Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all Performance Report (PR) received from the Oneworld Accuracy Accutest (OAA) for events Q1,2,3 in 2018 and Q1in 2019. The TP #1 listed on CMS form 209 confirmed on 10/30/19 at 12:45 am that PR were not retained. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed on the Cell Dyn Emerald series analyzer with the One World Accuracy AccuTest (OWAA) in the 2019 Cycle 2 event. The findings include: 1. The laboratory received "UNACC" unacceptable in 2019 cycle 2 on samples D - for Red Blood Cell Count, B and D - for Platelets. 2. The laboratory received "*ACC" ungradable results in 2019 cycle 2 on samples A trhough D for Granulocytes, Lymphocytes, and Monocytes. 3. There was no documented evidence that the laboratory evaluated and verified the failures. 4. The TP #1 listed on CMS form 209 confirmed on 10/3019 at 12:42 pm that the laboratory did not perform and document an evaluation of unacceptable PT results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 surveyor review of the Laboratory Records and interview with the Testing Personnel (TP), the laboratory failed to meet the analytic system requirements for Hematology tests. The findings include: 1. The laboratory failed to establish a