Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Virginia Urology-Reynolds Crossing on June 6, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), procedure manual, split sample proficiency testing (PT) records, and an interview, the laboratory failed to verify twice annual accuracy of vaginal wet preparation microscopy testing in calendar years 2017 and 2018 for testing personnel (TP) A. Findings include: 1. Review of the laboratory's CMS 209 form revealed TP A performed patient vaginal wet preparation microscopy examination testing. (See Testing Personnel Code Sheet) 2. Review of the procedure manual revealed a policy (title:Vaginal Wet Preparation) that stated: "Internal comparison by split sample (2 person read) of 2-3 specimens are performed annually". 3. Review of the available split sample PT records for 2017 to the date of the survey on 6/6/19 revealed documentation of vaginal wet preparation split sample testing by TP A once in calendar year 2017 (on 12/14/17) and once in calendar year 2019 (on 3 /13/19). The inspector requested to review additional records of the PT accuracy documentation for calendar year 2017 and 2018 for TP A. No documentation was available for review. 4. In an exit interview with the lab director and technical consultant, at approximately 12:30 PM, the above findings were confirmed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of procedures, quality assurance (QA) monthly check lists, and an interview, the laboratory failed to follow their written policy that outlined a monthly review to ensure the accuracy of manually transcribed patient Prostate Specific Antigen (PSA) and Testosterone results from June 2017 to the date of the survey on June 6, 2019. Findings include: 1. During a tour of the laboratory, at approximately 10:30 AM, the inspector noted that PSA and Testosterone patient results were manually entered from the Roche Cobas e411 analyzer into the electronic medical record (GE Centricity) by the testing personnel. The technical consultant (TC) and lab director (LD) stated: "We currently manually enter results from the Cobas analyzer. We are evaluating and hope to add a lab interface to eliminate the manual entries." 2. Review of the laboratory's procedure manual revealed a QA policy that included a plan to monitor and correct problems in patient result reporting. The policy outlined a monthly QA checklist chart was to be completed by the TC and reviewed by the LD. The monthly checklist chart included a category (Patient Test Management System Check) that stated: "patient reports checked for correctly reported results". 3. Review of the laboratory's monthly QA documentation checklists revealed no evidence of accuracy checks or review of manually transcribed Prostate Specific Antigen (PSA) and Testosterone results on the twenty-four (24) months of checklists reviewed (June 2017 to 6/6/19). 4. In an exit interview with the LD and TC, at approximately 12:30 PM, the above findings were confirmed. -- 2 of 2 --