LabPath is a full service laboratory consultancy comprising seasoned experts and business associates dedicated exclusively to the medical lab industry. We have extensive experience working with clinical laboratories, reference laboratories, academic medical center laboratories, physician-owned laboratories (POLs), pathology diagnostic laboratories, and molecular diagnostic laboratories.
LabPath delivers business intelligence solutions in such disciplines as laboratory formation and consolidation, information technology, quality performance efficiency (TQM/Lean), CLIA/CAP certification and proficiency, outreach development, regulatory compliance, and billing financial management.
An effective quality improvement or optimization program or both are essential to growing a high quality efficient business. Using tried and true team oriented approaches, such as Total Quality Management (TQM), LEAN, six sigma quality improvement, and Kaizen, LabPath has been able to assist organizations in developing a culture of continuous improvement, which is critical to maintaining a stream-line work flow, effective use of excess capacity, and the assurance of consistent high service quality.
During the initial phase (4-6 weeks) of the engagement period, LabPath will provide basic TQM and LEAN orientation and guidance for the purpose of creating a united team effort focused on delivering on-time error-free services to the organization's internal and external customers.
During this initial period, LabPath will work with the organization to stream-line process flow in its current environment and begin the process of eliminating waste (i.e., time, supplies, space, and re-work, poor performance).
During the second phase, LabPath will work with the team to identify and eliminate the larger more complex barriers that stand in the way of achieving the organization's full potential of efficiency and service excellence.
Irrespective of the laboratory size or specialty type, understanding and meeting the federal and state laboratory certification and licensing requirements (e.g., CLIA, COLA, Joint Commission, and CAP) is a complex process that requires assistance of a qualified and knowledgeable laboratorian. Laboratories that tackle this challenge without the experience or background often run into long delays in getting started or problems in meeting the routine requirements or both, which may result in a loss of accreditation.
For a new laboratory, LabPath will provide a qualified laboratory consultant knowledgeable of both the federal and state requirements for obtaining a CLIA licenses and certification from a qualified proficiency provider (e.g., CAP).
For an existing laboratory that is striving to overcome CLIA, CAP, Joint Commission, or other agency deficiencies, LabPath suggests its "Mock Auditing" to identify the areas of concern and define the "corrective actions" steps necessary. Our audit assessment process includes interviews with selected staff, a review of relevant policies and procedures, and an evaluation of CLIA-CAP laboratory practices related to the laboratory's area of certification.
The objectives of this assessment are as follows:
- Identify any areas of laboratory operation that do not meet the standards required for CLIA-CAP accreditation (e.g. compliance deficiencies);
- Identify areas of laboratory operation that are marginal and in jeopardy of failing accreditation standards
- Provide recommendations to meet CLIA-CAP accreditation standards.
The results of our inspection and recommendations are presented in a unique "report card" format designed to measure the level of compliance with CLIA-CAP accreditation standards.
Interim Management - If deemed necessary, LabPath will provide an interim manager to assist in developing a "Quality Assurance" department or function that will meet the ongoing certification requirement and ensure high-quality test performance.