Ut Erlanger Women's Oncology

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), personnel records, American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that one of two testing personnel (TP) who performed hematology and chemistry patient testing also participated in proficiency testing in 2023 and 2024. The findings include: 1. Observation on 10/09/2024 at 8:30 a.m. revealed the laboratory used a Beckman Coulter DxH 520 hematology analyzer (ID: BG100552) and a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. 2. A review of the FORM CMS-209 revealed two persons (TP1 and TP2) who perform moderately complex patient testing. 3. A review of the laboratory's personnel records revealed that TP1 and TP2 perform hematology and chemistry patient testing. 4. A review of the laboratory's 2023 and 2024 API PT attestation statements revealed that TP2 did not participate in any PT events (0 of 9 reviewed). 5. An interview with TP1 and the physician's office laboratory (POL) coordinator on 10/09/2024 at 3:30 p.m. confirmed that TP2 performed patient testing and did not participate in any PT events in 2023 and 2024. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 laboratory observation, a review of the manufacturer instructions for use (IFU), a review of the laboratory's policies, environmental monitoring records, and staff interviews, the laboratory failed to define appropriate freezer temperature ranges and monitor freezer conditions, leading to the improper storage of quality control (QC) material used in chemistry testing for 18 of 18 months reviewed in 2023 and 2024. The findings include: 1. An observation on 10/09/2024 at 8:30 a.m. revealed that the laboratory used a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. Two levels of Biorad Liquid Assayed Multiqual QC material (lot: 4596) were used to verify the test system's performance. The laboratory stored the QC material in a Frigidaire freezer (SN: BA02821407). 2. A review of the Biorad Liquid Assayed Multiqual IFUs revealed that the storage requirements are "-20 C to -70C." 3. A review of the laboratory's "Temperature Checking and Recording" policy (POL.063) revealed the following statements: - "It is recognized that some materials are only stable within certain prescribed temperature ranges and that some reagents are greatly influenced by small changes in temperature. For these reasons, it is necessary to verify that the correct temperatures are being maintained in all refrigerators and freezers used in the laboratory, as well as the ambient temperature of the laboratory itself." - "the temperatures of all refrigerators and freezers which contain either samples or reagents, and of the room itself, are to be recorded on a permanent record each day the office is open." 4. A review of the monthly "Laboratory Temperature Check Sheets" from April 2023 to October 2024 revealed the following: - The laboratory's stated acceptable freezer temperature range is "-15 to -25C." - The laboratory did not document freezer temps from April 2023 to September 2024. - The laboratory documented freezer temperatures warmer than -20C for all testing days in October 2024 (7 of 7). 5. An interview with TP1 and the POL coordinator on 10/09/2024 at 3:30 p.m. confirmed that the laboratory did not define freezer temperature ranges consistent with the manufacturer's instructions or verify that the correct temperatures were maintained, leading to the improper storage of QC materials in 2023 and 2024. Key: C = degrees celcius D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory observation, a review of laboratory policies, lack of documentation, and staff interviews, the laboratory failed to monitor chemistry testing quality control (QC) performance over time (18 of 18 months) in 2023 and 2024. The findings include: 1. An observation on 10/09/2024 at 8:30 a.m. revealed that the laboratory used a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. Two levels of Biorad Liquid Assayed Multiqual QC material (lot: 4596) were used to verify the test system's performance. 2. A review of the laboratory's "Quality Control Procedure" (POL.9247) revealed the following statements: - "On a monthly basis Levy-Jennings charts for all QC will be printed including the statistical calculations such as SD and CV." - "QC is evaluated for trends. If a trend is noted, an investigation should begin and/or technical support should be contacted." - "Results will be reviewed by the Lab Designee and the Laboratory Director and

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: Based on review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the White Blood Cell Differential (CELL-ID), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes (Refer to D2130) and the Hematology specialty (Refer to D2131) resulting in initial unsuccessful PT performance. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 and the laboratory's API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two of three test events for the White Blood Cell Differential (CELL-ID), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory scores: -2022 Event 3: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT -2023 Event 1: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT 2. Review of the laboratory's 2022 and 2023 API Hematology/ Coagulation PT evaluation reports revealed the following unsatisfactory scores: -2022 Event 3: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT -2023 Event 1: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 and the laboratory's API PT evaluation reports, laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in two of three PT events in 2022 and 2023. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory Hematology PT event scores: -2022 Event 3: 0% -2023 Event 1: 0% 2. Review of the laboratory's 2022 and 2023 API Hematology/ Coagulation PT evaluation reports revealed the following unsatisfactory Hematology event scores: -2022 Event 3: 0% -2023 Event 1: 0% -- 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: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Sodium (NA) analyte, resulting in the first unsuccessful PT occurrence for the Sodium analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Sodium (NA) analyte, resulting in the first unsuccessful PT occurrence for the Sodium analyte. The findings include: 1. Review of the report CMS 155 revealed the following scores for the Sodium (NA) analyte: 2022 event three = 60% 2023 event one = 0% 2. Review of the laboratory's API PT evaluation reports revealed the following: Sodium scored as 60% for 2022 event three and 0% for 2023 event one, resulting in the first unsuccessful PT occurrence for the Sodium (NA) analyte. -- 2 of 2 --

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 review and request of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the office manager and lead testing person, it was determined the testing personnel and/or the laboratory director failed to sign the attestation sheets for 11 of 12 PT events for 2021 and 2022. The findings include: 1. Request of the laboratory's PT records revealed the following: -No attestation pages available for the following: Hematology/Coagulation 2021 event one and two and 2022 event one Chemistry 2021 event one, two and three and 2022 event one -Attestation pages not signed by the testing personnel and/or laboratory director for the following: Hematology/Coagulation 2022 event two and three Chemistry 2022 event two and three 2. Interview with the office manager and lead testing person on 12.15.2022 at 1pm confirmed the above findings. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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: ===================================== The laboratory failed to maintain satisfactory participation in two out of two events for the analyte ALT (Alanine Transaminase), resulting in the first unsuccessful proficiency testing (PT) occurrence for ALT (Refer to D2096). ==================================== D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: ===================================== Based on a desk review of the CMS CASPER Report 0155D and the Laboratory's 2019 and 2020 Proficiency Testing (PT) Program Performance Summary, determined the Laboratory failed to maintain satisfactory performance in two consecutive events for the ALT (Alanine Transaminase) analyte, event three of 2019 and event one of 2020, resulting in the first unsuccessful occurrence. The findings include: 1. A review of the CMS CASPER Report 0155D for Proficiency Testing revealed the ALT scores as 60% for event three of 2019 and event one of 2020. 2. A review of the 2019 PT Program Performance Summary for ALT revealed an unsatisfactory score of 60% for event three of 2019 and event one of 2020, resulting in the first unsuccessful occurrence for the ALT analyte. ===================================== -- 2 of 2 --