Smp Health St Aloisius

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 record review and staff interview, the laboratory failed to verify the accuracy of results for 1 of 3 microbiology events in 2025 (2nd Event) the American Proficiency Institute (API) assigned as not graded. The laboratory performed 327 susceptibility testing patient tests in the past year. Findings include: 1. Reviewed at 9: 43 a.m. on 04/01/26, the 2nd Event 2025 Microbiology proficiency testing showed combination antibiotics Ticarcillin/Clavulanate as not graded for Susceptibility Testing sample BL-01, Susceptibility A sample UR-06, and Susceptibility B sample UR-07. The laboratory failed to evaluate the not graded results. 2. During an interview at 12:08 p.m. on 04/01/26, a laboratory manager (#1) confirmed the laboratory failed to evaluate the 2nd Event 2025 Ticarcillin/Clavulanate Susceptibility Testing, Susceptibility A, and Susceptibility B not graded results. 3. The laboratory failed to provide a policy regarding verification of accuracy of results for proficiency testing. 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: 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 -- Based on record review and staff interview, the laboratory failed to verify the accuracy of results for 1 of 3 microbiology events in 2025 (2nd Event) the American Proficiency Institute (API) assigned as unacceptable. The laboratory performed 327 susceptibility testing patient tests in the past year. Findings include: 1. Reviewed at 9: 43 a.m. on 04/01/26, the 2nd Event 2025 Microbiology proficiency testing Susceptibility Testing records failed to show the laboratory documented verification of accuracy for sample BL-01 antibiotic Imipenem and combination antibiotics Trimethoprim/Sulfamethoxazole. 2. During an interview at 12:08 p.m. on 04/01/26, a laboratory manager (#1) confirmed the laboratory failed to document review of the 2nd Event 2025 Imipenem and Trimethoprim/Sulfamethoxazole Susceptibility Testing unacceptable results. 3. The laboratory failed to provide a policy regarding verification of unacceptable proficiency testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (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 record review and staff interview, the laboratory failed to perform required quarterly maintenance for 4 of 4 quarters (1st quarter 2025 [January 2025 through March 2025], 2nd quarter 2025 [April 2025 through June 2025], 3rd quarter 2025 [July 2025 through September 2025], and 4th quarter 2025 [October 2025 through December 2025) reviewed. The laboratory performed 478 PT/INR (Prothrombin Time /International Normalized Ratio) and 145 PTT (Partial Thromboplastin Time) patient tests in the past year. Findings include: 1. Reviewed at 2:52 p.m. on 04/01/26, the Sysmex CA 600 Operator's Maintenance Checklist showed the quarterly maintenance "Clean DI (deionized) Water Rinse Bottle with Alcohol". 2. Reviewed the afternoon of 04/01/26, the January 2025 through December 2025 maintenance checklists for the Sysmex CA 600 series lacked evidence of the quarterly "Clean DI Water Rinse Bottle with Alcohol" maintenance performance. 3. During an interview at 2:57 p.m. on 04/01 /26, a laboratory manager (#1) confirmed the laboratory failed to complete quarterly "Clean DI Water Rinse Bottle with Alcohol" maintenance on the Sysmex CA 600 series in January 2025 through December 2025. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 record review and staff interview, the technical supervisor failed to evaluate the competencies for all non-waived test systems for 1 of 5 testing personnel (#1) in 2025. Failure to evaluate the competency of testing personnel limits the laboratory's ability to ensure testing personnel perform patient tests correctly to produce accurate and reliable results. Findings include: 1. Reviewed at 11:11 a.m. on 04/01/26, the -- 2 of 4 -- 2025 competency evaluation records for testing personnel (#1) lacked evidence of evaluation of the following elements for the listed non-waived testing systems: * Testing Personnel (#1): - Dimension EXL chemistry analyzer: direct observation of test performance, review of maintenance records, direct observation of maintenance, and assessment of problem solving skills - Stratus CS chemistry analyzer: direct observation of test performance, review of maintenance records, direct observation of maintenance, review of quality control, and assessment of problem solving skills - Epoc blood gas analysis system: review of patient test results, direct observation of test performance, review of quality control, and assessment of problem solving skills - Sysmex XS-1000i hematology analyzer: direct observation of test performance, review of maintenance records, direct observation of maintenance, and assessment of problem solving skills - Manual differentials: review of patient test results, direct observation of test performance, and assessment of problem solving skills - Diesse Minicube automated erythrocyte sedimentation rate analyzer: direct observation of test performance and assessment of problem solving skills - Urine microscopic examination: direct observation of test performance and assessment of problem solving skills - Sysmex CA 600 series coagulation analyzer: direct observation of test performance, review of maintenance records, direct observation of maintenance, review of quality control, and assessment of problem solving skills - Microbiology culture/minimum inhibitory concentration (MIC) procedures: review of patient test results, direct observation of test performance, review of maintenance records, direct observation of maintenance, review of quality control, and assessment of problem solving skills - Alere Clostridioides difficile (C. diff): review of patient test results, direct observation of test performance, review of quality control, and assessment of problem solving skills - Gram stain procedures: review of patient test results, direct observation of test performance, review of quality control, and assessment of problem solving skills - Blood culture procedures: review of patient test results, direct observation of test performance, and assessment of problem solving skills - Immunohematology crossmatch and direct antiglobulin test (DAT) procedures: direct observation of test performance, review of quality control, and assessment of problem solving skills 2. During an interview the afternoon of 04/01/26, a laboratory manager (#1) confirmed the 2025 competency evaluation for testing personnel (#1) failed to include all elements. 3. The laboratory failed to provide a policy regarding the six testing personnel competency assessment procedures. 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 record review and staff interview, the technical supervisor failed to evaluate and document the competency for 5 of 5 testing personnel (Testing Personnel #1, #2, #3, #4, and #5) requiring annual competency evaluations in 2025. Findings include: 1. Reviewed at 11:11 a.m. on 04/01/26, the competency evaluation records lacked evidence of annual competency evaluations in 2025 as follows: - Testing Personnel (#1) - post vasectomy semen analysis, ABO blood group, Rh factor, and antibody screen - Testing Personnel (#2) - post vasectomy semen analysis, ABO blood group, Rh factor, and antibody screen - Testing Personnel (#3) - Sysmex CA 600 series -- 3 of 4 -- coagulation analyzer, post vasectomy semen analysis, ABO blood group, Rh factor, and antibody screen - Testing Personnel (#4) - post vasectomy semen analysis, ABO blood group, Rh factor, and antibody screen - Testing Personnel (#5) - post vasectomy semen analysis, ABO blood group, Rh factor, and antibody screen 2. During interview at 12:22 p.m. on 04/01/26, a laboratory manager (#1) confirmed testing personnel (#3) did not have all annual competency evaluations completed in 2025. 3. The laboratory failed to provide a policy regarding annual competency evaluations. -- 4 of 4 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, staff interview, and procedure review, the laboratory failed to perform blood group/type and antibody screen quality control (QC) testing 1 of 15 immunohematology patient testing days (04/07) in April-May 2024. The laboratory performed blood group/type and antibody screen testing for one patient in April-May 2024 with no QC performance. Findings include: 1. Reviewed at 12:40 p.m. on 06/03 /24, the April-May 2024 immunohematology patient testing and QC records indicated the laboratory did not perform blood group/type and antibody screen QC on 04/07/24 for Patient #7025685. 2. During interview at 1:30 p.m. on 06/03/24, a technical supervisor (#1) confirmed the laboratory should perform QC each day of patient testing, and the laboratory did not document performance of blood group/type and antibody screen QC on 4/07/24 when the laboratory performed patient testing. 3. Reviewed on 06/03/24, the procedure "QC of MTS Manual Gel Test System Reagents," effective 03/18/24, stated, "Principle The purpose of daily quality control (QC) in the blood bank is to confirm the reliability of the test system. . . . Quality Control . . . Perform QC for antibody detection, ABO and D red blood cell typing and ABO reverse group testing using quality control materials . . ." D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) 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 -- (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (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 record review, staff interview, and policy/procedure manual review, the laboratory failed to test patients for Immunoglobin (Ig) M compatibility for 9 of 9 patient compatibility testing days (04/08, 04/19, 04/23, 04/30, 05/01, 05/09, 05/14, 05 /20, and 05/21) from April-May 2024. The laboratory performed seventeen patient compatibility tests with no IgM compatibility testing from April-May 2024. Findings include: 1. Reviewed at 12:40 p.m. on 06/03/24, the April-May 2024 immunohematology patient logbook failed to include evidence the laboratory performed immediate spin compatibility testing for IgM antibodies for the following: 04/08 Patient #7016593 - one test 04/19 Patient #7003939 - one test 04/23 Patient #7016593 - one test 04/30 Patient #7016593 - one test 04/30 Patient #7027795 - one test 05/01 Patient #7027795 - one test 05/09 Patient #5000356 - two tests 05/14 Patient #7016593 - two tests 05/14 Patient #7021119 - two tests 05/20 Patient #7014033 - two tests 05/21 Patient #7016593 - two tests 05/21 Patient #7024011 - one test 2. During interview at 1:20 p.m. on 06/03/24, a technical supervisor (#1) stated the following: the laboratory began using a new method for immunohematology patient testing on 04/01/24; the laboratory was unaware they should perform immediate spin crossmatch tests for IgM antibodies for all patient compatibility testing; and the laboratory did not perform immediate spin crossmatches for the above listed patient tests. 3. Upon review on 06/03/24, the immunohematology policy /procedure manual failed to include a policy/procedure for performing immediate spin crossmatch tests for IgM antibodies for patient compatibility testing. 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 record review, staff interview, and policy/procedure review, the laboratory failed to include the units of measure for 1 of 1 random urine microscopic patient report reviewed (Patient #7001295). The laboratory reported approximately 250 urine -- 2 of 3 -- microscopic patient test results since the start of a new electronic record system January 22, 2024. Findings include: 1. Reviewed on 06/03/24, a random urine microscopic patient report for Patient #7001295 on 06/03/24 failed to include the units of measure for white blood cell and red blood cell quantified results. 2. During interview at 4:40 p.m. on 06/03/24, a technical supervisor (#1) stated the laboratory began using a new electronic record system January 22, 2024 and confirmed the patient reports for urine microscopic results failed to include the units of measure. 3. Reviewed on 06/03/24, the policy/procedure "Microscopic Examination of Urine Sediment," dated September 1996, stated, ". . . Findings - Significant Elements: 1. Casts: Casts must be scanned for under low power and report the number seen per low power field (lpf). . . . 2. White Blood Cells (WBC's) and Red Blood Cells (RBC's): . . . the numbers of WBC's and RBC's are reported as number seen per high power field (hpf). . . ." D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review, observation, staff interview, and manufacturer's instructions review, the laboratory failed to use the correct mean normal protime (PT) values for calculating the International Normalized Ratios (INRs) for 20 of 20 weeks (January 9 - June 2, 2024) in 2024 since the laboratory began using a new lot number of Innovin (thromboplastin reagent used to analyze protime tests) on the Sysmex CA600 coagulation analyzer on 01/09/24. The laboratory performed approximately 200 patient tests during this timeframe. Findings include: 1. Reviewed at 3:10 p.m. on 06 /03/24, the Innovin lot number change records, dated 12/27/23, showed the mean normal PT value obtained for Innovin lot number 564624B was 10.2. 2. Observation of the Sysmex CA600 coagulation analyzer at 3:20 p.m. on 06/03/24 revealed a patient normal mean of 10.4 used to calculate patient INRs. 3. During interview at 3: 20 p.m. on 06/03/24, a technical supervisor (#1) confirmed the laboratory did not enter the new mean normal PT value of 10.2 in the coagulation analyzer when the laboratory began using the new lot number (564624B) of Innovin on 01/09/24. 4. Reviewed on 06/03/24, the Siemens Dade Innovin package insert, dated 10/2017, stated, ". . . Determination of INR (International Normalized Ratio) Values using Dade Innovin Reagent . . . 1. . . . the PT results for patients on vitamin K antagonist oral anticoagulants should be reported as INR values. . . . The INR is determined according to the following equation: INR = R [powered to the ISI (International Sensitivity Index) value], where R = Patient PT [divided by] MNPT* . . . *The mean normal PT (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples . . ." -- 3 of 3 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, staff interview, procedure review, and manufacturer's instructions review, the laboratory failed to perform negative Anti-D quality control (QC) testing 2 of 3 immunohematology patient testing days (04/02 and 04/03) in April 2022. The laboratory performed Anti-D testing for two patients on the days in April 2022 with no negative Anti-D QC performance. Findings include: 1. Reviewed at 1:25 p.m. on 07/28/22, the April 2022 immunohematology patient testing and QC records indicated the laboratory did not perform negative Anti-D QC for Anti-D patient testing on the following days: 04/02/22 Patient #11380 04/03/22 Patient #8514 2. During interview at 2:30 p.m. on 07/28/22, a technical supervisor (#1) confirmed the laboratory should perform positive and negative Anti-D QC each day of patient testing, and the laboratory did not document performance of negative Anti-D QC on two patient testing days in April 2022. 3. Reviewed on 07/28/22, the procedure "Blood Bank: RH TYPING," effective 02/12/13, stated, ". . . Quality Control: . . . Reagents are quality controlled with known positive and negative controls each day that blood bank work is done. . . ." 4. Reviewed on 07/28/22, the manufacturer's instructions "Blood Grouping Reagent Anti-D (Monoclonal Blend) Gamma-clone," dated 03/2019, stated, ". . . Quality Control: The reactivity of blood grouping reagents should be confirmed on each day of testing with red blood cells known to be negative and positive for the relevant antigen. . . ." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, manufacturer's instructions review, record review, and staff interview, the laboratory failed to store BioRad chemistry controls in the Crosley freezer according to the manufacturer's instructions on 38 of 50 days from December 1, 2020 through January 19, 2021 (12/03, 12/05 - 12/31, 01/21, 01/05 - 01/07, 01/11, 01/14 - 01/16, 01/18, and 01/19). Findings include: 1. Observation of the Crosley freezer occurred at 3:50 p.m. on 01/19/21. This freezer contained the following BioRad Liquichek chemistry controls: 9 vials Specialty Immunoassay, 11 vials Immunology, and 86 vials Immunoassay Plus. 2. Reviewed at 3:50 p.m. on 01/19/21, the manufacturer's labels on the BioRad Liquichek chemistry controls stated to store at -20 to -70 degrees Celsius. 3. Review of the December 1, 2020 through January 19, 2021 Crosley freezer temperature records occurred at 4:10 p.m. on 01/19/21. These records showed the temperature of the Crosley freezer was warmer than -20 degrees Celsius for the following 38 days from December 1, 2020 through January 19, 2021: 12/03, 12/05 - 12/31, 01/21, 01/05 - 01/07, 01/11, 01/14 - 01/16, 01/18, and 01/19). 4. During interview at 4:30 p.m. on 01/19/21, a technical supervisor (#1) confirmed the Crosley freezer had not been at the proper temperature for storage of the BioRad chemistry controls all days from December 1, 2020 through January 19, 2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --