St Anthony Regional Hospital

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 proficiency testing (PT) results and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 2:15 pm on 6/27 /2024, the laboratory failed to verify the accuracy of the non-graded PT analytes for three out of five events from 10/1/2022 - 6/28/2024. The findings include: 1. For 2023 event 1, the laboratory received non-graded PT results for the following analytes: alanine transaminase specimen CET -1; gentamicin specimen CET - 2; total iron binding capacity CET - 2; and antistreptolysin O specimens XS - 1, 2, 3, 4 & 5. 2. For 2023 event 2, the laboratory received non-graded PT results for the following analytes: high sensitivity C-reactive protein specimens IE - 6, 7, 8, 9 and 10; gamma- glutamyl transferase specimens CET - 6, 7, 8, 9 and 10; gentamicin specimens CET - 6, 7, 8, 9 and 10; cannabinoids specimen UD - 4; activated partial thromboplastin specimens CA - 6, 7, 8, 9 and 10; prothrombin time specimens CA - 6, 7, 8, 9 and 10; and antimicrobial susceptibility testing, rifampin specimen MC-14. 3. For 2023 event 3, the laboratory received non-graded PT results for the following analytes: activated partial thromboplastin specimens CA - 11, 12, 13, 14 and 15; fibrinogen specimens CA - 11, 12, 13, 14 and 15; and prothrombin time specimens CA - 11, 12, 13, 14 and 15. 4. At the time of the survey, the laboratory acknowledged the non-graded PT results but did not document verification of accuracy for the results. D5401 PROCEDURE MANUAL 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): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of quality controls records and review of the Testing for Blood Group Antigen procedure and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 10:06 am on 6/28/2024, the laboratory personnel failed to follow the blood group antigen control procedure for two out of two units of blood distributed on 6/13/2024. The findings include: 1. The Testing for Blood Group Antigen procedure stated, "Quality Control must be run once per day when blood group antigen typing is needed. Reagent red blood cells may be used directly from the vial. Positive Control - red blood cells known to possess the antigen. It should be heterozygous positive. Negative control - red blood cells known to lack the antigen." 2. On 6/13/2014, the laboratory performed antigen testing on units W037924148450 and W037924152068 of leukoreduced packed cells. 3. At the time of the survey, the laboratory did not have records of blood group antigen quality controls being performed on 6/13/2024 as outlined in the above procedure. 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 the laboratory analyzer test list and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 11:01 am on 6/28 /2024, the laboratory failed to perform comparison testing twice annually for the analytes SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and clostridium difficile for three out of three time periods from 1/1/2023 - 6/28/2024. The findings include: 1. The laboratory performed SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and clostridium difficile on the Cepheid analyzer. 2. The laboratory performed SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and clostridium difficile on the Biofire analyzer. 3. The laboratory performed clostridium difficile testing using the Techlab Toxin A/B Quick Check test kit. 4. At the time of the survey, the laboratory had not performed comparison testing for SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus performed between the Cepheid and Biofire analyzer. In addition, the laboratory had not performed comparison testing for clostridium difficile performed between the Cepheid, Biofire and Techlab Toxin A/B Quick Check test kit. -- 2 of 2 --

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies 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 review of chemistry calibration verification records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:30 am on 09/10/2020, the laboratory failed to perform calibration verification every six months for one out of three time periods for the analytes: sodium, potassium and chloride from 1/1/2019 - 9/10/2020. The findings include: 1. On 4/26/2019 and 12/11/2019, the laboratory performed calibration verification 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 2 -- the analytes: sodium, potassium and chloride. 2. At the time of the survey, the laboratory did not have calibration verification records for the time period between 12 /12/2019 - 9/10/2020. 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 arterial blood gas comparison records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:50 pm on 9/9/2020, the laboratory failed to perform arterial blood gas comparison activities twice annually between the two i-STAT instruments for two of three time periods from 1/1/2019 - 9/10/2020. The findings include: 1. The laboratory performed arterial blood gas testing using two different i-STAT instruments. 2. The laboratory perform comparison testing between the two instruments on 7/18/2019. 3. Laboratory personnel identifier #1 confirmed that is the only comparison testing performed between the two instruments from 1/1/2019 - 9/10 /2020. -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of coagulation reagent verification records, observation of the CA1500 coagulation instrument, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 9:35 am on 06/21/2018, the laboratory fails to meet the hematology (coagulation) requirements for test system /equipment/reagent verification as specified in the standard D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of coagulation reagent verification records, observation of the CA1500 coagulation instrument, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 9:35 am on 06/21/2018, the laboratory failed to verify, for each thromboplastin lot number in use, the correct normal patient prothrombin time (PT) mean is being used for calculating the International Normalized Ratio (INR) value for one out of one lot number of 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 -- thromboplastin reagent (lot number 539399, expiration 11/03/2019) in 2018. The findings include: 1. Reagent verification records from January and February 2018 indicated that the laboratory established a normal patient mean of 10.1 seconds for thromboplastin reagent lot number 539399, expiration 11/03/2019. 2. Observation of the coagulation analyzer's standard curve screen showed the normal patient mean programmed as 10.4 seconds. 3. Laboratory personnel identifier #3 confirmed that the laboratory began using thromboplastin reagent lot number 539399 on 02/17/2018 and that the actual normal patient mean was 10.1 seconds. 4. The laboratory did not have documentation verifying the correct normal patient PT mean was used for calculating the INR value for thromboplastin lot number 539399. 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. This STANDARD is not met as evidenced by: Based on lack of performance specification records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11: 40 am on 06/21/2018, the laboratory failed to verify the performance specifications of accuracy, precision, and reportable range for the Clinitek Advantus urinalysis test system prior to testing and reporting patient test results. The findings include: 1. The laboratory began using the Clinitek Advantus test system in September 2016. 2. At the time of the survey, the laboratory did not have performance specification records for this test system. 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 Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifiers #2 and #3 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 06/21 /2018, the laboratory failed to perform two levels of QC each day of patient testing for the AVOXimeter 4000 test system. The findings include: 1. The laboratory performed optical filter QC with yellow and orange filters each day of patient testing. 2. The -- 2 of 3 -- laboratory did not perform external liquid QC in addition to the optical filter QC. 3. Laboratory personnel identifiers #2 and #3 indicated that the laboratory intended to perform optical filter QC each day of patient testing. 3. At the time of the survey, the laboratory did not have an IQCP for the AVOXimeter 4000 test system. -- 3 of 3 --