To ensure it can provide effective oversight of labs as state law requires, Laboratory Services should improve its complaints policy and procedures to ensure that it either investigates allegations promptly or clearly documents its management's rationale for not investigating. It should also establish clear expectations for when staff must visit a lab to verify successful corrective action.
Laboratory Field Services (LFS) revised its complaint policies and procedures; increased staffing dedicated to focusing on complaints by three full-time staff, and enhanced its complaint database. Changes made to the complaint database include documenting the rationale for not investigating a complaint, and when to perform follow-up investigations to verify corrective action has been completed. In addition, the database now has a reporting function that provides "due dates" of complaint investigations, which staff review to ensure that the appropriate timeframes are being met.
LFS staff was trained on the new complaint policy and procedures on August 18, 2016.
Laboratory Services developed policies that reflect the recommended changes including time frames for investigating complaints, documenting decisions regarding complaints, and expectations for staff to verify corrective action.
The Laboratory Field Services Branch continues to convene work groups to analyze business processes, policies, and procedures to determine efficiencies and reduce redundancies related to complaints. This continues to result in change recommendations that are vetted internally and implemented when appropriate, and will be used to update the policies and procedures as necessary by April 30, 2016 as indicated in the Corrective Action Plan. Some examples of changes being reviewed include, implementing a process to assure that complaints are being investigated timely, and developing a process to investigate complaints in registered clinical laboratories. An Examiner I was fully trained and is performing complaint investigations. A Staff Services Analyst (SSA) was hired. The SSA provides administrative and analytical support to the examiners, allowing them more time to focus on complaints investigations.
LFS workgroups continue to review and revise its business processes related to the complaints policies and procedures, including timeliness, developing processes for tracking and investigating complaints in registered labs, criteria for when a complaints investigation or re-visit is warranted. In addition, LFS is developing processes for complaints in deemed facilities.
LFS is hiring a Staff Services Analyst (SSA) to provide administrative support to the investigations operations. The administrative tasks performed by the SSA will allow Examiners to focus on the actual complaint investigation. In addition, an Examiner I was hired in August 2015 and is currently in training. By January 2016, the Examiner I will be fully trained and begin to conduct complaint investigations. By adding this Examiner I to staff currently conducting investigations, LFS staff will not need to balance the needs of scheduled surveys against the need to investigate complaints.
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