Ascension St John Medical Center Emergency

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/14/2022. The findings were reviewed with the technical consultant and point of care technician at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. 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 records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of 12 events. Findings include: (1) On 04/14/2022, the surveyor reviewed 2021 proficiency testing records and identified the following failure: (a) Second (AQI-B) Critical Care Aqueous Event (i) pO2 - The laboratory failed the results for one of five samples (AQI-07). (2) A review of the records revealed there was no evidence proving the failure had been addressed; (3) The records were reviewed with the technical consultant. The technical consultant stated on 04/14/2022 at 02:35 pm

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from laboratory, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for Prothrombin Time. Refer to D2128 and D2130. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from the laboratory, the laboratory failed to achieve successful performance for Prothrombin Time testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2020 and the second event in 2021. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte pH Blood Gas. Refer to D2094 and D2096. 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for the analyte pH Blood Gas. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2020 and the Second 2020 Events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed 01/08/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and the point of care technician at the conclusion of the survey. 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 records and interview with the technical consultant and the point of care technician, the laboratory failed to review and evaluate proficiency testing results. Findings include: BIASES (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory used 3 i-STAT 1 analyzers and performed the following tests on arterial, venous, and capillary whole blood samples: (a) ABG's (Arterial Blood Gases)(i.e. pH, pO2, pCO2) using the G3+ cartridge (b) Sodium, Potassium, Chloride, Glucose, BUN (Blood Urea Nitrogen), Creatinine, Total CO2, Ionized Calcium, and Hematocrit using the Chem8+ cartridge (2) The surveyor reviewed the 2018 and 2019 Critical Care Aqueous Blood Gas proficiency testing records. The surveyor identified in the Third 2018 Event, the laboratory's results obtained biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program), as follows: (a) pCO2: A Negative bias (the results were below the proficiency testing program's assigned means) was obtained for 2 of the laboratory's 5 results: (i) AQI-13: SDI value of -2.6 (ii) AQI-15: SDI value of -3.9 (b) BUN: A Negative bias was obtained for 1 of the laboratory's 5 results: (i) AQI-12: SDI value of -9.4 (3) The surveyor could not locate documentation that the laboratory identified and investigated the biases for the analytes listed above; (4) The surveyor reviewed the findings with the technical 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 -- consultant and the point of care technician, who stated to the surveyor the laboratory failed to identify and investigate the biases obtained for the proficiency testing results listed above. FAILURES (1) At the beginning of the survey, the technical consultant stated to the surveyor, the laboratory performed PT/INR (Prothrombin Time /International Normalized Ratio) testing using the PT/INR cartridge with the i-STAT 1 analyzers; (2) The surveyor reviewed proficiency testing records for 2018 and 2019. The surveyor identified the following: (a) Third 2018 WB Prothrombin Time/INR, I- STAT Event: (i) The laboratory failed the result for 1 of the 5 samples (WP3-15) and obtained a score of 80%; (ii) There was no documentation in the records the laboratory identified the failure and took

Summary Statement of Deficiencies D0000 The findings were reviewed with the emergency department and point of care testing site manager, point of care technician, and point of care coordinator during an exit conference performed at the concluision of the survey. 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 a review of records and interview with the point of care coordinator and point of care technician, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Critical Care Aqueous Blood Gas (i) AQI - A 2017 Event (aa) 1 of 5 TCO2 - AQI -03 (ii) AQI -B 2017 Event (aa) 1 of 5 TCO2 - AQI-10 (iii) AQI - C 2017 Event (aa) 1 of 5 Creatinine - AQI-14 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) The surveyors asked the point of care coordinator and point of care technician if the results had been documented as evaluated. The point of care coordinator and point of care technician reviewed the records and stated the non-graded results had not been documented as reviewed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(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 -- (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the point of care coordinator, the laboratory failed to follow their policy for monitoring the effectiveness of their IQCP. Findings include: (1) At the beginning of the survey, the point of care coordinator stated the following to the surveyors: (a) The laboratory performed the following testing using the iSTAT 1 analyzer: (i) Sodium, Potassium, Chloride, BUN, Glucose, Creatinine, CO2, Ionized Calcium, Hematocrit, and Hemoglobin testing using the Chem 8+ cartridge and arterial, venous, and capillary specimens (making this a non- waived test system); (ii) pH, pO2, pCO2 testing using the G3+ cartridge; (iii) pH, pC2, pCO2, and Lactate testing using the CG4+ cartridge; (iv) PT/INR (Prothrombin Time/International Normalized Ratio) testing using the PT/INR cartridge. (b) IQCP's (Individualized Quality Control Plans) had been developed for the test systems. (2) Surveyor #1 reviewed the IQCP (dated as effective 07/13/15 for the Chem 8+ cartridge and dated as effective 08/04/15 for the G3+, CG4+, and PT/INR cartridges). The QA (Quality Assessment) portion of the IQCP stated, "Monitoring of this plan will occur annually at minimum"; (3) Surveyor #1 then reviewed records for the testing. There was no evidence of QA reviews for the IQCP's as follows: (a) Chem 8+ - between the effective date of 07/13/15 and 03/02/17; (b) G3+, CG4+, and PT/INR - between the effective date of 08/04/15 and 03/02/17. (4) Surveyor #1 reviewed the records with the point of care coordinator and asked if annual QA reviews had been performed in 2016. The point of care coordinator stated annual QA reviews had not been performed in 2016. 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 a review of a patient report and interview with the point of care coordinator and point of care technician, the laboratory failed to provide therapeutic reference intervals for INR test results. Findings include: (1) At the beginning of the survey, the point of care coordinator and point of care technician stated to the surveyors PT (Prothrombin Time) and INR (International Normalized Ratio) testing were performed using the Abbott iSTAT 1 analyzer; (2) Surveyor #2 reviewed one PT/INR report for a patient tested on 02/12/18. The report did not include a therapeutic range (range for treatment of venous thrombosis, treatment of pulmonary embolism, prevention of systemic embolism, etc); (3) The report was reviewed with the point of care coordinator and point of care technician, who stated that PT/INR reports did not include a therapeutic range. -- 2 of 2 --