Overland Park Regional Med Center Ed Of Shawnee

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) from the provider College of American Pathologists (CAP) performed 9/21/2019 to 1/24/2022 and interview with technical consultant #2 (TC#2), the laboratory director (LD) failed to attest that proficiency testing samples were handled in the same manner as patient samples on 4 of 30 events. Findings: 1. Review of the attestation pages for PT from CAP revealed no signature of the LD or designee was present on: a. 2021-CAR B Cardiac Markers b. 2021-D6 A Rapid Group A Strep Antigen c. 2021-UDS6 A Urine Drug Testing Screening d. 2021-CM-B Clinical Microscopy 2. Interview with the TC#2 on 1/24/22 at 10:00 a.m. confirmed, the LD failed to attest on 4 of 30 events that proficiency testing samples were handled in the same manner as patient samples. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 -- This STANDARD is not met as evidenced by: Based on the lack of documentation of performance verifications, non-waived test list, and interview with TC#2, the laboratory failed to verify two of two Siemen's epoc analyzer performance specifications prior to reporting patient test results. Findings: 1. Request was made to review the performance verifications for two of two Siemen's epoc analyzers; serial numbers (S/N) 427125 and 34172. No documentation of verification of the manufacturer's performance characteristics for accuracy, precision, reportable range, and normal values appropriate for the laboratory's patient population were made available for 10 of 10 analytes performed on two of two analyzers at the time of survey. 2. Non waived analytes performed were: pH, Sodium (Na), Potassium (K), Chloride (Cl), ionized Calcium (iCa), Lactate, Glucose, Creatinine, Blood Urea Nitrogen (BUN), and total Carbon Dioxide (tCO2). TC#2 stated the laboratory began reporting patient test results on two of two analyzers as of 3/2/21. 3. Patient results were released for 8917 tests on 1231 patients from 3/2/21 to date of survey. 4. Interview with the TC#2 on 1/24/22 at 10:15 a.m. confirmed, the laboratory failed to verify two of two Siemen's epoc analyzer performance specifications prior to reporting patient test results. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions, test complexity, quality control (QC) records from 3/2/21 to the time of survey, lack of Individualized Quality Control Plan (IQCP) and interview with TC#2, the laboratory failed to perform QC at least once each day of patient testing for quantitative procedures, to include two control materials of different concentrations. Findings: 1. The epoc Blood Analysis System Manual requires at least 2 levels of fluid control for each lot in each shipment of cards. 2. The epoc Blood Analysis System cards for pH, Sodium (Na), Potassium (K), Chloride (Cl), ionized Calcium (iCa), Lactate, Glucose, Creatinine, Blood Urea Nitrogen (BUN), and total Carbon Dioxide (tCO2) are categorized as moderate complexity tests and require quality control at least once a day of patient testing with two control materials of different concentrations per 493.1256. 3 QC was not performed for 290 of 304 patient testing days for 1166 of 1231 patients. 4. No IQCP had been performed to allow the laboratory to reduce the frequency of QC performance. 5. Interview with the TC#2 on 1/24/22 at 10:20 a.m. confirmed, the laboratory failed to perform QC at least once each day of patient testing for quantitative procedures, to include two control materials of different concentrations. 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 -- 2 of 3 -- 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 test lists, presence of two Siemens epoc analyzers, lack of comparison records and interview, the laboratory failed to evaluate and define the relationship between test results using two of two analyzers for the same analytes. Findings include: 1. Review of test lists revealed analytes pH, Sodium (Na), Potassium (K), Chloride (Cl), ionized Calcium (iCa), Lactate, Glucose, Creatinine, Blood Urea Nitrogen (BUN), and total Carbon Dioxide (tCO2) are performed on the Siemens epoc. 2. Two epoc analyzers are used for testing: S/N 27125 and S/N 34172. 3. No epoc testing comparison records from 3/2/21 to 1/24/22 were made available at the time of survey. 3. Interview with TC#2 on 1/24/22 at 10:45 a.m. confirmed, the laboratory failed to evaluate and define the relationship between two of two Siemens epoc test results for pH, Sodium (Na), Potassium (K), Chloride (Cl), ionized Calcium (iCa), Lactate, Glucose, Creatinine, Blood Urea Nitrogen (BUN), and total Carbon Dioxide (tCO2). D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of CMS form 209, competencies, and interview, the technical consultant failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for four of four testing personnel (TP). Findings: 1. Review of the site's CMS for 209 for personnel revealed four new testing personnel since last survey. 2. Review of personnel competency records revealed no semiannual compentency during the first year for TP#5, TP#9, TP#15 and TP#17. 3. Interview with the TC#2 on 1/24/22 at 9:15 a.m. confirmed, the technical consultant failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for four of four testing personnel. -- 3 of 3 --

Summary Statement of Deficiencies 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 2019 College of American Pathology (CAP) proficiency testing (PT) documentation and interview, the laboratory failed to verify the accuracy of chemistry and microbiology analytes that were assigned a ungraded proficiency testing score. Findings: 1. Review of the laboratory's 2019 CAP PT documentation for chemistry and microbiology found the following ungraded results: Chemistry General Chemistry and Therapeutic Drug Monitoring, C-B 2019 : Received "Grade" of "Not Graded" Bilirubin: CHM-10 Calcium: CHM-06, CHM-09 Microbiology Gram Stain, D5-A 2019: Received "Grade" of "Not Graded" Educational Challenge Leukocytes D5-01,02,03,04,05 2. Review of the laboratory's PT original evaluation forms for C-B 2019 and D5-A 2019 failed to find any documentation demonstrating a self-assessment or self-grade of the "Not Graded" samples. 3. Technical Consultant (TC) #2 confirmed the laboratory failed to verify the accuracy of chemistry and microbiology analytes that were assigned a ungraded proficiency testing score. The interview occurred Septemmber 20, 2019 at 9:15 am. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it 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 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance verification documentation for the Abbott i-STAT analyzer, the Siemens Stratus analyzer and interview, the laboratory failed to verify the reference intervals (normal values) for the analytes: beta natriuretic peptide (BNP), lactic acid, troponin, and D-Dimer were appropriate for the laboratory's patient population. Findings: 1. Review of the verification documentation of the Abbott i-STAT analyzer for lactic acid and BNP testing showed no verification of normal values. 2. Review of the verification documentation of the Siemens Stratus analyzer for troponin and D-Dimer testing showed no verification of normal values. 3. Interview with the TC #2 on September 20, 2019 at 10:30 AM confirmed the laboratory failed to verify the reference intervals (normal values) for the analytes: beta natriuretic peptide (BNP), lactic acid, troponin, and D-Dimer were appropriate for the laboratory's patient population. 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 were the test was performed on the patient report. Findings: 1. Review of the selected patient test reports for i-Stat analytes and Siemens Stratus analytes showed a lack of the name and address of the laboratory location where the test was performed. 2. Interview with TC #2 on September 20, 2019 at 10:50 AM confirmed the laboratory failed to include name and address of the laboratory location were the test was performed on the patient report. -- 2 of 2 --