Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based upon on quality assurance record review and interview with laboratory personnel #2 (TP#2) , the laboratory failed to retain all quality assurance activity records for 2 years as required. Findings include: 1. On the day of survey (03/15 /2018) records reviewed revealed quality assurance activities were missing from 2016 and 2017 records 9 of 12 months in 2017 1 of 12 months in 2016 2. TP#2 confirmed the findings above on 3/15/2018 around 10:15 am. 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