20 PM, Testing Personnel B stated a calibration was performed in December of 2021 and that she was unable to find the calibration documentation. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 8/18/2020 , found the South Florida Pediatrics Partners clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited : D5200- General Laboratory Systems 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 American Academy of Family Physicians (AAFP) Hematology proficiency testing attestations for all 3 (1st, 2nd and 3rd) events in 2019 and 2 (1st and 2nd) out 3 events in 2020. Findings Include: Review of AAFP proficiency record revealed Hematology proficiency testing attestations were missing for 3 (1st, 2nd and 3rd) out of 3 events in 2019 and 2 (1st and 2nd) out 3 events in 2020. An interview on 8/18/2020 at 1:37pm, with the office manager confirmed AAFP proficiency testing attestations were missing for 3(1st, 2nd and 3rd) out of 3 events in 2019 and 2 (1st and 2nd) out 3 events in 2020. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing 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 CONDITION is not met as evidenced by: Refer to D5209 : This is a repeat deficiency from 10-8-2018. The laboratory failed to perform and establish performance timeframes for 6-point competency assessment for testing personnel (TP). Refer to 5293:This is a repeat deficiency from 10-8-2018. The laboratory failed to document their monthly Quality Assurance Checklist for 10 out of 12 months in 2019 and 6 months in 2020. 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: This is a repeat deficiency from 10-8-2018. Based on record review and staff interview, the laboratory failed to perform and establish performance timeframes for testing personnel (TP) competency assessments. Annual competency assessments were not performed for 3 (TP#A, TP#B, and TP#D) out of 4 TP in 2019 and 2020. Initial and 6-month competency assessments were not performed for 1 (TP#C) out of 4 TP in 2019. Findings Include: Review of the procedure manual revealed no documentation of timeframes for when competency assessment will be performed. Review of CMS -209 Laboratory Personnel Form confirmed that TP#A, TP#B, TP#C and TP#D are all TP. Review of Personnel Competency Assessment record showed TP#A, TP#B, and TP#D had no documentation of performed annual competency assessments for 2019 and 2020. TP#C had no documentation of performed initial and 6-month competency assessments. An interview on 8/18/2020 at 1:37pm, with the office manager confirmed annual, initial and 6-month competency assessments were not done for TP in 2019 and 2020. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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 record review and interview with office manager, the laboratory failed to follow manufacturer's instructions of performing quality control. There is no documented record of quality control for the following waived tests: 10SG Urine Reagent Strips (URS), respiratory syncytial virus (RSV) in nasal swabs, human chorionic gonadotropin (hCG) in urine, Streptococcus (Strep) A antigen for throat swabs, Infectious Mononucleosis (IM) in whole blood test from 2016 to 2018. Findings include: Record review from 2016 to 10/2/2018 showed that the laboratory was not following manufacturer instructions of performing quality control for the following waived tests: - URS test, manufacturer instructions stated that user should do confirmation of performance of reagent strips by testing known positive and negative specimen with each new lot, each new shipment of strips, when new bottle opened, when strips stored for more than a month, training of new staff. -RSV test, manufacturer instructions stated to record daily quality control and to test external positive and negative control for each new shipment received. -Urine hCG test, as per manufacturer instructions it is recommended that a positive and negative control tested to verify a proper test performance with each new lot, each new shipment, monthly as a check to storage, each new untrained operator. -IM test, as per manufacturer instruction recommends the periodic use of external control materials to ensure proper kit performance -Strep A test, as per manufacturer instructions it is recomended that a positive and negative external control be run per kit During 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 3 -- interview on 10/02/2018 at 12:30 pm, the office manager confirmed that the laboratory was not documenting quality control on the waived tests listed above for the period of reference. D2122 HEMATOLOGY CFR(s): 493.851(b) 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 AAFP (American Academy of Family Physicians) proficiency testing records and interview with laboratory director, the laboratory failed to have a passing score for 2 out of 8 event for the specialty of hematology. Findings include: Review of AAFP proficiency records revealed that the laboratory failed second event of 2016 with 0 % score due to failure to report and second event of 2018 with 27 % score. During an interview on 10/02/2018 at 12:30 PM, the laboratory director confirmed that the laboratory failed the 2 events of reference. 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 interview with Office Manager (OM), the laboratory failed to perform the annual competency assessment on 3 out of 3 testing personnel since at least 2016. Findings include: Review of employee documentation found no competency evaluations on testing person #A to #C for the year 2016 to 2018. During an interview on 10/02/2018 at 12:30 PM, the OM confirmed that there were no competencies performed on the employees listed above for the years of reference. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of