Advanced Diagnostic Imaging Pc

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts/Medical Laboratory Evaluation(AAB/MLE) proficiency testing (PT) records, lack of procedure, and interview with the laboratory supervisor, the laboratory failed to test PT samples the same number of times it routinely tests patient samples for five of five events reviewed from 2024 and 2025. The findings include: 1. Review of the laboratory's proficiency testing records for Nonchemistry revealed the laboratory performed PT samples twice for five of five Nonchemistry events in 2024 and 2025 as follows: 2024 event M1- performed two times for all five samples 2024 event M2- performed two times for all five samples 2024 event M3- performed two times for all five samples 2025 event M1- performed two times for all five samples 2025 event M2- performed two times for all five samples 2. Review of the laboratory procedure manual revealed no requirement to re-test every patient CBC sample. 3. During an interview with the laboratory supervisor on 06/25/2025 at 11:45 am, the laboratory supervisor confirmed the laboratory failed to test proficiency testing samples the same number of times it routinely tests patient samples for five of five PT events reviewed from 2024 and 2025. . D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage 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 -- requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer control package insert, and interview with the laboratory supervisor, the laboratory failed to label three of three control vials used for performing quality control on the Complete Blood Count (CBC) hematology analyzer with an open date and a corrected expiration date on the date of the survey 06/25/2025. The findings include: 1. Observation of the laboratory on 06/25/2025, at 08:40 a.m., revealed the Sysmex XP-300 CBC analyzer (serial number A6258) used for patient testing. Also observed were three levels: Level 1- Low Abnormal [lot 51050710], Level 2- Normal [lot 51050711], and Level 3- High Abnormal [lot 51050712] of Eightcheck-3WP X-TRA Controls that were not labeled with an open date and corrected expiration date. 2. A review of the manufacturer's control package insert revealed the following: "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8 [degrees Celsius] after being recapped." 3. An interview with the laboratory supervisor on 06/25 /2025, at 8:45 a.m., confirmed the above survey findings. -- 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 review of the laboratory quality control (QC) records and interview with the laboratory supervisor, the laboratory failed to retain the complete blood count (CBC) QC manufacturer assay sheets in 2021, 2022, and 2023. The findings include: 1) Review of the laboratory quality control records for CBC testing revealed the following: - Lot numbers 1306, 2193, and 3080 of EightCheck 3WP Xtra were in-use in 2021, 2022, and 2023. - Manufacturer's assay sheets for lot numbers 1306 and 2193 could not be provided at the time of the survey. 2) Interview with the laboratory supervisor on April 10, 2023 at 1:30 pm confirmed the laboratory failed to retain the manufacturer assay sheets for historical CBC control lots in 2021, 2022, and 2023 including lot number 1306 and 2193. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 lack of records avaliable for review and interview with the lead testing person the laboratory failed to monitor and document the room temperature and humidity of the laboratory in 2017, 18 and 19. The findings include: 1. There were no room temperature and humidity records avaliable for review between July 26, 2017 through May 21, 2019. 2. Interview with the lead testing person on May 21, 2019 at 11:45 am confirmed the laboratory failed to monitor and document the room temperature and humidity of the laboratory between July 26, 2017 through May 21, 2019. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: 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 -- Based on review of employee personnel records and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency in 2017. The findings include: 1) Review of employee personnel records revealed missing documentation for 3 out of 6 testing persons (#1, 3 and 6) for the six required criteria of competency assessment that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills in 2017. 2) An interview with the lead testing person on May 21, 2019 at 11:30 am confirmed 3 of 6 testing personnel (#1, 3 and 6) were not evaluated using the six criteria for competency assessment required by Centers for Medicare and Medicaid (CMS) in 2017. -- 2 of 2 --