Aurora Health Center - West Bend, Gateway Ct

Summary Statement of Deficiencies 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 surveyor review of laboratory procedures, patient test logs, quality control records, and interview with the technical consultant, the laboratory did not perform quality control for serum human chorionic gonadotropin (HCG) on two days of patient testing in September 2018 and December 2019. Findings include: 1. Review of the "HCG Serum-Urine QuickVue +" procedure showed external quality controls are tested and recorded each day patient testing is performed. 2. Review of serum HCG patient test logs revealed the laboratory performed testing on Patient 1 on September 7, 2018 and Patient 2 on December 6, 2019. 3. Review of quality control records from September 2018 and December 2019 showed no documentation of quality control for September 7, 2018 and December 6, 2019. 4. Interview with the technical consultant on February 12, 2020 at 10:28 AM confirmed the laboratory did not document quality control on the serum HCG test on days of patient testing on September 7, 2018 and December 6, 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 1 --

Summary Statement of Deficiencies D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) worksheets and laboratory procedures, and interview with the technical consultant, the laboratory director did not ensure that the quality control program for the Erythrocyte Sedimentation Rate (ESR) test was established and maintained to assure the quality of laboratory services. Findings include: 1. Review of ESR Auto Plus Control / maintenance log worksheets for November 2017 shows two acceptable QC ranges are listed, one identified as ACL (Aurora Clinical Laboratory) and a second identified as Manuf (Manufacturer). The worksheet also shows five QC results for the Level One control that are not in the ACL range but are identified as being within the manufacturer's range (November 2, 9, 10, 11 and 12). 2. Review of the procedure, Reference #3798 Version #3 ESR-Auto Plus Erythrocyte Sedimentation Rate, shows the acceptable range for control samples is not defined. 3. Further review of the procedure shows QC results are to be entered into AML for statistical analysis. 4. Interview with the technical consultant on February 14, 2018 at 12:00 PM confirmed the Quality Control program has not been specifically defined in the procedure and does not identify how the acceptable ranges for quality control samples are developed. Further interview confirms the laboratory does not enter QC results in AML or perform any other statistical evaluation of control results. 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 --