Compass Memorial Healthcare

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 review of American Proficiency Institute (API) and WSLH proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 7:38 am on 6/4/2024, the laboratory director or designee failed to attest to the routine integration of PT samples into the patient workload by signing PT attestation statements for four out of five PT events from 08 /09/2022 - 6/4/2024. The findings include: 1. For 2022 event 3 - the laboratory director or designee failed to sign the API microbiology, API core chemistry, API immunohematology/immunology, API hematology/coagulation and WSLH bacteriology PT attestation statements. 2. For 2023 event 1 - the laboratory director or designee failed to sign the API microbiology, API immunohematology/immunology, and WSLH immunology attestation statements. 3. For 2023 event 2 - the laboratory director or designee failed to sign the API hematology/coagulation, API miscellaneous chemistry, and API immunohematology/immunology attestation statements. 3. For 2023 event 3 - the laboratory director or designee failed to sign the API microbiology attestation statement. 4. At the time of the survey, the laboratory director or designee did not sign the above PT attestation statements. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- 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 -- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) and WSLH proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 7:38 am on 6/4/2024, the laboratory failed to evaluate the accuracy of ungraded PT analytes for four out of five PT events from 8/9 /2022 - 6/04/2024. The findings include: 1. For 2023 event 1 - the laboratory did not evaluate the ungraded analyte API respiratory panel sample RSP-04. 2. For 2023 event 2 - the laboratory did not evaluate the ungraded analyte WSLH bacteriology antimicrobial susceptibility testing sample UC-10. 3. For 2023 event 3 - the laboratory did not evaluate the ungraded analytes API vaginal wet prep sample VA-03, WSLH bacteriology antimicrobial susceptibility testing sample UC-15, and API compatibility sample SER-12. 4. For 2024 event 1 - the laboratory did not evaluate the ungraded analytes API total bilirubin samples CH-02, CH-03 and CH-05 and lipase samples CH-01, CH-02, CH-03, CH-04 and CH-05. 5. At the time of the survey, the laboratory had not evaluated the accuracy of the above ungraded PT results. -- 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: A. Based on review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, total bilirubin for two consecutive proficiency testing events: 2022 testing event 3 and 2023 testing event 1 (refer to D2096). B. Based on review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, bacteriology, for two out of three consecutive proficiency testing events: 2022 testing events 1 and 3 (refer to D2028). D2028 BACTERIOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 review of proficiency testing reports and records, the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for the subspecialty, bacteriology (Wisconsin State Laboratory of Hygiene - WSHL). The laboratory received WSHL unsatisfactory performance scores zero for 2022 testing event 1 and 63% for 2022 testing event 3 for the subspecialty, bacteriology. 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 review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, total bilirubin, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 20% for 2022 testing event 3 and zero for 2023 testing event 1. -- 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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, general immunology and the analyte, anti-human immunodeficiency virus (HIV), for two consecutive testing events: 2020 event 3 and 2021 event 2 (refer to D2084 and D2085). D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, anti-human immunodeficiency virus (HIV), for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2020 testing event 3 and 40% for 2021 testing event 2. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of proficiency testing (PT) reports and records, the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for the subspecialty, general immunology. The laboratory received unsatisfactory performance scores of zero for 2020 testing event 3 and 40% for 2021 testing event 2 for the subspecialty, general immunology. -- 2 of 2 --

Summary Statement of Deficiencies D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of 2020 event 2 proficiency testing (PT) records for compatibility testing and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report CMS-209) at approximately 2:00 pm on 10/13/2020, the laboratory failed to take and document remedial action, including, but not limited to, appropriate training and technical assistance necessary to correct problems associated with the PT failure for compatibility testing for one out of one event (2020 event 2). The findings include: 1. For 2020 event 2, the laboratory received an unsatisfactory PT score of 80 percent (%) for compatibility testing. 2. Review of PT records revealed that the laboratory did not take and document remedial action to correct the problems associated with the PT failure. 3. Laboratory personnel identifier #1 confirmed that the laboratory did not take and document remedial action to correct the problems associated with the PT failure. 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. 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 review of proficiency testing (PT) records from 2018-2020, the laboratory test menu and annual volumes form and interview with laboratory personnel identifier #1 (refer to the Form CMS-209, Laboratory Personnel Report), at approximately 1:50 pm on 10/13/2020, the laboratory failed to verify the accuracy of the analyte, C- reactive protein (CRP), at least twice annually for 3 out of 4 time periods from 01/01 /2018-12/31/2019. The findings include: 1. According to the laboratory's test menu and volume form and confirmed by laboratory personnel identifier #1, the laboratory performed CRP testing during 2018-2020. 2. Laboratory personnel identifier #1 stated that in June 2018, the laboratory changed test methods and, at that time, stopped its enrollment in a proficiency testing program. 3. Laboratory personnel identifier #1 confirmed that the laboratory did not verify the accuracy of CRP testing from June 2018 through December 31, 2019. -- 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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for two consecutive testing events: 2018 event 3 and 2019 event 1 (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 2 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for two out of two testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 80 percent (% ) for 2018 testing event 3 and 80% for 2019 testing event 1. -- 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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), at approximately 10:00 am on 6/20/2018; the laboratory director failed to attest to the routine integration of PT samples into the patient workload for four out of five proficiency testing events (2017 events 1, 2, and 3 and 2018 event 1) from 1/1/2017 - 6/20/2018. The findings include: 1. For 2017 testing event 1, the laboratory director did not sign the bacteriology attestation statement. 2. For 2017 testing event 2, the laboratory director did not sign the non-chemistry, chemistry, and bacteriology attestation statements. 3. For 2017 testing event 3, the laboratory director did not sign the bacteriology attestation statement. 4. For 2018 testing event 1, the laboratory director did not sign the non-chemistry and chemistry attestation statements. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of patient compatibility records, the Ortho Anti-Human Globulin 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 -- Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 6/20/2018; the laboratory failed to meet immunohematology requirements for ensuring the laboratory performs compatibility testing following 21 CFR 606.151(a) through (e) as specified in D5551. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the Ortho immunohematology performance specification records, immunohematology procedures and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 6/20/18, the laboratory failed to establish a function check policy for the Ortho immunohematology dispenser, including the frequency for performing volume checks. The laboratory also failed to perform a volume check on the Ortho dispenser from 3/1/2017 - 6/20/2018. The findings include: 1. The laboratory implemented the Ortho immunohematology test system to perform unexpected antibody detection and compatibility testing in March 2017. 2. The laboratory used the Ortho dispenser to deliver specific volumes of diluent when performing immunohematology procedures. 2. At the time of the survey, the laboratory did not have a policy for performing volume checks on the Ortho dispenser. In addition, the laboratory had not performed a volume check on the dispenser since its implementation. 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 review of patient compatibility records, the Ortho Anti-Human Globulin Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on -- 2 of 3 -- 6/20/2018, the laboratory failed to perform compatibility testing using procedures that demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type for two out of two patients (Patient identifiers A and B) performed in March 2018. The findings include: 1. Patient identifier A had compatibility testing performed on four units of packed red blood cells on 3/18/2018. 2. Patient identifier B had compatibility testing performed on two units of packed red blood cells on 3/26 /2018. 3. The laboratory performed the compatibility testing on both patients using Ortho Anti-Human Globulin Anti-IgG gel cards. 4. The manufacturer's package insert for the Ortho Anti-Human Globulin Anti-IgG gel cards stated, "IH-Card Anti-IgG consists of six microtubes containing a gel impregnated with rabbit polyclonal antihuman globulin AHG IgG that does not contain antibodies to complement components. The Anti-IgG is light chain specific (sera from hyperimmunised rabbits) and thus may also agglutinate IgA or IgM antibodies." 5. At the time of the survey, the laboratory did not perform compatibility testing using a method that specifically demonstrated incompatibility for IgM antibodies between the donor's cell type and the recipient's serum or plasma. -- 3 of 3 --