Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review, observation, and interview with Technical Supervisor B the laboratory failed to follow manufacturer's instruction for labeling quality control and test strips for the glucometers located in the Emergency Department. Findings Included: Review of the manufacturer's instructions (MI) for the Nova StatStrip blood glucose monitoring system state that "Controls are valid for 90 days after opened, not to exceed the manufacturer's expiration date. Record the new expiration date on each vial." It also stated that "Glucose test strips are valid for 180 days after opened, not to exceed the manufacturer's expiration date. Record the open date and new expiration date on the test vial." Tour of the Emergency Department on 04/15/2021 at 11:45 AM revealed 2 bottles of test strips (Lot#0320265249, Expiration 09/21/2022). One bottle did not have an open or discard date and the second bottle did not have a discard date. There were 2 bottles of low level control (Lot#0420095301 Expiration 10/04/2022) both had a discard date of 03/06/2022 and a high level control (Lot#0420016303 Expiration 07/16/2022) that had a discard date of 03/06/2022. Both of these dates would exceed the MI of only being valid for 90 days after opening. Interview on 04/15 /2021 at 11:45 AM Technical Supervisor B confirmed that the controls and strips were not labeled per the MI. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their Training and Competency policy for the 2020 annual competency assessments for 4 (A, B, C, E) of 6 (A, B, C, D, E, F) Testing Personnel reviewed. Findings included: Review of the Training and Competency Procedure, section VI Competency Assessment, F, #2 notes "Monitoring records of reported information (paper or electronic) which must include the following: Name of test or task and date of records." Review of the competency assessment showed for the moderate complexity testing performed in patient care areas of the hospital, 4 (A, B, C, E) Testing Personnel's competency assessments failed to indicate which tests the Testing Personnel were being evaluated on. During an interview on 04/15/2021 at 4:35 PM, the Technical Supervisor B stated the annual competency evaluations did not indicate which tests the Testing Personnel were being evaluated on. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of