Aventura Pediatrics Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 19th, 2024. AVENTURA PEDIATRICS LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 laboratory failed to perform maintenance as specified by the manufacturer for 21 out of 22 months reviewed (from November of 2022 to August 2024) for the Hematology Analyzer. Findings included: 1-Review of the Beckman Coulter DxH500 maintenance records revealed that monthly bleaching was not performed monthly for November and December of 2022, January to September of 2023, November and December of 2023, and January to August of 2024. 2-Review of the CMS 209 form submitted by the laboratory revealed there are three testing personnel TP1, TP2 and TP3. 3-Review of the instrument manual PN C42118AA Table 12.1 Matrix of Frequency for Cleaning Procedures stated that the "frequency for Performing a Bleaching Cycle as Every 1,000 cycles or monthly, whichever comes first." 4-Interview on 9/19/2024 at 12:33 PM with TP1 admitted to not performing the bleaching procedure monthly as specified by the manufacturer. 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 D0000 A recertification survey conducted from 08/25/2022 to 09/06/2022 found the AVENTURA PEDIATRICS LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a record review and interview, the Laboratory Director (LD) failed to document the review and evaluation of the proficiency testing (PT) results for four out of five events reviewed for the Hematology specialty and for three out of five events for the Bacteriology sub-specialty in 2021 and 2022. Findings include: Review of College of American Pathologists (CAP) PT records, for 2021 and 2022 revealed that the LD failed to signed and date the Evaluation form for the following events: Year 2021 -Hematology first, second and third events. -Bacteriology first, second and third events. Year 2022 -Hematology second event. During an interview on 08/26/2022 at 2: 30 PM, the LD confirmed that she failed to sign and date the review of the PT events of reference. 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: 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 a record review and interview, the laboratory procedure manual was not updated with the new Complete Blood Cell Count (CBC) analyzer in use since 11/11 /2021 and the laboratory director (LD) failed to review and sign the procedure manual at least since 11/11/2021. Findings include: -Review of the laboratory procedure manual revealed that failed to include the procedure for the new CBC Beckman Coulter DXH 500 analyzer in use since 11/11/2021 -Review of the laboratory's procedure manual revealed that the laboratory director failed to sign and date the procedure manual at least since 11/11/2021. During an interview on 08/25/2022 at 02: 35 PM, the LD acknowledged that the procedure manual was not updated with the new CBC analyzer and that she failed to review, sign and date it at least since 11/11 /2021. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to label complete blood cells controls currently in use with the new expiration date. Findings include: - During the laboratory tour on 08/26/2022 at 10:00 AM, the surveyor observed that the laboratory had in use Beckman Coulter Tri Level Controls with Lot # 372213911, 372213912 and 372213913. The controls in use failed to have the opening date and the new expiration date. -Review of Beckman Coulter insert revealed that opened controls are stable for 16 days. During an interview on 08/26/2022 at 10:35 AM, the Testing Personnel # A, confirmed that controls in use were not labelled as described above and she explained that she started using the current controls on 08/10/2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the Quality Assurance activity since August 2020. Findings include: Review of the Monthly Quality Assurance Checklist records revealed no documentation of the QA activity since August 2020. During an interview on 08/25/2022 at 02:30 PM, with the Laboratory Director (LD), she confirmed that the laboratory failed to document the QA activity since August 2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 12 /16/2021 for Aventura Pediatrics, LLC. The Aventura Pediatrics LLC laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Refer to D2130. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and the review of the Centers for 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 -- Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 16, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell count (WBC) for two out of three testing events in 2021. 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 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 performance in proficiency testing in the specialty of hematology. Findings include: On December 16, 2021 on or about 10:00 AM the College of American Pathologists (CAP) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell count (WBC), as shown below. Event #1, 2021 WBC-20% Event #3, 2021 WBC-0% 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 specialty of hematology. Findings include: On December 16, 2021 on or about 10:00 AM, the College of American Pathologists (CAP) 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 out of three testing events for the analyte, white blood cell count (WBC), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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: -- 2 of 3 -- 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 specialty of hematology. Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on December 16, 2021 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #1, 2021 WBC-20% Event #3, 2021 WBC-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 8-31-2020, found that Aventura Pediatrics LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited : D5200- General Laboratory Systems D6063- Laboratory Testing Personnel 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 obtain a passing score of 80 percent for Bacteriology in the 2nd proficiency testing (PT) event for the College of American Pathologist (CAP) in 2019 . Findings Included: Review of CAP proficiency testing record revealed a score of 60 percent was received for the specialty of Bacteriology in the 2nd PT event of 2019. An interview on 8/31/2020 at 12:19 pm, with the laboratory director confirmed that the laboratory failed to receive a passing score of 80 percent for Bacteriology in the 2nd proficiency testing (PT) event in 2019 . 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 3 -- This CONDITION is not met as evidenced by: Refer to D5209 :Based on record review and staff interview, the laboratory failed to follow their policy and failed to perform competency assessments for testing personnel (TP). 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 10-19-2018. Based on record review and staff interview, the laboratory failed to follow their own policy and failed to perform competency assessments for testing personnel (TP). Annual competency assessment was not performed for 1 (TP#A) out of 2 TP in 2019 and 2020. Initial and 6-month competency assessments were not performed for 1 (TP#B) out of 2 TP in 2019. Finding Include: . Review of CMS -209 Laboratory Personnel Form confirmed staff #A and staff #B are TP. Review of Personnel Competency assessment record showed TP#A had no documentation of performed annual competency assessments for 2019 and 2020. T#B had no documentation of performed initial and 6-month competency assessments. An interview on 8/31/2020 at 12:19 pm, with the laboratory director confirmed that the annual, initial and 6-month competency assessments were not done for TP in 2019 and 2020. 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: Refer to D6065 : laboratory failed to ensure 1 (TP#A) out of 2 testing personnel (TP) has documentation of a high school diploma 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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of -- 2 of 3 -- Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure 1 (TP#A) out of 2 testing personnel (TP) has documentation of a high school diploma . Findings Include: Review of CMS -209 Laboratory Personnel Form confirmed that staff #A is TP. Review of Employee Records revealed that TP#A had no documentation of a high school diploma . An interview on 8/31/2020 at 12:19 pm, with the laboratory director confirmed TP#A had no documentation of high school diploma . -- 3 of 3 --

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 CMS Form 209, CAP (College of American Pathologists) proficiency testing for two-year period (2016 to 2018), and interview with testing personnel, the laboratory failed to rotate proficiency testing events to include all testing personnel who perform patient testing, for 6 of 6 events reviewed for hematology and bacteriology. The findings include: On September 20, 2018 at 12: 30pm, surveyor reviewed CMS form 209 completed by laboratory that had three testing personnel( #1, #2,#3) on the form. CAP proficiency testing record review for six events (2016-3rd event, 2017-three events, 2018-1st and 2nd event) revealed that (a) Testing person #1 performed only hematology proficiency testing for all six-test events. (b) Testing person #2 performed only bacteriology proficiency testing for all six-test events. During an interview on September 20, 2018, at 2:30pm, the testing person#1 confirmed that the testing person #1 and #2 performed both hematology and bacteriology patient testing but testing person #1 performed only hematology proficiency testing for all six-test events and testing person #2 performed only bacteriology proficiency testing for all six-test events. Testing person #3 was a new hire. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with testing person, laboratory failed to establish and follow written policies and procedures to access testing personnel competency for the two year record review period (9/2016 - 9/20/2018). The findings include: Laboratory Procedures and policy records reviewed on 9/20/18 at 1:30pm for two-year review period (9/2016 - 9/20/2018) did not show established policy to access testing personnel competency. There were no other personnel policy records to include the protocol to access testing personnel competency. During an interview on September 20, 2018, at 2:30pm, the testing person confirmed that the laboratory did not have the written policies and procedures to access testing personnel competency. 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 observation, record review and an interview with the testing person, the laboratory failed to monitor and record the daily room temperature and humidity from 9/2016 to 9/18/2018 (for two-year review period) for hematology specialty. The findings include: On 9/20/2018 at 1:30pm, surveyor did not see daily temperature and humidity check in instrument maintenance and temperature record logs. Beckman Coulter hematology analyzer manual had optimal temperature range as 20* -25*C. During a laboratory tour at 2:15 PM, surveyor did not observe temperature and humidity monitoring device. During an interview on September 20, 2018, at 2:30pm, testing person confirmed that the laboratory did not have the room temperature and humidity-monitoring device, and did not monitor the laboratory temperature and humidity as part of the environmental requirement for Beckman Coulter Hematology analyzer. 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 observation, record review and interview with testing person, laboratory failed to have the manufacturer's instructions -operator's manual for the recommended maintenance and function checks, and maintenance for Quest Diagnostics Horizon Mini E centrifuge. The findings include: During a laboratory tour on 9/20/18 at 2:00 -- 2 of 3 -- pm, surveyor observed Quest Diagnostics Horizon Mini E centrifuge with no manufacturer's instructions or operator's manual for the recommended maintenance and function checks. Maintenance record review at 1:30 pm did not show records for centrifuge maintenance. During an interview on September 20, 2018, at 2:30pm, the testing person confirmed that the laboratory - did not have manufacturer's instructions or operator's manual for the recommended maintenance and function checks for Quest Diagnostics Horizon Mini E centrifuge. - did not do maintenance on Quest Diagnostics Horizon Mini E centrifuge and had no records. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on interview with testing person and lack of competency performance records, technical consultant failed to access moderate complexity testing personnel annual competency for the two year record review period (9/2016 - 9/20/18). The findings include: Laboratory records reviewed on 9/20/18 at 1:30pm for two-year review period (9/2016 - 9/20/2018) did not show written documentation of moderate complexity testing personnel annual performance evaluations for testing person #1, #2, or #3. During an interview on September 20, 2018, at 2:30pm, the testing person #1 confirmed that the technical consultant did not perform annual performance evaluation for #1 or #2 for the years 2016 to 2018 or before. Testing person #3 was a new hire less than six months, and so was not due yet for the semiannual or annual performance evaluation. -- 3 of 3 --