Gables Pediatrics Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at GABLES PEDIATRICS LLC from 03/12/2025 to 03/13/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions was cited: - D6063 Laboratory Personnel Qualifications. 493.1421 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 staff interview, the laboratory failed to have attestations for Proficiency Testing (PT) three out of seven events reviewed from 2023 to 2025. Findings included: 1-Review of the PT records from College of American Pathologist (CAP) Hematology Automated Differential Survey FH16, revealed the following: a) FH16-C 2023 no attestation signed. b) FH16-A 2024 no attestation signed. c) FH16-B 2024 no attestation signed. 2-During the interview on 03/11/2025 at 12:20 PM, the LD confirmed that the attestations for the reference events were missing. 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: 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 record review and Laboratory Director (LD) interview, the Laboratory failed to verify the education of 1 out of 14 Testing Personnel. 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 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 Laboratory Director (LD) interview, the Laboratory failed to verify the education of 1 out of 14 testing personnel (TP). Findings included: 1- Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 03/11/2025 listed 14 TP (TP#1, TP#2, TP#3, TP#4, TP#5, TP#6, TP#7, TP#8, TP#9, TP#10, TP#11, TP#12, TP#13 and TP#14). 2-Review of employee files revealed that TP#9 who was hired since 06/07/2024, had a Foreign High School Diploma, the laboratory failed to have the equivalence for her Diploma. 3-During an interview on 03/12/2024 at 12:30 PM with LD, she confirmed that the Laboratory failed to have the equivalence for the Foreign High School Diploma for TP#9. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 4/29/2021 at GABLES PEDIATRICS LLC. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were not met: 5200- General Laboratory Systems 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. This CONDITION is not met as evidenced by: The laboratory failed to perform an initial competency assessment for 1 out 7 clinical consultants (CC), assessments for 6 out of 8 CC and 2 assessments fo the 2 technical consultants (TC) in 2020. A six- month competency assessment was not performed for 1 out 9 testing personnel (TP) in 2021. (see 5209) 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: 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 record review and interview, the laboratory failed to perform an initial competency assessment for 1 out 7 clinical consultants (CC), annual competency assessments for 6 out of 8 CC and 2 assessments for the 2 technical consultants (TC) in 2020. A six- month competency assessment was not performed for 1 of 9 testing personnel (TP) in 2021. This is a repeated deficiency from 9/09/2019 . Finding Included: Review of Laboratory Personnel Report revealed the following: 1. TP-I as TP 2. CC-A, CC-B, CC-D, CC-E, CC-F, CC-G, CC-H, CC-I as CC 3. TC-A and TC- B as TC Review of Clinical Consultant Competency Assessment records revealed CC#I had no documentation of an initial competency assessment in 2020. CC-A,-B, D, -E, -F, -G, and H had no documentation of an annual competency assessment in 2020. Review of Technical Consultants Competency Assessment records revealed TC- A and TC-B had no documentation of an annual competency assessment in 2020. Review of Testing Personnel Competency Assessment records for TP-I had no documentation of a six-month competency assessment in 2021. During an interview on 4/28/2021 at 3:40pm, the laboratory manager confirmed no performance of an initial competency assessment for 1 out 7 clinical consultants (CC), annual competency assessments for 6 out of 8 CC and 2 of 2 technical consultants (TC) in 2020, and a six- month competency assessment was not performed on 1 out 9 testing personnel (TP) in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at Gables Pediatrics LLC Doral on 9/09/2019 found that the laboratory is 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 personnel competency record review and interview with staff, the laboratory failed to have initial competencies for 1 out of 2 technical consultant (TC) and 6 out of 6 (CC#A, CC#B, CC#C, CC#D, CC#E, and CC#F) Clinical Consultants (CC) for year 2019. The findings include: -A review of CMS -209 laboratory personnel report revealed that: a) Laboratory Director (LD) is TC #A and CC#A b) CC# B is TC # B c) CC#C, CC#D, CC#E, and CC#F were clinical consultants. -Personnel competency review revealed that there was no initial competency assessments for the TC # B and CC B, C, D, E and F. During an interview with LD, on 09/09/2019 at 2:30 PM, he confirmed that the there was no initial competency assessment for the personnel listed above. 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 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 -- 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, user manual review and interview with the office manager (OM), the laboratory failed to document room humidity requirement to assure optimal operation of the Beckman coulter AcT Diff in 2019. The findings include: AcT coulter manual review revealed a room temperature requirement range of 16-35 C and humidity not greater than 85 %. Observation of laboratory indicated no thermometer /humidity meter to measure room temperature and humidity. Temperature log record review revealed no records of room temperature and humidity in 2019. During an interview on 09/9/2019 at 12:30 p.m., the OM confirmed that there was no record of room temperature and humidity control check. -- 2 of 2 --