to have been added to the original documents presented at the onsite survey with no explanation as to why it was added or when training will occur.
The following statements are documented on the Patient Impact Assessment: Training Records (Ex. AA, Tab 12):
- TP6 - "training documents are largely complete"
- TP31 - "informally trained . . . when asked if she [TP31] thought this training was adequate, she stated it was, and that she felt competent to do the work that she was doing"
- The records for TP6 and TP 11 show they received training on each instrument they operated even if the records did not comply with all components of the training and competency procedures. In addition, the laboratory's personnel files for TP6 and TP11 contain records of their competency to operate all of the instruments identified in D6102. Because the laboratory documentation reflects that TP6 and TP 11 were competent to operate these instruments, there is no potential for patient impact from this deficiency related to TP6 and TP11.
- Instrument training and competency records for TP31 were not contained in her personnel file. However, her attestation that she receiving training and was competent to operate those instruments demonstrate that there is no potential patient impact as a result of this deficiency as it relates to TP31.
We note that in the second submission the laboratory still concedes that it has not provided complete training records. We also note that the attestation from TP31 indicates that she/he felt that she was trained; however, it should be noted that it is the laboratory director's responsibility to make this determination.
It is not clear to CMS how the laboratory can make the assertion that no patient impact or potential impact could have resulted from this deficient practice as the laboratory has voided all patient results from the TPS 3.5 (Ex. AA, Tab 3) and BCS XP (Ex. AA, Tab 7) as well as various results from the Immulite (Ex. AA, Tab 8). In addition, the laboratory's submission from February 12, 2016 indicates that many patient specimens had "corrected reports" issued based on the laboratory's initial review.
The laboratory again failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information as set forth in our January 25, 2016 and March 18, 2016 letters. In addition, the laboratory again failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place, what systemic changes have been made to ensure the deficient practice does not recur, or how the corrective action is being monitored to ensure the deficient practice does not recur.
D6108
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