Utica Pediatrics, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/26/2024. The laboratory was found in compliance with a standard-level deficiency cited. The finding was reviewed with the technical consultant at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the technical consultant and testing person #1, the laboratory failed to follow their written policy for establishing the targets for new lot numbers of control materials prior to implementation for three of 12 lot numbers reviewed during the period of 04/03/2023 through 01/30/2024. Findings include: (1) On 03/26/2024 at 9:11 am, testing person #1 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN-330 analyzer; (b) Three levels of XN-LCHECK QC (Quality Control) materials were tested each day of patient testing; (c) Beyondcare Quality Monitor (BCQM) was used to set the target values and acceptability of quality control results. (2) A review of the procedure manual titled, "Complete Blood Count of Whole Blood on the Sysmex XN-330 Automated Hematology" under section VI. "Beyondcare Quality Monitor (BCQM), Part - C. "Registering and Modifying QC file lot input" stated the following: (a) "8. Parallel studies must be performed between production lot and new lot prior to production lot expiration. 9. Run NEW QC lots once registered 2 times daily for 5 days to get a total of 10 data points, once in the morning and once before shutdown. 10. Once all 10 data points have been run, auto set the targets." (3) A review of records for three of 12 control lot numbers used from 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 -- 04/03/2023 through 01/30/2024 identified the laboratory did not follow their policy as follows: (a) Lot #32941401 used from 11/02/2023 through 12/14/2023 - The controls had been tested eight times over four days as follows: (i) Once on 11/02/2023 (ii) Once on 11/03/2023 (iii) Once on 11/06/2023 (iv) Five times on 11/07/2023 (b) Lot #32941402 used from 11/01/2023 through 11/30/2023 - The controls had been tested ten times over five days as follows: (i) Once on 11/01/2023 (ii) Three times on 11/02 /2023 (iii) Once on 11/03/2023 (iv) Once on 11/06/2023 (v) Four times on 11/07/2023 (c) Lot #32941403 used from 11/02/2023 through 11/29/2023 - The controls had been tested nine times over four days as follows: (i) Once on 11/02/2023 (ii) Once on 11/03 /2023 (iii) Once on 11/06/2023 (iv) Six times on 11/07/2023 (4) The findings were reviewed with the technical consultant who stated on 03/26/2024 at 12:06 pm, the laboratory did not follow their written policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/22/2022. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the policy and procedure manual and interview with the technical consultant, the laboratory failed to follow written procedures for verifying quality control materials for three of 12 lot numbers. Findings include: (1) On 02/22 /2022 at 10:15 am, the technical consultant stated to the surveyor routine CBC (Complete Blood Count) testing was performed on the Sysmex KX-21N analyzer; (2) On 02/22/2022, the surveyor reviewed the written laboratory procedure titled, "LABORATORY POLICY AND PROCEDURE MANUAL" under the procedure titled, "COMPLETE BLOOD COUNT OF WHOLE BLOOD ON THE SYSMEX KX-21N AUTOMATED HEMATOLOGY ANALYZER" it stated, (a) "E. Starting a New Lot of Controls" (i) "Parallel test new controls by analyzing the three levels of control a minimum of 5 times prior to expiration of the previous lot.". (3) The surveyor reviewed 12 QC (quality control) lot numbers. For three of 12 lot numbers there was no indication the laboratory staff followed their written procedure as follows: (a) Eightcheck-3WP Lot# 00850710 low control ran one time before put into use; (b) Eightcheck-3WP Lot# 00850711 normal control ran one time before put into use; (c) Eightcheck-3WP Lot# 00850712 high control ran one time before put into use. (4) The surveyor reviewed the findings with the technical consultant. 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 2 -- technical consultant stated on 02/22/22 at 11:45 am that the procedure had not been followed as indicated above. 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 a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #1, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for five of eight quarterly maintenance procedures. Findings include: (1) On 02/222022 at 10:15 am, the technical consultant stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex KX-21N analyzer; (2) On 02/22/2022, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. (a) Quarterly maintenance (i) Clean SRV (3) The surveyor reviewed maintenance records for 24 months (January 2020 through December 2021) and identified the following: (a) There was no evidence the quarterly maintenance had been performed (i) Until 08/06/2020 (missing 2020 first quarter and second quarter); (ii) Between 09/02/2020 and 02/03/2021 (missing 2020 fourth quarter); (iii) After 05/05/2021 (missing 2021 third quarter and fourth quarter). (4) The surveyor reviewed the records with the technical consultant and testing person #1. Testing person #1 stated on 02/22/2022 at 11:05 am, the quarterly maintenance had been performed but not documented as performed as required. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/15/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant, testing person #1, and testing person #2, at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex KX-21N analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's weekly maintenance requirements as stated on the manufacturer's maintenance logs: (a) Clean SRV Tray (3) The surveyor then reviewed maintenance records from March 2018 through December 2019. There was no evidence the weekly maintenance had been performed between: (a) 05/21/18 and 06/04/18 (b) 07/25/18 and 08/06/18 (c) 03/25/19 and 04/08/19 (4) The surveyor reviewed the records with the technical consultant, who stated the weekly maintenance had not been documented as performed as indicated above. 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 The findings were reviewed with technical supervisor #1 at the conclusion of the survey. 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 a review of records and interview with techical consultant #1, the laboratory failed to maintain copies of proficiency testing records. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified for 1 of 6 testing events: (a) Third 2016 Hematology Event (i) The attestation could not be located. (2) The findings were reviewed with the technical consultant #1 who stated the attestation could not be located. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) Third 2016 Hematology Event (i) MCV (Mean Corpuscular Volume) - 5 of 5 results exhibited a positive bias (aa) HSY-11- SDI 2.1 (bb) HSY-12- SDI 2.5 (cc) HSY-13- SDI 2.4 (dd) HSY-14- SDI 2.3 (ee) HSY-15 - SDI 2.6 (2) Surveyor #2 could not locate evidence in the records proving the biases had been identified and addressed; (3) Surveyor #2 reviewed the above findings with the technical consultant #1 who stated the biases had not been addressed. 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 a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to ensure equipment maintenance was performed as required by the manufacturer. Findings include: (1) At the beginning of the survey, technical consultant #1 stated to the surveyors CBC (Complete Blood Count) testing was performed on the Sysmex KX-21 N analyzer; (2) Surveyor #2 reviewed 2016 and 2017 (24 months) manufacturer's maintenance logs for the analyzer with the following identified: (a) Daily - Execute Shutdown (i) The daily maintenance procedures had not been documented as performed: (aa) March 2016 - Day 4 (bb) April 2016 - Day 1 (cc) July 2017 - Days 5,6,7 (dd) August 2017 - Days 1,2,3,4 (ee) November 2017 - Day 2 (b) Quarterly - Clean SRV (Sample Rotator Value). The quarterly maintenance had not been documented as performed between: (i) 07/24/17 and 01/23/18 (3) Surveyor #2 reviewed the records with technical consultant #1 who stated there was no evidence the above maintenance had been performed as required. -- 2 of 2 --