Summary:
Summary Statement of Deficiencies 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: Based on review of laboratory procedure manual, patient test results and an interview with the technical consultant (TC); the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 for the testing of the Rhesus Factor (RhD) testing, affecting patient treatment. Findings Include: 1. The laboratory failed to meet the following analytic systems requirement: *Failed to establish written quality assurance (QA) policies and procedures to perform assessment of all analytic system. See D5791. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual, patient test results and an interview 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 -- with the technical consultant (TC); the laboratory failed to establish written policies and procedures to adequately identify the need for possible