Summary:
Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to have a passing proficiency test score for the first testing event of 2016 for the speciality of Hematology. The findings include: The 2/12/18 record review of the American Proficiency Institute testing results for the first event of 2016 showed a score of 47% for White Blood Cell Differential, 60% Granulocytes, 40% Lymphocytes, and 40% Monocytes. The 2/12/18 interview with the laboratory manager at 1:00pm confirmed the laboratory had failed proficiency testing. . 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 record review and interview with laboratory staff, the laboratory failed to have quality controls (QC) in acceptable range prior to reporting patient results for 1 of 31 days in August 2016. The findings include: Record review of the laboratory's QC records for August 2016 showed on 8/19/2016, the normal level control for the hematology test of Platelet was out of range at 258 (acceptable range was 174-244), the high level control for the hematology test of Platelet was 588 (acceptable range 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 -- was 395-565). The laboratory failed to document