Pembina County Memorial Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review conducted on October 21, 2024 found the laboratory out of compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 493.1780. A condition level deficiency was cited at 42 CFR 493.803 Condition: Successful Participation. 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 Certification and Survey Provider Enhanced Reports review, American Proficiency Institute proficiency testing record review, and staff interview, the 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 -- laboratory failed to achieve satisfactory performance in proficiency testing for the analyte creatine kinase (CK) for two of three consecutive events in 2024 (Event 2 and Event 3) resulting in unsuccessful performance (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Certification and Survey Provider Enhanced Reports (CASPER) review, proficiency testing record review, and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte creatine kinase (CK) for two of three consecutive events in 2024 (Event 2 and Event 3) resulting in unsuccessful performance. Findings include: 1. Review of CASPER Report 155D (individual laboratory proficiency testing scores) on 10/18/24 indicated the laboratory scored the following for the analyte CK in 2024: Event 2 - 20% Event 3 - 40% 2. Review of 2024 American Proficiency Institute (API) proficiency testing reports on 10 /18/24 for the analyte CK revealed the following results: Event 2-2024 - 20% Sample Lab Results Acceptable Range #06 135 139 - 259 #07 77 86 - 161 #09 56 69 - 130 #10 20 32 - 61 Event 3-2022 - 40% Sample Lab Results Acceptable Range #12 22 37 - 71 #13 58 68 - 127 #15 90 95 - 179 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 3. During a telephone interview at 11:35 a.m. on 10/21/24, the laboratory manager (#1) confirmed the laboratory had scored less than 80% for CK in Events 2 and 3 in 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An on-site, unannounced complaint survey conducted on October 7, 2024, found the laboratory in compliance with the Clinical Laboratory Improvement Amendments standard found at 42 CFR, Part 493.1242(a)(7). 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 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 Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte partial pressure of carbon dioxide (pCO2) for two of three consecutive events in 2023-2024 (Event 3-2023 and Event 2-2024), resulting in unsuccessful performance (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 5 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 pressure of carbon dioxide (pCO2) for two of three consecutive events in 2023-2024 (Event 3- 2023 and Event 2-2024), resulting in unsuccessful performance. Findings include: 1. Review of 2023-2024 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 08/14/24 for the analyte pCO2 revealed the following results: pCO2: Event 3-2023 - 0% Sample Lab Results #11 no results submitted #12 no results submitted #13 no results submitted #14 no results submitted #15 no results submitted pCO2: Event 2-2024 - 60% Sample Lab Results Acceptable Range #06 31 26 - 36 #07 61 64 - 75 Sample Lab Results Acceptable Range #08 49 48 - 58 #09 43 40 - 50 #10 59 60 - 70 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During interview at 5:00 p.m. on 08/14/24, the laboratory manager (#1) confirmed the laboratory had failed to submit proficiency testing results for pCO2 in Event 3-2023 and scored 60% for pCO2 in Event 2-2024. 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 policy review, record review, and staff interview, the laboratory failed to perform quality control (QC) as stated in their policy for 3 of 3 analytes (troponin, creatine kinase-myocardial band [CK-MB], and myoglobin) with individualized quality control plans (IQCPs) in 2024. The laboratory performed 190 troponin, 152 CK-MB, and 28 myoglobin patient tests during the timeframes when the laboratory failed to perform monthly QC. Findings include: 1. Reviewed on 08/15/24, the policy "IQCP for Biosite Triage," 07/14/16, stated, ". . . Final QCP [quality control plan] for Biosite Triage . . . Test System: Biosite Triage (Troponin, CK-MB, Myoglobin) . . . Based on the IQCP, assessment we feel that monthly QC or with each new shipment, whichever is more frequent will be satisfactory for our facility. . . ." 2. Review of the 2024 QC results for the analytes troponin, CK-MB, and myoglobin on the Triage Meter Pro analyzer occurred on 08/15/24. The laboratory failed to perform two levels of QC for the following: - March: QC not performed from 02/15/24 through 04/11/24 (56 days) - June: QC not performed from 05/19/24 through 07/27/24 (68 days) 3. During interview at 10:50 a.m. on 08/15/24, the laboratory manager (#1) stated the laboratory should perform QC each month for the Triage analyzer tests and confirmed the laboratory failed to perform monthly QC in March and June 2024. -- 2 of 5 -- 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 record review, staff interview, and policy review, the laboratory failed to perform two levels of quality control (QC) 6 of 31 days (May 9 - 14) for the analyte chloride in May 2024. The laboratory performed 83 chloride patient tests in May 2024 when the laboratory failed to perform QC. Findings include: 1. Review of the May 2024 QC records for the analyte chloride on the Ortho Vitros chemistry analyzer occurred on 08/15/24. The laboratory failed to perform two levels of QC May 9 - 14. 2. During interview at 11:50 a.m. on 08/15/24, the laboratory manager (#1) stated the laboratory should perform QC each day of patient testing and confirmed the laboratory failed to perform chloride QC May 9 - 14. 3. Reviewed on 08/15/24, the policy "Quality Control Frequency and QC Material," effective 04/16/19, stated, "Purpose: This protocol applies to all laboratory specialties and subspecialties performed at PCMH [Pembina County Memorial Hospital]. . . . all areas of the laboratory must be monitored with the use of at least 2 levels of quality control material. . . . The following information identifies the frequency of control . . . Chemistry: J&J Vitros 350 Once daily . . ." 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, policy and procedure review, and staff interview, the laboratory failed to ensure performance of blood type and antibody detection quality control (QC) testing 1 of 4 immunohematology patient testing days (04/29/24) in April 2024. The laboratory performed blood type and antibody detection testing for one patient on 04/29/24. Findings include: 1. Reviewed at 7:35 a.m. on 08/15/24, the April 2024 immunohematology patient testing and QC records indicated the laboratory performed blood type and antibody detection patient testing on 04/29/24 for Patient #1185605 and failed to perform QC. 2. Review of the following policies and procedures occurred on 08/15/24: - "Quality Control Frequency and QC Material," effective 04/16/19, stated, "Purpose: This protocol applies to all laboratory specialties and subspecialties performed at PCMH [Pembina County Memorial Hospital]. . . . all areas of the laboratory must be monitored with the use of at least 2 levels of quality control material. . . . The following information identifies the frequency of control . . . Blood Bank Each day of testing . . ." - "ABO [blood group -- 3 of 5 -- antigens] and RH [sic] [Rhesus blood factor] Testing Patient Samples Using MTS [Micro Typing System] Gel Method," effective 02/07/11, stated, ". . . Quality Control: Quality control will be performed each day (24 hours) patient samples are to be tested. . . ." - "Gel IGG [sic] [Immunoglobulin G] Antibody Screen Testing," effective 02/07 /11, stated, "Quality Control: 1. Gel Card - To confirm the specificity and reactivity . . . each lot is tested on each day of use . . ." 3. During interview at 8:35 a.m. on 08/15 /24, the laboratory manager (#1) confirmed the laboratory should perform quality control each day of patient testing and the laboratory did not document performance of blood type and antibody screen QC on 04/29/24. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing record review, record review, policy and procedure review, and staff interview, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory regarding the maintenance of quality control (refer to D6093) and quality assessment programs (refer to D6094). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the laboratory director failed to ensure the maintenance of a quality control (QC) program to identify quality failures and ensure quality laboratory results (refer to D5445, D5447, and D5451). Findings include: 1. The laboratory failed to perform monthly QC as stated in their policy for the analytes troponin, creatine kinase-myocardial band, and myoglobin with individualized quality control plans in March and June 2024 (refer to D5445). 2. The laboratory failed to perform two levels of QC six days in May 2024 for the analyte chloride (refer to D5447). 3. The laboratory failed to perform blood type and antibody detection QC testing one immunohematology patient testing day in April 2024 (refer to D5451). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: -- 4 of 5 -- Based on proficiency testing record review and staff interview, the laboratory director failed to ensure the maintenance of a quality assessment program to ensure satisfactory performance in proficiency testing (refer to D2096). Findings include: 1. The laboratory failed to achieve satisfactory performance in proficiency testing for the analyte partial pressure of carbon dioxide in Event 3-2023 and Event 2-2024 resulting in unsuccessful performance (refer to D2096). -- 5 of 5 --

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 the analyte creatine kinase for three of four consecutive events in 2022- 2023 (Events 2 and 3 in 2022 and Event 2 in 2023) and for the analyte total bilirubin for three consecutive events in 2022-2023 (Event 3 in 2022 and Events 1 and 2 in 2023), resulting in subsequent unsuccessful performance for both analytes (Refer to D2096). D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 creatine kinase for three of four consecutive events in 2022-2023 (Events 2 and 3 in 2022 and Event 2 in 2023) and for the analyte total bilirubin for three consecutive events in 2022-2023 ( Event 3 in 2022 and Events 1 and 2 in 2023), resulting in subsequent unsuccessful performance. Findings include: 1. Review of 2022-2023 American Proficiency Institute (API) proficiency testing reports on 07/25/23 for the analytes creatine kinase (CK) and total bilirubin (T Bili) revealed the following results: CK: Event 2-2022 - 20% Sample Lab Results Acceptable Range #06 131 145 - 271 #07 20 15 - 29 #08 109 112 - 209 #09 72 75 - 141 Sample Lab Results Acceptable Range #10 137 142 - 265 CK: Event 3-2022 - 40% Sample Lab Results Acceptable Range #11 61 116 - 217 #12 115 56 - 106 #13 94 97 - 182 #14 172 160 - 299 #15 142 133 - 248 CK: Event 2- 2023 - 40% Sample Lab Results Acceptable Range #06 78 77 - 145 #07 132 147 - 275 #08 40 41 - 78 #09 189 175 - 327 #10 125 127 - 237 T Bili: Event 3-2022 - 60% Sample Lab Results Acceptable Range #11 0.8 2.2 - 3.4 #12 2.4 0.4 - 1.3 #13 1.7 1.7 - 2.7 #14 4.3 3.6 - 5.6 #15 3.1 2.7 - 4.2 T Bili: Event 1-2023 - 40% Sample Lab Results Acceptable Range #01 0.2 0.2 - 1.1 #02 0.1 0.0 - 0.5 #03 2.9 3.2 - 5.0 #04 0.2 0.6 - 1.5 #05 1.9 2.2 - 3.4 T Bili: Event 2-2023 - 60% Sample Lab Results Acceptable Range #06 0.8 0.7 - 1.6 Sample Lab Results Acceptable Range #07 2.0 2.5 - 3.8 #08 0.2 0.0 - 0.8 #09 3.4 3.4 - 5.8 #10 1.8 2.0 - 3.1 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 1:40 p. m. on 07/25/23, the laboratory manager (#1) stated the laboratory had scored less than 80% for CK in Events 2 and 3 in 2023 and Event 2 in 2023; and for total bilirubin in Event 3 in 2022 and Events 1 and 2 in 2023. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on American Proficiency Institute proficiency testing record review and staff interview, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory regarding the maintenance of a quality assessment program to prevent a third out of four (Event 2 in 2022) unsatisfactory proficiency testing result for creatine kinase and a third consecutive (Event 2 in 2023) unsatisfactory proficiency testing result for total bilirubin resulting in subsequent unsuccessful participation in proficiency testing for both analytes (refer to D6094). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 2 of 3 -- The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory director failed to ensure the maintenance of a quality assessment program to help prevent unsatisfactory performance in proficiency testing for the analyte creatine kinase for the third event (Event 2 in 2023) in four consecutive events and for the analyte total bilirubin for the third consecutive event (Event 2 in 2023) in 2022-2023, resulting in subsequent unsuccessful proficiency testing performance for both analytes. Findings include: 1. Review of 2022-2023 American Proficiency Institute (API) proficiency testing reports on 07/25/23 for the analytes creatine kinase (CK) and total bilirubin (T Bili) revealed the following results: CK: Event 2-2022 - 20% Sample Lab Results Acceptable Range #06 131 145 - 271 #07 20 15 - 29 #08 109 112 - 209 #09 72 75 - 141 #10 137 142 - 265 CK: Event 3-2022 - 40% Sample Lab Results Acceptable Range #11 61 116 - 217 Sample Lab Results Acceptable Range #12 115 56 - 106 #13 94 97 - 182 #14 172 160 - 299 #15 142 133 - 248 CK: Event 2-2023 - 40% Sample Lab Results Acceptable Range #06 78 77 - 145 #07 132 147 - 275 #08 40 41 - 78 #09 189 175 - 327 #10 125 127 - 237 T Bili: Event 3-2022 - 60% Sample Lab Results Acceptable Range #11 0.8 2.2 - 3.4 #12 2.4 0.4 - 1.3 #13 1.7 1.7 - 2.7 #14 4.3 3.6 - 5.6 #15 3.1 2.7 - 4.2 T Bili: Event 1-2023 - 40% Sample Lab Results Acceptable Range #01 0.2 0.2 - 1.1 #02 0.1 0.0 - 0.5 #03 2.9 3.2 - 5.0 #04 0.2 0.6 - 1.5 #05 1.9 2.2 - 3.4 T Bili: Event 2-2023 - 60% Sample Lab Results Acceptable Range #06 0.8 0.7 - 1.6 #07 2.0 2.5 - 3.8 #08 0.2 0.0 - 0.8 #09 3.4 3.4 - 5.8 #10 1.8 2.0 - 3.1 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 1:40 p.m. on 07/25/23, the laboratory manager (#1) stated the laboratory had scored less than 80% for CK in Events 2 and 3 in 2023 and Event 2 in 2023; and for total bilirubin in Event 3 in 2022 and Events 1 and 2 in 2023. -- 3 of 3 --

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 the analyte total bilirubin for two consecutive events in 2022-2023 (Event 3-2022 and Event 1-2023), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 total bilirubin for two consecutive events in 2022-2023 (Event 3-2022 and Event 1-2023), resulting in unsuccessful performance. Findings include: 1. Review of 2022-2023 American Proficiency Institute (API) proficiency testing reports on 04/21/23 for the analyte total bilirubin revealed the following results: Total Bilirubin: Event 3-2022 - 60% Sample Lab Results Acceptable Range #11 0.8 2.2 - 3.4 #12 2.4 0.4 - 1.3 #13 1.7 1.7 - 2.7 #14 4.3 3.6 - 5.6 #15 3.1 2.7 - 4.2 Total Bilirubin: Event 1-2023 - 40% Sample Lab Results Acceptable Range #01 0.2 0.2 - 1.1 #02 0.1 0.0 - 0.5 #03 2.9 3.2 - 5.0 #04 0.2 0.6 - 1.5 Sample Lab Results Acceptable Range #05 1.9 2.2 - 3.4 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:50 a.m. on 04/28/23, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 3-2022 and 1-2023 for total bilirubin. -- 2 of 2 --

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 the analyte creatine kinase for two consecutive events in 2022 (Events 2 and 3) and for the analyte lactate dehydrogenase for two of three consecutive events in 2022 (Events 1 and 3), resulting in unsuccessful performance for both analytes. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 creatine kinase (CK) for two consecutive events in 2022 (Events 2 and 3) and for the analyte lactate dehydrogenase (LD) for two of three consecutive events in 2022 (Events 1 and 3), resulting in unsuccessful performance for both analytes. Findings include: 1. Review of 2022 American Proficiency Institute (API) proficiency testing reports on 11/28/22 for the analytes CK and LD revealed the following results: CK: Event 2-2022 - 20% Sample Lab Results Acceptable Range #06 131 145 - 271 #07 20 15 - 29 #08 109 112 - 209 #09 72 75 - 141 #10 137 142 - 265 CK: Event 3-2022 - 40% Sample Lab Results Acceptable Range #11 61 116 - 217 #12 115 56 - 106 #13 94 97 - 182 #14 172 160 - 299 #15 142 133 - 248 LD: Event 1-2022 - 0% Sample Lab Results Acceptable Range #01 326 129 - 194 #02 1978 665 - 983 #03 386 159 - 240 #04 1312 478 - 718 #05 741 281 - 422 LD: Event 3-2022 - 60% Sample Lab Results Acceptable Range #11 345 479 - 720 #12 577 264 - 398 #13 514 413 - 620 #14 820 680 - 1021 #15 694 555 - 833 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:55 a.m. on 11/28/22, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 2 and 3 in 2022 for CK and in Events 1 and 3 in 2022 for LD. -- 2 of 2 --

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 Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte compatibility for two consecutive events in 2022 (Events 1 and 2), resulting in unsuccessful performance. (Refer to D2181) D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 5 -- testing 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 compatibility in two of three consecutive events in 2022 (Events 1 and 2), resulting in unsuccessful performance. Findings include: 1. Review of 2022 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 08/02/22 for the analyte compatibility revealed the following results: Event 1-2022 - 20% Sample Lab Results Acceptable Results #1 not compatible compatible #2 not compatible compatible #3 not compatible compatible #4 not compatible compatible #5 not compatible not compatible Event 2-2022 - 80% Sample Lab Results Acceptable Results #6 not compatible not compatible #7 not compatible compatible #8 not compatible not compatible #9 not compatible not compatible #10 compatible compatible The analyte compatibility requires a score of 100% or greater for satisfactory performance. 2. During interview at 4:30 p.m. on 08/02/22, the laboratory manager (#1) confirmed the laboratory had scored less than 100% for compatibility in Events 1 and 2 in 2022. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation, record review, and staff interview, the laboratory failed to perform required weekly and monthly maintenance on the Vitros XT 3400 chemistry analyzer for 1 of 1 month (July 2022) reviewed. Findings include: 1. Observed at 11: 00 a.m. on 08/03/22, the Vitros XT 3400 analyzer maintenance module, showed the following requirements: "Periodic Maintenance - Weekly W 1. Clean Tip Sealer W 2. Clean Sample Supply W 3.Clean Tip Locator W 4. Clean Dispense Blade and Sensors W 5. Clean Leak Pad W 6. Clean touchscreen monitor and keyboard W 7. Process Vitros MicorSensor Check Fluids I and II Periodic Maintenance - Monthly M 1. Clean PM Discard Chute M 2. Clean/Replace PM Evaporation Caps M 3. Clean PM Incubator Slot and Insert Blade Channels M 4. Clean MicroSensor Cover M 5. Perform System Backup . . ." 2. Reviewed at 11:00 a.m. on 08/03/22, the July 2022 maintenance records for the Vitros XT 3400 chemistry analyzer lacked evidence of weekly and monthly maintenance performance. 3. During interview at 11:10 a.m. on 08/03/22, the laboratory manager (#1) confirmed the laboratory had not documented the performance of weekly and monthly maintenance in July 2022 for the Vitros XT 3400. 4. Reviewed on 08/03/22, the undated manufacturer's maintenance record forms for the Vitros XT 3400 from "Ortho Clinical Diagnostics document: Pub. No. J64191_EN_US Version 2.0" stated, "Weekly Maintenance Log . . . Clean Tip Sealer . . . Clean Sample Supply . . . Clean Tip Locator . . . Clean Dispense Blade and Sensors . . . Clean Leak Pad . . . Clean touchscreen monitor and keyboard . . . Process Vitros MicorSensor Check Fluids I and II . . . Monthly Maintenance Log . . . Clean PM Discard Chute . . . Clean/Replace PM Evaporation Caps . . . Clean PM Incubator Slot and Insert Blade Channels . . . Clean MicroSensor Cover . . . Perform System Backup . . ." -- 2 of 5 -- 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, procedure review, and staff interview, the laboratory failed to ensure documentation of A1 and B cell (reverse blood type) quality control (QC) testing 2 of 6 immunohematology patient testing days (05/23 and 06/20) in May-July 2022. The laboratory performed A1 and B cell testing for two patients on 05/23/22 and 06/20/22. Findings include: 1. Reviewed at 7:30 a.m. on 08/03/22, the May-July 2022 immunohematology patient testing and QC records indicated the laboratory performed A1 and B cell patient testing and failed to document the positive and negative A1 and B cell QC for the following: 05/23/22 Patient #610968 06/20/22 Patient #694385 2. Reviewed on 08/03/22, the procedure "MTS Gel Daily Reagent and Gel Card Quality Control," effective 02/12/13, stated, "Purpose: The purpose of daily quality control (QC) in the blood bank is to confirm the reliability of the test system. . . . Policy: 1. Gel System testing includes Ig [immunoglobulin]G Antibody Detection testing using Screening Cells, Panel Cells or Reverse A1 and B cells. 2. Gel System Quality Control for Antibody Detection Tests is completed each day (24 hours) of patient testing. 3. Gel QC results are reviewed for acceptability before reporting out patient results. . . . 3. During interview at 9:50 a.m. on 08/03/22, the laboratory manager (#1) confirmed the laboratory should perform positive and negative A1 and B cell QC each day of patient testing, and the laboratory did not document performance of positive and negative A1 and B cell QC on two patient testing days in May and June 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 ensure documentation of Immunoglobulin (Ig) M compatibility on 3 of 5 patient compatibility testing days (06/23, 07/09, and 07/29) from May-July 2022. The laboratory performed five patient tests with no IgM compatibility documentation from -- 3 of 5 -- May-July 2022. Findings include: 1. Reviewed at 7:30 a.m. on 08/03/22, the May-July 2022 immunohematology patient logbook failed to include evidence the laboratory performed compatibility testing for IgM antibodies when the antibody screen was negative for the following: 06/23/22 Patient #314787 - one test 07/09/22 Patient #419695 - two tests 07/29/22 Patient #496856 - two tests 2. Reviewed on 05/10/22, the procedure "Immediate Spin Cross Match - MTS Gel Method," effective 02/07/11, stated, "Principle: . . . If no clinically significant antibodies were detected in antibody screen test and there is no record of previous detection of such antibodies or no discrepancy in ABORH [blood group and Rhesus factor] typing, then only serological testing to detect ABO incompatibility is required. Pretransfusion immediate spin compatibility testing combines a potential recipient's serum with RBC [red blood cell] from an intended donor to ensure the recipient and the donor are ABO compatible. Immediate spin cross match testing is performed when the antibody screen is negative. . . ." 3. During interview at 9:50 a.m. on 08/03/22, the laboratory manager (#1) 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. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on observation, record review, procedure review, and staff interview, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory regarding the maintenance of a quality assessment program (refer to D6094). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on observation, record review, procedure review, and staff interview, the laboratory director failed to ensure the maintenance of a quality assessment program to ensure satisfactory performance in proficiency testing (refer to D2181); maintenance performance (refer to D5429); documentation of immunohematology quality control (refer to D5451); and documentation of patient compatibility testing (refer to D5551). Findings include: 1. The laboratory failed to achieve satisfactory performance in proficiency testing for the analyte compatibility in Events 1 and 2 in 2022 resulting in unsuccessful performance (refer to D2181). 2. The laboratory failed to perform required weekly and monthly maintenance on the Vitros XT 3400 chemistry analyzer in July 2022 (refer to D5429). 3. The laboratory failed to ensure documentation of A1 and B cell (reverse blood type) quality control testing on two immunohematology patient testing days in May-July 2022 (refer to D5451). 4. The -- 4 of 5 -- laboratory failed to ensure documentation of Immunoglobulin M compatibility testing on three patient testing days from May-July 2022 (refer to D5551). -- 5 of 5 --

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 Wisconsin State Laboratory of Hygiene and American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte Digoxin for three of four consecutive events in 2021 (Events 2 and 3) and 2022 (Event 2), resulting in subsequent unsuccessful performance. (Refer to D2118) D2118 TOXICOLOGY CFR(s): 493.845(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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 Digoxin in three of four consecutive events in 2021 (Events 2 and 3) and 2022 (Event 2), resulting in subsequent unsuccessful performance. Findings include: 1. Review of 2021 Wisconsin State Laboratory of Hygiene (WSLH) and 2022 American Proficiency Institute (API) proficiency testing reports on 07/26/22 for the analyte Digoxin revealed the following results: WSLH Event 2-2021 - 60% Sample Lab Results Acceptable Range #6 1.0 0.4 - 0.8 #7 1.2 0.7 - 1.1 #8 1.7 1.1 - 1.7 #9 1.5 1.0 - 1.6 #10 1.9 1.4 - 2.0 WSLH Event 3-2021 - 60% Sample Lab Results Acceptable Range #11 2.0 1.3 - 1.9 #12 1.2 1.0 - 1.6 #13 0.9 0.4 - 0.8 #14 1.0 0.7 - 1.1 #15 1.6 1.1 - 1.7 API Event 2-2022 - 60% Sample Lab Results Acceptable Range #6 1.4 1.1 - 1.8 #7 0.7 0.3 - 0.8 #8 3.4 0.8 - 1.3 #9 2.2 0.6 - 1.0 #10 1.3 1.0 - 1.7 The subspecialty of toxicology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 12:05 p.m. on 07/26/22, the laboratory manager (#1) stated the laboratory had scored less than 80% for Digoxin in Events 2 and 3 in 2021 and Event 2 in 2022. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Wisconsin State Laboratory of Hygiene and American Proficiency Institute proficiency testing record review and staff interview, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory regarding the maintenance of a quality assessment program to prevent a third out of four (Event 2 in 2022) unsatisfactory proficiency testing result resulting in subsequent unsuccessful participation in proficiency testing (refer to D6094). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory director failed to ensure the maintenance of a quality assessment program to help prevent unsatisfactory performance in proficiency testing for the analyte Digoxin for the third event (Event 2 in 2022) in four consecutive events in 2021-2022, resulting in subsequent unsuccessful proficiency testing performance. Findings include: 1. Review -- 2 of 3 -- of 2021 Wisconsin State Laboratory of Hygiene (WSLH) and 2022 American Proficiency Institute (API) proficiency testing reports on 07/26/22 for the analyte Digoxin revealed the following results: WSLH Event 2-2021 - 60% Sample Lab Results Acceptable Range #6 1.0 0.4 - 0.8 #7 1.2 0.7 - 1.1 #8 1.7 1.1 - 1.7 #9 1.5 1.0 - 1.6 #10 1.9 1.4 - 2.0 WSLH Event 3-2021 - 60% Sample Lab Results Acceptable Range #11 2.0 1.3 - 1.9 #12 1.2 1.0 - 1.6 #13 0.9 0.4 - 0.8 #14 1.0 0.7 - 1.1 #15 1.6 1.1 - 1.7 API Event 2-2022 - 60% Sample Lab Results Acceptable Range #6 1.4 1.1 - 1.8 #7 0.7 0.3 - 0.8 #8 3.4 0.8 - 1.3 #9 2.2 0.6 - 1.0 #10 1.3 1.0 - 1.7 The subspecialty of toxicology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 12:05 p.m. on 07/26/22, the laboratory manager (#1) stated the laboratory had scored less than 80% for Digoxin in Events 2 and 3 in 2021 and Event 2 in 2022. -- 3 of 3 --

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 Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte Digoxin for two consecutive events in 2021 (Events 2 and 3), resulting in unsuccessful performance. (Refer to D2096) D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 Digoxin in two of three consecutive events in 2021 (Events 2 and 3), resulting in unsuccessful performance. Findings include: 1. Review of 2021 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 11/24/21 for the analyte Digoxin revealed the following results: Event 2-2021 - 60% Sample Lab Results Acceptable Range #6 1.0 0.4 - 0.8 #7 1.2 0.7 - 1.1 #8 1.7 1.1 - 1.7 #9 1.5 1.0 - 1.6 #10 1.9 1.4 - 2.0 Event 3-2021 - 60% Sample Lab Results Acceptable Range #11 2.0 1.3 - 1.9 #12 1.2 1.0 - 1.6 #13 0.9 0.4 - 0.8 #14 1.0 0.7 - 1.1 #15 1.6 1.1 - 1.7 The subspecialty of toxicology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 1:15 p.m. on 11/23/21, the laboratory manager (#1) stated the laboratory had scored less than 80% in Events 2 and 3 in 2021 for Digoxin. -- 2 of 2 --

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 Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte sodium for three of four consecutive events in 2020 (Events 2 and 3) and 2021 (Event 2), resulting in subsequent unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 sodium in three of four consecutive events in 2020 (Events 2 and 3) and 2021 (Event 2), resulting in subsequent unsuccessful performance. Findings include: 1. Review of 2020-2021 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 07/27 /21 for the analyte sodium revealed the following results: Event 2-2020 - 0% Sample Lab Results Acceptable Range #6 153 144 - 152 #7 144 135 - 143 #8 149 140 - 148 #9 165 154 - 162 #10 140 129 - 137 Event 3-2020 - 40% Sample Lab Results Acceptable Range #11 158 149 - 157 #12 136 126 - 134 #13 128 122 - 130 Sample Lab Results Acceptable Range #14 164 152 - 160 #15 149 141 - 149 Event 2-2021 - 60% Sample Lab Results Acceptable Range #6 132 128 - 134 #7 140 134 - 142 #8 155 146 - 154 #9 150 142 - 150 #10 163 154 - 162 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 9:50 a.m. on 07/27/21, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 2 and 3 in 2020 and Event 2 in 2021 for sodium. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory regarding the maintenance of a quality assessment program to prevent a third out of four (Event 2 in 2021) unsatisfactory proficiency testing result resulting in subsequent unsuccessful participation in proficiency testing (refer to D6094). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory director failed to ensure the maintenance of a quality assessment program to help prevent unsatisfactory performance in proficiency testing for the analyte sodium for the third event (Event 2 in 2021) in four consecutive events in 2020-2021, resulting in subsequent unsuccessful proficiency testing performance. Findings include: 1. Review -- 2 of 3 -- of 2020-2021 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 07/27/21 for the analyte sodium revealed the following results: Event 2- 2020 - 0% Sample Lab Results Acceptable Range #6 153 144 - 152 #7 144 135 - 143 #8 149 140 - 148 #9 165 154 - 162 #10 140 129 - 137 Event 3-2020 - 40% Sample Lab Results Acceptable Range #11 158 149 - 157 #12 136 126 - 134 #13 128 122 - 130 #14 164 152 - 160 #15 149 141 - 149 Event 2-2021 - 60% Sample Lab Results Acceptable Range #6 132 128 - 134 #7 140 134 - 142 #8 155 146 - 154 #9 150 142 - 150 #10 163 154 - 162 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 9:50 a.m. on 07/27 /21, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 2 and 3 in 2020 and Event 2 in 2021 for sodium. -- 3 of 3 --

Summary Statement of Deficiencies 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 policy review, record review, and staff interview, the laboratory failed to perform quality control (QC) as stated in their policy for 3 of 3 tests (troponin, creatine kinase-myocardial band [CK-MB], and myoglobin) with Individual Quality Control Plans (IQCPs). The laboratory performed approximately 350 patient tests for troponin, CK-MB, and myoglobin in March, July, August, and October 2020 when the laboratory failed to perform monthly QC. Findings include: 1. Reviewed at 9:30 a. m. on 01/27/21, the IQCP for Biosite Triage (including troponin, CK-MB, and myoglobin), approved 7/14/16, stated, ". . . Final QCP [quality control plan] for Biosite Triage Based on the IQCP, assessment we feel that monthly QC or with each new shipment, whichever is more frequent will be satisfactory for our facility. . . ." 2. Review of the 2020 Biosite Triage QC records indicated the laboratory failed to perform external QC monthly for troponin, CK-MB, and myoglobin during the following months: March, July, August, and October. 3. Upon request on 01/27/21, the laboratory failed to provide additional evidence of external QC performance for the Biosite Triage tests in March, July, August, and October 2020. 4. During interview at 9:50 a.m. on 01/27/21, the laboratory supervisor (#1) confirmed the laboratory expected monthly external QC performance on the Biosite Triage tests, and the 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 -- laboratory did not have evidence of external QC for troponin, CK-MB, and myoglobin during March, July, August, and October 2020. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review, policy review, and staff interview, the laboratory failed to monitor the postanalytic system for 1 of 1 year reviewed (2020). Findings include: 1. Reviewed at 4:15 p.m. on 01/26/21, the 2020 quality assessment records lacked evidence of postanalytic system monitoring in 2020. 2. Reviewed on 01/26/21, the undated policy "Quality Assurance and Improvement" stated, ". . . Purpose 2. Shall be an ongoing project . . . encompassing all areas of laboratory function. . . ." 3. During interview at 10:00 a.m. on 01/27/21, the laboratory supervisor (#1) confirmed the laboratory had not performed postanalytic monitoring in 2020. 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 observation, record review, staff interview, and manufacturer's instructions review, the laboratory failed to use the correct mean normal protime (PT) value for calculating International Normalized Ratios (INRs) for 13 of 13 days (January 15-27, 2021) since the laboratory began using a new lot number of innovin reagent on their coagulation analyzer. The laboratory performed approximately 14 tests during this timeframe. Findings include: 1. Observation of the Sysmex CA-600 coagulation analyzer at 9:50 a.m. on 01/27/21 revealed a mean normal PT value of 9.9 used to calculate patient INRs. 2. Reviewed at 9:55 a.m. on 01/27/21, the undated data used to determine the mean normal PT for the new lot number of innovin reagent lacked evidence the laboratory calculated the value of the mean normal PT. 3. During interview at 9:55 a.m. on 01/27/21, the laboratory supervisor (#1) confirmed the laboratory started using the new lot number of innovin reagent for patient testing on 01 /15/21. The laboratory supervisor (#1) confirmed the laboratory did not have evidence of the mean normal PT calculation using the new lot number of innovin and confirmed 9.9 would not be an accurate value for the data collected using the new lot number of innovin. 4. Reviewed on 01/27/21, the Siemens CA-600 operator's instructions, dated 01/2013, stated, "XIV. Reagent Lot Roll-Over Studies . . . I. Verification of the Reference Range A. 20 Normal Individuals B. Assay samples on . . . new lot number reagents . . . C. Calculate mean . . . D. MNPT [Mean Normal PT] for INR calculation must be the geometric mean. . . . To 'go live' with the new lot numbers, follow these steps: . . . 2. Input the new . . . Mean Normal PT: . . . - Use the mean normal PT obtained from a minimum of 20 normal samples tested on new lot of reagent. . . ." -- 2 of 3 -- D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (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, policy review, and staff interview, the technical supervisor failed to include immunohematological testing in the annual competency evaluations for 8 of 8 sampled testing personnel (#1 - #8) in 2020. Findings include: 1. Reviewed at 3:15 p.m. on 01/26/21, the 2020 competency evaluation records for Testing Personnel #1 - #8 lacked evidence of completed competency evaluations for immunohematological testing (blood type, antibody screen, and compatibility). 2. Reviewed at 4:00 p.m. on 01/26/21, the policy "Assessment for Personnel," revised 04 /08/19, stated, "Purpose: The Clia [sic] '88 requires that the laboratory establish and maintain a mechanism to evaluate and demonstrate comptency in test performance of each person who performs a clinical diagnostic test. . . . Interval: . . . 4. Annually thereafter. . . ." 3. During interview at 8:30 a.m. on 01/27/21, the laboratory supervisor (#1) confirmed the competency evaluations for Testing Personnel #1 - #8 in 2020 did not include immunohematological testing. -- 3 of 3 --

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 Wisconsin State Laboratory of Hygiene proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte sodium for two consecutive events in 2020 (Events 2 and 3), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 sodium in two of three consecutive events in 2020 (Events 2 and 3), resulting in unsuccessful performance. Findings include: 1. Review of 2020 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports on 10/20/20 for the analyte sodium revealed the following results: Event 2-2020 - 0% Sample Lab Results Acceptable Range #6 153 144 - 152 #7 144 135 - 143 #8 149 140 - 148 #9 165 154 - 162 #10 140 129 - 137 Event 3-2020 - 40% Sample Lab Results Acceptable Range #11 158 149 - 157 #12 136 126 - 134 #13 128 122 - 130 Sample Lab Results Acceptable Range #14 164 152 - 160 #15 149 141 - 149 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 2:10 p.m. on 10/19/20, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 2 and 3 in 2020 for sodium. -- 2 of 2 --

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 record review, staff interview, and policy review, the laboratory failed to ensure the laboratory director and/or testing personnel signed the attestation statements for 18 of 18 (2-2017, 3-2017, and 1-2018 for bacteriology, aterial blood gases, coagulation/hematology, cardiac markers, blood banking, and chemistry /endocrinology/toxicology) proficiency testing events reviewed from the second event 2017 through the first event 2018. Findings include: 1. Reviewed at 1:45 p.m. on 06/05 /18, the second event 2017 through the first event 2018 proficiency testing records lacked evidence the laboratory director or qualified designee signed the proficiency testing attestation statements for the following eighteen events: 2-2017, 3-2017, and 1- 2018 for bacteriology, aterial blood gases, coagulation/hematology, cardiac markers, blood banking, and chemistry/endocrinology/toxicology. These records lacked evidence the testing personnel signed the proficiency testing attestation statements for the following three events: 2-2017 blood banking, 1-2018 bacteriology, and 1-2018 cardiac markers. 2. During an interview at 4:20 p.m. on 06/05/18, a general supervisor (#1) confirmed the laboratory director or qualified designee and/or testing personnel had not signed the eighteen proficiency testing attestation statements listed above. 3. Reviewed at 11:30 a.m. on 06/06/18, the undated policy "0610.01 Proficiency Testing Procedure," stated, ". . . Procedure: . . . Step 5 . . . Sign attestation statement, if applicable. . . ." D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 and staff interview, the laboratory failed to twice annually verify the accuracy of 1 of 3 non-regulated microscopy analytes (sperm absence /presence) in 2017. The laboratory performed two patient tests for sperm absence /presence in 2017. Findings include: 1. Reviewed at approximately 1:40 p.m. on 06/05 /18, the laboratory's test menu listed post vas semen analysis (sperm absence /presence) available for patient testing. 2. Reviewed at approximately 1:45 p.m. on 06 /05/18, the 2017 proficiency testing records indicated the laboratory did not participate in proficiency testing for sperm absence/presence. 3. Upon request on 06/06 /18, the laboratory failed to provide evidence of twice annual accuracy verification for sperm absence/presence in 2017. 4. During interview at approximately 10:45 a.m. on 06/06/18, a general supervisor (#1) confirmed the laboratory performed post vas semen analysis (sperm absence/presence) patient testing in 2017 and did not twice annually verify the accuracy. 5. Upon request on 06/06/18, the laboratory failed to provide a policy requiring twice annual accuracy verification for post vas semen analysis (sperm absence/presence). 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 record review and staff interview, the laboratory failed to verify calibration for 4 of 7 analytes (CK-MB [creatine kinase-muscle and brain subunits], troponin, myoglobin, and Prostate Specific Antigen [PSA]) calibrated with less than three calibrators at least once every six months in 2017. Findings include: 1. Reviewed at approximately 4:45 p.m. on 06/05/18, the 2017-2018 calibration records indicated the laboratory used less than three levels of calibrator to calibrate CK-MB, troponin, and -- 2 of 5 -- myoglobin on the Biosite Triage Meter Plus chemistry analyzer. 2. Reviewed at approximately 4:50 p.m. on 06/05/18, the 2017 calibration verification records lacked evidence the laboratory verified calibration of CK-MB, troponin, and myoglobin in 2017. 3. Reviewed at approximately 10:35 a.m. on 06/06/18, the 2017-2018 calibration records indicated the laboratory used less than three levels of calibrator to calibrate PSA on the TOSOH chemistry analyzer. 4. Reviewed at approximately 10: 40 a.m. on 06/06/18, the 2017 calibration verification records lacked evidence the laboratory verified calibration of PSA the first six months of 2017. 5. During interview at approximately 10:45 a.m. on 06/06/18, a general supervisor (#1) confirmed the laboratory did not perform calibration verification at least once every six months for PSA, CK-MB, troponin, and myoglobin in 2017. 6. Upon request on 06 /06/18, the laboratory failed to provide a policy requiring calibration verification at least once every six months. 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, staff interview, and policy review, the laboratory failed to perform a positive and negative control each day of patient testing for 3 of 3 patient testing days in May 2018 (05/03, 05/07, and 05/09) for serum pregnancy. The laboratory performed five serum pregnancy patient tests during this timeframe. Findings include: 1. Reviewed at 5:05 p.m. on 06/05/18, the May 2018 serum pregnancy quality control (QC) records lacked evidence the laboratory performed a negative and positive control on three patient testing days (05/03, 05/07, and 05/09). 2. During interview at approximately 5:10 p.m. on 06/05/18, a general supervisor (#1) stated the laboratory should perform positive and negative external QC each day of patient testing and failed to on 05/03/18, 05/07/18, and 05/09/18. 3. Reviewed on 06 /06/18, the policy "Quality Control Frequency and QC Material," dated 05/23/06, stated, ". . . Qualitative Pregnancy Once per lot . . ." The policy failed to require QC performance each day of patient testing for qualitative serum pregnancy. 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 policy review, the laboratory failed to perform quality control (QC) testing each day of immunohematologic patient testing -- 3 of 5 -- for 2 of 8 patient testing days in February-March 2018 (02/01/18 and 03/06/18). Findings include: 1. Reviewed at approximately 7:30 a.m. on 06/06/18, the February- March 2018 patient testing and QC records indicated the laboratory did not perform QC on the following immunohematologic patient testing days: 02/01/18 Patient #53848 - Blood type and antibody screen 03/06/18 Patient #1063755 - Blood type 2. During interview at approximately 8:55 a.m. on 06/06/18, a general supervisor (#1) confirmed the laboratory did not document results of QC testing on 02/01/18 and 03 /06/18. 3. Review of the laboratory's immunohematologic policies occurred at 9:00 a. m. on 06/06/18. The policy "ABO and RH Testing Patient Samples Using MTS [Micro Typing Systems] Gel Method," dated 02/07/11, stated, ". . . Quality Control: Quality Control will be performed each day (24 hours) patient samples are to be tested. . . ." The policy "Gel IGG [Immunoglobulin G] Antibody Screen Testing," dated 02/07/11, stated, ". . . Quality Control: 1. Gel Card - To confirm the specificity and reactivity of the MTS Anti-IgG Card each lot is tested on each day of use with known positive and negative antibody samples with the appropriate red blood cells. . . ." D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, staff interview, and policy review, the laboratory failed to perform quality control (QC) for 1 of 1 microbiology reagents (potassium hydroxide [KOH]) before use. The laboratory performed approximately 50 patient tests using KOH reagent in 2017. Findings include: 1. Observation of the laboratory on 06/06/18 at approximately 10:55 a.m. revealed KOH reagent, lot number 1711407, available for patient testing. 2. Upon request at approximately 10:55 a.m. on 06/06/18, the laboratory failed to provide evidence of performing QC for KOH reagent lot number 1711407. 3. During interview at approximately 10:55 a.m. on 06/06/18, a general supervisor (#1) confirmed the laboratory had used KOH reagent for patient testing and had not performed QC on the KOH reagent. 4. Reviewed on 06/06/18, the policy "Quality Control Frequency and QC Material," dated 05/23/06, failed to include QC requirements for KOH reagent. 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 -- 4 of 5 -- (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 review, the laboratory failed to test patients for Immunoglobin (Ig) M compatibility for 6 of 6 compatibility tests (2 on 09/23/17, 2 on 09/26/17, and 2 on 01/31/18) performed for Patient #258692 in September 2017 and January 2018. Findings include: 1. Reviewed at approximately 7: 30 a.m. on 06/06/18, the test records for Patient #258692 indicated the laboratory did not perform IgM (ABO) compatibility testing for 2 units on 09/23/17, 2 units on 09/26 /17, and 2 units on 01/31/18. 2. During interview at approximately 8:55 a.m. on 06/06 /18, a general supervisor (#1) confirmed the laboratory did not document results of immediate spin compatibility testing for Patient #258692. 3. Reviewed at 9:00 a.m. on 06/06/18, the policy "Immediate Spin Cross Match MTS [Micro Typing Systems] Gel Method," dated 02/07/11, stated, "Principle: . . . Pretransfusion immediate spin compatibility testing combines a potential recipient's serum with RBC from an intended donor to ensure the recipient and the donor are ABO compatible. . . ." -- 5 of 5 --