| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 01D0300027 | (X3) Date Survey Completed 07/28/2021 |
| Name of Provider or Supplier Bibb Medical Center | Street Address, City, State 208 Pierson Avenue, Centreville, 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 |
| D5447 | CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the 2021 Chemistry quality control (QC) records for the Access 2 and an interview with the General Supervisor, the laboratory failed to ensure at least two levels of quality control were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted one day out of 3 months reviewed February 2019, September 2020, and March 2021 by the surveyor. The findings include: 1. A review of the QC records for the Access 2 analyzer revealed on 03/20/2021: a) Low control was run at 10:06 AM and within acceptable limits b) High control was not run on 03/20/2021 2. During an interview on 07/28/2021 at 2:00 PM, the General Supervisor confirmed the high control was not run on 03/20/2021. It was also confirmed one patient was run at 12:46 PM that day. |