Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Review of one patient test report and interview with the general supervisor, the laboratory failed to ensure the correct name of the laboratory is on the patient test report. The findings include: 1) Review of one patient test report dated April 7, 2019 revealed the performing laboratory name: NJJMC. 2) Interview on April 10, 2019 at 1: 30 p.m. with the general supervisor confirmed the laboratory's new name (North Jackson Health) was not correct in the electronic patient final report system. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 observation of the laboratory, review of the quality control and maintenance records, and interview with the general supervisor, the laboratory director failed to ensure the quality assessment review was maintained for the chemistry, hematology, coagulation, and urinalysis instruments, and the mono rapid test kit, in 2019. The findings include: 1) Observation of the laboratory on April 10, 2019 at 9:30 a.m. revealed the following instruments and test kit in use for patient testing: Chemistry- Ortho Clinical Diagnostics Vitros 5600 (serial numbers J56002835 and J56002844), Abbott i-Stat (serial numbers 358669, 365443, and 343693); Hematology- Beckman Coulter Unicel DxH 600 (serial numbers AY36861 and AY36862); Coagulation- Siemens Sysmex CA-1500 (serial number A2181); Urinalysis-Siemens Clinitek Advantus (serial number KPS60911241), and, Cardinal Health Mono rapid test kit. 2) Review of the quality control and maintenance January 2019 to current survey date records revealed no review by the laboratory director for the following: Vitros 5600, iStat, DxH 600, CA-1500, Advantus instruments and the mono rapid test kit. 3) Interview on April 11, 2019 at 10:45 a.m. with the general supervisor confirmed the laboratory director did not review the daily quality control and maintenance records for the Vitros, iStat, DxH 600, CA-1500, Advantus, and mono rapid test kit in January to current survey date, 2019. -- 2 of 2 --