Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and interview with staff, the laboratory did not retain the maintenance log for the BS200 analyzer for September 2017. Findings include: 1. Review of maintenance records for the BS200 analyzer showed no record of maintenance performed in September 2017. 2. Interview with staff B on May 29, 2018 at 12:45 PM confirmed the maintenance log for September 2017 could not be located. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor comparison of laboratory procedures and interview with the executive director, the "Quality Control Guidelines" policy in the procedure manual does not include a date of initial use. Findings include: 1. Comparison of the "Quality Control Guidelines" policy in the procedure manual with the version provided with the