Summary:
Summary Statement of Deficiencies D0000 A validation survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 1/30/24. Avera Medical Group Pierre Laboratory was found not in compliance with the following requirements: D3001. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to provide adequate workspace to ensure four of four staff (A, B, C, and D) were not at risk for injury or exposure to hazardous material. Findings include: 1. Observation on 1/31/24 from 11: 15 a.m. to 11:35 a.m. revealed: -The main specimen processing area was located across from the Beckman Access 2 chemistry analyzer (a large countertop model analyzer) and directly in front of the Beckman AU 480 chemistry analyzer (a large floor model analyzer).Laboratory personnel working at this station would block access to the chemistry analyzers and to the other side of the laboratory. -The water purification system was located between the Beckman AU 480 chemistry analyzer and the wall with limited space to complete routine maintenance. -The main laboratory refrigerator was located against the adjoining wall with its front double doors facing the Beckman AU 480 chemistry analyzer and the water purification system located behind that analyzer. There was limited space to allow laboratory personnel to access all the supplies and specimens stored in the refrigerator. -There were three specimen sampling racks stored on top of the Beckman Access 2 chemistry analyzer. One of these racks contained specimen sampling tubes. Interview on 1/31/24 from 11:15 a.m. to 11:35 a.m. with laboratory supervisor E revealed she confirmed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- the lack of available counter and storage space within the laboratory for staff to work. She stated that 3 days a week they had four staff working and it could be difficult to access analyzers to process patient specimens. -- 2 of 2 --