Centracare Richmond

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 observation, document review, and interview with laboratory personnel, the laboratory failed to retain Hematology quality control (QC) records from 2022 and 2023 for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 9:05 a.m. on 09/13/24. 2. A Beckman Coulter DxH 520 hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory implemented Complete Blood Count testing using this analyzer in November 2022. 3. Hematology QC testing with three levels of QC material was required daily as established in the Beckman Coulter DxH 520 procedure found in PolicyStat, the laboratory's policies and procedures software. 4. QC documentation from the time period reviewed, January through March 2023, was not found in laboratory records nor was this information retained in data available in the analyzer. The laboratory was given on opportunity to provide the missing documentation within five days of the survey. 5. In an interview at 9:50 a.m. on 09/13 /24, the TC confirmed the above finding. 6. In an email received at 3:45 p.m. on 09/17 /24, the laboratory director indicated the QC records from November 2022 through March 2023 could not be provided. . 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 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure two levels of acceptable quality control (QC) results were obtained on one of sixty two days of quantitative Hematology testing in 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:05 a. m. on 10/06/22. 2. An Abbott Cell-Dyn Emerald blood analyzer was observed as present and available for use during the tour of the laboratory. The laboratory performed Complete Blood Count (CBC) quantitative analysis using this analyzer. 3. The Emerald Procedure, found in the electronic procedure software PolicyStat, indicated testing with three levels of QC material was required each day of patient testing. 4. Cell-Dyn Emerald Quality Control reports indicated two levels of acceptable QC results were not obtained on one of sixty two days of testing in January through March 2021. See below. Date of testing: 02/17/21 Low control: three analytes out of range - Platelets - Mean Corpuscular Hemoglobin - Mean Corpuscular Hemoglobin Concentration Normal control: No record of testing High control: Acceptable 5. Six patient CBC test results were obtained on 02/17/21 as indicated on the Cell-Dyn Emerald History report. 6. In an interview at 1:25 p.m. on 10/06/22, the TC confirmed the above finding. . 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 Center for Medicare and Medicaid Services reports, American Proficiency Institute proficiency testing reports, and voicemail communication with Testing Personnel, the laboratory failed to successfully participate in proficiency testing (PT) for White Blood Cell Differential testing under the specialty of Hematology. Findings are as follows: D2121 - the laboratory failed to obtain a PT score for White Blood Cell Differential of at least 80 percent D2123 - the laboratory failed to participate in the 2018 3rd Hematology testing event D2130 - the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two of three consecutive PT events 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 -- D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API) and voicemail communication with Testing Personnel, the laboratory failed to obtain a PT score for White Blood Cell Differential of at least 80 percent which resulted in unsatisfactory performance for the analyte. Per API reports, unsatisfactory White Blood Cell Differential PT performance was obtained in the following API events. -2018 3rd event 0% -2019 2nd event 0% In a voicemail received at 3:30 p.m. on 10/18/19, the Testing Personnel indicated the 2019 2nd event PT failure was due to incorrect data entry. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to participate in one PT event for White Blood Cell differential testing. Findings are as follows: The laboratory failed to participate in White Blood Cell differential PT for the 2018 third Hematology event. Failure to participate in the testing event resulted in unsatisfactory performance for the analyte. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two out of three consecutive PT events. Findings are as follows: The laboratory received unsatisfactory scores for White Blood Cell Differential testing in two out of three consecutive PT events which constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory White Blood Cell Differential scores. -2018 3rd event 0% -2019 2nd event 0% -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between Hematology procedures and patient final test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 10/19/18 at 10:05 a.m. 2. An Abbott Emerald hematology analyzer was observed as present and available for use during the tour. 3. The reference values intervals listed in the Hematology Normal Values table, located in the on-line procedure manual, were not consistent with those included on a patient test report (Female - 58 years, Date performed = 3/30/17) reviewed on date of survey. See below. Analyte Table Report Mid Range Absolute 1.5 - 2.5 0.0 - 1.8 4. In an interview on 10/19/18 at 12:15 p.m., the LD confirmed the above findings. . 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 --