Ssm Health Dean Medical Group -Portage

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the laboratory did not maintain records of the identity of one of two testing personnel who performed hematology testing on the Sysmex XN1000. Findings include: 1. Review of maintenance logs showed testing personnel (Staff A) performed daily maintenance and quality control testing on the Sysmex XN1000 analyzer. 2. Interview with testing personnel (staff B) on November 15, 2022 at 10:45 AM revealed Staff A routinely does the daily maintenance including running quality control samples on the Sysmex XN1000. Further interview revealed Staff A occasionally performs STAT patient testing on the Sysmex XN1000 and revealed the laboratory did not document the identity of the testing person when Staff A tested patient samples on the Sysmex XN1000. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 surveyor review of competence evaluations and interview with a technical consultant, the technical consultant did not evaluate competence since 2020 for one of the two regularly scheduled testing personnel in performing testing with the Sysmex XN1000 analyzer. Findings include: 1. Review of competence evaluations for staff A showed Sysmex XN1000 competence evaluation was last documented in 2020. 2. Interview with a technical consultant (staff C), confirmed no documented Sysmex XN1000 competence evaluations were available for staff A since 2020 and confirmed staff A and staff B are the two regularly scheduled testing personnel at this laboratory. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory director, the laboratory had not documented evaluation of two of two "Not Graded" "PPM/URINE SEDIMENT" results in event one of 2019. Findings include: 1. Review of API PT records showed no documentation of evaluation for two of two "Not Graded" "PPM/URINE SEDIMENT" results in event one of 2019. 2. Interview with the laboratory director on March 24, 2021 at 10:00 AM confirmed the laboratory did not document evaluation for two of two "Not Graded" "PPM/URINE SEDIMENT" results in event one of 2019. This is a repeat deficiency from September 13, 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 --

Summary Statement of Deficiencies 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 surveyor review of hematology proficiency testing (PT) records and interview with the laboratory director, the laboratory has not documented evaluation of not graded hematology cell identification results in event three of 2016, events one, two and three of 2017, and event one of 2018. Findings include: 1. Review of PT records for hematology in 2016, 2017, and 2018 show no documented review for ten of ten not graded results in event three of 2016, events one, two and three of 2017, and event one of 2018. 2. Interview with the laboratory director on September 13, 2018 at 11:30 AM confirmed that the laboratory did not review results of not graded samples. 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 --