North Shore Childrens Healthcare

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on December 24, 2025, 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) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D), American Proficiency Institute (API) PT summary reports, 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 3 -- laboratory failed to 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 2025 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 API summary reports from 2025, 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: 2025 Second Event = 20% 2025 Third Event = 0% 2. HCT (Non-Waived) Test Analyte: 2025 Second Event = 40% 2025 Third Event = 0% b. A review of the PT scores from API (2025) 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 API PT summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty Hematology. FINDINGS: a. A review of the CASPER 0155D report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2025 Second Event = 76% 2025 Third Event = 0% 2. A review of the PT scores from API (2025) confirmed the above 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 API summary reports from 2025, 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 API 2025-2, and 2025-3 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 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of analyzer calibration records, Standard Operating Procedure (SOPs), as well as interview with the Technical Supervisor (TS), the laboratory failed to perform and document patient specimen processing analyzer calibration verification. FINDINGS: 1. The only Horiba ABX Micros 60 analyzer calibration documentation for 2023 was performed May 12, 2023. 2. This is contrary to instructions included in the current, approved SOPs which require twice per year analyzer calibration performance. 3. The TS confirmed the findings on January 21, 2025, at approximately 12:00 P.M. 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 -- D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on review of SOPs as well as interview with the TS, the laboratory failed to establish or verify the criteria for acceptability of all control materials. FINDINGS: 1. The current, approved SOPs for external Quality Control (QC) did not include instructions for new lot number validation and guidelines to verify control results correlated with established limits. 2. The TS confirmed the findings on January 21, 2025, at approximately 11:30 A.M. -- 2 of 2 --

Summary Statement of Deficiencies 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 the lack of humidity documentation, the laboratory failed to follow manufacturer requirement of hematology analyzer Horiba Micros 60 humidity requirement of 20-80%. Confirmed on an interview with technical supervisor on 10/21 /2022 about 12pm, humidity monitoring and documentation were not performed for 2020 through survey date. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of hematology calibration records and interview with the clinical consultant/laboratory supervisor, calibration of the hematology analyzer was not performed at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the analyzers. FINDINGS: The laboratory's calibration policy and the manufacturer of the Horiba ABX Micros 60 hematology analyzer require analyzer calibration every six months. The documentation of the hematology analyzer calibration available for review was for calibrations performed on 3/6/17 and 6/27/17. The analyzer was therefore out of calibration from 12/28/17 through this survey date. Approximately 2000 patient specimens were tested and reported for hematology during the time period when analyzer was out of calibration. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON JUNE 9, 2017. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 -- 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 a surveyor findings and interview with the clinical consultant/laboratory supervisor, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. maintained the