Smp Health St Aloisius

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 --