Wayne County Hospital

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 interview with General Supervisor #1 (GS #1) at 10:15 am on 03/12/2025, the laboratory director failed to attest to the routine integration of PT samples into the patient workload for five out of six PT events from 01/01/2023 - 12/31/2024. The findings include: 1. For 2023 event 1, the laboratory director did not sign the Miscellaneous Chemistry and Core Chemistry PT attestation statements. 2. For 2023 event 2, the laboratory director did not sign the Immunology/Immunohematology and Hematology/Coagulation PT attestation statements. 3. For 2024 event 1, the laboratory director did not sign the the Miscellaneous Chemistry, Immunology/Immunohematology, and Hematology /Coagulation PT attestation statements. 4. For 2024 event 2, the laboratory director did not sign the Miscellaneous Chemistry, Immunology/Immunohematology, and Hematology/Coagulation PT attestation statements. 5. For 2024 event 3, the laboratory director did not sign the Hematology/Coagulation attestation statement. 6. At the time of the survey, GS #1 confirmed the laboratory director did not sign the PT attestation statements listed above. 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 the Laboratory Test List and Annual Volume form, proficiency testing records, and confirmed by interview with general supervisor #1 (GS #1) at 10: 15 am on 03/12/2025, the laboratory failed to verify the accuracy of the direct antiglobulin test (DAT) and procalcitonin testing twice annually for three out of three time periods from 01/01/2024 - 03/12/2025. The findings include: 1. The Laboratory Test List and Annual Volume form listed DAT and procalcitonin testing as testing performed by the laboratory. 2. At the time of the survey, GS #1 confirmed the laboratory did not enroll in proficiency testing or perform twice annual accuracy testing for DAT and procalcitonin testing by another method from 01/01/2024- 03/12 /2025. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records and confirmed by interview with General Supervisor #1 (GS #1) at 1:00 pm on 03/12/2025, the laboratory failed to perform two levels of QC at least once each day of patient testing for one out of 30 days of patient testing reviewed from 11/01/2024- 11/30/2024. The findings include: 1. The laboratory performed chemistry testing on the Ortho Vitros 7600 instrument. 2. Review of the Ortho Vitros 7600 QC records revealed that the laboratory only performed level two QC for sodium on 11/08/2024. 3. The laboratory performed and reported 32 patient sodium results on 11/08/2024. 4. At the time of the survey, GS #1 confirmed the laboratory failed to perform two levels of QC at least each day of patient testing for one out of 30 days of patient testing reviewed from 11 /01/2024- 11/30/2024. D5783

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 confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 4 /14/2023, the laboratory failed to successfully participate in a proficiency testing program for the analyte, albumin for two consecutive proficiency testing events: 2022 event 3 and 2023 event 1 (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 review of proficiency records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 4 /14/2023, the laboratory failed to achieve satisfactory performance for the analyte, albumin, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 3 and 2023 testing event 1. D5783

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the Indirect Antiglobulin Testing (Antibody Screen) procedure and patient antibody screen records and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 3:00 pm on 10/4/2022, the laboratory failed to follow the laboratory's Indirect Antiglobulin Testing (Antibody Screen) procedure for one out of four patients who had a positive antibody screen from 1/1/2022 - 10/4/2022. The findings include: 1. The Indirect Antiglobulin Testing (Antibody Screen) procedure states, "Investigate any result that is interpreted as positive....Refer specimen to the blood center for antibody investigation and antibody identification. Request an antibody titer if appropriate (e.g. Anti-D in a pregnant patient)." 2. On 9/7/2022, patient identifier A had ABO grouping, D(Rho) typing and an antibody screen performed. The laboratory received a positive results for the antibody screen. 3. The laboratory did not follow the procedure and refer the specimen to the blood center for antibody investigation and antibody identification. 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 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 10/4/2022, the laboratory failed to perform two levels of QC for one out of 34 days of patient testing for the analyte, cholesterol from 9/1/22 - 10/4/2022. The findings include: 1. On 9/26/2022, the laboratory ran level 1 and level 3 of QC on the chemistry analzyer. 2. For the analyte cholesterol, the laboratory received an error, "No result". 3. The laboratory reran level 1 QC, but did not rerun level 3 QC. 4. Laboratory personnel #1, confirmed the laboratory only performed one level of QC for the analyte, cholesterol on 9/26/2022. 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 review of personnel records and confirmed by testing personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 4:00 pm on 10 /4/2022; the laboratory director failed to meet the responsibilities for the overall operation and administration of the laboratory by ensuring that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results (refer to D6102). D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifiers #1 and #2 (refer to Laboratory Personnel Report) at approximately 4:00 pm on 10/04/2022, the laboratory director failed to ensure that prior to testing patient specimens, all testing personnel received the appropriate training for four out of 35 testing personnel. The findings include: 1. Since the last survey on 05/24/2021, the laboratory hired laboratory personnel identifiers #3, #4, #5, and #6. 2. Laboratory personnel #1 and #2 confirmed that identifiers #3 - #6 all performed patient testing. 3. At the time of the survey, the laboratory did not have training records available for testing personnel identifier #3 - #6. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 05/24/2021, the laboratory failed to retain hematology complete blood count (CBC) QC records for 12 out of 12 lot numbers of QC and 122 out of 122 days from 08/31/2020- 12/30/2020. The findings include: 1. The laboratory performed three levels of CBC QC for each 24-hour period of patient testing on the Beckman Coulter DXH 600 hematology instrument. 2. At the end of use for each lot number, the laboratory printed the QC files stored on the hematology instrument and kept them as documentation of QC results. The laboratory also submitted QC data to Beckman Coulter's Interlaboratory Quality Assurance Program (IQAP) at the same time. 3. The laboratory's IQAP records indicated that the following lot numbers were used between 08/31/2020 and 09/27/2020: 123173290 (low); 133183290 (normal); and 143193290 (high). 4. The laboratory's IQAP records indicated that the following lot numbers were used between 09/27/2020 and 10/25/2020: 123173330 (low); 133183330 (normal); and 143193330 (high). 5. The laboratory's IQAP records indicated that the following lot numbers were used between 10/25/2020 and 11/22 /2020: 123173380 (low); 133183370 (normal); and 143193380 (high). 6. The laboratory's IQAP records indicated that the following lot numbers were used between 11/22/2020 and 12/30/2020: 123173440 (low); 133183430 (normal); and 143193440 (high). 7. Review of printed QC records revealed that the laboratory did not have QC records from 08/31/2020- 12/30/2020. 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 -- 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 lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:15 pm on 05/24/2021, the laboratory failed to perform a positive and negative control each day of patient testing for the Cardinal Health serum human chorionic gonadotropin (HCG) qualitative test system. The findings include: 1. The laboratory performed controls with each new lot and shipment of Cardinal Health serum HCG tests. 2. Laboratory personnel identifier #2 indicated that the laboratory intended to follow the manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the Cardinal Health serum HCG qualitative test system. -- 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, sodium, for two consecutive proficiency testing events: 2018 events 1 and 2 (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 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 reports and records, the laboratory fails to achieve satisfactory performance for the analyte, sodium, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2018 testing events 1 and 2. -- 2 of 2 --