Langdon Prairie Health

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 1 of 2 non-regulated analytes (troponin) on the iSTAT analyzer in 2023. The laboratory performed one troponin patient test on the iSTAT analyzer in 2023. Findings include: 1. Reviewed at 08:15 a.m. on 03/19/24, the 2023 proficiency testing records indicated the laboratory did not participate in proficiency testing for iSTAT troponin. 2. Upon request, the laboratory failed to provide evidence of a second accuracy verification in 2023 for iSTAT troponin. 3. Reviewed at 1:50 p.m. on 03/19/24, the 2023 iSTAT patient records showed one patient troponin test performed on 07/02/23. 4. During interview at 10:15 a.m. on 03 /19/24, the laboratory supervisor (#1) confirmed the laboratory performed patient testing for iSTAT troponin in 2023 and did not verify the accuracy of this test a second time in 2023. 5. Reviewed on 03/19/24 the policy "Proficiency Testing," dated 01/28/15, stated, ". . . The lab must perform PT [proficiency testing] at least three times per year on each analyte. . . ." D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on record review, procedure review, and staff interview, the laboratory failed to perform a positive and negative control each day of patient testing for urine drug screens on the MEDTOX Scan analyzer for 5 of 5 patient testing days (February 1, 2, 7, 21, and 29) in February 2024. The laboratory performed six urine drug screen patient tests on days with no quality control (QC) performance in February 2024. Findings include: 1. Reviewed on 03/19/24, the patient testing records for urine drug screens on the MEDTOX Scan analyzer indicated performance of patient testing on the following days in February 2024: February 1, 2, 7, 21, and 29. 2. Reviewed on 03 /19/24, the February 2024 QC records for urine drug screens on the MEDTOX Scan analyzer indicated the performance of positive and negative controls on February 3, 10, 17, and 24. Upon request on 03/19/24, the laboratory failed to provide evidence of QC performance on February 1, 2, 7, 21, and 29. 4. During interview at 3:10 p.m. on 03/19/24, the laboratory supervisor (#1) confirmed the laboratory performed QC weekly and had failed to perform QC each day of patient testing for urine drug screens on the MEDTOX Scan analyzer. 3. Reviewed on 03/19/24, the procedure "MEDTOX URINE DRUG SCREEN," effective August 2021, stated, ". . . MEDTOX External Liquid Control (Weekly) . . . Liquid QC is run after weekly . . . maintenance, with each new lot and shipment prior to patient testing . . ." The policy failed to require QC performance each day of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, procedure review, and staff interview, the laboratory failed to ensure testing personnel did not use outdated immunohematology reagents (refer to D5417); failed to perform a positive and negative control each day of patient testing for severe acute respiratory syndrome coronavirus 2 (refer to D5449); failed to perform quality control each day of immunohematology patient testing days (refer to D5451); and failed to test patients for Immunoglobulin M compatibility (refer to D5551). The cumulative effect of these systemic problems limited the laboratory's ability to ensure accurate and reliable patient test results. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review, procedure review, and staff interview, the laboratory failed to 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 -- ensure testing personnel did not use outdated immunohematology reagents on 2 of 6 patient testing days (01/26 and 02/07) in January and February 2022. The laboratory performed testing for two patients using the outdated immunohematology reagents. Findings include: 1. Reviewed at 4:25 p.m. on 05/09/22, the January and February 2022 immunohematology patient testing and reagent records indicated the laboratory performed patient testing using outdated immunohematology reagents for the following: 01/26/22 Patient #395108 - selectogen screening cells, lot #V5406, expiration date 01/25/22. 02/07/22 Patient #426288 - Anti-Immunoglobulin G, lot #033021001-08, expiration date 02/03/22. 2. Reviewed on 05/10/22, the procedure "Blood Bank Quality Control of Gel Cards and Reagents," effective 05/11/11, stated, ". . . Reagents: Do not use reagents beyond expiration date. . .." 3. During interview at 11:25 a.m. on 05/10/22, a general supervisor (#2) confirmed the laboratory used outdated reagents for patient immunohematology testing on 01/26/22 and 02/07/22. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, procedure review, and staff interview, the laboratory failed to perform a positive and negative control each day of patient testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on the GeneXpert System for 19 of 20 patient testing days (February 1-5, 7-11, 13-17, 21, 24, 25, and 28) in February 2022. The laboratory performed 79 SARS-CoV-2 patient tests on days with no quality control (QC) performance. Findings include: 1. Reviewed on 05/10/22, the patient testing records for SARS-CoV-2 on the GeneXpert System indicated performance of patient testing on the following days in February 2022: February 1-5, 7-11, 13-17, 21, 24, 25, and 28. 2. Reviewed on 05/10/22, the February 2022 QC records for SARS- CoV-2 on the GeneXpert System indicated the performance of a positive and negative control on 02/20/22. Upon request on 05/10/22, the laboratory failed to provide evidence of QC performance on February 1-5, 7-11, 13-17, 21, 24, 25, and 28. 3. Reviewed on 05/10/22, the procedure "Flu/RSC [sic]/Covid," for SARS-CoV-2 on the GeneXpert System, effective 08/24/21, stated, ". . . QC Materials & Process: QC is performed every 30 days or new lot or new lot and new shipment. . .." The policy failed to require QC performance each day of patient testing. 4. During interview at 11:25 a.m. on 05/10/22, a technical supervisor (#1) confirmed the laboratory had failed to perform QC each day of patient testing for SARS-CoV-2 on the GeneXpert System. 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 -- 2 of 4 -- (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, procedure review, and staff interview, the laboratory failed to perform quality control (QC) testing 2 of 4 immunohematology patient testing days (01/14 and 01/28) in January 2022. The laboratory performed immunohematology testing for two patients on the days in January 2022 with no QC performance. Findings include: 1. Reviewed at 4:25 p.m. on 05/09/22, the January 2022 immunohematology patient testing and QC records indicated the laboratory did not perform QC for immunohematology (blood type, antibody screen, and compatibility) patient testing on the following days: 01/14/22 Patient #426288 01/28/22 Patient #283747 2. Reviewed on 05/10/22, the procedure "Blood Bank Quality Control of Gel Cards and Reagents," effective 05/11/11, stated, "Principle: The purpose of daily quality control (QC) in the blood bank is to confirm the reliability of the test system. . .. Quality Control (QC) must be performed on the day of patient testing. . .. Quality Control: . . . Record results on the laboratory Blood Bank Control Log . . ." 3. During interview at 11:25 a.m. on 05/10/22, a general supervisor (#2) confirmed the laboratory should perform QC each day of patient testing, and the laboratory did not document performance of QC on two patient testing days in January 2022. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (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, procedure review, and staff interview, the laboratory failed to test patients for Immunoglobulin (Ig) M compatibility on 6 of 10 patient compatibility testing days (11/29/21, 12/07/21, 12/13/21, 01/10/22, 02/07/22, and 02/28/22) from November 2021-April 2022. The laboratory performed eleven patient tests without IgM compatibility from November 2021-April 2022. Findings include: 1. Reviewed at 4:25 p.m. on 05/09/22, the November 2021-April 2022 immunohematology patient logbook indicated the laboratory did not perform compatibility testing for IgM antibodies on the following days: 11/29/21 Patient #282442 - two tests 12/07/21 Patient #457666 - two tests 12/13/21 Patient #282442 - two tests 01/10/22 Patient #426288 - two tests 02/07/22 Patient #426288 - two tests 02/28/22 Patient #426288 - one test 2. Reviewed on 05/10/22, the procedure "Immediate Spin (IGM) Crossmatch," effective 05/11/11, stated, "Principle: The crossmatch compatibility test is used to detect the presence of blood group antibodies in an intended recipient's serum/plasma directed towards antigens present on donor red blood cells. . .. Interpretation of Results . . . If both Immediate Spin Crossmatch and Antiglobulin Crossmatch are compatible, record as 'compatible' on the Blood Issue and Transfusion -- 3 of 4 -- Record. If the unit is incompatible, record 'incompatible' on the Blood Issue and Transfusion Record and also write 'Do Not Use' after this unit. . .." 3. During interview at 11:25 a.m. on 05/10/22, a general supervisor (#2) confirmed the laboratory should perform immediate spin crossmatch tests for all patient compatibility testing, and the laboratory did not document performance of an immediate spin crossmatch for the above listed patient tests. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on policy review and staff interview, the laboratory director failed to evaluate and approve performance verification procedures for 2 of 2 newly implemented procedures (high sensitivity troponin and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) in 2021. The laboratory performed approximately 100 high sensitivity troponin and 500 SARS-CoV-2 patient tests since implementation of the new tests. Findings include: 1. Reviewed on 05/10/22, the policy "Evaluating a New Test," effective 09/01/05, failed to require the laboratory director's approval of the performance verification data for newly implemented tests. An attached, blank form titled "New Method Validation," dated 07/11/16, stated, ". . . When all data has been collected and evaluated as satisfactory, implement the test. Date: ___ Director: ___". 2. Upon request on 05/10/22, the laboratory failed to provide evidence the laboratory director had evaluated and approved the performance verification data for the newly implemented high sensitivity troponin on the Unicel DxC 600i chemistry analyzer and SARS-CoV-2 on the GeneXpert analyzer in 2021. 3. During interview at 11:25 a.m. on 05/10/22, a technical supervisor (#1) confirmed the laboratory did not have evidence the laboratory director had evaluated and approved the performance verification data for the newly implemented high sensitivity troponin and SARS-CoV- 2 tests. -- 4 of 4 --

Summary Statement of Deficiencies 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 American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for Partial Thromboplastin Time for two of three consecutive testing events in 2021 (Event 2 and Event 3), resulting in unsuccessful performance. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte Partial Thromboplastin Time (PTT) two of three consecutive events in 2021 (Event 2 and Event 3), resulting in unsuccessful performance. Findings include: 1. Review of 2021 American Proficiency Institute (API) proficiency testing reports on 01/27/22 for the analyte PTT (measured in seconds) revealed the following results: Event 2 - 40% Sample Lab Results Acceptable Range #06 62 34 - 47 #07 50 52 - 71 #08 24 24 - 34 #09 27 26 - 36 #10 52 94 - 128 Event 3 - 40% Sample Lab Results Acceptable Range #11 50 52 - 72 #12 38 36 - 49 #13 24 25 - 35 Sample Lab Results Acceptable Range #14 26 26 - 36 #15 61 33 - 46 The specialty of hematology requires a score of 80% or greater for satisfactory performance. 2. During interview at 10:30 a.m. on 01/26/22, a testing personnel (#1) confirmed the laboratory scored 40% on Events 2 and 3 in 2021 for PTT. -- 2 of 2 --