After ProLab Consulting, LLC has performed an initial assessment of the laboratory for compliance with all CLIA regulations and provided our client with a “Report of Laboratory Assessment”, the laboratory director may recognize a need for on-going assistance.
On-going CLIA Assistance is based on the assessment findings. ProLab Consulting, LLC works with the laboratory director and / or the laboratory representative to determine a course of action to correct any problems identified during the assessment. We then create any documentation needed (i.e. policies and procedures; forms; etc.), and provide that documentation to the laboratory director and / or laboratory representative. Any documents developed may be delivered to the laboratory electronically or in the form of a hard copy (may be subject to an additional printing fee). Additionally, ProLab Consulting, LLC provides our clients with necessary support and educational services needed to implement the new policies and / or procedures supplied during an on-site visit. ProLab Consulting, LLC does not take responsibility for any revision of documents (including, but not limited to policies, procedures, and forms) performed solely by the laboratory.
Once the new documentation has been provided to the laboratory and new policies / procedures have been implemented, ProLab Consulting, LLC provides continued support to the laboratory for the remaining term of the contract. This support can be electronic, by phone, or in person. Additionally, ProLab Consulting, LLC may perform (depending on the laboratory’s preferences) the quality assessment activities, as required by CLIA regulations and in accordance with the laboratory’s written policies and procedures, for the remaining term of the contract.
On-going services include, but are not limited to:
establish / revise policies and procedures to meet CLIA regulations;
establish / assist with maintaining required personnel records;
establish / assist with maintaining a quality control program;
establish / revise instrument calibration and calibration verification practices;
assist with maintaining calibration and calibration verification protocols;
assist with instrument validation / performance specifications, as needed;
monitor proficiency testing program (including non-regulated analytes);
preparation of Quality Assurance reports;
assistance with problem solving / troubleshooting activities;
documentation of all quality assurance activities in accordance with approved policies and procedures;
review of effectiveness of corrective actions taken for problems identified through the quality assurance program.
During the term of the contract, ProLab Consulting, LLC offers support to the laboratory during their CLIA inspection. This support may include:
- Assistance with preparing paperwork required by inspectors prior to the inspection date;
- Assistance with gathering information needed for the inspection;
- Assistance during the inspection, either via phone, or in person, depending on the laboratory’s need;
- Prepare the plan of correction, if deficiencies are cited.
This service is offered through a one or two year contract.