Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) policies and procedures, review of patient test reports maintained in the Electronic Medical Record (EMR) and interview with the facility personnel, the laboratory failed to (A) identify errors found in the reporting of throat culture test results and failed to (B) follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. The laboratory performs throat culture testing under the sub-specialty of Bacteriology, with an approximate annual test volume of 3,667. It is the practice of the laboratory to report all patient test results in the patient's EMR. A1. Review of throat culture test results in the EMR for patient ( Z.N. on 8/12/2017) that were entered in the 'Patient Visit Note' stated, "An oropharynx culture for streptococcus was negative FROM PHARYNX and was plated and incubated for further evaluation. This will be checked at 24 hours for a preliminary read and 48 hours for a final read." A2. Review of the laboratory's culture log and review of the 'Chart Note' documented in the patient's EMR on 8/13 /2017 indicated the throat culture performed on 8/12/2017 was positive. The Chart Note documented in the EMR on 8/13/2017 at 9:19am stated, "Positive strep throat culture". A3. The facility personnel stated that it is the practice of the laboratory to document the strep screen test result in the 'Patient Visit Note" section of the EMR and the throat culture test result should be documented in the 'Chart Note' section of the EMR The facility personnel confirmed that the canned comment found in the 'Patient Visit Note' is incorrect and references the throat culture instead of the strep screen. B1. The laboratory's existing procedure for the "Annual Spot Check of 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 -- Transcribed or Transmitted Results" states, "Each instrument will need to have its test result(s) checked against the result(s) scanned, transmitted or transcribed to the laboratory information system (LIS)." B2. No documentation was presented for review from 2017 and 2018 to indicate the laboratory performed the annual spot check of test results that are manually entered into the EMR for the throat culture test. B3. The facility personnel confirmed that the laboratory failed to include throat culture test results as part of the annual spot check of Transcribed Results during 2017 and 2018. -- 2 of 2 --