Cancer Team At Bellin Health,The

Summary Statement of Deficiencies D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of manufacturer's environmental specifications for the Atellica chemistry analyzer and laboratory records and evidence provided in the laboratory's

Summary Statement of Deficiencies D5785

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 survey review of a patient's Complete Blood Count (CBC) test report and laboratory procedures and interview with the technical consultant, the reference range shown on the patient report was not the same as the approved reference range for a male hemoglobin in the procedure for one of one patient reviewed. Findings include: 1. Review of the reference range of the CBC test report from May 17, 2023, in the electronic medical record (EMR) for patient one (a 73-year-old male) showed the expected range was 14.0-17.2 grams per deciliter (g/dl). 2. Review of the "Sysmex XN-10" hematology procedure showed the approved hemoglobin reference range for a male is 13.5-17.5 g/dl. 3. Interview with the technical consultant on May 17, 2023, at 12:55 PM confirmed the reference range in the EMR was not consistent with the approved reference range in the procedure. 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 D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on surveyor review of training and competence evaluation records and interview with the technical consultant, the technical supervisor did not evaluate and document all elements of competency for three of three testing personnel in 2018 and 2019. Findings include: 1. Review of training and competence evaluation forms showed: Staff A: The technical supervisor did not sign the 2018 annual competence evaluation form and did not document direct observation. Staff B: New employee review sheet (February 2019) was not signed and observation of duties was not completed. Staff C: The initial competence evaluation form (April 2019) was not signed by the technical supervisor, the competency checklist for the Dimension was not signed or dated. 2. Interview with the technical consultant on May 29, 2019 at 9: 45 AM confirmed the technical supervisor had not completed training and competency records for testing personnel. 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 --