1. Check Feasibility
Before starting your own in-house laboratory, you need to know if it will be cost-effective. Laboratory Consulting, LLC, 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.
2. 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.
Laboratory Consulting, LLC offers advice that is based upon your individual situation and needs and upon your consultant's years of experience.
3. Recommend Instrumentation
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. You have Laboratory Consulting, LLC to represent your interests. We only recommend the best instruments in the industry for urine drug screening or any other type of testing you intend to perform.
4. 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.
5. Validate New Methods
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 Laboratory Consulting, LLC guide you through this complex process and provide documentation for your inspection. The rules require the instrument operator to perform the validations, but we remain with them through the process.
6. 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 Laboratory Consulting, LLC have been inspected and praised by regulating and accrediting agencies sine 1998. (See comments by CLIA inspectors in our testimonials section) Our system is copyrighted and and is designed for ease of use by both technical and non-technical personnel.
7. Assist with Interviews
Before you schedule time for a personal interview, have Laboratory Consulting, LLC and Precision Testing Soultions review résumés and screen applicants to determine to what extent their technical training and experience meet your needs.
8. Aid in Acquisition of Qualified Candidates In these times especially, qualified candidates for all medical positions are scarce. Your consultant will network with other clients, vendors, and colleagues to help find the right candidate for your open position.
9. Manage all Initial and Supplemental Training
Laboratory Consulting, LLC provides initial compliance training upon hiring new staff members and supplemental training as needed. Test equipment vendors provide training for their systems. Add to that training with initial and on-going training on total laboratory operations. Routine competency assessments are included as part of the program. All training is documented for your personnel files.
10. Perform Six Month & Annual Competency Assessments
CLIA and COLA require competency assessments at six months from initial training and annually thereafter for all testing personnel. These assessments measure the employee's technical capability to perform laboratory testing and are separate from more general performance reviews. Laboratory Consulting, LLC performs assessments as required by your regulatory agency, recommends/provides supplemental training, and furnishes documentation of assessments and supplemental training.
11. Manage Duties CLIA Allows Delegated by Lab Director
Delegation frees the director to perform tasks only he/she is capable of doing, while the technical aspects of laboratory oversight are performed by a Laboratory Consulting, LLC consultant who is highly qualified and experienced in these areas. This is possible because CLIA allows that certain duties of the Lab Director may be delegated to a qualified technical consultant/supervisor.
12. 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.. Laboratory Consulting, LLC's coprighted 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.
13. 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.
14. Implement Daily Quality Control
All clinical laboratory testing benefits from quality control. QC is designed to assure “all systems are GO” before testing and reporting out patient results. QC is used to fine-tune your laboratory data and catch potential problems before they affect patient results. If choosing monthly monitoring, (see below) your consultant will review all QC produced for the month, check for problems, shifts or trends, and recommend a course of action to correct and prevent future problems.
15. 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. Laboratory Consulting, LLC 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.
16. Consult on Inspections by Regulatory Agencies
Laboratory Consulting, LLC has a terrific reputation among regulatory and accrediting agencies. The presence of our consultant during an inspection will have a positive effect, reassuring your staff and indicating a "hands on” approach to the inspector.
17. 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. Laboratory Consulting, LLC will guide you in preparing a plan of correction and help you achieve compliance within the agency's timeframe for correction.