Lucas County Health Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List and Annual Volume form, lack of proficiency testing records and confirmed by interview with general supervisor #1 (GS #1) at 8:47 am on 4/23/2025, the laboratory failed to verify the accuracy twice annually for heroin testing for four out of four time periods from 1/1/2023 - 12/31 /2024. The findings include: 1. The laboratory performed non-waived heroin testing. Refer to D5423. 2. GS #1 confirmed the laboratory did not verify the accuracy of heroin testing twice annually in 2023 or 2024. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by interview with the general supervisor identifier #1 (GS #1) at approximately 8:47 am on 4/23/2025, the laboratory failed to document

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10: 30 am on 04/25/2023, the laboratory failed to perform a self evaluation when the laboratory received 24 ungraded PT scores from five out of seven PT testing events from 01/01/2021- 04/25/2023. The findings include: 1. For 2021 testing event 2, the laboratory received ungraded PT test scores for the following: *Q2 Chemistry 2021: Acetaminophen (specimens 6-10) 2. For 2021 testing event 3, the laboratory received ungraded PT test scores for the following: *Q3 Chemistry 2021: Acetaminophen (specimens 11-15) and troponin T (specimen 15) 3. For 2022 testing event 1, the laboratory received ungraded PT test scores for the following: *Q1 Chemistry 2022: Troponin T (specimens 2, 4, and 5) *Q1 Non-Chemistry 2022: Direct antiglobulin test (specimen 2) 4. For 2022 testing event 2, the laboratory received ungraded PT test scores for the following: *Q2 Chemistry 2022: Acetaminophen (specimens 6-10) and troponin T (specimen 9) 5. For 2022 testing event 3, the laboratory received ungraded PT test scores for the following: *Q3 Chemistry 2022: Troponin T (specimens 13 and 14) *Q3 Non-Chemistry 2022: Compatibility testing (specimen 14) 6. At the time of the survey, the laboratory did not have additional documentation or

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:30 am on 6/8/2021, the laboratory failed to perform a self evaluation of ungraded PT scores for four out of six PT testing events from 1/1/2019 - 12/31/2020. The findings include: 1. For 2019 testing event 1, the laboratory received ungraded PT test scores for the following: *opiates, sample 1 2. For 2020 testing event 1, the laboratory received ungraded PT test scores for the following: *total creatine kinase, sample 1 *acetaminophen, sample 1 *unexpected antibody identification, sample 4 3. For 2020 testing event 2, the laboratory received ungraded PT test scores for the following: *albumin, samples 1 - 5 *unexpected antibody identification, sample 6 *compatibility testing, sample 6 4. For 2020 testing event 3, the laboratory received ungraded PT test scores for the following: *manual white blood cell identification, sample 11 5. At the time of the survey, the laboratory did not perform a self evaluation for the ungraded PT test scores. 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 3 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the Laboratory Test List & Annual Volume list and confirmed by testing identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 6/08/21, the laboratory failed to verify the accuracy of the analyte, procalcitonin twice annually for three out of three time periods from 1/1/2020 - 6/8/2021. At the time of the survey, the laboratory did not enroll in proficiency testing for procalcitonin and they did not verify the accuracy of the testing by another method from 1/1/2020 - 6/8/2021. 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 review of Clostridium difficile Individualized Quality Control Plan (IQCP), quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:45 pm on 6/8/2021, the laboratory failed to perform QC for one out of one lot number of Clostridium difficile test kits in February 2021. The findings include: 1. The Clostridium difficile IQCP plan states that external QC will be performed with each new lot and/or shipment of test kits. 2. Patient identifier A had Clostridium difficile testing performed on 2/27 /2021 using lot number 7120OSMO80 and expiration date 11/25/21 of test kit. 3. At the time of the survey, the laboratory did not have external QC records for lot number 7120OSMO80 of Clostridium difficile test kit. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of performance specification and calibration verification records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:45 pm on 6/8/2021, the laboratory director failed to ensure that the performance specification and calibration verification procedures are adequate to determine accuracy, precision and reportable range on the Roche Cobas chemistry analyzer from 11/1/2019 - 6/8/2021. The findings include: 1. The laboratory verified the performance specifications for the new Roche Cobas chemistry analyzer in November of 2019. 2. The laboratory performed calibration verification -- 2 of 3 -- procedures on the Roche Cobas chemistry analyzer on 4/14/2020 and 10/6/2020. 3. At the time of the survey, the laboratory director failed to ensure that the performance specification and calibration verification procedures are adequate. The records did not indicate they had been reviewed by the laboratory director or other laboratory staff. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 testing records and reports, the laboratory fails to successfully participate in a proficiency testing program for the subspecialty, toxicology, for two consecutive testing events: 2020 events 2 and 3 (refer to D2119). D2119 TOXICOLOGY CFR(s): 493.845(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and reports, the laboratory fails to achieve an overall testing event score of satisfactory performance for two consecutive testing events for the subspecialty, toxicology. The laboratory received unsatisfactory performance scores of 50% for 2020 testing event 2 and 70% for 2020 testing event 3 for the subspecialty, toxicology. -- 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 out of three consecutive testing events: 2019 event 2 and 2020 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 three consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 80% for 2019 testing event 2 and 80% for 2020 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of Sysmex XN-550 performance specification records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:15 pm on 03/05/2019, the laboratory failed to perform the performance specification of accuracy for one out of one new test system (Sysmex XN-550) implemented in 2017. The findings include: 1. The laboratory began performing patient testing on the Sysmex XN-550 in November 2017. 2. The laboratory performed and documented the performance specifications of precision, reportable range, and verification of reference intervals for the Sysmex XN-550. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform and document the performance specification of reportable range for the Sysmex XN-550 hematology instrument. 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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, creatine kinase isoenzyme (CK-MB) for two out of three consecutive proficiency testing events: 2018 events 1 and 3 (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 review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, creatine kinase isoenzyme (CK- MB), for two out of three testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2018 testing events 1 and 3. -- 2 of 2 --