Summary:
Summary Statement of Deficiencies D0000 The State Agency conducted a validation survey on August 14, 2018 through August 16, 2018. At the time of the survey, the laboratory was not in compliance with the following condition: CFR 42 493.1250 - Analytic Systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through review of the laboratory's policy and procedure manual, the laboratory's Individualized Quality Control Plans (IQCP), quality control data reports, patient test logs, personnel records, observation, lack of documentation, and interview it was determined that the laboratory failed to meet analytic system requirements or monitor and correct problems in the analytic systems as evidenced by: D5413- the laboratory failed to monitor the temperature in storage areas in which supplies with a storage temperature requirement were stored, D5417- the laboratory had supplies available for use after their expiration date, D5449- the laboratory failed to perform positive and negative controls for QuickVue Mono tests on each day of patient testing, D5451- The laboratory failed to include a control material with titred reactivity on days when patient specimens were assayed for syphilis serology, D5469- the laboratory failed to document all quality control procedures performed, D5481- the laboratory failed to ensure quality control results were acceptable before reporting patient results, D5545 - the laboratory failed to document quality control results on each day when activiated clotting time tests are performed and reported, D5781- the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- document