Oconto Hospital And Medical Center

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 surveyor review of proficiency testing (PT) records and interview with the technical supervisor, the laboratory did not verify the accuracy of ungraded hematology PT results in 2020 and 2021, Findings include: 1. Review of PT reports for the first event in 2021 showed the laboratory reported blood cell identification BCP-10 as a reactive lymphocyte. The target result was a blast cell. The records showed no evidence of review. The third event in 2020 included cell BCP-27 reported as hypogranular platelet. The target was normal platelet. The records showed no evidence of review. The PT program did not grade results for Large Unclassified Cells for the first, second, and third events in 2020 and the records showed no evidence the laboratory reviewed the results. 2. Interview with the technical supervisor on April 7, 2021 at 9:35 AM confirmed the laboratory had not verified the accuracy of hematology analytes that the PT program did not grade. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the 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 -- laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Individualized Quality Control Plan (IQCP) developed by the laboratory and interview with the technical consultant, the laboratory did not establish the number, type, and frequency of testing of control materials for the Siemens epoc blood analysis system. Findings include: 1. Review of the laboratory's IQCP for the epoc blood analyzer, signed on August 30, 2020, shows the only reference to the number type and frequency of testing of control material is the following statement, "Manufacturer requires that from each lot in each shipment of cards, at least two (2) levels of fluid controls in duplicate must be analyzed. Per CAP point of care requirements QC will be run at least every 30 days." 2. Interview with the technical consultant on April 7, 2021 at 1:30 PM confirmed the IQCP did not specify the laboratory's requirements for control testing, including the specific levels and identification of the control material used on the epoc blood analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER (Certification And Survey Provider Enhanced Reports) report and proficiency testing records, and interview with the technical consultant, the laboratory did not authorize the proficiency testing program to release to HHS (Health and Human Services) the laboratory's proficiency testing results for protime (PT) and activated partial thromboplastin time (aPTT) for five out of five events in 2017 and 2018. Findings include: 1. Review of the federal CASPER report 0155D (Individual Laboratory Profile) for the laboratory shows no proficiency testing scores for PT or aPTT were available for events one, two and three for 2017, and events one and two for 2018. 2. Review of CAP (College of American Pathologists) proficiency testing records shows the reports for the laboratory do not include the CLIA (Clinical Laboratory Improvement Amendments) identification number for the laboratory. 3. Email correspondence with technical supervisor on January 10, 2019 at 12:01 AM and phone interview on January 16, 2019 at 11:00 AM confirms the laboratory had not provided the CLIA identification number to the proficiency testing provider to authorize the program to release the laboratory's PT and aPTT results to HHS for five out of five events in 2017 and 2018. 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 --