Summary:
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 record review and interview, the laboratory failed to document the identity of the testing personnel for 12 of 12 patient reports (Toxicology) reviewed. Annual toxicology test volume=750,000. Findings Include: 1) Review of the following patient test reports indicated no identity for the testing personnel (PT=patient): Patient=date tested/toxicology result: PT#1=1-29-18/Positive PT#2=3-14-18/Positive PT#3=5-4-18 /Positive PT#4=7-9-18/Positive PT#5=9-12-18/Positive PT#6=11-5-18/Positive PT#7=1-18-17/Positive PT#8=3-16-17/Positive PT#9=5-4-17/Positive PT#10=7-10-17 /Positive PT#11=9-12-17/Positive PT#12=11-16-17/Positive 2) In interview on 11/19 /18 at 2:18 pm, SP-1 confirmed the above patient toxicology test reports did not have the identity of the testing personnel, nor was it documented anywhere else in the laboratory. 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 --