Madison Core Laboratories

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 Sysmex CA-600 records and interviews with Testing Personnel (TP) #2, and the Technical Consultant (TC), the surveyor determined the laboratory failed to utilize the correct samples to determine the normal patient mean for the Innovin (Protime) reagent, and failed to verify the INR (International Normalized Ratio) generated by the analyzer until the day of the survey. This affected one of one lot numbers of Innovin reagent in use for seven months since 2/6/2020. The findings include: 1. A review of the calibration information on the Sysmex CA-600 (used for Protime testing) revealed the laboratory has used Innovin Lot # 549720 for PT/INR testing since 2/6/2020. 2. On 9/10/2020 at 8:55 AM when the surveyor requested the validation information for Lot # 549720, the TC stated all he had were the instrument printouts of the Level 1 and Level 3 Quality Control (QC) run ten times each on 2/6 /2020 by TP #2. 3. In an interview on 9/10/2020 at 9:00 AM, the surveyor asked TP #2 how she determined the normal patient mean (NPM) for new lot numbers of Innovin reagent. TP #2 stated she had established the mean using the normal Level 1 QC. The surveyor explained plasma from normal patients must be used to calculate the NPM; the plasma may be acquired commercially or obtained from health donors. TP #2 stated she had not known that was required. 4 The surveyor then asked the Technical Consultant if the laboratory had verified (via manual calculations) the INR generated by the Sysmex CA-600. The TC stated he had not realized this was required; thus the above noted deficiencies were confirmed. . 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 -- D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of quality assurance records and an interview with the Technical Consultant (TC), the laboratory failed to ensure

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 review of API (American Proficiency Institute) proficiency testing evaluations and CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), the surveyor determined the laboratory failed to successfully participate in proficiency testing for two consecutive testing events for the WBC (White Blood Cell) Differential. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. The laboratory scored twelve percent (12 %) for the WBC Differential [ zero percent for the Basophils, Eosinophils, Monocytes and Neutrophils; and sixty percent for Lymphocytes] for the 2019 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 -- Hematology testing event #3. The laboratory scored 28 % for the WBC Differential [zero percent for the Basophils, Eosinophils and Neutrophils; and 60 % for the Lymphocytes] for event #1, 2020. 2. These two consecutive failures of the WBC Differential for Event #3, 2019 and Event #1 of 2020 resulted in an initial unsuccessful proficiency testing participation. 3. The surveyor confirmed the above noted findings by review of the CASPER reports and the API proficiency testing records for 2017 - 2020 (first event). 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 a review of API (American Proficiency Institute) proficiency testing evaluations and CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), the surveyor determined the laboratory failed to perform satisfactorily in proficiency testing for the WBC (White Blood Cell) Differential for Event #3, 2019 and Event #1, 2020, two consecutive testing events. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An abbreviated survey was conducted on 5/24/2018 for the investigation of complaint report number AL00035635. As a result of the investigation of this complaint, 493.1251 Standard: Procedure Manual, 493.1291 Standard: Test Report, and 493.1441 Condition: Laboratories performing high complexity testing; Laboratory Director were cited as deficiencies. The facility, Madison Core Laboratories was not in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)