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 record review and interview with the Director of Quality Improvement (DQI), the Point-of-Care representative, and Testing Personnel (TP) #4, the Laboratory Director (LD) and/or designee failed to attest to the routine integration of the chemistry proficiency testing samples into the patient workload for 2 (AQI-A and AQI-B) of 2 events reviewed. Findings include: 1. Record review of the College of American Pathologists (CAP) proficiency testing documents revealed the following: a. AQI-A - the attestation statement sheet was not signed by the LD and/or designee b. AQI-B - lack of documentation of an attestation statement sheet 2. An interview on 9 /07/2021 at 10:44 am, the DQI, Point-of-Care representative, and TP4 confirmed the LD and/or designee did not sign the attestation statement sheet and lack of documentation of the attestation statement sheet for event AQI-B. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require