Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Nurse Practioner (NP), the laboratory failed to evaluate competency accurately on 11 out of 11 Testing Personnel (TP) from 5/4/17 to the date of the survey. The findings include: 1. The laboratory failed to use the CA evaluation tools accurately as follows: a. Monitoring the recording and reporting of test results, Quality Control (QC), Proficiency Test (PT) performance and preventative maintenance logs was used to assess: 1. Specimen collection performed accurately 2. Specimens processed and stored in a timely manner 3. Testing material stored and handled correctly 4. Observation of all phases of testing 5. Instrument maintenance and function checks. 6. Accurate test performance has been proven by PT testing 7. The testing analyst recognizes calibration failures b. Direct observation of preventative maintenance and function checks was used to assess the testing analyst documents all corrective plan of actions associated with QC, instrument maintenance and PT. c. Assessment of test performance through blind patient samples or PT was used to assess the testing analyst documents all corrective plan of actions associated with QC, instrument maintenance and PT. 2. The NP stated at the time of the survey TP do not report results, perform PT, or do any maintenance or function checks. 3. The NP stated on 5/7/19 at 11:30 am the laboratory did not uses the CA evaluation tools accurately. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- 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 surveyor review of the Final Reports (FR) and interview with the Nurse Practioner (NP), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR from 5/4/17 to the date of survey. The NP confirmed on 5/7/19 at 11:40 am that the TRD was not on the FR. -- 2 of 2 --