Summary:
Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on by review of the quality control records and personnel interview with the Laboratory Director and Medical Assistant, the laboratory failed to check each batch or shipment of media before or concurrent with initial use, for its ability to support growth from (11/02/2017 through 08/29/2019). Findings: 1. Review of the quality control records revealed ability to support growth was not documented for Hardy Diagnostics Tri Plate media, from (11/02/2017 through 08/29/2019). 2. Approximately 69 patients had urine cultures performed from (09/01/2018 through 08 /29/2019). 3. During the survey (11:00 12/13/2016), the Medical Assistant confirmed the above findings. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved