ADDING A LAB TO A CLINIC
By: Robert Reza, Hari Mitra, Kristin Do, Melvin Young
PROJECT CHARTER Identification
o Name – Addition of a laboratory to a practiceo Group – Dr. Nick Rivera, Dr. Julius Hibbert
PROJECT BACKGROUND Adding a lab to a clinic in a rural setting
a lot of the patients at our clinic have the need to get laboratory testing
recently implemented an EHR system and the diagnostic clinic does not have a system that is compatible
PURPOSE / BUSINESS NEED Rapid results needed due to
overwhelming volume of tasks Lack of interoperability causing issues
Wasted time spent scanningWasted time manually inputting data which
could be automated Further source of human error
PROJECT SCOPE:OBJECTIVES Location of appropriate site for
laboratory Hiring a contractor to do work in
conversion Contacting laboratory testing supply
vendors Obtain pricing quotes on
Equipment Supplies
Hire qualified staff for laboratory Train staff in clinic procedures Operational laboratory testing
PROJECT DELIVERABLES Establish and Implement Project Management
Team (Week 1) Validate Total Project Cost Estimate (Week 2) Finalize Initial Finance Plan and Request for
Proposal for Project (Week 3) Finalize ownership agreements (Week 5) Validate Project Schedule (Week 9)
PROJECT DELIVERABLES (CONT.) Develop Specific Design Plan for Construction
Process (Week 12) Procure Section Design Consultants (Week 15) Develop/Adjust Oversight Agreements
(Week 18) Establishment of an overall agreement
between the contractors and the clinic (Week 22)
construction equipment lease / supplies Construct agreements with other
clinics/practices (Week 25)
PROJECT DELIVERABLES (CONT.) Construction begins (Week 28) Hiring process beings (Week 34) Construction is done (Week 40) Installation of equipment (Week 42) Certification / Accreditation complete
(Week 46) Laboratory testing commences (Week
52)
ASSUMPTIONS/LIMITATIONS Leasing an office building next to the
clinic to create a laboratory The lab will work interoperability with
the clinic Renting the laboratory equipment Referring provider responsible for
transportation of specimens
RISK ASSESSMENT Unrealistic expectations can cause a
loss of staff morale Availability of qualified staff in a rural
area may be low Changing demands of lab tests
New sectors of testing like genomics may have to be accounted for
Reliability of local suppliers in a rural area Greater cost to get materials.
Budgetary issues Realistic expectations for initial year
METRICS 75,000 to 125,000 tests performed
annually Efficiency
Positive cash flow within 2 yearsAverage time for test results
Less than 2% error
BUDGET (INITIAL) Building remodeling – $100,000 Equipment Installation – $300,000 Supplies - $75,000
Total = $475,000
BUDGET (ANNUAL) Building rental – $25,000 Staff – $550,000 (techs / administration) Equipment / supplies – $225,000
(leasing & restocking) Testing costs / transportation of samples
/ blood collection – $575,000 for testing Licensing Fees – $7,000 EQAS Fees – $2,000 Software / Support – $150,000
Total cost = $1,509,025
QUALITY ASSESSMENT (EXTERNAL) Analytical performance of the lab to be
assessed periodically and retrospectively by an independent agency3rd party objective evidence to referring
clinics / providers / etc. Assures accuracy and allows for comparison
to national benchmarks and standards. Goal for employees to minimize errors
Identification of training needs and corrective procedures.
SOPS for integrity of reagents and proper disposal of.
QUALITY ASSESSMENT (INTERNAL) Audits will be done as a tool to maintain
quality using ISO 15189 as is required Lab techs will ensure quality indicators for
each type of test will match benchmarks. A combination of internal and external
methods will help ensure referring clinics and providers have the utmost confidence in our lab analyses.
SUMMARY Need for rapid results and
interoperability Remodeling a existing space and
converting to a lab Project plan 6 months Construction schedule 6 months Total cost for 1st year = $1,984,025