date and time of report release 10.1.6 conditions of specimen that may adequacy 10.1.7 of testing name of laboratory performing the test(s) 10.1.8 specimen source 10.1.9 specimen collected by 10.1.10 Are established criteria for immediate 10.2 notification of critical test results? Is there documentation of notification to the 10.3 proper clinical individual of results of all critical values? Does the laboratory have a policy regarding 10.4 back” of critical values that are “read communicated verbally or by phone? Is confidentiality ensured for laboratory results 10.5 received and distributed by the laboratory via: Fax 10.5.1 Electronic Mail 10.5.2 Mail 10.5.3 Delivery 10.5.4 Is there a procedure to identify and trace late/lost 10.6 reports? Is there a policy for retention of patient reports? 10.7 Does the laboratory promptly notify clinical 10.8 personnel and issue a corrected report when errors are detected in patient test reports? Is there a documented system to ensure that all revised reports for previously reported incorrect 10.9 patient results are identified as amended on all forms of patient reports? Is there a policy regarding the communication 10.10 and documentation of reportable diseases? Are all patient results reported with reference 10.11 ranges? Are references ranges verified or established by 10.12 the laboratory for the population being tested? Is there a stat list in place? 10.13 Are stat results available within a reasonable 10.14 time? Are routine results available within a reasonable 10.15 time? Is the referral laboratory identified on the final 10.16 report, if specimens are referred out? Do reports for laboratory-developed assays 10.17 contain a description of the method, a statement
10.1.6 date and time of report release 10.1.7 conditions of specimen that may adequacy of testing 10.1.8 name of laboratory performing the test(s) 10.1.9 specimen source 10.1.10 specimen collected by 10.2 Are established criteria for immediate notification of critical test results? 10.3 Is there documentation of notification to the proper clinical individual of results of all critical values? 10.4 Does the laboratory have a policy regarding “read back” of critical values that are communicated verbally or by phone? 10.5 Is confidentiality ensured for laboratory results received and distributed by the laboratory via: 10.5.1 Fax 10.5.2 Electronic Mail 10.5.3 Mail 10.5.4 Delivery 10.6 Is there a procedure to identify and trace late/lost reports? 10.7 Is there a policy for retention of patient reports? 10.8 Does the laboratory promptly notify clinical personnel and issue a corrected report when errors are detected in patient test reports? 10.9 Is there a documented system to ensure that all revised reports for previously reported incorrect patient results are identified as amended on all forms of patient reports? 10.10 Is there a policy regarding the communication and documentation of reportable diseases? 10.11 Are all patient results reported with reference ranges? 10.12 Are references ranges verified or established by the laboratory for the population being tested? 10.13 Is there a stat list in place? 10.14 Are stat results available within a reasonable time? 10.15 Are routine results available within a reasonable time? 10.16 Is the referral laboratory identified on the final report, if specimens are referred out? 10.17 Do reports for laboratory-developed assays contain a description of the method, a statement
CRA-F-05-15189-S-04-Molecular%20Diagnostics%20Inspection%20Checklist.docx