Summary:
Summary Statement of Deficiencies D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to monitor and maintain correction for a standard level deficiency cited on the previous survey of 9/14/2016 (see D5805). This results in the condition of postanalytic systems not met. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the general supervisor and 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 -- testing personnel at 11:35 AM on 9/12/2018, the laboratory failed to have the report date on the patient test reports. Findings are: 1. Review of 2 printed patient test reports for hematology and chemistry testing collected on 9/6/2018 and 9/9/2018, revealed no report date on either of the reports reviewed. 2. Interview with the general supervisor confirmed these reports did not have the report date on them and this type of printed report was routinely used for reporting results to physicians not located at this facility. 3. Testing personnel stated the report date had been fixed after this deficiency had been cited at the last survey on 914/2016 and had been monitored for a period of time, but the notebook used to record the monitoring could not be produced at the time of survey. -- 2 of 2 --