Howard County Medical Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's list of tests performed, lack of documentation, and interview with the general supervisor the laboratory failed to verify the accuracy for moderate complexity neonatal, bilirubin. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed neonatal, bilirubin. Interview with the general supervisor on 1/20/2021 at 2:23 PM confirmed the laboratory performed 63 neonatal, bilirubin tests from January 1, 2018 through January 20, 2021. 2. No documentation could be presented through proficiency testing or laboratory comparison to verify the accuracy of neonatal, bilirubin. 3. Interview with the technical consultant on 1/20/2021 at 2:23 PM confirmed the laboratory had not enrolled in proficiency testing or had comparison testing performed for neonatal, bilirubin. 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 D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of tachometer readings and and interview with the general supervisor on 8/29/2018, the laboratory personnel failed to properly perform the preparation of urine sediment for microscopic examination. Findings are: 1. Review of the director approved textbook procedure for the preparation of urine sediment for microscopic examination stated to "centrifuge 12 ml of urine for 5.0 minutes at 1500 rpm (400 rcf)". 2. Review of the tachometer readings for the centrifuge being used for the preparation of urine sediment revealed a fixed rate centrifuge with the last tachometer verification performed on 6/18/2018 to be 3422 rpm. 3. Interview with the general supervisor confirmed the urines were being spun at this increased speed. The general supervisor stated the urine centrifuge quit working in July and they replaced it with a high speed centrifuge and were spinning the urines at this high rate of speed for 10 minutes. 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 --