North Shore Hematology Oncology Associates Pc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) Proficiency Testing (PT) summary reports as well as interview with the Quality Assurance Coordinator (QAC), the Laboratory Director (LD) failed to document review and date of review for the CAP PT summary reports. FINDINGS: 1. There was no documented CAP hematology PT summary report LD review and date of review for the third event of 2023 as well as the third event of 2024. 2. There was no documented CAP urine analysis PT summary report LD review and date of review for the second event of 2023 as well as the second event of 2024. 3. QAC confirmed the findings on February 5, 2025, at approximately 12:00 P.M. 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 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 -- 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 Sysmex XN-450 analyzer Calibration Verification (CV) certificates as well as interview with the QAC, the laboratory failed to perform and document

Summary Statement of Deficiencies 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 laboratory's policy and procedure manual, QC records for the Influenza A&B and Strep A, and an interview with the general supervisor, the laboratory failed to follow external Quality Control (QC) policy. FINDINGS: 1. The laboratory failed to perform external QC every new lot or new shipment as stated in laboratory's policy. 2. The external QC log of Influenza A&B and Strep A are not available for review. 3. The general supervisor confirmed during interview on 7/1/22 at approximately 11am. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the laboratory records and confirmed in an interview at the time 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 -- of this survey with the general supervisor, the laboratory director failed to ensure that the QC program for the Influenza A&B and Strep A maintained to assure quality of laboratory services. Refer to D5401. -- 2 of 2 --