Gables Pediatrics Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 15, 2024. GABLES PEDIATRICS LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical 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 staff interview, the laboratory failed to have all attestations for Proficiency Testing (PT) signed as follow: Testing person (TP) failed to sign one (3rd event) out of 6 events of Hematology (1, 2, 3 events of 2023 and 1,2 and 3 events of 2024) reviewed and the laboratory director (LD) failed to sign two (3rd event 2023 and 1st event 2024) out of 6 events (1,2,3 for 2023 and 1,2,3 for 2024). Findings included: 1-Review of the PT records from College of American Pathologist (CAP) Hematology Automated Differential Survey FH1-C 2023 revealed that the TP and LD failed to sign attestation for the testing performed on 10/09/2023. 2-Review of PT records from CAP for 1st event of 2024 revealed that the LD failed to sign on 02/09/2024. 3-During the interview on 10/15/2024 at 11:26 AM, the LD confirmed that the signature for the events of reference were missing. 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 on 10/27/2022 found the GABLES PEDIATRICS LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for 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 review of form CMS 209, Laboratory Personnel form, personnel files, a review of College of American Pathologists (CAP) proficiency testing (PT) records and staff interview, the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the Hematology specialty during 2021 and 2022. Findings include: Review of CMS 209 form signed and dated by the Laboratory Director (LD) on 10/26/2022 revealed that the laboratory had nine Testing Personnel listed (TP# A, TP# B, TP# C, TP# D, TP# E, TP# F, TP# G, TP# H and TP# I). Personnel files review revealed that TP# A, TP# B, TP# C, TP# D and TP# F, had competency records in 2021 and 2022. Review of CAP PT records for 2021 and 2022, revealed that TP# A signed attestation for the three events of 2021 and the two events of 2022. During an interview on 10/27/2022 at 03:00 PM, TP# A confirmed that she was the TP that performed all the PT events for the period reviewed. 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 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 -- 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 Quality Assessment (QA) process failed to monitor, assess and correct deficiencies in the storage of complete blood controls (CBC); which were outside of the acceptable range for 19 out of 517 days reviewed. Findings include: -Review of refrigerator temperature logs for 2021 and 2022 revealed that the temperatures were outside of the acceptable range of 35.6 to 46.4 Degrees Celsius on the following dates: 09/01/2021, 10/01/2021, 10/04/2021, 10/08 /2021, 12/20/2021, 01/05/2022, 01/06/2022, 01/10/2022, 01/13/2022, 01/14/2022, 01 /17/2022, 02/02/2022, 02/07/2022, 02/28/2022, 03/01/2022, 03/17/2022, 03/25/2022, 03/30/2022 and 04/28/2022. -No documentation of

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Gable Pediatrics LLC on 10/14/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of College of American Pathology (CAP) proficiency testing and interview with Testing Person #D the laboratory failed to test the Proficiency Testing the number of times that Patients are tested for 5 (1st, 2nd Testing Event in 2020 and 1st, 2nd, 3rd Testing Event in 2019) out of 5 Testing Events. Findings Included: Review of the CAP proficiency testing instructions revealed that "Proficiency Testing (PT) specimens must be tested with the laboratory's regular workload, using routine methods, and testing the PT specimens the same number of times it routinely tests patient specimens." Review of CAP proficiency testing revealed that the 1st Testing Event in 2020 was due no later than 02/18/20. The Laboratory received five samples to be tested. All 5 samples were ran 2 times on 02/11/20 and 1 time on 02/12/20 by 3 separate Testing Personnel for a total of 3 times each. Review of CAP proficiency testing revealed that the 2nd Testing Event in 2020 was due no later than 06/09/20. The Laboratory received five samples to be tested. All 5 samples were ran 3 times on 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 -- 05/06/20, 1 time on 05/07/20, and 1 time on 06/03/20 by 5 separate Testing Personnel for a total of 5 times each. Review of CAP proficiency testing revealed that the 1st Testing Event in 2019 was due no later than 02/19/19. The Laboratory received five samples to be tested. All 5 samples were ran 4 times on 01/29/19 by 4 separate Testing Personnel for a total of 4 times each. Review of CAP proficiency testing revealed that the 2nd Testing Event in 2019 was due no later than 05/28/19. The Laboratory received five samples to be tested. All 5 samples were ran 4 times on 05/21 /19 by 4 separate Testing Personnel for a total of 4 times each. Review of CAP proficiency testing revealed that the 3rd Testing Event in 2019 was due no later than 10/15/19. The Laboratory received five samples to be tested. All 5 samples were ran 4 times on 10/10/19 by 4 separate Testing Personnel for a total of 4 times each. Interview on 10/14/20 at 10:50 AM Testing Person #D confirmed that the Proficiency testing was not ran like Patient specimens. 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 the Laboratory Director the laboratory failed to perform competency evaluations on 7 (#TP-A, TP-B, TP-C, TP-D, TP-E, TP- F, and TP-G) out of 7 Testing Personnel, 2 (#CC-B and CC-C) out of 3 (#CC-A, CC- B, and CC-C) Clinical Consultants, and 1 (#TC-B) out of 2 (#TC-A and TC-B) Technical Consultants for 2 out of 2 (2019-2020) years reviewed. Findings Included: Review of the CMS 209 signed by the Laboratory Director 10/13/20 revealed that there are 3 Clinical Consultants (CC-A is the Laboratory Director), 2 Technical Consultants (TC-A is the Laboratory Director), and 7 Testing Personnel. Review of Personnel files revealed no competency evaluations for 2 Clinical Consultants (CC-B and CC-C), 1 Technical Consultant (TC-B), or 7 Testing Personnel (TP-A, TP-B, TP- C, TP-D, TP-E, TP-F, and TP-G). Interview on 10/14/20 at 11:57 AM the Laboratory Director confirmed that there were no competency evaluations performed on the aforementioned staff in 2019 or 2020. 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 record review and interview with the Laboratory Director and Testing Person #D the laboratory failed to store Hematology quality control (QC) per the manufacturer's instructions (MI) 48 days out of 98 days reviewed and failed to -- 2 of 3 -- document room temperature for 2 (2019-2020) out of 2 years reviewed. Findings Included: Review of the MI for the Hematology controls revealed that they should be stored 2-8 degrees Celsius or 35.6-46.4 degrees Fahrenheit. Review of refrigerator temperature log revealed that it had an incorrect range of 30-40 degrees Fahrenheit. The months selected for review were January 2019, September 2019, February 2020, and July 2020. In January 2019 the laboratory was open 26 days and the refrigerator temperature was out of the 35.6-46.4 degree Fahrenheit range for 11 days (01/02=35 degrees, 01/04=35 degrees, 01/14=35 degrees, 01/17=34 degrees, 01/18=35 degrees, 01/19=35 degrees, 01/21=34 degrees, 01/22=32 degrees, 01/23=34 degrees, 01/25=35 degrees, and 01/26=34 degrees). In September 2019 the laboratory was open for 22 days and the refrigerator temperature was out of the 35.6-46.4 degree Fahrenheit range for 10 days (09/03=34 degrees, 09/04=34 degrees, 09/06=35 degrees, 09/09=34 degrees, 09/11=34 degrees, 09/12=34 degrees, 09/18=33 degrees, 09/25=32 degrees, 09/26=34 degrees, and 09/28=34 degrees). In February 2020 the laboratory was open for 25 days and the refrigerator temperature was out of the 35.6-46.4 degree Fahrenheit range for 13 days (02/01=34 degrees, 02/03=34 degrees, 02/05=35 degrees, 02/06=34 degrees, 02/07=35 degrees, 02/08=35 degrees, 02/12=34 degrees, 02/14=34 degrees, 02/18=34 degrees, 02/22=34 degrees, 02/25=34 degrees, 02/27=32 degrees, and 02/28=34 degrees. In July 2020 the laboratory was open for 25 days and the refrigerator temperature was out of the 35.6-46.4 degree Fahrenheit range for 14 days (07/02=34 degrees, 07/04=34 degrees, 07/06=34 degrees, 07/07=34 degrees, 07 /13=32 degrees, 07/14=32 degrees, 07/15=34 degrees, 07/16=34 degrees, 07/20=34 degrees, 07/22=35 degrees, 07/23=33 degrees, 07/28=35 degrees, 07/29=35 degrees, and 07/31=35 degrees). Interview on 10/14/20 at 11:57 AM the Laboratory Director and Testing Person #D confirmed that the range needed to be changed and that the temperature reading were not within manufacturer's guidance for storage. Review of the procedures for the Sysmex XP-300 Automated Hematology Analyzer revealed that the CELLPACK reagent needs to be stored at a controlled temperature of 15-30 degrees Celsius. Interview on 10/14/20 at 11:57 AM the Laboratory Director and Testing Person #D confirmed that the room temperature was not being documented. -- 3 of 3 --

Summary Statement of Deficiencies 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 College of American Pathologists (CAP) proficiency testing (PT) record review and interview with laboratory director, the laboratory failed to achieve an 80% testing score for Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB) and Hematology for 1 out of 6 events reviewed for the specialty of Hematology. Findings include: Review of CAP PT records for 2017 and 2018, revealed that the laboratory failed first event of 2017 with 60 % score for RBC, HCT, HGB and 77 % score for Hematology specialty. During an interview on 11/19/2018 at 12:00 PM, the laboratory director confirmed that the laboratory had unsatisfactory score on that PT event. 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