Legacy Pediatrics Pllc

Summary Statement of Deficiencies D0000 Based on a Proficiency Testing (PT) desk review survey performed on July 16, 2026, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) PT Certification and Survey Provider Enhanced Reporting system (CASPER 0155D), College of American Pathologists (CAP) PT summary reports, the laboratory failed to 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 -- successfully participate in the CMS approved PT program for two out of three consecutive testing events in the Hematology specialty for the Red Blood Cell (RBC) and Hematocrit (HCT) (Non-Waived) test analytes in 2026 resulting in unsuccessful performance. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 CMS PT CASPER 0155D and CAP summary reports from 2026, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events in the Hematology specialty for the analytes RBC and HCT (Non-Waived). FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. RBC Test Analyte: 2026 First Event = 60% 2026 Second Event = 60% 2. HCT (Non-Waived) Test Analyte: 2026 First Event = 60% 2026 Second Event = 60% b. A review of the PT scores from CAP (2026) confirmed the above test event findings. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and CAP summary reports from 2026, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events in the Hematology specialty. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2026 First Event = 60% 2026 Second Event = 76% b. A review of the PT scores from CAP (2026) confirmed the above test event findings. 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 review of CMS PT CASPER 0155D and CAP summary reports from 2026, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and CAP 2026-1 and 2026-2 summary reports, the LD failed to ensure successful participation in a CMS-approved PT program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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 direct observation, review of Standard Operating Procedures (SOPs), as well as interview with the Testing Person (TP), the laboratory failed to follow manufacturers' instructions for performing the waived test. FINDINGS: 1. The surveyor's observations on December 11, 2025, at approximately 1:30 P.M., confirmed the following Quality Control (QC) material utilized for monitoring the accuracy of the Ascensia Contour blood glucose monitor were not removed from inventory when they exceeded their expiration date: a. Contour Low QC, lot: 3BW1B42, expiration: August 31, 2025. b. Contour High QC, lot: 3BW3L39, expiration: August 31, 2025. 2. The current, approved SOPs did not include instructions for removal of expired testing and QC materials from inventory. 3. The TP informed the surveyor that the expired QC blood glucose monitoring materials were utilized prior to patient specimen processing. The number of patient specimens processed utilizing the respective expired QC materials could not be determined. 4. The TP confirmed the findings on December 11, 2025, at approximately 1:30 P.M. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of SOPs, test kit manufacturer's package inserts, lack of room temperature and humidity records, as well as interview with the TP, the laboratory failed to monitor and document conditions that are essential for proper storage of reagents and specimens in the area where test kits were stored, patient specimens processed, and testing was performed. FINDINGS: 1. Sysmex XP-300 automated hematology analyzer manufacturer instructions specified operating ambient temperature range of 15C to 30C (59F to 86F) and humidity range of 30% to 85%. 2. There was no documentation of ambient room temperature and humidity for the area where test kits were stored, patient specimens processed, and testing was performed. 3. No thermometer or humidistat were present to monitor ambient room temperature or humidity. 4. The current, approved SOPs did not include instructions for performing such activity. 5. The TP confirmed the findings on December 11, 2025, at approximately 1:30 P.M. -- 2 of 2 --