Before starting your own in-house laboratory, you need to know if it will be cost-effective.
BioMedDx Consult performs studies that take physical space, staff needs, and your anticipated test selection and test volume into consideration. Cost analyses are performed for each proposed test and include general materials and clinical analyzers plus consumables; specimen collection, processing, and storage; compliance costs, including certification and licensing fees, and proficiency testing. Reimbursement is estimated based upon the insurance mix of your patient population. Each test study concludes with a summary of costs vs. revenue and a profitability estimate.
Equipment Selection & Recommendations
There are a herd of instrument vendors competing for your laboratory business. The vendors have sales representatives to elicit the most profit for their companies.
BioMedDx Consult with deep understanding of biomedical instrumentation engineering and reagents will represent your interests and sift through the sales talk. We help you to select the instruments and test kits that are right for you, your test menu, your staff, and your budget.
Facility Startup & Design
Service model should fit your agency’s operational need. Determining factors can be geographic area of coverage, national laws, and agency size.
Decentralized organizational structures require strong central program management.
Service model needs to reflect case workload, case priorities, and operational economics.
Legal system, search warrant rules, and scope of warrant are the most significant determining factors on how service delivery models are designed..
New CLIA regulations took effect April 24, 2003. Even labs performing moderate complexity testing must show the accuracy, precision, and reportable range for each method plus establish or verify reference ranges for its patient population. Let Princeton Laboratory Management service guide you through this complex process and provide documentation for your inspection.
Facilitate CLIA and/or State Applications
Red tape swallows you when applying for your first laboratory certificate or license. Your consultant will translate application jargon and facilitate the application process so that you can move forward with your laboratory plans as smoothly as possible. We can fill out your initial application, expedite its path through CMS, and make any changes as your needs change
Create a Test Menu
Your laboratory's test menu should be based your needs as a physician and the patients you serve. Start out with a small and expand, or have an extensive menu of testing from day one. BioMedDx
Consult offers advice that is based upon your individual situation and needs and upon your consultant's years of experience.
Write Laboratory Procedure Manual
Procedure manuals are required by CLIA and many state agencies. More than that, they convey vital information for staff training, producing reliable test results, and achieving efficient operation. Manuals written by Princeton Laboratory Management service have been inspected and praised by regulating and accrediting agencies sine 2004. Our system is copyrighted and is designed for ease of use by both technical and non-technical personnel
Quality Planning and Quality documentation
Initiate a Comprehensive QA Plan
CLIA and certain states require laboratories performing any non-waived testing to have and implement a comprehensive Quality Assurance plan.. BioMedDx copyrighted QA program has been repeatedly inspected by regulatory and accrediting agencies and has been praised for its completeness and ease of use. Perhaps more importantly, clients find the program easy to use by both the technical and non-technical personnel. This program is designed for ease of use while assuring quality patient services.
Monitor Proficiency Testing
Especially in the POL setting, PT can be seen as complex and difficult. We take staff through the lab's first PT experience, providing training, support and building confidence every step of the way. Our pre-event checklists and PT failure investigation forms provide needed documentation and a basis for learning and improved performance.
On-going Compliance Management
Continuous Inspection Readiness
As new regulations crop up we will be there to walk you through the changes and insure compliance. We will advise you on the most effective method of meeting new regulations without complicating systems that are already in place. Princeton Laboratory Management service will perform a pre-inspection as your regulatory inspection draws near. We will compile a list of possible deficiencies and help to correct them when possible.
Write and Implement a Plan of Correction for Cited Deficiencies
You will be given a list of "deficiencies" found by the inspector at the end of your regulatory inspection. Princeton Laboratory Management service will guide you in preparing a plan of correction and help you achieve compliance within the agency's timeframe for correction. |
