Honorhealth Tempe Medical Center

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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of manual cell count test records on April 1, 2025, lack of the manufacturer's assay sheet for Quality Control (QC) material and interview with the Technical Supervisor (TS-2), the laboratory failed to retain the manufacturer's QC assay sheets for at least 2 years for each lot of Body Fluid Cell Count QC used in January 2025. Findings include: 1. The laboratory performs one level of Control material every 8 hours of patient testing for manual cell counts performed on body fluid specimens. The laboratory utilizes 2 levels of control material which are alternated equally. 2. Review of the laboratory's monthly 'Cell Count Control Log Sheet' for January 2025 indicated the laboratory performed one manual cell count on 1 /12/25 for one patient (#781732) and tested one level of quality control material (Level 1-UC, lot# 42320412). 3. The laboratory failed to produce evidence of the manufacturer's QC assay sheet for the control materials that were in use during January 2025: Streck Cell-Chex Body Fluid Cell Count Control, Level 1-UC, lot# 42320412, expiration date: 2/19/25; and Level 2-L2, lot# 42320413, expiration date: 2 /19/25. 4. The TS-2 interviewed on 4/01/25 at 2:15 PM confirmed the laboratory failed to retain the manufacturer's assay information sheet for at least 2 years for each lot of QC material used by the laboratory in January 2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of maintenance logs for the Siemens CS-2500 Coagulation Analyzer and interview with the Technical Supervisor (TS-2), the laboratory failed to perform and document the monthly maintenance activity of cleaning the filters as required by the manufacturer for 18 out of 20 months between August 2023 and March 2025. Findings include: 1. Review of the monthly maintenance logs for the Siemens CS- 2500 analyzer indicated the laboratory failed to perform and document the monthly maintenance activity of 'cleaning the filters' for 18 out of 20 months between August 2023 and March 2025. 2. The TS-2 interviewed on 4/01/25 at 2:35 PM acknowledged the maintenance activities listed above were not performed and documented each month on the CS-2500 analyzer as required by the manufacturer. 3. The laboratory's reported annual test volume for the specialty of Hematology is 160,116. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 lack of calibration verification documentation for the Siemens Dimension EXL 200 chemistry analyzers and interview with the Technical Consultant (TC-2), the laboratory failed to perform and document calibration verification procedures at least once every 6 months during 2024. Findings include: 1. The laboratory utilizes two Siemens Dimension EXL chemistry analyzers (instrument #1 - Serial# SN12252743 and instrument #2 - Serial# SN DE271590) to conduct patient testing in the subspecialties of Routine Chemistry, Toxicology and Endocrinology, with a reported annual test volume of 182,186. 2. No documentation was presented for review to indicate the laboratory performed calibration verification procedures on each chemistry analyzer at least once every six months during 2024 for the analytes Sodium (Na), Potassium (K) and Chloride (Cl), 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. 3. The laboratory's policy titled, Dimension EXL Linearity/Calibration Verification, states, "Linearity or calibration -- 2 of 4 -- verification must be performed when any of the following conditions are met: D. Every six months....The only methods that require a separate AMR verification are the electrolytes (Na, K, Cl) will be verified using Maine Standards and assayed according to the manufacturer's instructions." 4. The TC-1 interviewed on 4/01/25 at 10:15 AM confirmed the laboratory failed to perform calibration verification procedures on each chemistry analyzer at least once every 6 months during 2024 for the analytes indicated above. **This is a repeat deficiency from the previous inspection conducted on July 18, 2023. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: (A) Review of 2024 instrument comparisons for Activated Clotting Time (ACT) testing performed under the specialty of Hematology and interview with the technical consultant (TC-1), the laboratory failed to perform instrument comparisons for four of four i-Stat analyzers. Findings include: A1. The laboratory performs ACT testing utilizing i-Stat analyzers to perform patient testing under the specialty of Hematology. The laboratory rotates the testing among four i-Stat analyzers. A2. No evidence was presented for review from 2024 to indicate the laboratory evaluated and defined the relationship between test results for four of four i-STAT analyzers in December 2024. A3. The TC-1 interviewed on 4/1/25 at 1:00 PM confirmed the laboratory failed to perform instrument comparisons for four of four i-Stat analyzers in December 2024. A4. The number of patients affected could not be determined at the time of the survey. **(B) Based on lack of test comparison results from 2024 for two Dimension EXL chemistry analyzers and interview with the Technical Consultant (TC-2), the laboratory failed to, twice a year, evaluate and define the relationship between test results using two separate Chemistry analyzers. Findings include: B1. The laboratory utilizes two separate Siemens Dimension EXL analyzers to perform testing in the specialty of Chemistry, with a reported annual test volume of 182,186. The laboratory distinguishes each analyzer as EXL 1 (Serial# SN 12252743) and EXL 2 (Serial# SN DE271590). B2. The laboratory failed to, twice a year, evaluate and define the relationship between test results generated from each EXL chemistry analyzer during 2024. B3. The TC-2 interviewed on 4/01/25 at 10:19 AM confirmed the laboratory failed to, twice a year, evaluate and define the relationship between test results generated from the two EXL chemistry analyzers during 2024. **This is a repeat deficiency from the previous inspection performed on July 18, 2023. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on lack of documentation of an annual competency evaluation from 2023 and interview with the Technical Supervisor (TS-5), the technical consultant failed to -- 3 of 4 -- evaluate and document the performance for six out of six individuals responsible for moderate complexity testing at least annually after the first year the individual tested patient specimens. Findings include: 1. No evidence of an annual competency evaluation was presented for review from 2023 for six out of six testing personnel who performs moderate complexity testing performed in the specialties of Diagnostic Immunology, Hematology, Microbiology, and Chemistry. 2.. The TS-5 interviewed on 4/1/25 at 12:00 PM confirmed the technical supervisor failed to evaluate and document an annual competency evaluation for the testing personnel indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of documentation of an annual competency evaluation from 2023 and interview with the Technical Supervisor (TS-5), the technical supervisor failed to evaluate and document the performance for six out of six individuals responsible for high complexity testing at least annually after the first year the individual tested patient specimens. Findings include: 1. No evidence of an annual competency evaluation was presented for review from 2023 for six out of six testing personnel who performs high complexity testing performed in the specialties of Hematology, Immunohematology, and Microbiology. 2.. The TS-5 interviewed on 4/1/25 at 12:00 PM confirmed the technical supervisor failed to evaluate and document an annual competency evaluation for the testing personnel indicated above. -- 4 of 4 --

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 Proficiency Testing (PT) reports from 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Theophylline. Findings include: 1. The laboratory's PT performance was unsatisfactory for the second event of 2023 for the regulated analyte, Theophylline, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the third event of 2023 for the regulated analyte, Theophylline, with a score of 0%. 3. Unsatisfactory participation in the second and third events of 2023 (two consecuive testing events) for the regulated analyte, Theophylline, constitutes an 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 3 -- D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 information the Proficiency Testing (PT) provider furnishes to the State Agency for 2023, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the regulated analyte, Theophylline. See D2016 for findings. D2118 TOXICOLOGY CFR(s): 493.845(f) 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, Theophylline, for the second and third events of 2023 resulting in unsuccessful PT performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, Theophylline, for the second and third events of 2023. See D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency policies and interview with the Technical Consultant (TC-1), the laboratory failed to follow established policies and procedures to assess employee competency. Findings include: 1. The laboratory performs patient testing in the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology and Pathology, with an approximate annual test volume of 729,560. 2. The laboratory policy reviewed during the survey titled, "Employee Training and Competency (policy# GE.045)" states, " 1. The Laboratory Medical Director assures the performance of the following annually: 2. Personnel roster is updated to accurately indicate qualified individuals performing roles of testing personnel, clinical consultant, technical consultant, technical supervisor, and general supervisor, as applicable. 3. Delegation of laboratory functions document is updated and signed by the Laboratory Medical Director authorizing individuals by name and/or job title to perform functions on behalf of the Laboratory Medical Director. 4. Assessment of all personnel that have been assigned or delegated functions". 3. The laboratory failed to follow the established policy indicated above to assess employee competency, including the role of Clinical Consultant, Technical Consultant, Technical Supervisor and General Supervisor. 4. The TC-1 interviewed on July 18, 2023 at 10:55 AM confirmed the laboratory failed to follow the established personnel competency policy indicated above to assess employee competency. D5433 MAINTENANCE AND FUNCTION CHECKS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on lack of pipet carryover study documentation and interview with the Technical Consultant (TC-1), the laboratory failed to perform function checks on the pipets used on the Siemens Dimension EXL chemistry analyzers as required by laboratory policy. Findings include: 1. The laboratory's established policy titled, "Pipet Carry-Over Procedure" states, "To evaluate the test system where automatic pipetting is used to check for carryover. Carryover will be performed every six months". 2. The laboratory failed to provide evidence that carryover studies were performed on the pipets contained on the Siemens Dimension EXL analyzers every six months during 2021 and 2022, as required per laboratory policy. 3. The laboratory utilizes two separate Siemens Dimension EXL analyzers, with an annual reported test volume of 475,000. 4. The TC-1 interviewed on July 18, 2023 at 3:10 PM confirmed that the pipets were not tested for carryover as required during 2021 and 2022. 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 lack of calibration verification documentation for the Siemens Dimension EXL 200 chemistry analyzers and interview with the Technical Consultant (TC-1), the laboratory failed to perform and document calibration verification procedures at least -- 2 of 6 -- once every 6 months during 2022. Findings include: 1. The laboratory utilizes two Siemens Dimension EXL chemistry analyzers (instrument #1 and instrument #2) to conduct patient testing in the subspecialties of Routine Chemistry and Endocrinology, with an approximate annual test volume of 475,000. 2. No documentation was presented for review to indicate the laboratory performed a calibration verification on each chemistry analyzer at least once every six months during 2022, 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. 3. Review of calibration verification records for each chemistry analyzer revealed the laboratory performed a calibration verification on each analyzer on 10/10/2021, 8/10/2022 and 01 /15/2023. 4. The TC-1 interviewed on July 18, 2023 at 2:15 PM confirmed the laboratory failed to perform a calibration verification on each chemistry analyzer at least once every 6 months. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of test comparison results from 2021 and 2022 and interview with the Technical Consultant (TC-1), the laboratory failed to evaluate and define the relationship between test results using two separate Chemistry and two separate Hematology instruments, twice a year Findings include: 1. The laboratory utilizes two separate Siemens Dimension EXL instruments to perform chemistry testing on patient specimens. The laboratory's approximate annual test volume in the specialty of Chemistry is 475,000. The laboratory distinguishes each analyzer as EXL 1 and EXL 2. 2. The laboratory failed to evaluate and define the relationship between test results generated from each EXL chemistry analyzer twice a year during 2021 and 2022. 3. The laboratory utilizes two separate Sysmex XN 2000 instruments to perform Complete Blood Count (CBC) testing on patient specimens. The laboratory's approximate annual test volume in the specialty of Hematology is 244,000. The laboratory distinguishes each analyzer as XN-1 and XN-2. 4. The laboratory failed to evaluate and define the relationship between CBC test results generated from each Sysmex XN 2000 (XN-1 and XN-2) analyzer twice a year during 2021 and 2022. 5. The laboratory failed to evaluate and define the relationship between test results obtained from an automated white blood cell (WBC) differential versus a manual WBC differential on each analyzer (XN-1 and XN-2) twice a year during 2021 and 2022. 6. The TC-1 interviewed on July 18, 2023 at 2:35 PM confirmed the laboratory failed to evaluate and define the relationship between test results twice a year for results generated from the chemistry and hematology analyzers as indicated above, including a comparison of test results between the manual and automated WBC differential. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to -- 3 of 6 -- ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the Technical Consultant (TC-1), the laboratory failed to have a system in place to ensure the accuracy of test results that are manually entered and electronically interfaced into the Laboratory Information System (LIS) and the patient's electronic medical record (EMR). Findings include: 1. The laboratory performs approximately 729,560 patient tests annually under the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology and Pathology. 2. No documentation was presented for review during the survey to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are electronically interfaced from the analyzers to the LIS and from the LIS to the EMR, or for test results that are manually entered into the LIS and then electronically interfaced from the LIS to the patient's EMR. 3. The TC-1 interviewed on July 18, 2023 at 4:05 PM confirmed the laboratory did not have a system in place to verify the accuracy of patient test results that are electronically interfaced or manually entered into the LIS, and then electronically interfaced to the EMR. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of Activated Clotting Time (ACT) test reports maintained in the patients' Electronic Medical Record (EMR) and interview with the Technical Consultant (TC-1), the laboratory failed to include documentation of positive patient identification as required on the final test report for one patient. Findings include: 1. One out of two ACT test reports (TL0006037493) reviewed in the EMR during the survey failed to include either the patient's name and identification number, or a unique patient identifier and identification number on the final test report. 2. The TC- 1 interviewed on July 18, 2023 at 12:45 PM acknowledged the test report indicated above was missing at least two positive patient identifiers. D5813 TEST REPORT CFR(s): 493.1291(g) -- 4 of 6 -- The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of test results for CG8+testing performed on the i-Stat analyzer and interview with the Technical Consultant (TC-1), the laboratory failed to immediately alert the individual or entity requesting the test when the test result indicates an imminently life-threatening condition, or panic or alert values. Findings include: 1. Review of blood gas and chemistry test results for patient ID# TL0005967922 performed on 04/09/2023 at 13:22:16 indicated three critical test results: pH = 7.005 (critical low); TCO2 = 7 mmol/L (critical low); and Potassium (K) = 6.4 mmol/L (critical high). 2. No documentation was presented for review to indicate the laboratory notified the entity requesting the test of the critical test results for the testing indicated above. 3. The TC-1 interviewed on July 18, 2023 at 1:35 PM confirmed the laboratory failed to provide documented evidence that the critical test results referenced above were communicated to the entity requesting the test. 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: Based on review of competency records and interview with the Technical Consultant (TC-1), the technical consultant failed to evaluate the annual competency assessment of 14 out of 14 testing personnel who perform testing on the i-Stat analyzer. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) and Activated Clotting Time (ACT) testing on the i-Stat analyzer. 2. The technical consultant failed to evaluate the annual competency evaluations for 14 out of 14 testing personnel during 2022, for testing personnel who perform testing on the i-Stat analyzer. 3. Review of annual competency evaluations from 2022 for the testing personnel referenced above indicated the competency evaluations were performed by an individual who does not meet the qualification requirements of Technical Consultant as listed under 493.1411. 4. The TC-1 interviewed on July 18, 2023 at 10:30 AM acknowledged the competency evaluations performed during 2022 for the testing personnel indicated above were not performed by an individual listed as Technical Consultant on the CMS-209, Laboratory Personnel Form. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on lack of education records for two out of two testing personnel and interview with the technical supervisor, the laboratory director failed to ensure that all testing personnel have the appropriate education prior to testing patients' specimens. Findings include: 1. During the survey performed on July 18, 2023, documentation of a foreign diploma was presented for review for two out of two testing personnel. 2. No documentation was presented for review during the survey to indicate the laboratory had the diploma and corresponding transcripts evaluated by a foreign transcript evaluation agency to ensure the equivalent education requirements for the two testing personnel indicated above. 3. The technical supervisor interviewed on July 18, 2023 at 10:05 AM confirmed the laboratory failed to complete the process of having the foreign transcripts evaluated for the testing personnel indicated above, prior to the individual testing patients' specimens. -- 6 of 6 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of employee competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess the competency of Technical Consultants, Technical Supervisors and General Supervisors. Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on June 28, 2021 listed 15 Technical Supervisors, 4 Technical Consultants and 22 General Supervisors. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Supervisors, Technical Consultants and General Supervisors. 3. The facility personnel confirmed that the laboratory did not have policies established to assess the competency of the laboratory personnel indicated above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) 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 3 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for testing performed in the specialty of Diagnostic Immunology. Findings include: 1. The laboratory performs Mono testing on patient specimens using the Cardinal Health Mono II Rapid Test kit under the specialty of Diagnostic Immunology, with an annual approximate test volume of 46. 2. On the date of the survey, June 28, 2021, review of the manufacturer's package insert for the test kit indicated above stated, "For external QC testing, use the controls provided in the kit....Quality Control requirements should be established in accordance with local, state and federal regulations or accreditation requirements. Minimally, Cardinal Health recommends that positive and negative external controls be run with each new lot and with each new untrained operator." Each mono kit includes 1 Mono Positive control and 1 Mono Negative control. 3. One patient test report (specimen ID# 0624: S00002S) for mono testing performed on 06/24/21 was reviewed during the survey. 4. The laboratory log used to track QC performance for the mono test kit indicated that external QC (positive and negative, lot# 16201240) was last performed by the laboratory on 06/01/21. 5. No other QC documentation was provided for review during the survey for the Mono II Rapid test, to indicate the laboratory performed two levels of control material of different concentrations each day of patient testing (including patient testing that occurred on 06/24/21, see #3 above) as required since January 1, 2016. The laboratory had not established an Individualized Quality Control Plan (IQCP) for this test. 6. Approximately 3 patients were tested using the mono test kit in June 2021, to the date of the survey. 7. The facility personnel confirmed that the laboratory did not perform and document external controls each day of patient testing as required since January 1, 2016. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory test records for Body Fluid testing and interview with the facility personnel, the laboratory failed to perform at least one control material each day of patient testing. Findings include: 1. The laboratory performs body fluid counts using a hemacytometer. The laboratory's 'Cell Count Control Log Sheet' used to document the body fluid controls states, "One level of Control every 8 hours of patient testing. Count and record each side of the counting chambers - results should match within 10%. The 2 levels should be alternated equally." 2. Patient test report (0609:BF00005S) for a Cerebrospinal Fluid (CSF) analysis performed by the laboratory on 06/09/21 was reviewed during the survey conducted on June 28, 2021. 3. No cell count Quality Control (QC) documentation was presented for review to indicate the laboratory performed one level of control material every 8 hours of -- 2 of 3 -- patient testing on 06/09/21. 4. The facility personnel confirmed that the laboratory failed to perform and document one level of control material every 8 hours of patient testing on 6/09/21, as indicated in laboratory policy. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of quality control records and review of control procedures, the laboratory director failed to ensure that quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5445 and D5543 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient test requisitions for frozen section testing performed under the sub-specialty of histopathology and interview with the facility personnel, one out of one pathology test requisitions failed to include the time of specimen collection. Findings include: 1. The laboratory performs frozen section testing under the sub- specialty of histopathology, with an approximate annual test volume of 20. 2. The laboratory's policy titled, Specimen Requisition and Log (PA.003), states, "Examine each specimen and the accompanying requisition for completeness and accuracy... Compare labels on specimen containers with the requisitions. Examine labels to assure that the required information is present. (d.) Date and time specimen was obtained." 3. The pathology test requisition presented for review during the survey for 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 -- patient# TSL-17000021531 for testing performed on 5/31/2018 failed to include the time of specimen collection. 4. The facility personnel confirmed that the time of specimen collection was not listed on the test requisition referenced above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation for review and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for the ROM (Rupture of Membrane) test. Findings include: 1. The laboratory performs ROM testing using the ROM Plus test kit under the specialty of Chemistry, with an approximate annual test volume of 50. On the date of the survey, June 28, 2018, the laboratory's quality control procedure reviewed stated, "External QC will be done with every new lot number, every new shipment and each day of patient testing until IQCP is completed." 2. Review of the ROM test report for patient# 17000603324 indicated the testing occurred on 6/07/18, while QC records reviewed revealed the external QC was last performed on 6/04/18. 3. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016 and as required by laboratory policy. 4. The laboratory presented evidence of an Individualized Quality Control Plan (IQCP) that was performed for the ROM test but the IQCP was not reviewed and approved by laboratory personnel. 5. The facility personnel confirmed that the laboratory did not perform and document controls as required since January 1, 2016 and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for testing performed on the ROM Plus test. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on Instrument to Instrument twice yearly comparison studies for two chemistry analyzers (ExL1 and ExL2) that the laboratory utilizes for patient testing and interview with the laboratory personnel, the laboratory failed to indicate the -- 2 of 3 -- acceptability of the difference in values resulted for each analyte tested during the comparison testing performed in March 2018. Findings include: 1. A total of 39 analytes were tested on the each instrument respectively with the testing done using 2 specimens per analyte. 2. The acceptability column on the data log was blank for all 39 analytes. 3. Two laboratory personnel signed off on the data log without any reference to the acceptability of the testing between the two instruments for each analyte. 4. The laboratory personnel acknowledged that the acceptability was not documented. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports for frozen section testing performed in the sub- specialty of histopathology and interview with the facility personnel, the laboratory failed to include the correct test date on one out of one test report reviewed during the survey. Findings include: 1. The laboratory performs frozen section testing under the sub-specialty of histopathology, with an approximate annual test volume of 20. The laboratory issues the frozen section diagnosis, which is included on the final test report. 2. One out of one pathology test reports reviewed during the survey (S18- 032095 for patient# 17000021531) failed to include the correct test date. The test requisition and pathology report indicated the specimen was collected on 5/31/18, but the frozen section diagnosis included as part of the final test report stated, "Results transmitted to (Physician) at 10:15 am on 5/30/18/HLM". 3. The facility personnel confirmed that the frozen section diagnosis included on the final test report for the patient indicated above listed the incorrect testing date. -- 3 of 3 --