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