Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a surveyor's review of hematology quality control (QC) records and an interview with the laboratory administrator and the laboratory supervisor, it was determined that the laboratory failed to ensure that hematology QC test results were within acceptable range prior to testing patient specimens. Findings Include: Review of QC records found and it was confirmed with the laboratory supervisor on July 18, 2018 at approximately 11:30 AM during review of QC data that the following levels of control materials were out of acceptable range and remediation was not performed: 1. On 11/8/2017, 12/1/2017, 12/30/2017, 1/2, 3, 6, 10, 26, 27, 29, 31/2018, 3/21, 26, 27/2018, 5/12, 14, 31/2018, 6/20, 25/2018 two out of three hematology controls were out of range. 2. On 5/18, 19, 21, 22/2018 three out of three hematology controls were out of range 3. No records of hematology QC were found for October 2017. 4. Approximately 100 patient specimens were tested and results reported for hematology testing during this time period. PLEASE NOTE: THIS IS A REPEATED CITATION FROM THE SURVEY CONDUCTED ON MARCH 28, 2017. D5783