Univ Of Ks Health System - Great Bend Campus, The

Summary Statement of Deficiencies 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 review of chemistry Backmen Coulter DXC 600 and Abbott iStat Chem 8+; Immunohematology Ortho-Clinical Diagnostics ID-Micro Typing System and Manual Blood Bank Tube method procedures, lack of comparison records and interview, the laboratory failed to evaluate and define the relationship between test results using different methodologies and instruments twice annually (every six months). Findings include: 1. Review of chemistry analytes Sodium, Potassium, Chloride, Carbon Dioxide, Urea Nitrogen, Creatinine and Glucose showed they are performed with two methods: the Beckmen Coulter DXC 600 and the Abbott iStat Chem 8+. a. No procedure was available on how to evaluate and define the relationship between the chemistry test results twice annually (every six months). b. No comparison testing records performed twice (every six months) annully from January 1, 2022 to June 27, 2023 were made available at the time of survey. 2. Review of Immunhematology analytes ABO and Rh showed they are performed with two methods: Ortho-Clinical Diagnostics ID-Micro Typing System and Manual Blood Bank Tube method. a. No procedure was available on how to evaluate and define the relationship between the Immunohematology results twice annually (every six months). b. No comparison testing records performed twice annually (every six months) from January 1, 2022 to June 27, 2023 were made available at the time of survey. 3. Interview with the general supervisor#2 on June 27, 2023 at 12:18 PM confirmed the laboratory failed to 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 -- evaluate and define the relationship twice annually (every six months) between the Beckmen Coulter DXC 600 and Abbott iStat Chem 8+; Immunohematology Ortho- Clinical Diagnostics ID-Micro Typing System and Manual Blood Bank Tube method procedures. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on review of the laboratory's emergency blood release paper documents and electronic medical record (EMR), Sunquest, the final patient forms and interview, the laboratory failed to show the State Surveyor (SA) the completed emergency blood release documents (paper) in the patient's EMR which is the hospital information system (HIS), Sunquest. There was not an adequate data entry system(s) review in place that ensured test results were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to the patient's electronic medical record (EMR). Findings: 1. No documentation could be provided to the State Surveyor (SA) in patients' EMR of twelve or twelve patients' emergency release of blood products paper documents at time of survey. 2. An entry system review request made available at the time of survey for the emergency release (paper) reports from August 17, 2021 to June 27, 2023. None of the twelve patient emergency release of blood products completed forms were entered into the patient's EMR of the HIS Sunquest. 3. Interview with general supervisor #2 and the Laboratory Director on June 27, 2023 at 1:57 p.m. confirmed, the laboratory failed to show the State Surveyor (SA) the completed emergency blood release documents (paper) in the patient's EMR and have an adequate data entry system(s) review in place that ensured test results were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to the electronic medical record (EMR). D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of approved reference ranges in the laboratory "Hematology Reference Range" procedure manual and interview with the general supervisor #2 (GS#2), the laboratory failed to ensure the test report included correct normal ranges and unit of reports as determined by the laboratory "Reference Range" policy at time of survey. Findings: 1. Review of the patient reports from the Laboratory Information System (LIS) revealed 4 out of 18 parameters for normal ranges and unit of reports did not correctly match those reference ranges for the complete blood count (CBC) test in the laboratory "Reference Range" procedure manual. Reference Range and Unit of Report, LIS patient report (Unisex): Absolute Neutrofil Count: None, No Unit of Report Absolute Lymph Count: None, No Unit of Report Absolute Eosinophil Count: None, No Unit of Report Absolute Basophil Count: None, No Unit of Report -- 2 of 3 -- Procedure Manual Parameters (Unisex): Neut# 1.8 - 7.0, No Unit of Report Lymph# 1.0 - 4.8, No Unit of Report Eos# 0.0 - 0.45, No Unit of Report Baso# 0.0 - 0.2, No Unit of Report 2. Interview with GS#2 on June 27, 2023 at 12:18 p.m. confirmed, the laboratory failed to ensure the correct reference ranges and unit of reports for 4 of 18 paramentes approved in the "Reference Range" procedure manual were in correlation with the LIS patient report. -- 3 of 3 --

Summary Statement of Deficiencies D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of Immunohematology Suspected Transfusion Reaction reports, electronic medical record (EMR) search, and interview, the laboratory failed to document the pathologist interpretation on 4 of 4 suspected transfusion reaction reports in the patients EMR. Findings: 1. Review of 4 of 4 Suspected Transfusion Reaction Reports revealed each listed the pathologist's interpretive comments for the results for the pre-transfusion and post-transfusion specimens tested and clerical checks. 2. Suspected Transfusion Reaction Reports are paper forms and are scanned to be placed into the patient EMR. Request was made to see the report in each of the related patients' EMR. 3. An electronic search of the patients' records by General Supervisor #4 was unable to produce an electronic copy for 4 of 4 Suspected Transfusion Reaction reports containing the pathologist's interpretive comments for the results for the pre-transfusion and post-transfusion specimens tested and clerical 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 -- checks. 4. GS #4 in interview on 8/17/21 at 1:05 p.m. confirmed, the laboratory failed to document the pathologist interpretation on 4 of 4 suspected transfusion reaction reports in the patients 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 patient test reports and interview, the laboratory failed to include the name and address of the laboratory location where the test was performed on the patient report. Findings: 1. Review of selected patient test reports showed the laboratory name and address where the test was performed was not present on the report. 2. Interview with GS#1 on 8/17/21 at 2:35 p.m. confirmed the laboratory failed to include the name and address of the laboratory where the test was performed on the patient report. -- 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: A Proficiency Testing desk review on 2/11/2019 revealed the lab failed to successfully participate in proficiency testing from American Proficiency Institute (API) Fibrinogen testing. Finding is as follows: 1. Based on review of proficiency testing from API for 0825 Fibrinogen revealed the laboratory received the scores 2018 event 2 and 2018 event 3 as follows: Event 2 2018 Fibrinogen testing 40% Event 3 2018 Fibrinogen testing 40% D2130 HEMATOLOGY 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 -- 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: A desk review on 2/11/2019 revealed the laboratory failed 2 of three events and failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the subspecialty, Hematology. Findings were as follows: 1. Based upon review of proficiency testing from API for 0825 Fibrinogen revealed the laboratory received the scores event 2 and event 3 for 2019 as follows: Event 2 2019 Fibrinogen testing 40% Event 3 2019 Fibrinogen testing 40% -- 2 of 2 --

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 policies and procedures and interview with General Supervisor (GS) #1, the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings Include: 1. Review of the laboratory's policies and procedures failed to find a competency assessment policy and procedure. 2. GS #1 confirmed the laboratory did not have policy or procedure for assessing employee competency. The interview occurred 09/10/2018 at 8:41 AM. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interview with General Supervisor (GS) #1, 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 6 -- laboratory failed to verify the accuracy of any analyte assigned a proficiency testing score that did not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part). Findings Include: 1. Review of the laboratory's API PT documentation found the following analytes that received a PT of "Not Graded": Hematology / Coagulation 2018 - 2nd Testing Event Blood Cell ID (Educational) BCI- 13 BCI-14 Blood Cell Identification BCI-10 2018 - 1st Testing Event Blood Cell ID (Educational) BCI-06 BCI-07 Blood Cell Identification BCI-01 Cell Count (Manual) PMN (CSF/Body Fluid) % BFL-01 BFL-02 Microbiology 2018 - 2nd Testing Event Blood Culture BL-01 Educational Culture ID ES-02 Educational Susceptibility ES-02 BioFire FilmArray RP / Influenza A RSP-10 MIC Testing / Piperacillin/Tazobactam UR-06 Immunology / Immunohematology 2018 - 2nd Testing Event C-Reactive Protein (quan) QCP-03 ABO Group (Educational) EDU-03 Antibody Screen (EDU) EDU-03 D Type (Rho) (Educational) EDU-03 Chemistry / Miscellaneous 2018 - 1st Testing Event UDS Opiates (qual) UDS-02 No documentation of a self-assessment or evaluation of the "Not Graded" samples above was present. 2. GS #1 confirmed the laboratory had not documented self-assessments or evaluations of the "Not Graded" PT samples. The interview occurred 09/10/2018 at 10:14 AM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interview with General Supervisor (GS) #1, the laboratory failed to document all proficiency testing evaluation and verification activities. Findings Include: 1. Review of the laboratory's API PT documentation found the laboratory's received a score of "Unacceptable" on the follow PT samples: Microbiology 2018 - 2nd Testing Event Gram Stain Morphology GS-10 No documentation of