Summary:
Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) (a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based upon observations made during a tour of facilities and interview with laboratory staff, the laboratory failed to establish a uni-directional workflow for molecular amplification procedures in which amplified specimens were transported back to the specimen preparation area. Findings follow: A) During a tour of the laboratory testing facilities on 6/10/26 at 01:30 p.m. the surveyor observed the room in which molecular amplification procedures were performed. The room is rectangular with longer sides (side "A" and side "B") and shorter sides (side "C" and side "D"). Entry is via a door in side "A" at the corner formed at conjuction with side "D". Side "A" had a workbench and sink. Side "C" had a work bench. On side "B" was a Thermo Fisher Scientific QuantStudio instrument used for analyzing samples after amplification and a centrifuge used for specimen preparation. Side "D" had a door to another testing area and nothing used in the molecular amplification process. B) During an interview on 6/10/26 at 03:30 p.m., the testing personnel ( # 2 on the form CMS 209) described the testing process workflow as specimens entering from the door on side "A", proceeding to side "C" for preparation , moving to side"B" for centrifugation, moving to side "A" for amplification, and moving to side "B" for final analysis on the QuantStudio instrument. C) In an interview on 6/10/26 at 3:35 p.m., the testing personnel (# 2 on the form CMS 209) confirmed that the testing flow was not uni-directional, that testing was halted in May for a temporary period when reagents became contaminated through "user error". Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based upon review of policy and procedure, observation, and interview, the laboratory failed to establish and follow policies that ensure patient identification through the testing and reporting process. Findings follow: A) Review of policy and procedure revealed that the laboratory would maintain two unique patient identifiers through the specimen collection and testing porcess. B) During a tour of the laboratory on 6/10/26 at 04:45 p.m., The surveyor observed urine specimens that were labeled with patient first and last names and patient dates of birth, and test tubes to be placed on the AUA 450 urine analyzer that were labeled with patient first and last names and a specimen number. C) In an interview on 6/10/26 at 04:45 p.m., the testing personnel (# 2 on the form CMS 209) stated that urine samples were poured from the original containers labeled with patient names and dates of birth in to test tubes to be placed on the analyzer labeled with patient names and specimen numbers and confirmed that two unique identifiers were not used in common throughout the testing process. 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 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based upon a review of an email with the header of "AutoUA 2026 Quant A Survey RESULTS", a report "2026 AutoUA Quant A Survey Graded Results", lack of documentation, and interview with laboratory staff, the laboratory failed to assess and provide