Lost Rivers Medical Center

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the Wisconsin State Laboratory of Hygiene (WSLH) and an interview with the laboratory manager on 11/7/2024, the laboratory director or designee failed to sign PT attestations in 2023 and 2024. The findings include: 1. A review of PT documents from WSLH for 2023 identified that the laboratory director or designee failed to sign the attestation statements for chemistry/endocrinology/toxicology event two and three, hematology event three, blood gas event three and immunology event three. 2. A review of PT documents from WSLH for 2024 identified that the laboratory director or designee failed to sign the attestation statements for microbiology event one, blood gas event one, immunohematology event one, coagulation event one, chemistry/endocrinology /toxicology event two, blood gas event two and immunology event three. 3. An interview with the laboratory manager on 11/7/2024 at 9:30 am confirmed that the laboratory director or designee failed to sign the above attestation statements. 4. The laboratory reports performing 279,013 tests annually. 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 -- 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 a review of the Cepheid GeneXpert maintenance logs and an interview with the laboratory manager on 11/7/2024, the laboratory failed to perform quarterly maintenance as required by the manufacturer in 2023 and 2024. The findings include: 1. A review of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform the quarterly maintenance (disinfection of the cartridge bay interior and the plunger rod) three of four quarters in 2023 and three of four quarters in 2024 as required by the manufacturer. 2. An interview with the laboratory manager on 11/7 /2024 at 12:58 pm confirmed that quarterly disinfection of the Cepheid GeneXpert was not performed as required by the manufacturer. 3. The laboratory reports performing 1,140 tests annually on the Cepheid. 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 a lack of Quality Control (QC) records and an interview with the laboratory manager on 11/7/2024, the laboratory failed to successfully perform two levels of QC each day of use for the Ortho Vitros 5600 in 2022. The findings include: 1. A lack of QC documents for the Ortho Vitros 5600 on 12/27/2022 identified that the laboratory failed to perform at least two levels of QC for each chemistry, endocrinology and immunology analyte on 12/27/2022. 2. A review of patient testing records from 12/27 /2022 identified 43 patient samples tested on the Ortho Vitros 5600. 3. An interview with the laboratory manager on 11/7/2024 at 11:44 am confirmed that there was no QC for the 43 patient samples tested on 12/27/2022. 4. The laboratory reports performing 208,810 tests on the Ortho Vitros 5600 annually. 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. -- 2 of 3 -- (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 a record review of immunohematology quality control (QC), patient test reports and an interview with the laboratory manager on 11/7/2024, the laboratory failed to document control results for immunohematology testing in 2023. The findings include: 1. A review of immunohematology QC for 2023 and 2024 identified that the laboratory failed to document QC on 3/8/2023 for ABO grouping, Rh typing, and unexpected antibody detection. 2. A review of patient test reports identified ABO grouping, Rh typing, and unexpected antibody detection was performed on one patient (203135) on 3/8/2023. 3. An interview with the laboratory manager on 11/7/2024 at 3: 53 pm confirmed the above findings. 4. The laboratory reports performing 123 immunohematology tests annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the laboratory manager on 11 /7/2024, the laboratory failed to evaluate results for chemistry analytes performed on multiple analyzers to ensure the allowed acceptable difference between analyzers. The findings include: 1. A lack of documentation for analyte result comparison between the laboratory's Ortho Vitros 5600 and 350 analyzers identified that the laboratory failed to evaluate test results for alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, BUN (blood urea nitrogen), calcium, carbon dioxide (bicarbonate), chloride, creatinine, glucose, potassium, sodium and total protein to ensure that they were within the allowed acceptable difference between the two analyzers every six months in 2023 and 2024. 2. An interview with the laboratory manager on 11/7/2024 at 11:01 am confirmed that the laboratory failed to compare analyte results between analyzers to ensure accurate patient testing. 3. The laboratory reports performing 208,810 tests annually on the Vitros analyzers. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the prothrombin time (PT) documents, the Dade Innovin Reagent package insert, a direct observation and an interview with the laboratory manager on 11/30/2022, the laboratory failed to verify the normal patient PT mean and use the correct international sensitivity index (ISI) for patient International Normalized Ratio (INR) calculations. The findings include: 1. A review of PT reagent documents identified that the laboratory failed to perform a normal patient PT mean study for the current Innovin lot number 564616. 2. A review of the Dade Innovin package insert for lot 564616 identified an ISI of 1.04. 3. A direct observation of the ISI in Sysmex CA600, the laboratory coagulation analyzer, identified an ISI of 1.07. The laboratory failed to use the correct ISI to calculate the INR for patient reporting. 4. An interview with the laboratory manger on 11/30/2022 at 11:49 am confirmed that the laboratory was using the incorrect ISI and normal mean to calculate patient INRs since the new lot of reagents were put in use on 8/25/2022. 5. The laboratory reports performing 240 PT/INR tests annually. 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the Wisconsin State Laboratory of Hygiene (WSLH), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the specialty of hematology. D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the Wisconsin State Laboratory of Hygiene (WSLH) and telephone interview with the laboratory manager on 10/18/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the specialty of hematology for the analyte white blood cell (WBC) differential. The findings include: 1. A PT desk review of Report 155D and graded PT results from WSLH identified that the laboratory failed to achieve overall satisfactory scores for event one (1) and event two (2) in 2022 for the specialty of hematology for the analyte WBC differential. Analyte Year Event Score WBC Differential 2022 1 0% WBC Differential 2022 2 68% 2. A telephone interview with the laboratory manager on 10 /18/2022 at 3:22 pm confirmed the above findings. 3. The laboratory reports performing 8000 - 9000 WBC Differentials annually. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene (WSLH), the CASPER 96D report and an interview with the laboratory manager on 7/13/2021, the laboratory failed to enroll in proficiency testing for the analyte rheumatoid factor. The findings include: 1. A review of proficiency testing records from WSLH and the CASPER 96D identified that the laboratory failed to enroll and participate in PT for the analyte rheumatoid factor for 2019, 2020 and 2021. 2. An interview with the Laboratory manager on 7/13/2021 at 10:05 am confirmed that the laboratory failed to enroll and participate in PT for the analyte rheumatoid factor for 2019, 2020 and 2021. 3. The laboratory reports performing 253 rheumatoid factor tests annually. 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. 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 a review of proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene (WSLH) and an interview with the laboratory manager on 7/13 /2021, the laboratory failed to ensure that the laboratory director or designee sign the PT attestation statements. The findings include: 1. A review of PT records from WSLH identified that the laboratory director or their delegated designee failed to attest to the routine integration of the PT samples in to the routine workload for all PT shipments for events 2 and 3 in 2020. 2. An interview with the laboratory manager on 7/13/2021 at 9:58 am confirmed that the laboratory failed to sign the attestations for all PT testing for events 2 and 3 in 2020. 3. The laboratory reports performing 200,000 moderate and high complexity tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation and an interview with the laboratory manager, the laboratory failed to follow the procedure to ensure positive patient identification for blood samples collected in the laboratory as observed on the day of inspection. Findings: 1. An observation of patient blood samples collected on December 11, 2018 revealed 3 blood collection tubes labeled with only the patient's name. 2. An interview on December 11, 2018 at 1:05 P.M., with the laboratory manager, confirmed laboratory personnel failed to follow the procedure for blood collection of patient samples to ensure integrity and positive patient identification. 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- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of chemistry analytes not scored for all three events in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 2018. Findings: 1. A review of AAB PT documents revealed the laboratory failed to evaluate results not scored by AAB for the blood gas analytes pH, pCO2, and pO2, as well as total triiodothyronine (TT3) for all three events in 2018. 2. An interview on December 11, 2018 at 9:15 A.M., with the laboratory manager, confirmed chemistry results that were not scored by AAB were not evaluated and verified for accuracy. 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 proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of chemistry analytes scored an artificial 100% for all three events in 2018. Findings: 1. A review of AAB PT documents revealed the laboratory failed to evaluate all artificial scores received from AAB for the blood gas analytes pH, pCO2, and pO2, as well as insulin, total triiodothyronine (TT3), and low- density lipoproteins (LDL) for all three events in 2018. 2. An interview on December 11, 2018 at 9:15 A.M., with the laboratory manager, confirmed artificial scores of 100% received from AAB for the chemistry analytes were not evaluated and verified for accuracy. 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 proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to verify the accuracy at least twice a year for the chemistry analytes either scored with an artificial 100% or not graded during all three events in 2018. Findings: 1. A review of AAB PT documents revealed the laboratory failed to evaluate and verify the accuracy for artificial 100% scores and results not graded by AAB for insulin, troponin, and low-density lipoproteins (LDL) during all three events in 2018. 2. An interview on December 11, 2018 at 9:55 A.M., with the laboratory manager, confirmed results not graded and artificial scores of 100% received from AAB for the chemistry analytes were not verified for accuracy at least twice a year. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to document the evaluation of unsatisfactory PT results for troponin in event 2 and insulin in event 3 of 2018. Findings: 1. A document review of PT results from AAB revealed the laboratory failed to document the evaluation and