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Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of laboratory proficiency testing records and an interview with the general supervisor on 02/01/2023 at 3:00 PM, it was determined that the laboratory failed to participate in the College of American Pathologists (CAP) second hematology testing event of 2021. The laboratory received an unsatisfactory score of 0 for its performance in survey FH9-B. The laboratory performs an annual volume of 45,185 hematology tests. The findings include: 1. The general supervisor stated the laboratory failed to notify CAP of its facility address change. 2. The general supervisor stated the laboratory failed to instruct clerical staff remaining at the former address to contact laboratory personnel when the kit was delivered. 3. The general supervisor stated the laboratory failed to track survey FH9-B's shipment and delivery to the laboratory based on CAP's shipping calendar. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory proficiency testing records and an interview with the general supervisor on 02/01/2023 at 3:00 PM, it was determined that the laboratory failed to document the remedial action it undertook for its unsatisfactory performance in the College of American Patholoists (CAP) second hematology testing event of 2021. The laboratory failed to participate in survey FH9-B and received a score of 0. The laboratory performs an annual volume of 45,185 hematology tests. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the general supervisor on 02/01/2023 between 1:45 PM and 3:00 PM, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in their general laboratory systems. The laboratory performs an annual volume of 45,185 hematology tests. The findings include the following: 1. The laboratory failed to participate in the College of American Pathologists (CAP) second hematology testing event of 2021. See D2123. 2. The laboratory failed to document the remedial action it undertook for its unsatisfactory performance in the College of American Pathologists (CAP) second hematology testing event of 2021. See D2128. 3. The laboratory failed to follow Sysmex calibration verification instructions for its hematology test system model XN850, SN 14154 at least once every 6 months. See D5439. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 -- 2 of 3 -- 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 a review of laboratory maintenance records and an interview with the general supervisor on 02/01/2023 at 1:45 PM, it was determined that the laboratory failed to follow Sysmex calibration verification instructions for its hematology test system model XN850, SN 14154 at least once every 6 months. The laboratory performs an annual volume of 45,185 hematology tests. The findings include the following: 1. Sysmex manufacturer instructions state "Following installation calibration, the operator is requested to verify the instrument calibration every 6 months" to ensure the accuracy of the system. 2. Calibration verification was not performed in 2020. 3. Calibration verification was performed once in 2021 and once in 2022. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 a 05/22/2019 review of laboratory quality control records and an interview with the laboratory supervisor at 1:30 p.m., it was determined that the laboratory failed to define temperature criteria for the proper storage of its test reagents. The findings include: 1. Manufacturer labeling on Sysmex hematology reagent containers stated storage temperatures as follows: Cell clean 1-30 degrees Celcius Cell Pack DCL 2-35 degrees Celcius Flurocell 2-35 degrees Celcius Lysercell 2-35 degrees Celcius Sulfolyser 2-30 degrees Celcius 2. Manufacturer labeling on each tray of BD Vacutainer blood collection tubes used for hematology and sendout chemistry testing stated a storage temperature range of 4-25 degrees Celcius. 3. The laboratory supervisor stated that ambient temperature in the laboratory was not monitored. 4. The laboratory reported an annual hematology test volume of 40,700. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. 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 a 05/22/2019 review of laboratory quality control records and an interview with the laboratory supervisor at 1:30 p.m., it was determined that the laboratory failed to ensure the proper storage of its test reagents. Refer to D tag 5413. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a 05/22/2019 review of laboratory job descriptions and personnel competency records, and an interview with the laboratory supervisor at 1:30 p.m., it was determined that the laboratory failed to ensure that policies and procedures were established to monitor individuals who conduct Sysmex hematology testing. The findings include: 1. The laboratory supervisor is also the primary testing personnel for the laboratory. The supervisor stated that annual competency assessments were self performed to include direct observation of test performance and instrument maintenance and function checks. 2. Documentation of Laboratory Director participation in and review of laboratory supervisor competency assessment activities was not available for review. -- 2 of 2 --