University Health System

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing records and an interview with the laboratory lead, the laboratory testing personnel and laboratory director/designee failed to sign two of six attestation statements from 2023 and 2024. The findings include: 1. A review of the laboratory's 2023 and 2024 CAP proficiency testing attestation statements revealed the testing personnel and laboratory director/designee failed to sign the attestation statements for the following: - Hematology 2023 third event - Hematology 2024 second event 2. An interview with the laboratory lead on 11.07.2024 at 11:00 a.m. confirmed the above survey findings. 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 the laboratory's College of American Pathologists (CAP) proficiency testing records and an interview with the laboratory lead, the laboratory failed to review proficiency testing and evaluate the laboratory's results for three of six events reviewed from 2023 and 2024. The findings include: 1. A review of 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 2 -- laboratory's 2023 and 2024 CAP proficiency testing results revealed the laboratory had not reviewed the following events: - Hematology 2023 third event - Hematology 2024 first event - Hematology 2024 third event 2. An interview with the laboratory lead on 11.07.2024 at 11 a.m. confirmed the above survey findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (Form CMS-209), review of personnel records, and staff interview, the technical consultant failed to perform annual competency assessments for two of three testing personnel who performed complete blood count (CBC) patient testing in 2023. The findings include: 1. Observation of the laboratory on 11.07.2024 at 9:30 a.m. revealed a Sysmex XS-1000i (serial # 69129) in use for patient testing. 2. A review of Form CMS-209 revealed three testing personnel (TP1, TP2, TP3) who perform moderately complex patient testing. 3. A review of personnel records revealed no documentation of annual competency assessment for two of three testing personnel (TP1 and TP2) in 2023. 4. An interview with the laboratory lead on 11.07.2024 at 10:00 a.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies 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: Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Cell I.D. or WBC Diff analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for Cell I.D. of WBC Diff (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the CMS CASPER Report 0155D and the laboratory's 2023 Proficiency Testing (PT) performance summary records from the College of American Pathologists (CAP) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Cell I.D. or WBC Diff analyte in the 1st event 2023 and 2nd event 2023, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 0% for the 1st and 2nd events of 2023. 2. A review of the laboratory's CAP Proficiency Testing records revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 0% for the 1st and 2nd events of 2023, resulting in the intial unsuccessful PT occurrence. -- 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 observation of the laboratory, review of manufacturer's instructions for use manual, lack of documentation and interview what the technical consultant, the laboratory failed to monitor the ambient temperature and relative humidity in the area where the complete blood count (CBC) instrument was being used for patient testing in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on April 18, 2023 at 9 a.m. revealed the Sysmex XS-1000i CBC instrument (serial #69129) in use for performing patient testing for CBC. 2. Review of the manufacturer's specifications for operating revealed an operating ambient temperature range of 15 degrees Celsius - 30 degrees Celsius and a relative humidity range of 30% - 80%. 3. There were no environmental records for monitoring of ambient temperature and relative humidity for surveyor review. 4. Interview with the technical consultant on April 18, 2023 at 9:10 a.m. confirmed the laboratory failed to monitor the ambient temperature and relative humidity in the area where the Sysmex CBC instrument was used for patient testing in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer complete blood count (CBC) quality control package insert and interview with the technical consultant, the laboratory failed to label complete blood count quality control vials with open date and corrected expiration date on the date of the survey (04.18.2023). The findings include: 1. Observation of the laboratory on April 18, 2023 at 9:00 a.m. revealed the Sysmex XS-1000i CBC instrument (serial #69129) in use for patient testing. Observation of the control vials in use revealed no labeling to indicate when they were opened or the corrected expiration date. 2. Review of the manufacturer quality control package insert revealed the following statement: "Open and recapped vials whose caps have been pierced will retain stability for 14 days if stored at 2-8 degrees C." 3. Interview with the technical consultant on April 18, 2023 at 9:05 a.m. confirmed the laboratory had not labeled CBC quality control vials with open date and corrected expiration date on the date of the survey (04.18.2023). Word Key C = Celsius -- 2 of 2 --

Summary Statement of Deficiencies 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 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 the Laboratory's Procedure, Calibration Verification records and interview with the Lead Testing Person determined the laboratory failed to ensure calibration verification was performed every six months for 2019 and 2020. The findings include: 1. A review of the Laboratory's Procedure for Calibration Verification stated that Calibration Verification is to be done every six months. 2. A review of Calibration Verification 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 -- records for the hematology analyzer showed the following: -calibration was performed on 06.11.2019 and 09.16.2020, equaling a 15 month period between calibrations -calibration was performed on 09.16.2020 and 09.03.2021, equaling a 12 month period between calibrations 3. An interview with the Lead Testing Person at 2: 35 p.m. on September 9, 2021 confirmed the calibration verifications for the Hematology Analyzer were not performed every six months for the two year period. ==================================== -- 2 of 2 --