North Shore Hematology Oncology Associates Pc

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 review of humidity log, the laboratory failed to maintain manufacturer humidity requirement of 30-85% for Sysmex Poch 100i. Findings: 1. Following months humidity fell below 30% a. 2020 - January, February, March, December b. 2021 - January, February, and March c. 2022 - January, February, March, May, June 2. Confirmed on an interview with Quality Assessment (QA) Coordinator on 7/20 /2022 about 12:30pm. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of Quality Assessment (QA) review for year 2020 through survey date, the laboratory director failed to maintain the quality of laboratory services, including the identification of failures in quality as they occur. Refer: D5413 -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a surveyor review of the calibration and quality control (QC) records for the hematology analyzers, and interview with the two laboratory supervisors, the laboratory failed to retain QC and calibration records for one of two hematology analyzers from May 18, 2016 through July 25, 2017. FINDINGS: The laboratory used two Coulter AcT Diff analyzers from May 18, 2016 through 7/25/17. On February 27, 2018 at approximately 11:00 AM, the two supervisors confirmed that the binder containing the QC and calibration records for one of the two Coulter AcT Diff analyzers was misplaced during the laboratory relocation. 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 a review of College of American Pathologist (CAP) Proficiency Testing (PT) reports and confirmed in an interview with the two laboratory supervisors at the time of this survey, the laboratory failed to evaluate, perform and document remedial action for the PT score 0% for hematology Cell ID for the third event in 2017. 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 -- 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 a surveyor's review of hematology calibration records and interview with the two laboratory supervisors, calibration of the hematology analyzers was not performed at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the analyzers. FINDINGS: 1. The laboratory used two Coulter AcT Diff analyzers up to 7/25/17. Documentation of one of the two Coulter AcT Diff analyzer (infusion room analyzer) was not available for review from 5/18/16 through 7 /25/17. 2. The laboratory validated and initiated the new Sysmx XS Series 1000i and the new POCH-100i hematology analyzers in 7/26/17. Calibration records available for review for the Sysmex XS Series 1000i and the POCH-100i analyzers were for calibration done as part of validation study in 7/26/17. The analyzers therefore, were out of calibration from 1/27/18 through the survey date 3. Approximately 2000 patient specimens were tested and reported for hematology during the above time period. -- 2 of 2 --