Summary:
Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Supervisor (TS), the laboratory had broken printers for 3 (Roche Cobas Miras Plus, AVL 9180, and IsoComp I) of 4 analyzers observed. Findings include: 1. An observation by the surveyor on 12/9/19 at 9:10 am revealed the following analyzers equipped with printers were present in the laboratory: a. Cobas Miras Plus chemistry analyzer b. AVL 9180 electrolyte analyzer c. IsoComp I 2. The surveyor requested the laboratory's instrument printouts for quality control, calibrations, and patient testing performed on the analyzers listed above on 12/9/19 at 9:10 am and they were not made available. 3. An interview on 12/9/19 at 9:10 am with the TS confirmed the printers on the analyzers listed above were broken and no longer functioned. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to establish a procedure for performing electrolyte testing on the AVL 9180 analyzer. Refer to D5401. 2. The laboratory failed to establish a step-by-step performance procedure, preparation of materials procedure, calibration procedure,