Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391

Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 01D0027697 (X3) Date Survey Completed 02/27/2023
Name of Provider or Supplier Auburn University Medical Clinic Laboratory Street Address, City, State 400 Lem Morrison Drive, Auburn, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies
D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT
CFR(s): 493.1239(a)

The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at ยงยง493.1231 through 493.1236.


This STANDARD is not met as evidenced by:
Based on a review of the personnel records and an interview with Testing Personnel #4, the laboratory failed to update and document Quality Assurance (QA) reviews, and implement corrective actions when needed in the general laboratory systems. This was noted from the previous survey on 6/10/2021 to 2/27/2023 (current survey). The findings include: 1. A review of the Personnel records revealed the laboratory failed to implement QA procedures to ensure Testing Personnel competency evaluations were performed and documented. (Refer to D6054.) 2. During an interview on February 27th, 2023, at 11:02 AM, Testing Personnel #4 confirmed the above findings.