Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: =================================== Based on review of Proficiency Testing (PT) reports for 2018 and 2019, attestation sheets which lacked testing personnel and director signatures and upon interview with the Nurse Practitioner, determined the testing personnel and laboratory director failed to sign attestation sheets. The findings include: 1. Review of PT reports for 2018 and 2019. 2. Review of attestation sheets revealed lack of testing personnel and director signatures for the first event of 2018 and lack of director signature for the second event of 2018 and the first event of 2019. 3. Interview at approximately 3:00 p.m. July 16, 2019 with the Nurse Practitioner confirmed the PT attestation sheets for 2018 and 2019 lacked testing personnel and director signatures as stated. =================================== D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)