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 Beckman Coulter AcT diff 2 Hematology analyzer and interviews with Testing Personnel #3 (TP #3) and the Laboratory Director, the surveyor determined the Laboratory Director failed to document his 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. During the entrance tour of the laboratory on 11/26/2019 at approximately 11:15 AM, when asked if the laboratory had any new analyzers or tests, TP #3 stated the Beckman Coulter (B/C) AcT diff 2 Hematology analyzer was installed on 11/29/2017, and the laboratory began using the analyzer for patient testing in December 2017. 2. A review of Hematology records revealed a Beckman Coulter "Customer Service Call" report dated 11/29/2017, "... Install AcT diff 2, also ran repro [reproducibility], carry over, S-cal [calibration], Lin- C [linearity], start up and controls and they all passed ...". 3. During an interview on 11 /26/2019 at 1:30 PM, the surveyor requested the validation documentation from the installation procedures on 11/29/2017. Testing Personnel #3 was unable to locate the records during the on-site survey. 4. As the interview continued (with TP #3 and the Laboratory Director present), the surveyor questioned whether the Laboratory Director (who also acts as the Technical Consultant) had reviewed the data to 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 -- determine whether the initial validation procedures verified the manufacturer's performance specifications for the analyzer. The Laboratory Director stated he was told by the B/C installer everything was "OK". However, the surveyor explained it was the Laboratory Director's responsibilty to make that assessment, and document his review and approval (as indicated by his signature and date). The surveyor was not provided validation records or documentation of the Lab Director's approval while on site on 11/26/2019. 5. On 12/2/2019 at 8:08 AM, the CLIA State Agency Office received a voice mail message from TP #3 stating she had located the B/C AcT diff 2 installation documentation, and asking if she could submit the information to CLIA for review. The surveyor allowed the laboratory to fax the documents. A review of the validation records revealed no indication of review and approval by the Laboratory Director (as indicated by a signature and date) on any of the initial verification procedures performed on 11/29/2017. Thus the above noted findings were confirmed. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --