Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish and follow written quality assessment policies and procedures for preanalytical testing in the specialty of hematology. Findings include: 1. Record review of the laboratory's electronic medical records (EMR) for patient #1 and patient #2 on 5/24/18 revealed PT /INR result values were entered in the EMR with no documentation of tests being ordered by a physician. 2. Record review of the laboratory procedure manual on 5/24 /17 revealed the laboratory failed to provide evidence of any quality assessment policies to monitor, assess and if necessary correct situation involving pre-analytical systems. 3. Staff interview with the technical consultant 5/24/18 at 11:30 AM confirmed the above findings and that the laboratory did not have any policies in place for quality assessment. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 record review and staff interview, the laboratory failed to establish and follow written quality assessment policies and procedures for postanalytical systems in the specialty of hematology. Findings include: 1. Record review of the laboratory's patient result log versus electronic medical record (EMR) on 5/24/18 revealed patient #1 final result values for prothrombin time (PT) and international normalized ratio (INR) were incorrectly entered. 2. Record review of the laboratory procedure manual on 5/24/18 revealed quality assessment policies to monitor, assess and if necessary correct situation involving postanalytical systems were not available. 3. Staff interview with the technical consultant 5/24/18 at 11:30 AM confirmed the above findings. -- 2 of 2 --