Summary:
Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of installation and validation documentation for the new Abbott Cell Dyn Emerald Hematology analyzer and an interview with the Laboratory Manager (also Testing Personnel #1), the Laboratory Director failed to document review and approval of the initial validation procedures as verifying the manufacturer's performance specifications for the analyzer, before patient testing began. The findings include: 1. A review of the new Abbott Cell Dyn Emerald's installation documentation (Serial number 030817-007292) revealed no review and approval by the Laboratory Director on the initial verification procedures performed on 2/19/2019. Use of this analyzer for patient CBC (Complete Blood Count) testing began in February 2019. 2. During an interview and review of these records on 10/17 /2019 at 12:38 PM, the Laboratory Manager was unable to find any documentation of review and approval of the validation data by the Laboratory Director (as indicated by a signature and date). At 12:50 the Manager stated the Director had "looked" at the installation data, however he had not signed it because the previous analyzer had also been an Abbott Cell Dyn Emerald. Thus the above noted findings were confirmed. . D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the Quality Assurance (QA) Program procedure and other laboratory records, the surveyor determined the Laboratory Director failed to follow the QA policy in the overseeing the plan and documenting routine QA reviews. The findings include: 1. A review of the Quality Assurance Program procedure revealed the following: "The Laboratory Director oversees the implementation of our plan and helps identify and correct problems as they occur. ...". 2. A review of laboratory processes revealed no documentation of the Laboratory Director's QA reviews of Hematology calibrations, maintenance, quality control records,